CN1817359A - Chinese medicinal preparation for treating gynecopathy and production thereof - Google Patents

Abstract

A Chinese medicine for treating gynopathy, such as pelvic inflammation, endometritis and cervicitis, is prepared from Chinese angelica root, pilose asiabell root, green chiretta, etc. Its preparing process is also disclosed.

Description

Chinese medicine preparation of treatment gynaecopathia and preparation method thereof

Technical field: the present invention is a kind of Chinese medicine preparation for the treatment of gynaecopathia and preparation method thereof, belongs to technical field of Chinese medicine.

Technical background: gynaecopathia such as pelvic inflammatory disease, endometritis, cervicitis etc. all are to threaten the able-bodied common disease of women in the world today, brought great misery for numerous women, traditional Therapeutic Method mostly is antibiotic or physical therapy, the life-time service antibiotic, can make the patient that drug resistance takes place and easily cause double infection, physical therapy then makes most of patients not adhere to and therapy discontinued for a long time.Prevent and treat purpose in order to reach, a large amount of research has been done by many inventors and medicine enterprise, and the product of some treatments also is provided; As: number of patent application is: 99115683, name is called " a kind of manufacture method of FUKE QIANJIN JIAONANG ", number of patent application is: 99115682, name is called " a kind of processing technology of FUKE QIANJIN JIAONANG " and number of patent application is: 98112696, name is called " a kind of process for preparing medicine for the treatment of gynaecopathia " these three kinds of products and is treatment this type of disease and developing, but, tablet, the extraction process of capsule is reasonable inadequately, perfect, these technologies are carried based on water, paste-forming rate is bigger, because medical materials such as Radix Angelicae Sinensis contain a large amount of polysaccharide compositions, the extractum hygroscopicity that makes is very strong, make tablet, the capsule hygroscopicity is stronger, storage benefit for a long time is rotten, unstable product quality.And the dosage form kind is abundant inadequately, is suitable for crowd's narrow range, and bioavailability, the medicine stability of conventional dosage forms are undesirable, and the problem that especially bioavailability of its water-insoluble effective ingredient andrographolide is not high is badly in need of solving; In view of such circumstances, improve the thing that technology or improvement dosage form have just become people to be badly in need of solving.

Summary of the invention: the objective of the invention is to: a kind of Chinese medicine preparation for the treatment of gynaecopathia and preparation method thereof is provided; The present invention is directed to prior art, two kinds of more reasonable, feasible pre-treating technologies are provided; The extractum effective ingredient that assurance obtains can more effectively be used to prepare relevant preparation; Micropill provided by the invention, dispersible tablet, disintegrative are good, and the bioavailability height is particularly suitable for infant, old people and swallow tablet or the inconvenient patient of capsule take; Soft capsule preparation provided by the invention forms drug blockage in soft gel coat, solved medicine and met damp and hot problem of unstable, can also cover adverse drug taste, abnormal smells from the patient, can play the effect that increases stability, improves bioavailability; Granule good mouthfeel provided by the invention does not need disintegrate, absorbs soon taking convenience.

The present invention constitutes like this: calculate according to components by weight percent, it is with 7～11 parts of Radix Angelicae Sinensis, 7～11 parts of Radix Codonopsis, 7～11 parts of Herba Andrographis, 7～11 parts of Fructus Zanthoxyli Dissiti, 14～18 parts of Radix Rosae Laevigataes, 14～18 parts of Caulis Spatholobis, all acceptable dosage forms on 14～18 parts of Caulis Mahoniaes and 14～18 parts of pharmaceuticss that are made of Radix Flemingiae Philippinensis comprise: injection, the powder pin, freeze-dried powder, tablet, dispersible tablet, capsule, soft capsule, microcapsule, granule, pill, micropill, powder, drop pill, slow releasing preparation, controlled release preparation, gel, oral liquid, soft extract, extractum and membrane.

Described preparation is dispersible tablet, soft capsule, granule, micropill, gel, oral liquid, drop pill, sustained-release preparation, tablet, effervescent tablet or capsule.

The preparation method of the Chinese medicine preparation of described treatment gynaecopathia: get Herba Andrographis, add 85% alcohol reflux 2 times, the 1st 6 times of amounts after soaked overnight or direct the pulverizing, the 2nd 5 times of amounts, each 3 hours, merge extractive liquid,, filter, reclaim ethanol and be condensed into extractum; Get Radix Angelicae Sinensis, add 70% alcohol dipping 96 hours after the pulverizing, percolation extracts, and collects percolate, reclaims ethanol and is condensed into extractum; Get Fructus Zanthoxyli Dissiti, Caulis Mahoniae, add 8 times of water gagings and decoct 2 times, the 1st time 3 hours, the 2nd time 2.5 hours, collecting decoction filtered, and filtrate is condensed into extractum; Get Radix Flemingiae Philippinensis, Radix Codonopsis, Radix Rosae Laevigatae, Caulis Spatholobi, add 10 times of water gagings for the 1st time and decocted 2 hours, the 2nd filtering residue with Herba Andrographis, Radix Angelicae Sinensis adds 8 times of water gagings and decocted 2 hours, filters, and is condensed into extractum, and merging extractum is made different preparations then respectively.

Granule in the described preparation prepares like this: Herba Andrographis is ground into coarse powder, extracts secondary with 85% alcohol heating reflux, for the first time 6 times of amount ethanol, measure ethanol, each 3 hours, merge extractive liquid, for 5 times for the second time, filter, filtrate recycling ethanol, and be 1.10 clear paste when being concentrated into 80 ℃ of relative densities; Radix Angelicae Sinensis powder is broken into coarse powder, makes solvent with 70% ethanol, floods after 96 hours slowly percolation, collects percolate 2400ml, is 1.10 clear paste when reclaiming ethanol and being concentrated into 80 ℃ of relative densities; Fructus Zanthoxyli Dissiti, Caulis Mahoniae two flavors decoct with water secondary, and 3 hours for the first time, 2.5 hours for the second time, collecting decoction filtered, and filtrate is 1.10 clear paste when being concentrated into 80 ℃ of relative densities; All the other Radix Flemingiae Philippinensiss etc. four flavor decocts with water secondary, and each 2 hours, the medicinal residues that add above-mentioned Herba Andrographis and Radix Angelicae Sinensis when decocting for the second time decocted together, and collecting decoction filters, and filtrate is 1.10 clear paste when being concentrated into 80 ℃ of relative densities; Merge above-mentioned four kinds of clear paste, mixing, it is an amount of to add aspartame 20g and dextrin, and mixing is got about 2/3 medicinal liquid drying, makes extract powder, gets the residue medicinal liquid again and does binding agent, granulates, and makes 1000g, promptly.

Specifically: the granule in the described preparation prepares like this: Herba Andrographis is ground into coarse powder, extract secondary with 85% alcohol heating reflux, measure ethanol for 6 times for the first time, measure ethanol for 5 times for the second time, each 3 hours, merge extractive liquid, filtered, filtrate recycling ethanol, and be 1.10 clear paste when being concentrated into 80 ℃ of relative densities; Radix Angelicae Sinensis powder is broken into coarse powder, makes solvent with 70% ethanol, floods after 96 hours slowly percolation, collects percolate 2400ml, is 1.10 clear paste when reclaiming ethanol and being concentrated into 80 ℃ of relative densities; Fructus Zanthoxyli Dissiti, Caulis Mahoniae two flavors decoct with water secondary, and 3 hours for the first time, 2.5 hours for the second time, collecting decoction filtered, and filtrate is 1.10 clear paste when being concentrated into 80 ℃ of relative densities; All the other Radix Flemingiae Philippinensiss etc. four flavor decocts with water secondary, and each 2 hours, the medicinal residues that add above-mentioned Herba Andrographis and Radix Angelicae Sinensis when decocting for the second time decocted together, and collecting decoction filters, and filtrate is 1.10 clear paste when being concentrated into 80 ℃ of relative densities; Merge above-mentioned four kinds of clear paste, mixing, it is an amount of to add aspartame 20g and dextrin, and mixing is got about 2/3 medicine liquid spray drying, makes extract powder, gets the residue medicinal liquid again and does binding agent, boiling granulating in fluid bed, feed liquor speed 50～55ml/min; Atomisation pressure 0.15Mpa; 55～60 ℃ of temperature of charge; 80～100 ℃ of inlet temperature; 60～65 ℃ of leaving air temps, when granulation, packing, storage, envionmental humidity should be controlled at below 67%, promptly.

Dispersible tablet in the described preparation prepares like this: Herba Andrographis is ground into coarse powder, spend the night with 85% soak with ethanol, heating and refluxing extraction secondary then, 6 times of amount ethanol are measured ethanol, each three hours for 5 times for the second time for the first time, merge extractive liquid,, filter, filtrate recycling ethanol, and be 1.10 clear paste when being concentrated into 80 ℃ of relative densities; Radix Angelicae Sinensis powder is broken into coarse powder, makes solvent with 70% ethanol, floods after 96 hours slowly percolation, collects percolate 1200ml, is 1.10 clear paste when reclaiming ethanol and being concentrated into 80 ℃ of relative densities; Fructus Zanthoxyli Dissiti, Caulis Mahoniae two flavors decoct with water secondary, add 6 times of decoctings for the first time and boil 3 hours, add 6 times of decoctings for the second time and boil 2.5 hours, and collecting decoction filters, and filtrate is 1.10 clear paste when being concentrated into 80 ℃ of relative densities; All the other Radix Flemingiae Philippinensiss etc. four flavor decocts with water secondary, adds 6 times of decoctings to boil 2 hours at every turn, and the medicinal residues that add above-mentioned Herba Andrographis and Radix Angelicae Sinensis when decocting for the second time decoct together, and collecting decoction filters, and filtrate is 1.10 clear paste when being concentrated into 80 ℃ of relative densities; Merge above-mentioned four kinds of clear paste, it when continuing to be concentrated into 80 ℃ of relative densities 1.20 clear paste, merge extractum, dry, pulverize, extract powder, be disintegrating agent, be aided with micropowder silica gel, polyvinylpyrrolidone (PVP-K with in crospolyvinylpyrrolidone (PVPP) or crosslinked carboxymethyl fecula sodium (CCMS-Na) or the cross-linking sodium carboxymethyl cellulose (CCMC-Na) one or more ₃₀), in the mannitol, carboxymethyl starch sodium (CMC-Na), microcrystalline Cellulose, sodium bicarbonate, lactose two or more, add an amount of pigment again, as the pharmaceutical adjunct of dispersible tablet, according to extract powder: the ratio of pharmaceutical adjunct=1: 0.6-2, the mixing that sieves, tabletting, promptly.Specifically: the dispersible tablet in the described preparation prepares like this: Herba Andrographis is ground into coarse powder, spend the night with 85% soak with ethanol, heating and refluxing extraction secondary then, 6 times of amount ethanol are measured ethanol, each three hours for 5 times for the second time for the first time, merge extractive liquid,, filter, filtrate recycling ethanol, and be 1.10 clear paste when being concentrated into 80 ℃ of relative densities; Radix Angelicae Sinensis powder is broken into coarse powder, makes solvent with 70% ethanol, floods after 96 hours slowly percolation, collects percolate 1200ml, is 1.10 clear paste when reclaiming ethanol and being concentrated into 80 ℃ of relative densities; Fructus Zanthoxyli Dissiti, Caulis Mahoniae two flavors decoct with water secondary, add 6 times of decoctings for the first time and boil 3 hours, add 6 times of decoctings for the second time and boil 2.5 hours, and collecting decoction filters, and filtrate is 1.10 clear paste when being concentrated into 80 ℃ of relative densities; All the other Radix Flemingiae Philippinensiss etc. four flavor decocts with water secondary, adds 6 times of decoctings to boil 2 hours at every turn, and the medicinal residues that add above-mentioned Herba Andrographis and Radix Angelicae Sinensis when decocting for the second time decoct together, and collecting decoction filters, and filtrate is 1.10 clear paste when being concentrated into 80 ℃ of relative densities; Merging above-mentioned four kinds of clear paste, is 1.20 clear paste when continuing to be concentrated into 80 ℃ of relative densities; Merge extractum, drying is pulverized, and gets extract powder; Get CMC-Na: PVPP: mannitol: micropowder silica gel=1: 3-4: 1-3: 3-4 adds an amount of pigment mixing as pharmaceutical adjunct, gets 4/5 pharmaceutical adjunct and is equivalent to the extract powder mix homogeneously that CMC-Na10 doubly measures, the PVP-K with 1.5% approximately ₃₀Anhydrous alcohol solution is made binding agent, and 40 order system material, granulate remain 1/5 pharmaceutical adjunct and an amount of caramel color mixing, be added on outward in the particle that makes, and tabletting, promptly.Pellet in the described preparation prepares like this: Herba Andrographis is ground into coarse powder, extracts secondary with 85% alcohol heating reflux, for the first time 6 times of amount ethanol, 5 times of amounts for the second time, each three hours, merge extractive liquid,, filter, filtrate recycling ethanol, and be 1.10 clear paste when being concentrated into 80 ℃ of relative densities; Radix Angelicae Sinensis powder is broken into coarse powder, makes solvent with 70% ethanol, floods after 96 hours slowly percolation, collects percolate 4800ml, is 1.10 clear paste when reclaiming ethanol and being concentrated into 80 ℃ of relative densities; Fructus Zanthoxyli Dissiti, Caulis Mahoniae two flavors decoct with water secondary, and 3 hours for the first time, 2.5 hours for the second time, collecting decoction filtered, and filtrate is 1.10 clear paste when being concentrated into 80 ℃ of relative densities; All the other Radix Flemingiae Philippinensiss etc. four flavor decocts with water secondary, and each 2 hours, the medicinal residues that add above-mentioned Herba Andrographis and Radix Angelicae Sinensis when decocting for the second time decocted together, and collecting decoction filters, and filtrate is 1.10 clear paste when being concentrated into 80 ℃ of relative densities; Merge above-mentioned four kinds of clear paste, mixing at 60～70 ℃ of vacuum dryings, is pulverized, and adds an amount of starch, with 75% ethanol and soybean oil system soft material, and extruding-round as a ball pill or the general ball of making of employing coating pan, drying, promptly.

Specifically: the pellet in the described preparation prepares like this: Herba Andrographis is ground into coarse powder, extract secondary with 85% alcohol heating reflux, measure ethanol for 6 times for the first time, 5 times of amounts for the second time, each three hours, merge extractive liquid, filtered, filtrate recycling ethanol, and be 1.10 clear paste when being concentrated into 80 ℃ of relative densities; Radix Angelicae Sinensis powder is broken into coarse powder, makes solvent with 70% ethanol, floods after 96 hours slowly percolation, collects percolate 4800ml, is 1.10 clear paste when reclaiming ethanol and being concentrated into 80 ℃ of relative densities; Fructus Zanthoxyli Dissiti, Caulis Mahoniae two flavors decoct with water secondary, and 3 hours for the first time, 2.5 hours for the second time, collecting decoction filtered, and filtrate is 1.10 clear paste when being concentrated into 80 ℃ of relative densities; All the other Radix Flemingiae Philippinensiss etc. four flavor decocts with water secondary, and each 2 hours, the medicinal residues that add above-mentioned Herba Andrographis and Radix Angelicae Sinensis when decocting for the second time decocted together, and collecting decoction filters, and filtrate is 1.10 clear paste when being concentrated into 80 ℃ of relative densities; Merge above-mentioned four kinds of clear paste, mixing, at 60～70 ℃ of vacuum dryings, pulverize, add an amount of starch, with 75% ethanol and 1.5% soybean oil system soft material, the soft material that makes micropill mechanism ball, wet feed pushed the 0.8mm sieve aperture, and the wet grain of strip cuts off round as a ball, 50～60 ℃ of drying and mouldings, crossing 16～20 mesh sieves selects ball or merges above-mentioned four kinds of clear paste, spray drying, wet-milling granulation molding places mould to add the great achievement ball in the coating pan, medicated powder: water is 1: 1, the coating pan rotating speed is 40r/min, and capping selects ball; When granulation, packing, storage, envionmental humidity should be controlled at below 54%, promptly.

Soft capsule in the described preparation prepares like this: Herba Andrographis is ground into coarse powder, spend the night with 85% soak with ethanol, heating and refluxing extraction secondary then, 6 times of amount ethanol are measured ethanol, each three hours for 5 times for the second time for the first time, merge extractive liquid,, filter, filtrate recycling ethanol, and be 1.10 clear paste when being concentrated into 80 ℃ of relative densities; Radix Angelicae Sinensis powder is broken into coarse powder, makes solvent with 70% ethanol, floods after 96 hours slowly percolation, collects percolate 1200ml, is 1.10 clear paste when reclaiming ethanol and being concentrated into 80 ℃ of relative densities; Fructus Zanthoxyli Dissiti, Caulis Mahoniae two flavors decoct with water secondary, add 6 times of decoctings for the first time and boil 3 hours, add 6 times of decoctings for the second time and boil 2.5 hours, and collecting decoction filters, and filtrate is 1.10 clear paste when being concentrated into 80 ℃ of relative densities; All the other Radix Flemingiae Philippinensiss etc. four flavor decocts with water secondary, adds 6 times of decoctings to boil 2 hours at every turn, and the medicinal residues that add above-mentioned Herba Andrographis and Radix Angelicae Sinensis when decocting for the second time decoct together, and collecting decoction filters, and filtrate is concentrated into that relative density surveys in the time of 80 ℃ be 1.10 clear paste; Merging above-mentioned four kinds of clear paste, is 1.20 clear paste when continuing to be concentrated into 80 ℃ of relative densities, and drying is pulverized, and crosses 80 mesh sieves, and it is an amount of to add soybean oil, and mixing is pressed into 1000 of soft capsules, promptly.

Specifically: the soft capsule in the described preparation prepares like this: Herba Andrographis is ground into coarse powder, spend the night with 85% soak with ethanol, heating and refluxing extraction secondary then, 6 times of amount ethanol are measured ethanol, each three hours for 5 times for the second time for the first time, merge extractive liquid,, filter, filtrate recycling ethanol, and be 1.10 clear paste when being concentrated into 80 ℃ of relative densities; Radix Angelicae Sinensis powder is broken into coarse powder, makes solvent with 70% ethanol, floods after 96 hours slowly percolation, collects percolate 1200ml, is 1.10 clear paste when reclaiming ethanol and being concentrated into 80 ℃ of relative densities; Fructus Zanthoxyli Dissiti, Caulis Mahoniae two flavors decoct with water secondary, add 6 times of decoctings for the first time and boil 3 hours, add 6 times of decoctings for the second time and boil 2.5 hours, and collecting decoction filters, and filtrate is 1.10 clear paste when being concentrated into 80 ℃ of relative densities; All the other Radix Flemingiae Philippinensiss etc. four flavor decocts with water secondary, adds 6 times of decoctings to boil 2 hours at every turn, and the medicinal residues that add above-mentioned Herba Andrographis and Radix Angelicae Sinensis when decocting for the second time decoct together, and collecting decoction filters, and filtrate is 1.10 clear paste when being concentrated into 80 ℃ of relative densities; Merging above-mentioned four kinds of clear paste, is 1.20 clear paste when continuing to be concentrated into 80 ℃ of relative densities, and drying is pulverized, and crosses 80 mesh sieves, and by medication amount: substrate amount=1: 1.5 adds soybean oil, mixing; The prescription of rubber is a gelatin: glycerol: water: titanium dioxide=100g: 45g: 100g: 1g, batchingization adhesive tape part is: weigh batching, in the inputization glue jar, merceration is warming up to 65 ± 5 ℃ gradually after 30 minutes, stirred 5 hours and simultaneously evacuation remove bubble, treat evenly back blowing of sizing material, incapsulate after the filtration in the sizing material bucket of machine; The debugging pellet press, 65 ℃ of gelatin box temperature controls, mould rotating speed 2.0 is rolled in 45 ℃ of sprinkler body temperature controls, rubber thickness 0.8mm, 18～25 ℃ of indoor temperatures, relative humidity＜40%, pelleting; The dry typing drying of rolling that adopts combined with two steps of tray dried, dry 2 hours of the typing of rolling, and 22 ℃ of baking temperatures, dry relative humidity should be lower than 40%, and drying time is at 24～48 hours, promptly.

Drop pill in the described preparation prepares like this: Herba Andrographis is ground into coarse powder, spend the night with 85% soak with ethanol, heating and refluxing extraction secondary then, 6 times of amount ethanol are measured ethanol, each three hours for 5 times for the second time for the first time, merge extractive liquid,, filter, filtrate recycling ethanol, and be 1.10 clear paste when being concentrated into 80 ℃ of relative densities; Radix Angelicae Sinensis powder is broken into coarse powder, makes solvent with 70% ethanol, floods after 96 hours slowly percolation, collects percolate 1200ml, is 1.10 clear paste when reclaiming ethanol and being concentrated into 80 ℃ of relative densities; Fructus Zanthoxyli Dissiti, Caulis Mahoniae two flavors decoct with water secondary, add 6 times of decoctings for the first time and boil 3 hours, add 6 times of decoctings for the second time and boil 2.5 hours, and collecting decoction filters, and filtrate is 1.10 clear paste when being concentrated into 80 ℃ of relative densities; All the other Radix Flemingiae Philippinensiss etc. four flavor decocts with water secondary, adds 6 times of decoctings to boil 2 hours at every turn, and the medicinal residues that add above-mentioned Herba Andrographis and Radix Angelicae Sinensis when decocting for the second time decoct together, and collecting decoction filters, and filtrate is 1.10 clear paste when being concentrated into 80 ℃ of relative densities; Merge above-mentioned four kinds of clear paste, mixing, qinghuo reagent and 1.5-2.5 water-soluble base mix homogeneously doubly, fusion in the water-bath stirs evenly, and drips to become ball in dimethicone or other fat-soluble coolants, promptly.

Specifically: the drop pill in the described preparation prepares like this: Herba Andrographis is ground into coarse powder, spend the night with 85% soak with ethanol, heating and refluxing extraction secondary then, 6 times of amount ethanol are measured ethanol, each three hours for 5 times for the second time for the first time, merge extractive liquid,, filter, filtrate recycling ethanol, and be 1.10 clear paste when being concentrated into 80 ℃ of relative densities; Radix Angelicae Sinensis powder is broken into coarse powder, makes solvent with 70% ethanol, floods after 96 hours slowly percolation, collects percolate 1200ml, is 1.10 clear paste when reclaiming ethanol and being concentrated into 80 ℃ of relative densities; Fructus Zanthoxyli Dissiti, Caulis Mahoniae two flavors decoct with water secondary, add 6 times of decoctings for the first time and boil 3 hours, add 6 times of decoctings for the second time and boil 2.5 hours, and collecting decoction filters, and filtrate is 1.10 clear paste when being concentrated into 80 ℃ of relative densities; All the other Radix Flemingiae Philippinensiss etc. four flavor decocts with water secondary, adds 6 times of decoctings to boil 2 hours at every turn, and the medicinal residues that add above-mentioned Herba Andrographis and Radix Angelicae Sinensis when decocting for the second time decoct together, and collecting decoction filters, and filtrate is 1.10 clear paste when being concentrated into 80 ℃ of relative densities; Merge above-mentioned four kinds of clear paste, mixing, qinghuo reagent portion, a and polyoxyethylene monostearate S-40 portion of PEG4000, mix homogeneously, fuse in the water-bath, stir evenly, drip and in dimethicone, to become ball, drip apart from 5cm drip footpath 2.5mm/2mm, mix 80 ℃ of ointment temperature, liquid coolant height 80cm, promptly.

The preparation method of the Chinese medicine preparation of described treatment gynaecopathia can also be: Herba Andrographis, Radix Angelicae Sinensis, Caulis Mahoniae, Caulis Spatholobi and Fructus Zanthoxyli Dissiti are ground into coarse powder, use ethanol extraction, filter, and filtrate recycling ethanol concentrates; Radix Rosae Laevigatae, Radix Flemingiae Philippinensis and Radix Codonopsis decoct with water, and collecting decoction filters, and filtrate concentrates; Merge above-mentioned two kinds of clear paste, mixing adds adjuvant and makes different dosage form.

Say accurately: Herba Andrographis, Radix Angelicae Sinensis, Caulis Mahoniae, Caulis Spatholobi and Fructus Zanthoxyli Dissiti were ground into coarse powder, with 8 times of amount 70% alcohol reflux secondaries, each 2 hours, merge extractive liquid,, filter, filtrate recycling ethanol, and relative density is 1.05～1.15 clear paste when being concentrated into 80 ℃; Radix Rosae Laevigatae, Radix Flemingiae Philippinensis and Radix Codonopsis decoct with water secondary, add 6 times of water gagings decocted 2 hours at every turn, the medicinal residues that add when decocting for the second time after Herba Andrographis, Radix Angelicae Sinensis, Caulis Mahoniae, Caulis Spatholobi and Fructus Zanthoxyli Dissiti extract decoct together, collecting decoction, filter, relative density was 1.055～1.15 clear paste when filtrate was concentrated into 80 ℃; Merge above-mentioned two kinds of clear paste, evenly, add adjuvant and make different dosage form.

Tablet in the described preparation prepares like this: Herba Andrographis, Radix Angelicae Sinensis, Caulis Mahoniae, Caulis Spatholobi and Fructus Zanthoxyli Dissiti are ground into coarse powder, with 8 times of amount 70% alcohol reflux secondaries, each 2 hours, merge extractive liquid,, filter, filtrate recycling ethanol, and relative density is 1.05～1.15 clear paste when being concentrated into 80 ℃; Radix Rosae Laevigatae, Radix Flemingiae Philippinensis and Radix Codonopsis decoct with water secondary, add 6 times of water gagings decocted 2 hours at every turn, the medicinal residues that add when decocting for the second time after Herba Andrographis, Radix Angelicae Sinensis, Caulis Mahoniae, Caulis Spatholobi and Fructus Zanthoxyli Dissiti extract decoct together, collecting decoction, filter, relative density was 1.055～1.15 clear paste when filtrate was concentrated into 80 ℃; Merge above-mentioned two kinds of clear paste, evenly, drying under reduced pressure gets dry extract; Dried cream powder is broken into fine powder, adds microcrystalline Cellulose 25g, uses 85% alcohol granulation, drying, and granulate adds magnesium stearate 1g, mixing, tabletting, coating is made 1000, promptly.

Capsule in the described preparation prepares like this: Herba Andrographis, Radix Angelicae Sinensis, Caulis Mahoniae, Caulis Spatholobi and Fructus Zanthoxyli Dissiti are ground into coarse powder, with 8 times of amount 70% alcohol reflux secondaries, each 2 hours, merge extractive liquid,, filter, filtrate recycling ethanol, and relative density is 1.05～1.15 clear paste when being concentrated into 80 ℃; Radix Rosae Laevigatae, Radix Flemingiae Philippinensis and Radix Codonopsis decoct with water secondary, add 6 times of water gagings decocted 2 hours at every turn, the medicinal residues that add when decocting for the second time after Herba Andrographis, Radix Angelicae Sinensis, Caulis Mahoniae, Caulis Spatholobi and Fructus Zanthoxyli Dissiti extract decoct together, collecting decoction, filter, relative density was 1.055～1.15 clear paste when filtrate was concentrated into 80 ℃; Merge above-mentioned two kinds of clear paste, evenly, drying under reduced pressure, dry extract is broken into fine powder, adds starch and adjusts total amount, and mix homogeneously is granulated, 50～60 ℃ of dryings, the granulate that sieves incapsulates, and makes 1000, promptly.

Granule in the described preparation prepares like this: Herba Andrographis, Radix Angelicae Sinensis, Caulis Mahoniae, Caulis Spatholobi and Fructus Zanthoxyli Dissiti are ground into coarse powder, with 8 times of amount 70% alcohol reflux secondaries, each 2 hours, merge extractive liquid,, filter, filtrate recycling ethanol, and relative density is 1.05～1.15 clear paste when being concentrated into 80 ℃; Radix Rosae Laevigatae, Radix Flemingiae Philippinensis and Radix Codonopsis decoct with water secondary, add 6 times of water gagings decocted 2 hours at every turn, the medicinal residues that add when decocting for the second time after Herba Andrographis, Radix Angelicae Sinensis, Caulis Mahoniae, Caulis Spatholobi and Fructus Zanthoxyli Dissiti extract decoct together, collecting decoction, filter, relative density was 1.055～1.15 clear paste when filtrate was concentrated into 80 ℃; Merge above-mentioned two kinds of clear paste, evenly, merge above-mentioned four kinds of clear paste, mixing, it is an amount of to add aspartame 15g and dextrin, and mixing is got about 3/4 medicine liquid spray drying, makes extract powder, get the residue medicinal liquid again and do binding agent, boiling granulating in fluid bed is made 1000g, promptly.

Pellet in the described preparation prepares like this: Herba Andrographis, Radix Angelicae Sinensis, Caulis Mahoniae, Caulis Spatholobi and Fructus Zanthoxyli Dissiti are ground into coarse powder, with 8 times of amount 70% alcohol reflux secondaries, each 2 hours, merge extractive liquid,, filter, filtrate recycling ethanol, and relative density is 1.05～1.15 clear paste when being concentrated into 80 ℃; Radix Rosae Laevigatae, Radix Flemingiae Philippinensis and Radix Codonopsis decoct with water secondary, add 6 times of water gagings decocted 2 hours at every turn, the medicinal residues that add when decocting for the second time after Herba Andrographis, Radix Angelicae Sinensis, Caulis Mahoniae, Caulis Spatholobi and Fructus Zanthoxyli Dissiti extract decoct together, collecting decoction, filter, relative density was 1.055～1.15 clear paste when filtrate was concentrated into 80 ℃; Merge clear paste, mixing at 60～70 ℃ of vacuum dryings, is pulverized, and adds an amount of starch, with 80% ethanol and soybean oil system soft material, and extruding-round as a ball pill or the general ball of making of employing coating pan, drying, promptly.

Drop pill in the described preparation prepares like this: Herba Andrographis, Radix Angelicae Sinensis, Caulis Mahoniae, Caulis Spatholobi and Fructus Zanthoxyli Dissiti are ground into coarse powder, with 8 times of amount 70% alcohol reflux secondaries, each 2 hours, merge extractive liquid,, filter, filtrate recycling ethanol, and relative density is 1.05～1.15 clear paste when being concentrated into 80 ℃; Radix Rosae Laevigatae, Radix Flemingiae Philippinensis and Radix Codonopsis decoct with water secondary, add 6 times of water gagings decocted 2 hours at every turn, the medicinal residues that add when decocting for the second time after Herba Andrographis, Radix Angelicae Sinensis, Caulis Mahoniae, Caulis Spatholobi and Fructus Zanthoxyli Dissiti extract decoct together, collecting decoction, filter, relative density was 1.055～1.15 clear paste when filtrate was concentrated into 80 ℃; Merge above-mentioned two kinds of clear paste, evenly, the qinghuo reagent portion, two parts of PEG4000 and polyoxyethylene monostearate S-40 portion, mix homogeneously fuses in the water-bath, stirs evenly, and drips to become ball in dimethicone, promptly.

Dispersible tablet in the described preparation prepares like this: Herba Andrographis, Radix Angelicae Sinensis, Caulis Mahoniae, Caulis Spatholobi and Fructus Zanthoxyli Dissiti are ground into coarse powder, with 8 times of amount 70% alcohol reflux secondaries, each 2 hours, merge extractive liquid,, filter, filtrate recycling ethanol, and relative density is 1.05～1.15 clear paste when being concentrated into 80 ℃; Radix Rosae Laevigatae, Radix Flemingiae Philippinensis and Radix Codonopsis decoct with water secondary, add 6 times of water gagings decocted 2 hours at every turn, the medicinal residues that add when decocting for the second time after Herba Andrographis, Radix Angelicae Sinensis, Caulis Mahoniae, Caulis Spatholobi and Fructus Zanthoxyli Dissiti extract decoct together, collecting decoction, filter, relative density was 1.055～1.15 clear paste when filtrate was concentrated into 80 ℃; Merge above-mentioned two kinds of clear paste, dry, pulverize, get extract powder, select crospolyvinylpyrrolidone (PVPP) or crosslinked carboxymethyl fecula sodium (CCMS-Na) or cross-linking sodium carboxymethyl cellulose (CCMC-Na), micropowder silica gel, polyvinylpyrrolidone (PVP-K ₃₀), in the mannitol, carboxymethyl starch sodium (CMC-Na), microcrystalline Cellulose, sodium bicarbonate, lactose two or more are as adjuvant, according to extract powder: the ratio of adjuvant=1: 0.8-1.5, the mixing that sieves, tabletting, promptly.

Soft capsule in the described preparation prepares like this: Herba Andrographis, Radix Angelicae Sinensis, Caulis Mahoniae, Caulis Spatholobi and Fructus Zanthoxyli Dissiti are ground into coarse powder, with 8 times of amount 70% alcohol reflux secondaries, each 2 hours, merge extractive liquid,, filter, filtrate recycling ethanol, and relative density is 1.05～1.15 clear paste when being concentrated into 80 ℃; Radix Rosae Laevigatae, Radix Flemingiae Philippinensis and Radix Codonopsis decoct with water secondary, add 6 times of water gagings decocted 2 hours at every turn, the medicinal residues that add when decocting for the second time after Herba Andrographis, Radix Angelicae Sinensis, Caulis Mahoniae, Caulis Spatholobi and Fructus Zanthoxyli Dissiti extract decoct together, collecting decoction, filter, relative density was 1.055～1.15 clear paste when filtrate was concentrated into 80 ℃; Merge clear paste, drying is pulverized, and crosses 80 mesh sieves, and the adding soybean oil is an amount of, and mixing is pressed into 1000 of soft capsules, promptly.

Among the present invention, Radix Rosae Laevigatae clearing away heat and eliminating dampness leukorrhagia stopping is a monarch drug, Radix Flemingiae Philippinensis clearing away heat-damp and promoting diuresis, detoxifcation, and the Caulis Mahoniae clearing away heat and cooling blood, the Herba Andrographis heat-clearing and toxic substances removing, Fructus Zanthoxyli Dissiti promoting blood circulation and detoxication, reducing swelling and alleviating pain, Chinese Angelica blood replonishing is invigorated blood circulation, and stomachache is monarch drug altogether towards only appointing for channels sootheing and network vessel quickening, accent; The Caulis Spatholobi promoting the circulation of blood of enriching blood, Radix Codonopsis invigorating the spleen and replenishing QI, invigorating the spleen to clear away damp pathogen are adjuvant drug altogether, all medicines are harmonious, and play the effect of damp-clearing pain-relieving, menstruction regulating and pain relieving altogether.

Compared with prior art, micropill disintegrative of the present invention is good, and the bioavailability height is particularly suitable for the old people and swallow tablet or the inconvenient patient of capsule take; Medicine tablet formulation provided by the invention, the mode of taking is more, can swallow, buccal and sucking take, it is convenient to use more than other oral solid formulations, simultaneously, these product are met water can rapid disintegrate form homodisperse aqueous solution in 3 minutes, solved the not high problem of bioavailability of water-insoluble effective ingredient andrographolide; Soft capsule of the present invention is that drug blockage is formed in soft gel coat, has solved medicine and has met damp and hot problem of unstable, can also cover adverse drug taste, abnormal smells from the patient, plays the effect that increases stability, improves bioavailability; Granule provided by the invention, good mouthfeel absorbs soon the bioavailability height simultaneously.

The applicant finds in the process of development granule, granule enters in the body with solution state, compare with oral solid formulation, reduced disintegrating procedue in the body, help the absorption of this product, shortened onset time greatly, but also there is certain problem in this product granule, is exactly that hygroscopicity is strong, mouthfeel is bitter.The inventor intends solving this two problems by adding correctives with preferred supplementary product kind.Because consider among the crowd of being suitable for and have diabetics, draw up and be equipped with sugar-free granule, with high-potency sweetener as correctives, whole supplementary product consumption is reduced significantly, simultaneously, also need under the situation that does not increase supplementary product consumption, solve in the raw material medicated powder by the kind and the technological parameter of strict screening adjuvant because the strong excessively problem of former powder hygroscopicity that the existence of compositions such as Radix Angelicae Sinensis polysaccharide causes.The applicant finds when the development dispersible tablet, pharmacopeia regulation dispersible tablet must disintegrate fully in the 3min in 19 ℃～21 ℃ water, suspension ability, bioavailability, dispersed homogeneous degree etc. are also had higher requirements, make and select to require very strict the kind and the consumption of various adjuvants in the moulding process prescription, deviation is arranged slightly, will cause product defective.The diameter of micropill is less than 2.5mm, and class is in particle properties, the bioavailability height, and the applicant is when development product of the present invention, and maximum difficulty is exactly that the extractum hygroscopicity is strong and mobile poor, and poor plasticity is difficult to molding and molten diffusing slower.Soft capsule disintegrate in gastrointestinal tract is fast, and after softgel shell broke, medicine disperseed rapidly, so the drug release stripping is fast, produce effects is rapid, the bioavailability height; Semi-transparent soft capsule can protect medicine not to be subjected to the effect of oxygen, light in dampness and the air with packaging material preferably, thereby improves the stability of labile elements such as andrographolide; So the stability of soft capsule itself and moulding process directly influence the stability of product, be very crucial technology.In the process of development drop pill, find, substrate polyethylene glycols commonly used is that esterification forms, be the surface-active water-soluble base of a kind of tool (fusing point is 46～51 ℃), dissolubility to insoluble drug is not good, we add S-40 change polyethylene glycols itself and do not have close ester structure and surface-active character, help the absorption of medicine, if but the consumption of S-40 is too high, and can cause product to draw moist enhancing.And find after deliberation, also can be with Herba Andrographis, Radix Angelicae Sinensis, Caulis Mahoniae, Caulis Spatholobi and Fructus Zanthoxyli Dissiti ethanol extraction, the sheet that makes, capsule hygroscopicity improve, and the drug effect basically identical has improved the quality of conventional dosage forms to a certain extent; Because the technology difference, so the performances such as paste-forming rate of extractum difference to some extent is to guarantee product quality, the screening of adjuvant, process conditions is just most important.The applicant has carried out a series of experiments, with the supplementary product kind of the preparation technology that selects pharmaceutical preparation provided by the invention, use and consumption, ratio etc.; Guarantee its science, reasonable, feasible; The preparation that obtains has effective therapeutic effect.

Technology advanced person of the present invention, simple; The preparation that obtains has reasonable prevention effect for gynaecopathia such as pelvic inflammatory disease, endometritis, cervicitis etc.; But and the little patients life-time service of preparation untoward reaction provided by the invention.This theoretical basis is guidance to we so that the kidney being the origin of congenital constitution, adopts Radix Codonopsis, Radix Angelicae Sinensis kidney tonifying arresting seminal emission; Compatibility Radix Rosae Laevigatae, Caulis Spatholobi heat clearing and blood circulation promoting collateral dredging.All medicines match, giving consideration to both the incidental and fundamental, and flat nourishing YIN sun is supported interpromoting relation in five elements mutually, plays the merit of the kidney invigorating and essence nourishing altogether, also can be used for treating diseases such as leukocyte sperm disease, epidemic hemorrhagic conjunctivitis, chronic prostatitis, chronic pharyngitis, man's immune infertility.

Experimental example 1: the research of extractum 1

Get Herba Andrographis, add 85% alcohol reflux 2 times after soaked overnight or direct the pulverizing, the 1st 6 times of amounts, the 2nd 5 times of amounts, each 3 hours, merge extractive liquid, filtered, and reclaimed ethanol and also was condensed into extractum; Get Radix Angelicae Sinensis, add 70% alcohol dipping 96 hours after the pulverizing, percolation extracts, and collects percolate, reclaims ethanol and is condensed into extractum; Get Fructus Zanthoxyli Dissiti, Caulis Mahoniae, add 8 times of water gagings and decoct 2 times, the 1st time 3 hours, the 2nd time 2.5 hours, collecting decoction filtered, and filtrate is condensed into extractum; Get Radix Flemingiae Philippinensis, Radix Codonopsis, Radix Rosae Laevigatae, Caulis Spatholobi, add 10 times of water gagings for the 1st time and decocted 2 hours, the 2nd filtering residue with Herba Andrographis, Radix Angelicae Sinensis adds 8 times of water gagings and decocted 2 hours, filters, and is condensed into extractum, must extractum 1.

(1) granule Study on Forming

The applicant finds that it is exactly that hygroscopicity is strong, mouthfeel is bitter that this product is made the greatest problem of granule in development process.Because consider the crowd of being suitable for, draw up and be equipped with sugar-free granule, so supplementary product consumption is just fewer, and this product contains the high medical materials of polyoses content such as Radix Angelicae Sinensis, the former powder hygroscopicity of extractum is very strong, supplementary product consumption can not be too much situation under, strictness screening and control that must be by adjuvant and process conditions just can address these problems.

(1) supplementary product kind and consumption thereof are investigated

1. correctives is selected

The function as sweeteners comparison sheet

Kind	Sucrose	Aspartame	Cyclamate
				The safety of sugariness flavor quality and price lattice consumption	1, (standard of comparison) 1, (standard of comparison) is unrestricted, (but diabetes are avoided usefulness) is good	180～300 times 80 times unrestricted good	50 times have the low consumption of metalloid flavor cost limited, generally are no more than 0.1% better

Through relatively comprehensive, selected aspartame is made the correctives of this product, and institute's expense per os sense is debugged and got.Screening experiment: get extract powder 40g, be divided into four parts, portion does not add any adjuvant, and three parts add 1%, 2%, 3% aspartame mixing respectively in addition, adds an amount of boiled water and takes after mixing it with water, and tastes its flavor through many people, judges the quality of mouthfeel, and it the results are shown in Table.

The aspartame scale

Tested number	1	2	3	4
					The addition mouthfeel	Do not add adjuvant pained (-)	Add the sweet slightly bitterness (+) that still has of 1% aspartame	Add 2% aspartame sugariness moderate (++)	Add 3% aspartame sweet excessively (+++)

The result shows, adds 2% aspartame, and mouthfeel is moderate.

2. wettability test is got two parts of extract powders, a dextrin that adds, and mixing is put respectively in the flat weighing bottle of having weighed, and accurate the title, decide, and is to measure its hygroscopic capacity under 75.0% condition at 25 ℃ of temperature, relative humidity, the results are shown in Table.

The wettability test result

Sample		Pure extract powder	Extract powder+dextrin
				The weighing bottle numbering		1	2
Weight of material (g)		1.0014	0.9986
				Moisture absorption blanking time percentage (%)	1h	1.55	1.18
2h	4.70	2.56
			3h		6.79	4.64
4h	8.34	6.23
			6h		10.20	7.71
8h	12.82	9.77
			10h		15.47	11.31
12h	18.45	13.11
			24h		21.74	16.21
36h	25.13	18.41
			48h		36.45	22.51
72h	42.76	28.72
			84h		45.84	32.57
96h	46.02	32.96

(2) granulating process

1. method of granulating is investigated

Method of granulating once adopted wet granulation, selected for use Different concentrations of alcohol and PVP to granulate, and easily bonding is softening because of extractum, and operating difficulties is so abandon this kind method.Boiling method in the fluid bed is adopted in the back, for mix homogeneously, after clear paste merged, adds an amount of correctives, and mixing is got a part of medicine liquid spray drying, makes behind the extract powder and the dextrin mixing, and get the residue medicinal liquid again and do binding agent, boiling granulating in fluid bed, promptly.

2. the granulating process condition is investigated

Spray drying clear paste and boiling granulating clear paste ratio investigate because of spray drying clear paste and boiling granulating clear paste relative density consistent, extracting solution can be concentrated into 1.10 (80 ℃), press the different proportion separated into two parts again, a part is carried out spray drying and is made behind the extract powder and the dextrin mixing, a part is as binding agent, and its ratio investigation situation sees Table.

Spray drying clear paste and boiling granulating clear paste ratio are investigated

Spray drying clear paste: boiling granulating clear paste (Kg: Kg)	The granulation situation
		2∶1 2∶3 1∶1	Easily granulate, granular size is suitable, evenly the granulation time long, the big granulation time of gained granule is long, the gained granule is big, bed easily collapses

The investigation of fluidized granulating important technological parameters is screened the fluidized granulating important technological parameters, and concrete outcome sees Table.

The fluidized granulating important technological parameters is investigated

Feed liquor speed (ml/min)	55～60	50～55	45～50	40～45
					Atomisation pressure, (Mpa) steam pressure, (Mpa) temperature of charge, (℃) inlet temperature, (℃) leaving air temp, (℃) the granulation situation	0.15 0.5 65～60 98～88 50～45 granules are inhomogeneous, easily bonding	0.15 0.5 60～55 80～100 60～65 uniform particles are easily granulated	0.15 0.5 55～50 78～68 40～35 uniform particles, but the granulation time is long	0.15 0.5 50～45 68～58 35～30 uniform particles, but the granulation time is long

The important technological parameters of fluidized granulating is as seen from table: feed liquor speed 50～55ml/min; Atomisation pressure 0.15Mpa; 55～60 ℃ of temperature of charge; 80～100 ℃ of inlet temperature; 60～65 ℃ of leaving air temps.

(3) critical relative humidity (CRH) is measured

Affected by environment during the examination packing, especially humidity effect has carried out the granule critical relative humidity and has measured.Concrete operations are as follows: get 7 parts of granules respectively, and every part of about 1g, the accurate title, decide, put in the weighing botle, open bottle cap, putting into relative humidity respectively is 22.45%, 33.00%, 42.76%, 57.70%, in 75.28%, 84.26%, 92.48% the environment, in 25 ℃ of incubators, placed 84 hours, take out weighing botle, add a cover the accurate title in back and decide, calculate its moisture absorption percentage rate.The results are shown in Table.

Particulate moisture absorption percentage rate (%) under the different relative humiditys

The saturated salt solution kind	Relative humidity (%)	Moisture absorption percentage rate (%)
			CH 3COOK.1.5H 2O MgCl 2.6H 2O K 2CO 3.2H 2O NaBr.2H 2O NaCl KCl	22.45 33.00 42.76 57.70 75.28 84.26	3.54 4.98 8.47 15.75 32.61 40.21

KNO 3

92.48

47.25

The result shows, to moisture absorption percentage rate (%) mapping, its CRH% is about 67%, wants strict control in the preparation process with relative humidity (CRH), otherwise the moisture absorption very easily.

(2) dispersible tablet Study on Forming

Dispersible tablet meet water rapidly disintegrate form the water dispersion tablet of uniform sticky suspension, it is poor to have solved former dosage form disintegrative, stripping is shortcoming slowly, and the dispersible tablet that the applicant makes is disintegrate fully in the 3min in 19 ℃～21 ℃ water, and suspension ability is good, bioavailability is high, dispersed homogeneous degree.

1. adjuvant screening

Prescription	Extract powder (g)	PPVP(g)		CMC-Na(g)		K30(％)	Disintegration time/s
								1 2 3 4 5 6	20 10 20 10 20 10	Add 2.60 2.60 1.95 1.95 1.30 1.30	In add 0.65 0.65 0.63 0.63 0.42 0.42	Add 0.84 0.84 1.30 1.30 1.95 1.95	In add 0.21 0.21 0.42 0.42 0.63 0.63	1.5 1.5 1.0 1.0 0.8 0.8	65 25 69 76 50 39

2. granulating process relatively

Check disintegration: adopting changes the basket method, and lift disintegration tester, tablet are got 6, observes the situation by screen cloth.Percent of pass height then disintegrative is good, more pleasant bulk absorption.

Group	Disintegration (s)
							Tablet FUKE QIANJIN PIAN of the present invention	1 25 1202	2 28 1500	3 30 1532	4 32 1568	5 27 1590	6 26 1600

The result shows that the dispersible tablet product of the inventive method preparation is easy to disintegrate.

(3) pellet Study on Forming

The micropill diameter is less than 2.5mm, and class is in particle properties, the bioavailability height, and the applicant is when development product micropill of the present invention, and maximum difficulty is exactly that hygroscopicity is strong and mobile poor, and poor plasticity is difficult to molding.The micropill manufacturing technology and the adjuvant that adopt the applicant's screening to obtain make product be easy to disintegrate, and the bioavailability height is well-behaved.

1, extrudes-the spheronization pill

(1) supplementary product kind and consumption are selected

Wettability test is got two parts of extract powders, a starch that adds, and mixing is put respectively in the flat weighing bottle of having weighed, and accurate the title, decide, and is to measure its hygroscopic capacity under 75.0% condition at 25 ℃ of temperature, relative humidity, the results are shown in Table.

The wettability test result

Sample		Pure extract powder	Extract powder+starch
				The weighing bottle numbering		1	2
Weight of material (g)		0.9881	0.991
				Moisture absorption blanking time percentage (%)	1h	1.65	1.08
2h	4.80	2.46
			3h		6.79	4.74
4h	8.44	6.13
			6h		10.10	7.81
8h	12.92	9.70
			10h		15.57	11.28
12h	18.39	13.07
			24h		21.89	16.13
36h	25.05	18.35
			48h		36.38	22.44
72h	42.70	28.69
			84h		45.87	38.81
96h	46.11	39.07

The result shows that it is rationally feasible to adopt starch to make adjuvant.

(2) system soft material

Get extractum fine powder and starch, soybean oil and ethanol and make soft material with wet granulation process in right amount, make it to reach and hold agglomeratingly, that pinches can loose, standby.Research emphasis concentration of alcohol and soybean oil consumption influence pill, and experimental result sees Table.

Concentration of alcohol is investigated

Tested number	Concentration of alcohol	System soft material situation
			1	80% ethanol	Soft material viscosity is not enough

2 3

75% ethanol, 70% ethanol

The moderate soft material of soft material easily bonds

The soybean oil consumption is investigated

Tested number	The soybean oil consumption	The pill situation
			1 2 3	75% ethanol, 1% soybean oil, 75% ethanol, 1.5% soybean oil, 75% ethanol, 2% soybean oil	Soft material viscosity is not enough, and is can't the pill soft material moderate, and suitable pill soft material easily bonds the pill difficulty

The result as seen, it is more satisfactory to adopt 75% ethanol, 1.5% soybean oil to be that adhesive is granulated, otherwise is difficult to molding.

(3) pill

The soft material that makes is with micropill mechanism ball, and wet feed pushed the 0.8mm sieve aperture, and the wet grain of strip cuts off round as a ball, and 50～60 ℃ of drying and mouldings are crossed 16～20 mesh sieves and selected ball.

(4) critical relative humidity (CRH) is measured

Affected by environment during the examination packing, especially humidity effect has carried out the micropill critical relative humidity and has measured.Concrete operations are as follows: get 7 parts of micropills respectively, and every part of about 1g, the accurate title, decide, put in the weighing botle, open bottle cap, putting into relative humidity respectively is 22.45%, 33.00%, 42.76%, 57.70%, in 75.28%, 84.26%, 92.48% the environment, in 25 ℃ of incubators, placed 84 hours, take out weighing botle, add a cover the accurate title in back and decide, calculate its moisture absorption percentage rate.The results are shown in Table.

Particulate moisture absorption percentage rate (%) under the different relative humiditys

The saturated salt solution kind	Relative humidity (%)	Moisture absorption percentage rate (%)
			CH 3COOK.1.5H 2O MgCl 2.6H 2O K 2CO 3.2H 2O NaBr.2H 2O NaCl KCl KNO 3	22.45 33.00 42.76 57.70 75.28 84.26 92.48	6.28 9.74 13.59 22.37 38.81 49.08 58.50

The result shows, CRH% is about 54%, and when granulation, packing, storage, envionmental humidity should be controlled at below 54%, to guarantee stability of formulation.

2, general method for making pill

Because the extruding that the humidification of water and coating pan rotate makes medicated powder be bonded into ball.Because of the medical materials such as Radix Angelicae Sinensis of this product contain polysaccharide, viscosity is bigger, and is general when making ball, and water spray is fast and to add medicated powder speed slow, causes that it is bonding closely the time that then prolongs into ball, makes dry back hard, is unfavorable for the infiltration of moisture and influences molten loosing and the absorbing of medicine.

Numbering	Coating pan rotating speed (r/min)	The molten diffusing time (min)	Mouldability
				1 2 3 4 5	30 40 50 70 100	5.12 7.10 12.35 15.41 15.58	Relatively poor better hard hard

The result shows that it is optimum that the coating pan rotating speed is selected 40r/min for use.

(4) soft capsule Study on Forming

Soft capsule disintegrate in gastrointestinal tract is fast, and after softgel shell broke, medicine disperseed rapidly, so the drug release stripping is fast, produce effects is rapid, the bioavailability height; Semi-transparent soft capsule can protect medicine not to be subjected to the effect of oxygen, light in dampness and the air with packaging material preferably, thereby improves the stability of labile elements such as andrographolide; So capsular stability and moulding process are very crucial technology.

(1) supplementary product kind and consumption are selected

1. disperse medium (or claiming substrate) is selected

At fill material and substrate energy mix homogeneously, and under the prerequisite of unobstructed defeated material of energy and pelleting, reduce substrates quantity as far as possible.By test of many times, determine medication amount (g): substrate amount (g)=be advisable at 1: 1.5, experimental result sees Table.

Substrates quantity is investigated

Medication amount (g): substrate amount (g)	1∶1	1∶1.5	1∶2
				Quality of liquid medicine	Viscosity is big, mobile poor	Viscosity, flowability are all good	Differences in viscosity is mobile big

2. capsule shells prescription screening

According to the form below proportion scale batching, put into the 500ml bottle,suction, 65 ℃ of water-baths are dissolved, automatic stirringization glue, the while evacuation, about vacuum 0.095Mpa, insulation was placed 1 hour after 5 hours, filtered glue, get a part of glue and measure viscosity and other performance, part glue evenly is paved into skim (smear below earlier one deck liquid paraffin) on iron plate, be positioned over to observe the rubber performance next day and judge again, with the investigation result of each index by good to poorly using " +++" successively, " ++ ", "+", "-" expression the results are shown in Table.

Rubber batching The selection result

Prescription	Viscosity (Mpas)	Flexibility	Elasticity	Toughness	Characteristics	Overall merit
							1.100g∶35g∶100g 2.100g∶45g∶100g 3.100g∶55g∶100g 4.100g∶45g∶80g 5.100g∶45g∶120g 6.100g∶35g∶ 5g∶100g 7.100g∶35g∶ 10g∶100g 8.100g∶45g∶ 5g∶100g 9.100g∶45g∶ 10g∶100g 10.100g∶25g∶ 10g∶100g 11.100g∶35g∶ 20g∶90g 12.100g∶55g∶ 5g∶90g 13.84g∶28g∶ 28g∶20g 14.100g∶25g∶ 35g∶100g 15.85g∶15g∶ 45g∶100g 16.85g∶15g∶ 60g∶10g∶60g 17.50g∶150g∶ 10g∶60g∶55g 18.85g∶15g∶ 45g∶10g∶110g 19.85g∶15g∶ 60g∶10g∶90g 20.100g∶25g∶ 45g∶5g∶100g	3.66 3.35 3.64 3.83 3.06 3.48 3.48 3.51 3.46 3.62 3.57 3.32 3.57 3.50 3.47 3.68 3.52 3.39 3.36	-- + + ++ +++ -- + ++ ++ + + ++ - - + + + + +	---++ ++ ++++++ +++++ ++ glue is too thick,---++-++--	+ +++++--++++-++++ can't change glue++ ++-++-	Crisp; Firmly tough; Good film-forming property good springiness good springiness; The big too soft tough good tough soft tough following rubber of the good 0.8mm of performance that pierces through of performance that pierces through of viscosity is easily broken crisp; The following rubber poor flexibility of ash 0.2～0.8mm partially grey 0.5mm of the big crisp color of rubber tearing strength is crisp partially for color belt ash color, the color belt ash	Fine general fine difference is better fine better general better fine general fine general than good job

Through above screening, overall merit, prescription 2,4,7,11,16 prepared rubber quality are good, consider the characteristics of fill material, select prescription 2, i.e. gelatin 100g: glycerol 45g: water 100g.

3. opacifier is selected

The transparent adhesive tape softgel shell easily causes instability, so need to add a certain amount of opacifier.Select titanium dioxide (titanium dioxide) to make opacifier through investigation and can reach effective shaded effect, and steady quality, not with rubber cement and fill material generation chemical change.Its consumption is through investigating with gelatin: glycerol: water: titanium dioxide=100g: 45g: 100g: 1g is advisable, and little to the rubber quality influence, the results are shown in Table.

The opacifier consumption is selected

Usage ratio	The rubber transparency	Rubber cement viscosity (Mpas)	Overall merit
				Gelatin 100g: glycerol 45g: water 100g: titanium dioxide 0.5g gelatin 100g: glycerol 45g: water 100g: titanium dioxide 1g gelatin 100g: glycerol 45g: water 100g: titanium dioxide 2g gelatin 100g: glycerol 45g: water 100g: titanium dioxide 3g	Translucent opaque	3.36 3.38 3.38 3.52	The big viscosity of the good inadequately viscosity of consumption is bigger

Quality is more stable after adding opacifier in the capsule formula.

(2) molding technological condition is investigated

1. the extractum grinding particle size is investigated

Extractum is pulverized, crossed 60 orders, 80 orders, 100 orders, 120 mesh sieves respectively, press extractum: substrate=1: 1.5 is even through the colloid mill mill, and observation mixing situation the results are shown in Table.

The extractum grinding particle size is investigated

Granularity (order)	60	80	100	120
					The mixing situation	Can not mixing, high speed centrifugation (10000/min) 30min layering	The energy mixing, 30min is not stratified for high speed centrifugation (10000/min)	The energy mixing, 30min is not stratified for high speed centrifugation (10000/min)	The energy mixing, 30min is not stratified for high speed centrifugation (10000/min)

As seen from the above table, extractum was pulverized just energy mixing of 80 mesh sieves, therefore, selected extractum to pulverize 80 mesh sieves.

2. fill material mixes

Laboratory is got extractum and was pulverized 80 mesh sieves, presses extractum: substrate=add soybean oil at 1: 1.5, use the colloid mill mixing, and evacuation removes bubble, and is standby.

3. batchingization glue is investigated

By aforementioned preferred prescription is gelatin: glycerol: water: titanium dioxide=100g: 45g: 100g: the 1g weigh batching with different temperatures glue, the results are shown in Table.

Changing the glue temperature investigates

Temperature (℃)	Change the glue time (H)	The rubber quality
			50 60 70 80 90	6 5 5 5 4	Good have bubble than the ebonite skin carefully, hard

By the table prompting, it is the most suitable with 60～70 ℃ to change the glue temperature.So batchingization adhesive tape part is: weigh batching, in the inputizations glue jar, merceration is warming up to 65 ± 5 ℃ gradually after 30 minutes, stirs 5 hours also the while evacuation except that bubble, treat sizing material even after blowing, incapsulate after the filtration in the sizing material bucket of machine.

4. pelleting: the sizing material bucket and the spice bucket of room temperature of insulation are delivered to the capsule machine top, be connected, debug pellet press with machine, 65 ℃ of gelatin box temperature controls, mould rotating speed 2.0 is rolled in 45 ℃ of sprinkler body temperature controls, rubber thickness 0.8mm, 18～25 ℃ of indoor temperatures, relative humidity＜40%.Treat that it is the 400mg/ grain that ball content loading amount is regulated in pellet press debugging back.Survey loading amount once every half an hour in the pelleting process.

5. dry:

The dry soft capsule through pellet press extrusions of typing is in conveyer belt is delivered to rotating cage, and rotating cage is blown a cold wind over while rotating, rotates about 2 hours of the drying of finalizing the design.

Tray dried soft gelatin capsule of cold air drying in rotating cage is contained in clean rustless steel charging tray splendid attire, moves to about 22 ℃ of temperature, and airing is 48 hours in the hothouse of relative humidity below 40%, and constantly stirs, and surveys capsule moisture and is being dry suiting below 10%.

The drying lime light: the dry typing drying of rolling that adopts combined with two steps of tray dried, and the typing of rolling is dry is advisable with two hours through investigation, and overlong time is then rough; Baking temperature is advisable about investigating with 22 ℃, and it is long that it's low drying time is past temperature, though increase in temperature can shorten drying time, easily produces Testudinis to capsule surface and splits; Dry relative humidity should be lower than 40% through investigating, otherwise is difficult for dry; Got final product below 10% with control moisture drying time about 24～48 hours.

(5) drop pill moulding process

(1) screening of substrate

The fusion situation of substrate and principal agent relatively

The prescription number	Prescription 1	Prescription 2	Prescription 3	Prescription 4	Prescription 5	Prescription 6	Prescription 7	Prescription 8
									Medicine (g)	10	10	10	10	10	10	10	10
Macrogol 4000 (g)	30	20	10	30	-----20-----	-----10------	---------	---------
									Polyethylene glycol 6000 (g)	---------	---------	---------	20	30	35	40	45
S-40			10	10			10
									The fusion situation of principal agent and substrate	Principal agent can merge with substrate, but system does not have flowability	Principal agent can merge with substrate, and system is better mobile	Principal agent can merge with substrate, and the system flowability is fine	Principal agent can merge with substrate, and the system flowability is fine	Principal agent and substrate merge relatively poor	Principal agent can merge with substrate, but system does not have flowability	Principal agent can merge with substrate, and the system flowability is relatively poor	Principal agent can merge with substrate, and system is better mobile
The drop pill outward appearance	---------	Roundness is poor, hangover	Smooth, roundness is good	Smooth, roundness is good	---------	---------	Roundness is poor, hangover	Roundness is poor slightly, and hangover is arranged slightly
									Drop pill hardness	---------	Hardness is little	Hardness is better	Hardness is better	--------	---------	Hardness is better	Hardness is better
The ball method of double differences is different		20％	8.0％	8.5％		---------	25％	20％
									Dissolve scattered time limit (min)	---------	7～8	4～5	9～10	---------	---------	6～8	6～8

The result shows, the drop pill stripping that composite interstitial substance makes is very fast, because the esterification of polyethylene glycols substrate forms, be the surface-active water-soluble base of a kind of tool (fusing point is 46～51 ℃), S-40 has changed polyethylene glycols itself and has not had close ester structure and surface-active character, improve the dissolubility of insoluble drug, help the absorption of medicine.

2. drip distance, drip selection fast, temperature

Drip distance, drip selection fast, temperature: the interior external diameter of drip is fixed as 4.1,6.1mm.Evaluation index: the heavy qualification rate of ball is by mass discrepancy requirement of Pharmacopoeia of the People's Republic of China version in 2000: meet ± 7.5% within.

Group	Temperature/℃	Drip distance/cm	Liquid coolant height/cm	Heavy qualification rate/the % of ball
					1 2 3 4 5 6 7 8	90 90 90 80 80 80 70 70	4 5 8 4 5 8 4 5	50 60 80 60 80 50 80 50	79.5 86.8 82.0 91.7 95.6 90.5 91.9 91.4

9

70

8

60

86.3

The result shows, the optimum condition of preparation drop pill of the present invention: drip to become ball in dimethicone, drip apart from 5cm, drip footpath 2.5mm/2mm mixes 80 ℃ of ointment temperature, liquid coolant height 80cm.

(6) bioavailability relatively

The SD rat, body weight 250～280g, male and female half and half, fasting overnight (can't help water), next day gastric infusion, dosage is 3.8g/kg.15min before administration and after the administration, 30min, 50min, 80min, 2h, 3h, the blood sampling of 4h and 8h heart, each blood sample point is with 6 rats.Blood sample is put the anticoagulant heparin pipe, the centrifugal 5min of 3000r/min, and separated plasma is put-30 ° and is saved to analysis.High performance liquid chromatograph is by the M510 pump, the U6K injector, and M490 variable-wavelenght detector and 810 chromatographic data treating stations are formed (Waters, the U.S.).Analytical column is μ BondpakaC ₁₈(0.45mm * 25cm); Mobile phase is methanol: water=6: 4; Flow velocity: 0.8mL/min; Detect wavelength: λ=230nm.Andrographolide extracts in the blood plasma: get 0.5mL blood plasma, add 5mLCHCl ₃, interior mark 50 μ L, test tube is done 30 ° and is favoured horizontal direction jolting device, and 15min is extracted in jolting, centrifugal (3000r/min) 10min, aqueous phase discarded, the accurate 4mL organic facies of drawing is in a clean tube, at 37 ℃ of water-baths, N ₂Dry up under the air-flow, residue dissolves the sample introduction analysis again with 200 μ L mobile phases.

Time/h	Rat plasma Herba Andrographis concentration change (N=6) blood plasma Herba Andrographis concentration/(mgL -1)
								0 0.25 0.50 0.83 1.33 2.00 3.00 4.00 6.00 8.00	Dispersing tablet of the present invention-1.72 ± 0.45 3.65 ± 1.14 2.32 ± 0.42 1.68 ± 0.43 1.38 ± 0.28 1.08 ± 0.25 0.84 ± 0.24 0.46 ± 0.18 0.22 ± 0.14	FUKE QIANJIN PIAN-0.61 ± 0.18 0.95 ± 0.42 1.82 ± 0.73 1.20 ± 0.66 0.88 ± 0.47 0.56 ± 0.24 0.36 ± 0.11 0.18 ± 0.06 0.08 ± 0.13	Micropill of the present invention-1.60 ± 0.19 3.54 ± 1.16 2.29 ± 0.34 1.65 ± 0.63 1.34 ± 0.21 1.03 ± 0.13 0.80 ± 0.27 0.44 ± 0.15 0.24 ± 0.20	Soft capsule of the present invention-1.78 ± 0.28 3.35 ± 1.10 2.50 ± 0.27 1.75 ± 0.40 1.36 ± 0.23 1.06 ± 0.18 0.81 ± 0.13 0.47 ± 0.27 0.25 ± 0.11	Particle of the present invention-1.69 ± 0.13 3.60 ± 1.04 2.21 ± 0.32 1.65 ± 0.47 1.31 ± 0.25 1.02 ± 0.21 0.89 ± 0.20 0.31 ± 0.17 0.26 ± 0.21	' Qianjin ' capsule to treat ganopathy-0.72 ± 0.16 1.09 ± 0.35 1.94 ± 0.58 1.37 ± 0.29 1.03 ± 0.43 0.79 ± 0.21 0.47 ± 0.09 0.25 ± 0.07 0.10 ± 0.15	Dripping pill of the present invention-1.79 ± 0.12 3.72 ± 0.15 2.60 ± 0.23 1.69 ± 0.33 1.32 ± 0.17 1.09 ± 0.23 0.81 ± 0.27 0.47 ± 0.31 0.26 ± 0.25

The result shows that the bioavailability of product of the present invention is greater than existing commercially available tablet, capsule.

(7) anti-inflammatory and antalgic reaches the pharmacological research to the uterus effect of contraction

(1) antiinflammatory action

1. the influence of xylol induced mice auricle edema

Experimental technique faces with preceding that dispersible tablet of the present invention, micropill, soft capsule are mixed with the 0.10g/ml suspension with 0.5% Carboxymethyl cellulose sodium (CMC-Na) is standby, and animal is used healthy Kunming mouse, body weight 20 grams.Mice is divided into 7 groups (matched group normal saline) at random, irritate the long-pending 20ml/kg of being of body of stomach, two weeks of continuous irrigation stomach, once a day, the last administration after 30 minutes with microsyringe only with 0.05ml/, dimethylbenzene is applied to mouse right ear, put to death mice after 15 minutes, cut two ears, dash with the 8mm diameter steel and lay round auricle in left and right sides auricle same area respectively along the auricle baseline, torsion balance claims two auricle weight in wet bases, with two auricle weight differences as the swelling level index.Inhibitory rate of intumesce equals the difference of average swelling degree of matched group and the average swelling degree of administration group and takes advantage of 100% again divided by the average swelling degree of matched group.

Group	Dosage (g/kg)	Animal (only)	Average swelling degree (mg)	Suppression ratio (%)
					Control group hydrocortisone group FUKE QIANJIN PIAN group ' Qianjin ' capsule to treat ganopathy group dispersing tablet group of the present invention micropill group of the present invention soft capsule group of the present invention	20ml/kg 0.04 2.0 2.0 2.0 2.0 2.0	8 8 8 8 8 8 8	24.21±4.60 7.03±2.58 16.65±5.32 16.42±8.12 14.50±4.70 13.97±8.55 13.57±3.32	70.80 30.24 30.15 32.17 34.09 33.25

The result shows that preparation of the present invention has good antiinflammatory action, and effect is better than commercially available FUKE QIANJIN PIAN, FUKE QIANJIN JIAONANG.

2. to the influence of rat uterus inflammation

Experimental technique: animal is selected the female rat of SD kind for use, about 200 grams of body weight.Animal is divided 7 groups, each treated animal under etherization cuts off the hypogastric region hair, and long mouthful of 2cm is cut in the sterilization back in the abdomen center, expose the uterus, make a kerf in the place along 1cm on the left hand corner of uterus, with a plastic hoop (caliber 2cm, long 0.5cm, heavy 2mg, alcohol disinfecting) be positioned over intrauterine, with the uterine incision sutured, postoperative beginning in 2 hours administration, once a day, the administration volume is the 20ml/kg body weight, puts to death animal after 7 days, takes out the uterus, both sides, remove fat, analytical balance is weighed, and left side, every Mus uterus is inflammation swelling degree with the difference on right side, calculates the swelling rate and the suppression ratio of administration group.The swelling rate equals to cause scorching uterus average weight and not multiply by 100% with the difference that does not cause scorching uterus average weight divided by causing scorching uterus average weight, and the difference that suppression ratio equals average swelling rate in matched group uterus and the average swelling rate in administration group uterus multiply by 100% divided by the average swelling rate in matched group uterus.

Group	Dosage (g/kg)	Animal (only)	Swelling rate (%)	Suppression ratio (%)
					Control group hydrocortisone group FUKE QIANJIN PIAN group ' Qianjin ' capsule to treat ganopathy group dispersing tablet group of the present invention dripping pill group of the present invention soft capsule group of the present invention	20ml/kg 0.04 2.0 2.0 2.0 2.0 2.0	10 10 10 10 10 10 10	210.40 6.72 18.41 18.82 15.40 15.32 15.01	96.57 91.41 91.37 91.98 92.13 92.28

The result shows that preparation of the present invention has good anti-inflammation of uterus effect, and effect is better than FUKE QIANJIN PIAN, FUKE QIANJIN JIAONANG.

(2) analgesic activity

Inhibitory action to the mouse writhing reaction

Experimental technique: mice is divided into 7 groups at random, continuous irrigation stomach 8 days, the last administration after 90 minutes mouse peritoneal inject 0.7% glacial acetic acid 0.1ml/10 gram body weight, observe the counting mice and turn round the body number of times in 15 minutes.

Group	Dosage (g/kg)	Animal (only)	Turn round the body number of times	Suppression ratio (%)
					Control group hydrocortisone group FUKE QIANJIN PIAN group ' Qianjin ' capsule to treat ganopathy group dispersing tablet group of the present invention micropill group of the present invention soft capsule group of the present invention	20ml/kg 0.04 2.0 2.0 2.0 2.0 2.0	10 10 10 10 10 10 10	33.2±8.5 10.1±3.8 23.4±5.7 23.8±2.6 18.8±3.4 18.2±2.1 18.5±8.9	69.75 26.35 26.29 27.24 27.31 27.80

The result shows that preparation of the present invention has the reagentia of obvious suppression mouse writhing, illustrates that it has good analgesic activity, and effect is better than commercially available FUKE QIANJIN PIAN, FUKE QIANJIN JIAONANG.

(8) treatment chronic prostatitis zoopery

Grouping and dosage blank group: normal saline gavages.The each 100g body weight of rat 10mL, mice 10g body weight 0.2mL.Dispersible tablet group of the present invention: dosage rat 6g/ (kgd), mice 10g/ (kgd).Micropill group of the present invention: dosage rat rat 6g/ (kgd), mice 10g/ (kgd).QIANLIEKANG PIAN (positive control drug) group: dosage rat 12g/ (kgd), mice 20g/ (kgd).

Influence to rat chronic prostatitis model due to the xiaozhiling injection: press the Zhang Yaqiangshi modeling method, cause the chronic prostatitis model.Get 30 of male rats, behind the amobarbital sodium 40mg/kg intraperitoneal injection of anesthesia, aseptic operation, the prostate notopodium injects XIAOZHILING ZHUSHEYE 0.2mL respectively in both sides, every intramuscular injection penicillin 40,000 u of the continuous 3d of postoperative.Postoperative the 7th d is divided into 4 groups at random with rat, gastric infusion, 2 times/d, continuous 30d.31d, disconnected ridge is put to death rat, gets prostata tissue specimen observed and recorded finding of naked eye; The routine pathology section, HE dyeing, ordinary optical microscope is observed the prostata tissue morphological change; Take from the rat prostate notopodium, about 1 * 1mm, 25% glutaraldehyde, phosphate buffer pH7.4,1%O _SO ₄, two fixing, the dehydration of ethanol acetone gradient, epoxy resin Epon812 embedding, ultrathin section, sodium acetate, citric acid double staining, the pathological change of transmission electron microscope observing ultrastructure.Other gets one group of normal rat prostata tissue specimen, observes as the normal control group.

The normal control group: the rat prostate tissue is soft, ruddy, glossy; Prostatic epithelium is cube under the light microscopic, has more rich powder to dye albumen liquid in the lumen of gland, and a matter is a spot of fibrous tissue and blood vessel, no inflammatory cell infiltration; Epithelial cell karyomorphism rule under the Electronic Speculum, kernel is obvious, and mitochondrion is little in the kytoplasm, and rough endoplasmic reticulum is abundant, slightly expands into the pond, Golgi complex prosperity, the metal secretory granule of visible a large amount of fine particulate secretions and small number of coarse in the lumen of gland of cell top.

The normal saline group of modeling: the general and surrounding tissue adhesion of rat prostate body of gland, body of gland is kermesinus or pale brown color, and matter is hard, and tangible scleroma is arranged; Prostatic epithelium destruction, atrophy, come off, interstitial fibers hamartoplasia is obvious, and massive inflammatory cells infiltrated mostly is mononuclear cell and lymphocyte; Prostate epithelial cell nuclear increases under the Electronic Speculum, out-of-shape, and rough endoplasmic reticulum severe expands into big blister, myelinfigure occurs in the part cell cytoplasm, sees a large amount of secretory granule and thick metallic particles in the lumen of gland.

The QIANLIEKANG PIAN group: prostate body of gland and surrounding tissue adhesion are lighter, and part body of gland matter is hard, nodosity, and color is pale brown; Light microscopic sees that the epithelium degeneration comes off, and neutrophilic leukocyte is oozed out more in the lumen of gland; Prostate epithelial cell karyon shape is regular under the Electronic Speculum, does not see kernel, and the part kernel is less, object line plastochondria in the kytoplasm, the expansion of partial line plastochondria is the cavity shape and changes, the expansion of rough endoplasmic reticulum moderate, visible infantilism Golgi body and the higher lysosome of electron density.

Dispersible tablet of the present invention, micropill group: prostate body of gland and surrounding tissue adhesion are light, and it is little to harden, and the part body of gland is pale brown color, and some body of gland is Mild edema only, body of gland softness, ruddy, glossy, and outward appearance is identical with normal prostatic; Light microscopic sees that the degeneration of micropill group rat prostate epithelium comes off, fibroid interstitial proliferation, lymphocytic infiltration, the rarely seen interstitial proliferation that has and body of gland is normal substantially, the slight hypertrophy of dispersible tablet group rat prostate plastid stroma, several no inflammatory cell infiltrations; Low dose group rat prostate epithelial cell karyon increases under the Electronic Speculum, is the hypertrophy sample and changes, and rough endoplasmic reticulum slightly expands into the pond, visible more lysosome granule.Mitochondria number increases in the dispersible tablet group prostate epithelial cell kytoplasm, volume increases, and rough endoplasmic reticulum is abundant, slightly expands into the pond, the visible a large amount of immaturity Golgi bodys of part cell, visible a large amount of fine particle shape secretions and higher metallic particles of electron density in the cell lumen of gland.

Above-mentioned experimental result shows that xiaozhiling injection can cause the rat prostate tissue to produce tangible chronic inflammatory disease pathological change.Preparation administration of the present invention can make all that prostatitis alleviates due to the xiaozhiling injection, and the dispersible tablet group is more obvious.

Experimental example 2 Study on extraction process

Extraction process 1: get the Herba Andrographis alcohol extraction; Get the Radix Angelicae Sinensis alcohol dipping; Fructus Zanthoxyli Dissiti, Caulis Mahoniae water are carried; Radix Flemingiae Philippinensis, Radix Codonopsis, Radix Rosae Laevigatae, Caulis Spatholobi, water is carried.

Extraction process 2: Herba Andrographis, Radix Angelicae Sinensis, Caulis Mahoniae, Caulis Spatholobi and Fructus Zanthoxyli Dissiti alcohol extraction, all the other water are carried.

Extraction process 3: Herba Andrographis, Radix Angelicae Sinensis, Radix Codonopsis are pulverized, and all the other water are carried.

Extraction process 4: Herba Andrographis, Radix Angelicae Sinensis alcohol extraction, Fructus Zanthoxyli Dissiti, Caulis Mahoniae water are carried, and all the other water are carried.

(1) stability test

	Moisture (%)
					The tablet that the tablet technology 4 that the tablet technology 3 that the tablet technology 2 that technology 1 makes makes makes makes	1 6.0 3.2 4.5 4.1	2 7.8 3.5 7.5 5.5	3 9.1 4.0 8.0 7.3	4 12.9 4.5 10.8 8.2

(2) wettability test

Get totally six parts of each about 2g of capsule 's content, put in the weighing botle, the accurate title, decide, the weighing bottle cap is opened, put into relative humidity respectively and be 20%, 33%, 43%, 60%, 75%, 92% environment, in 25 ℃ of constant incubators, place and reached balance to moisture absorption in 84 hours, take out weighing botle, the accurate title, decide, and calculates the moisture absorption percentage rate.

The moisture absorption percentage rate (%) of filler particles

Constant humidity solution	25℃	CH 3COOK	MgCl 2	K 2CO 3	NaBr	NaCl	KNO 3
								RH equilibrium moisture content (technology 1) equilibrium moisture content (technology 2) equilibrium moisture content (technology 3) equilibrium moisture content (technology 4)	％ ％ ％ ％ ％	20 1.01 1.00 1.02 1.05	33 2.40 1.40 3.38 3.25	43 4.45 2.07 5.87 5.62	60 6.81 4.86 7.09 7.88	75 15.30 12.30 19.32 18.97	92 29.74 24.25 32.56 30.35

The result shows that sheet, capsule stability that second preparation technology provided by the invention makes are good.

(3) anti-inflammatory and antalgic reaches the pharmacological research to the uterus effect of contraction

(1) antiinflammatory action

1. the influence of xylol induced mice auricle edema

Experimental technique faces with preceding that dispersible tablet of the present invention, micropill, soft capsule are mixed with the 0.10g/ml suspension with 0.5% Carboxymethyl cellulose sodium (CMC-Na) is standby, and animal is used healthy Kunming mouse, body weight 20 grams.Mice is divided into 7 groups (matched group normal saline) at random, irritate the long-pending 20ml/kg of being of body of stomach, two weeks of continuous irrigation stomach, once a day, the last administration after 30 minutes with microsyringe only with 0.05ml/, dimethylbenzene is applied to mouse right ear, put to death mice after 15 minutes, cut two ears, dash with the 8mm diameter steel and lay round auricle in left and right sides auricle same area respectively along the auricle baseline, torsion balance claims two auricle weight in wet bases, with two auricle weight differences as the swelling level index.Inhibitory rate of intumesce equals the difference of average swelling degree of matched group and the average swelling degree of administration group and takes advantage of 100% again divided by the average swelling degree of matched group.

Group	Dosage (g/kg)	Animal (only)	Average swelling degree (mg)	Suppression ratio (%)
					Control group hydrocortisone group FUKE QIANJIN PIAN group ' Qianjin ' capsule to treat ganopathy group sheet group of the present invention micropill group of the present invention Capsules group of the present invention	20ml/kg 0.04 2.0 2.0 2.0 2.0 2.0	8 8 8 8 8 8 8	24.21±4.60 7.03±2.59 16.55±5.38 16.48±8.17 14.52±4.49 13.85±8.16 13.49±3.10	70.80 30.24 30.15 31.08 32.12 33.51

The result shows that preparation of the present invention has good antiinflammatory action, and effect is better than commercially available FUKE QIANJIN PIAN, FUKE QIANJIN JIAONANG.

2. to the influence of rat uterus inflammation

Experimental technique: animal is selected the female rat of SD kind for use, about 200 grams of body weight.Animal is divided 7 groups, each treated animal under etherization cuts off the hypogastric region hair, and long mouthful of 2cm is cut in the sterilization back in the abdomen center, expose the uterus, make a kerf in the place along 1cm on the left hand corner of uterus, with a plastic hoop (caliber 2cm, long 0.5cm, heavy 2mg, alcohol disinfecting) be positioned over intrauterine, with the uterine incision sutured, postoperative beginning in 2 hours administration, once a day, the administration volume is the 20ml/kg body weight, puts to death animal after 7 days, takes out the uterus, both sides, remove fat, analytical balance is weighed, and left side, every Mus uterus is inflammation swelling degree with the difference on right side, calculates the swelling rate and the suppression ratio of administration group.The swelling rate equals to cause scorching uterus average weight and not multiply by 100% with the difference that does not cause scorching uterus average weight divided by causing scorching uterus average weight, and the difference that suppression ratio equals average swelling rate in matched group uterus and the average swelling rate in administration group uterus multiply by 100% divided by the average swelling rate in matched group uterus.

Group	Dosage (g/kg)	Animal (only)	Swelling rate (%)	Suppression ratio (%)
					Control group hydrocortisone group FUKE QIANJIN PIAN group ' Qianjin ' capsule to treat ganopathy group dispersing tablet group of the present invention dripping pill group of the present invention soft capsule group of the present invention	20ml/kg 0.04 2.0 2.0 2.0 2.0 2.0	10 10 10 10 10 10 10	210.40 6.72 18.41 18.82 15.52 15.69 15.23	96.57 91.41 91.37 91.80 92.47 92.34

The result shows that preparation of the present invention has good anti-inflammation of uterus effect, and effect is better than commercially available FUKE QIANJIN PIAN, FUKE QIANJIN JIAONANG.

(2) analgesic activity

Inhibitory action to the mouse writhing reaction

Experimental technique: mice is divided into 7 groups at random, continuous irrigation stomach 8 days, the last administration after 90 minutes mouse peritoneal inject 0.7% glacial acetic acid 0.1ml/10 gram body weight, observe the counting mice and turn round the body number of times in 15 minutes.

Group	Dosage (g/kg)	Animal (only)	Turn round the body number of times	Suppression ratio (%)
					Control group hydrocortisone group FUKE QIANJIN PIAN group ' Qianjin ' capsule to treat ganopathy group dispersing tablet group of the present invention micropill group of the present invention soft capsule group of the present invention	20ml/kg 0.04 2.0 2.0 2.0 2.0 2.0	10 10 10 10 10 10 10	33.2±8.5 10.1±3.8 23.4±5.7 23.8±2.6 18.9±2.9 18.1±3.8 18.2±6.3	69.75 26.35 26.29 27.56 27.79 27.32

The result shows that preparation of the present invention has the reagentia of obvious suppression mouse writhing, illustrates that it has good analgesic activity, and effect is better than commercially available FUKE QIANJIN PIAN, FUKE QIANJIN JIAONANG.

Concrete embodiment:

Embodiments of the invention 1: 9 parts of Radix Angelicae Sinensis, 9 parts of Radix Codonopsis, 9 parts of Herba Andrographis, 9 parts of Fructus Zanthoxyli Dissiti, 16 parts of Radix Rosae Laevigataes, 16 parts of Caulis Spatholobis, 16 parts of Caulis Mahoniaes, 16 parts of Radix Flemingiae Philippinensiss, Herba Andrographis is ground into coarse powder, extract secondary with 85% alcohol heating reflux, 6 times of amount ethanol are measured ethanol, each 3 hours for 5 times for the second time for the first time, merge extractive liquid,, filter, filtrate recycling ethanol, and be 1.10 clear paste when being concentrated into 80 ℃ of relative densities; Radix Angelicae Sinensis powder is broken into coarse powder, makes solvent with 70% ethanol, floods after 96 hours slowly percolation, collects percolate 2400ml, is 1.10 clear paste when reclaiming ethanol and being concentrated into 80 ℃ of relative densities; Fructus Zanthoxyli Dissiti, Caulis Mahoniae two flavors decoct with water secondary, and 3 hours for the first time, 2.5 hours for the second time, collecting decoction filtered, and filtrate is 1.10 clear paste when being concentrated into 80 ℃ of relative densities; All the other Radix Flemingiae Philippinensiss etc. four flavor decocts with water secondary, and each 2 hours, the medicinal residues that add above-mentioned Herba Andrographis and Radix Angelicae Sinensis when decocting for the second time decocted together, and collecting decoction filters, and filtrate is 1.10 clear paste when being concentrated into 80 ℃ of relative densities; Merge above-mentioned four kinds of clear paste, mixing, it is an amount of to add aspartame 20g and dextrin, and mixing is got about 2/3 medicine liquid spray drying, make extract powder, get the residue medicinal liquid again and do binding agent, boiling granulating in fluid bed is made 1000g, promptly get granule, oral, three times on the one, one time one bag.

Embodiments of the invention 2: 9 parts of Radix Angelicae Sinensis, 9 parts of Radix Codonopsis, 9 parts of Herba Andrographis, 9 parts of Fructus Zanthoxyli Dissiti, 16 parts of Radix Rosae Laevigataes, 16 parts of Caulis Spatholobis, 16 parts of Caulis Mahoniaes, 16 parts of Radix Flemingiae Philippinensiss, Herba Andrographis is ground into coarse powder, extract secondary with 85% alcohol heating reflux, 6 times of amount ethanol are measured ethanol, each 3 hours for 5 times for the second time for the first time, merge extractive liquid,, filter, filtrate recycling ethanol, and be 1.10 clear paste when being concentrated into 80 ℃ of relative densities; Radix Angelicae Sinensis powder is broken into coarse powder, makes solvent with 70% ethanol, floods after 96 hours slowly percolation, collects percolate 2400ml, is 1.10 clear paste when reclaiming ethanol and being concentrated into 80 ℃ of relative densities; Fructus Zanthoxyli Dissiti, Caulis Mahoniae two flavors decoct with water secondary, and 3 hours for the first time, 2.5 hours for the second time, collecting decoction filtered, and filtrate is 1.10 clear paste when being concentrated into 80 ℃ of relative densities; All the other Radix Flemingiae Philippinensiss etc. four flavor decocts with water secondary, and each 2 hours, the medicinal residues that add above-mentioned Herba Andrographis and Radix Angelicae Sinensis when decocting for the second time decocted together, and collecting decoction filters, and filtrate is 1.10 clear paste when being concentrated into 80 ℃ of relative densities; Merge above-mentioned four kinds of clear paste, mixing, it is an amount of to add aspartame 20g and dextrin, and mixing is got about 2/3 medicine liquid spray drying, makes extract powder, gets the residue medicinal liquid again and does binding agent, boiling granulating in fluid bed, feed liquor speed 50～55ml/min; Atomisation pressure 0.15Mpa; 55～60 ℃ of temperature of charge; 80～100 ℃ of inlet temperature; 60～65 ℃ of leaving air temps, when granulation, packing, storage, envionmental humidity should be controlled at below 67%, promptly gets granule.

Embodiments of the invention 3: 9 parts of Radix Angelicae Sinensis, 9 parts of Radix Codonopsis, 9 parts of Herba Andrographis, 9 parts of Fructus Zanthoxyli Dissiti, 16 parts of Radix Rosae Laevigataes, 16 parts of Caulis Spatholobis, 16 parts of Caulis Mahoniaes, 16 parts of Radix Flemingiae Philippinensiss, Herba Andrographis is ground into coarse powder, spend the night with 85% soak with ethanol, then heating and refluxing extraction secondary, 6 times of amount ethanol for the first time, measure ethanol for 5 times for the second time, each three hours, merge extractive liquid, filtered, filtrate recycling ethanol, and be 1.10 clear paste when being concentrated into 80 ℃ of relative densities; Radix Angelicae Sinensis powder is broken into coarse powder, makes solvent with 70% ethanol, floods after 96 hours slowly percolation, collects percolate 1200ml, is 1.10 clear paste when reclaiming ethanol and being concentrated into 80 ℃ of relative densities; Fructus Zanthoxyli Dissiti, Caulis Mahoniae two flavors decoct with water secondary, add 6 times of decoctings for the first time and boil 3 hours, add 6 times of decoctings for the second time and boil 2.5 hours, and collecting decoction filters, and filtrate is 1.10 clear paste when being concentrated into 80 ℃ of relative densities; All the other Radix Flemingiae Philippinensiss etc. four flavor decocts with water secondary, adds 6 times of decoctings to boil 2 hours at every turn, and the medicinal residues that add above-mentioned Herba Andrographis and Radix Angelicae Sinensis when decocting for the second time decoct together, and collecting decoction filters, and filtrate is 1.10 clear paste when being concentrated into 80 ℃ of relative densities; Merge above-mentioned four kinds of clear paste, it when continuing to be concentrated into 80 ℃ of relative densities 1.20 clear paste, merge extractum, dry, pulverize, extract powder, be disintegrating agent, be aided with micropowder silica gel, polyvinylpyrrolidone (PVP-K with in crospolyvinylpyrrolidone (PVPP) or crosslinked carboxymethyl fecula sodium (CCMS-Na) or the cross-linking sodium carboxymethyl cellulose (CCMC-Na) one or more ₃₀), in the mannitol, carboxymethyl starch sodium (CMC-Na), microcrystalline Cellulose, sodium bicarbonate, lactose two or more, add an amount of pigment again, as the pharmaceutical adjunct of dispersible tablet, according to extract powder: the ratio of pharmaceutical adjunct=1: 0.6-2, the mixing that sieves, tabletting promptly gets dispersible tablet.

Embodiments of the invention 4: 9 parts of Radix Angelicae Sinensis, 9 parts of Radix Codonopsis, 9 parts of Herba Andrographis, 9 parts of Fructus Zanthoxyli Dissiti, 16 parts of Radix Rosae Laevigataes, 16 parts of Caulis Spatholobis, 16 parts of Caulis Mahoniaes, 16 parts of Radix Flemingiae Philippinensiss, Herba Andrographis is ground into coarse powder, spend the night with 85% soak with ethanol, then heating and refluxing extraction secondary, 6 times of amount ethanol for the first time, measure ethanol for 5 times for the second time, each three hours, merge extractive liquid, filtered, filtrate recycling ethanol, and be 1.10 clear paste when being concentrated into 80 ℃ of relative densities; Radix Angelicae Sinensis powder is broken into coarse powder, makes solvent with 70% ethanol, floods after 96 hours slowly percolation, collects percolate 1200ml, is 1.10 clear paste when reclaiming ethanol and being concentrated into 80 ℃ of relative densities; Fructus Zanthoxyli Dissiti, Caulis Mahoniae two flavors decoct with water secondary, add 6 times of decoctings for the first time and boil 3 hours, add 6 times of decoctings for the second time and boil 2.5 hours, and collecting decoction filters, and filtrate is 1.10 clear paste when being concentrated into 80 ℃ of relative densities; All the other Radix Flemingiae Philippinensiss etc. four flavor decocts with water secondary, adds 6 times of decoctings to boil 2 hours at every turn, and the medicinal residues that add above-mentioned Herba Andrographis and Radix Angelicae Sinensis when decocting for the second time decoct together, and collecting decoction filters, and filtrate is 1.10 clear paste when being concentrated into 80 ℃ of relative densities; Merging above-mentioned four kinds of clear paste, is 1.20 clear paste when continuing to be concentrated into 80 ℃ of relative densities; Merge extractum, drying is pulverized, and gets extract powder; Get CMC-Na: PVPP: mannitol: micropowder silica gel=1: 3-4: 1-3: 3-4 adds an amount of pigment mixing as pharmaceutical adjunct, gets 4/5 pharmaceutical adjunct and is equivalent to the extract powder mix homogeneously that CMC-Na10 doubly measures, the PVP-K with 1.5% approximately ₃₀Anhydrous alcohol solution is made binding agent, and 40 order system material, granulate remain 1/5 pharmaceutical adjunct and an amount of caramel color mixing, are added on outward in the particle that makes, and tabletting promptly gets dispersible tablet.

Embodiments of the invention 5: 9 parts of Radix Angelicae Sinensis, 9 parts of Radix Codonopsis, 9 parts of Herba Andrographis, 9 parts of Fructus Zanthoxyli Dissiti, 16 parts of Radix Rosae Laevigataes, 16 parts of Caulis Spatholobis, 16 parts of Caulis Mahoniaes, 16 parts of Radix Flemingiae Philippinensiss, Herba Andrographis is ground into coarse powder, extract secondary with 85% alcohol heating reflux, 6 times of amount ethanol for the first time, 5 times of amounts for the second time, each three hours, merge extractive liquid,, filter, filtrate recycling ethanol, and be 1.10 clear paste when being concentrated into 80 ℃ of relative densities; Radix Angelicae Sinensis powder is broken into coarse powder, makes solvent with 70% ethanol, floods after 96 hours slowly percolation, collects percolate 4800ml, is 1.10 clear paste when reclaiming ethanol and being concentrated into 80 ℃ of relative densities; Fructus Zanthoxyli Dissiti, Caulis Mahoniae two flavors decoct with water secondary, and 3 hours for the first time, 2.5 hours for the second time, collecting decoction filtered, and filtrate is 1.10 clear paste when being concentrated into 80 ℃ of relative densities; All the other Radix Flemingiae Philippinensiss etc. four flavor decocts with water secondary, and each 2 hours, the medicinal residues that add above-mentioned Herba Andrographis and Radix Angelicae Sinensis when decocting for the second time decocted together, and collecting decoction filters, and filtrate is 1.10 clear paste when being concentrated into 80 ℃ of relative densities; Merge above-mentioned four kinds of clear paste, mixing at 60～70 ℃ of vacuum dryings, is pulverized, and adds an amount of starch, with 75% ethanol and soybean oil system soft material, and extruding-round as a ball pill or the general ball of making of employing coating pan, drying promptly gets micropill.

Embodiments of the invention 6: 9 parts of Radix Angelicae Sinensis, 9 parts of Radix Codonopsis, 9 parts of Herba Andrographis, 9 parts of Fructus Zanthoxyli Dissiti, 16 parts of Radix Rosae Laevigataes, 16 parts of Caulis Spatholobis, 16 parts of Caulis Mahoniaes, 16 parts of Radix Flemingiae Philippinensiss, Herba Andrographis is ground into coarse powder, extract secondary with 85% alcohol heating reflux, 6 times of amount ethanol for the first time, 5 times of amounts for the second time, each three hours, merge extractive liquid,, filter, filtrate recycling ethanol, and be 1.10 clear paste when being concentrated into 80 ℃ of relative densities; Radix Angelicae Sinensis powder is broken into coarse powder, makes solvent with 70% ethanol, floods after 96 hours slowly percolation, collects percolate 4800ml, is 1.10 clear paste when reclaiming ethanol and being concentrated into 80 ℃ of relative densities; Fructus Zanthoxyli Dissiti, Caulis Mahoniae two flavors decoct with water secondary, and 3 hours for the first time, 2.5 hours for the second time, collecting decoction filtered, and filtrate is 1.10 clear paste when being concentrated into 80 ℃ of relative densities; All the other Radix Flemingiae Philippinensiss etc. four flavor decocts with water secondary, and each 2 hours, the medicinal residues that add above-mentioned Herba Andrographis and Radix Angelicae Sinensis when decocting for the second time decocted together, and collecting decoction filters, and filtrate is 1.10 clear paste when being concentrated into 80 ℃ of relative densities; Merge above-mentioned four kinds of clear paste, mixing, at 60～70 ℃ of vacuum dryings, pulverize, add an amount of starch, with 75% ethanol and 1.5% soybean oil system soft material, the soft material that makes micropill mechanism ball, wet feed pushed the 0.8mm sieve aperture, and the wet grain of strip cuts off round as a ball, 50～60 ℃ of drying and mouldings, crossing 16～20 mesh sieves selects ball or merges above-mentioned four kinds of clear paste, spray drying, wet-milling granulation molding places mould to add the great achievement ball in the coating pan, medicated powder: water is 1: 1, the coating pan rotating speed is 40r/min, and capping selects ball; When granulation, packing, storage, envionmental humidity should be controlled at below 54%, promptly gets micropill.

9 parts of embodiments of the invention 7 Radix Angelicae Sinensis, 9 parts of Radix Codonopsis, 9 parts of Herba Andrographis, 9 parts of Fructus Zanthoxyli Dissiti, 16 parts of Radix Rosae Laevigataes, 16 parts of Caulis Spatholobis, 16 parts of Caulis Mahoniaes, 16 parts of Radix Flemingiae Philippinensiss, Herba Andrographis is ground into coarse powder, spend the night with 85% soak with ethanol, then heating and refluxing extraction secondary, 6 times of amount ethanol for the first time, measure ethanol for 5 times for the second time, each three hours, merge extractive liquid, filtered, filtrate recycling ethanol, and be 1.10 clear paste when being concentrated into 80 ℃ of relative densities; Radix Angelicae Sinensis powder is broken into coarse powder, makes solvent with 70% ethanol, floods after 96 hours slowly percolation, collects percolate 1200ml, is 1.10 clear paste when reclaiming ethanol and being concentrated into 80 ℃ of relative densities; Fructus Zanthoxyli Dissiti, Caulis Mahoniae two flavors decoct with water secondary, add 6 times of decoctings for the first time and boil 3 hours, add 6 times of decoctings for the second time and boil 2.5 hours, and collecting decoction filters, and filtrate is 1.10 clear paste when being concentrated into 80 ℃ of relative densities; Four flavors such as all the other Radix Flemingiae Philippinensiss decoct with water secondary, add 6 times of decoctings to boil 2 hours at every turn, and the medicinal residues that add above-mentioned Herba Andrographis and Radix Angelicae Sinensis when decocting for the second time decoct together, and collecting decoction filters, and filtrate is concentrated into the clear paste that relative density is 1.10 (80 ℃); Merging above-mentioned four kinds of clear paste, is 1.20 clear paste when continuing to be concentrated into 80 ℃ of relative densities, and drying is pulverized, and crosses 80 mesh sieves, and it is an amount of to add soybean oil, and mixing is pressed into 1000 of soft capsules, promptly gets soft capsule.

9 parts of embodiments of the invention 8 Radix Angelicae Sinensis, 9 parts of Radix Codonopsis, 9 parts of Herba Andrographis, 9 parts of Fructus Zanthoxyli Dissiti, 16 parts of Radix Rosae Laevigataes, 16 parts of Caulis Spatholobis, 16 parts of Caulis Mahoniaes, 16 parts of Radix Flemingiae Philippinensiss, Herba Andrographis is ground into coarse powder, spend the night with 85% soak with ethanol, then heating and refluxing extraction secondary, 6 times of amount ethanol for the first time, measure ethanol for 5 times for the second time, each three hours, merge extractive liquid, filtered, filtrate recycling ethanol, and be 1.10 clear paste when being concentrated into 80 ℃ of relative densities; Radix Angelicae Sinensis powder is broken into coarse powder, makes solvent with 70% ethanol, floods after 96 hours slowly percolation, collects percolate 1200ml, is 1.10 clear paste when reclaiming ethanol and being concentrated into 80 ℃ of relative densities; Fructus Zanthoxyli Dissiti, Caulis Mahoniae two flavors decoct with water secondary, add 6 times of decoctings for the first time and boil 3 hours, add 6 times of decoctings for the second time and boil 2.5 hours, and collecting decoction filters, and filtrate is 1.10 clear paste when being concentrated into 80 ℃ of relative densities; All the other Radix Flemingiae Philippinensiss etc. four flavor decocts with water secondary, adds 6 times of decoctings to boil 2 hours at every turn, and the medicinal residues that add above-mentioned Herba Andrographis and Radix Angelicae Sinensis when decocting for the second time decoct together, and collecting decoction filters, and filtrate is 1.10 clear paste when being concentrated into 80 ℃ of relative densities; Merging above-mentioned four kinds of clear paste, is 1.20 clear paste when continuing to be concentrated into 80 ℃ of relative densities, and drying is pulverized, and crosses 80 mesh sieves, and by medication amount: substrate amount=1: 1.5 adds soybean oil, mixing; The prescription of rubber is a gelatin: glycerol: water: titanium dioxide=100g: 45g: 100g: 1g, batchingization adhesive tape part is: weigh batching, in the inputization glue jar, merceration is warming up to 65 ± 5 ℃ gradually after 30 minutes, stirred 5 hours and simultaneously evacuation remove bubble, treat evenly back blowing of sizing material, incapsulate after the filtration in the sizing material bucket of machine; The debugging pellet press, 65 ℃ of gelatin box temperature controls, mould rotating speed 2.0 is rolled in 45 ℃ of sprinkler body temperature controls, rubber thickness 0.8mm, 18～25 ℃ of indoor temperatures, relative humidity＜40%, pelleting; The dry typing drying of rolling that adopts combined with two steps of tray dried, dry 2 hours of the typing of rolling, and 22 ℃ of baking temperatures, dry relative humidity should be lower than 40%, and promptly got soft capsule at 24～48 hours drying time.

11 parts of embodiments of the invention 9 Radix Angelicae Sinensis, 11 parts of Radix Codonopsis, 11 parts of Herba Andrographis, 11 parts of Fructus Zanthoxyli Dissiti, 18 parts of Radix Rosae Laevigataes, 18 parts of Caulis Spatholobis, 18 parts of Caulis Mahoniaes, 18 parts of Radix Flemingiae Philippinensiss, get Herba Andrographis, add 85% alcohol reflux 2 times after the pulverizing, the 1st 6 times of amounts, the 2nd 5 times of amounts, each 3 hours, merge extractive liquid,, filter, reclaim ethanol and be condensed into extractum; Get Radix Angelicae Sinensis, add 70% alcohol dipping 96 hours after the pulverizing, percolation extracts, and collects percolate, reclaims ethanol and is condensed into extractum; Get Fructus Zanthoxyli Dissiti, Caulis Mahoniae, add 8 times of water gagings and decoct 2 times, the 1st time 3 hours, the 2nd time 2.5 hours, collecting decoction filtered, and filtrate is condensed into extractum; Get Radix Flemingiae Philippinensis, Radix Codonopsis, Radix Rosae Laevigatae, Caulis Spatholobi, add 10 times of water gagings for the 1st time and decocted 2 hours, the 2nd filtering residue with Herba Andrographis, Radix Angelicae Sinensis adds 8 times of water gagings and decocted 2 hours, and filtration is condensed into extractum; Merge extractum, drying is pulverized, and is substrate with the Polyethylene Glycol-4000 of 4 times of amounts, and methyl-silicone oil: liquid paraffin (3: 1) is a coolant, and pill promptly gets drop pill.

7 parts of embodiments of the invention 10 Radix Angelicae Sinensis, 7 parts of Radix Codonopsis, 7 parts of Herba Andrographis, 7 parts of Fructus Zanthoxyli Dissiti, 14 parts of Radix Rosae Laevigataes, 14 parts of Caulis Spatholobis, 14 parts of Caulis Mahoniaes, 14 parts of Radix Flemingiae Philippinensiss, get Herba Andrographis, add 85% alcohol reflux 2 times after the pulverizing, the 1st 6 times of amounts, the 2nd 5 times of amounts, each 3 hours, merge extractive liquid,, filter, reclaim ethanol and be condensed into extractum; Get Radix Angelicae Sinensis, add 70% alcohol dipping 96 hours after the pulverizing, percolation extracts, and collects percolate, reclaims ethanol and is condensed into extractum; Get Fructus Zanthoxyli Dissiti, Caulis Mahoniae, add 8 times of water gagings and decoct 2 times, the 1st time 3 hours, the 2nd time 2.5 hours, collecting decoction filtered, and filtrate is condensed into extractum; Get Radix Flemingiae Philippinensis, Radix Codonopsis, Radix Rosae Laevigatae, Caulis Spatholobi, add 10 times of water gagings for the 1st time and decocted 2 hours, the 2nd filtering residue with Herba Andrographis, Radix Angelicae Sinensis adds 8 times of water gagings and decocted 2 hours, and filtration is condensed into extractum; Merge extractum, add syrup, distilled water, promptly get oral liquid.

7 parts of embodiments of the invention 11 Radix Angelicae Sinensis, 7 parts of Radix Codonopsis, 7 parts of Herba Andrographis, 7 parts of Fructus Zanthoxyli Dissiti, 14 parts of Radix Rosae Laevigataes, 14 parts of Caulis Spatholobis, 14 parts of Caulis Mahoniaes, 14 parts of Radix Flemingiae Philippinensiss, get Herba Andrographis and be ground into coarse powder, spend the night with 85% soak with ethanol, then heating and refluxing extraction secondary, 6 times of amount ethanol for the first time, measure ethanol for 5 times for the second time, each three hours, merge extractive liquid, filtered, filtrate recycling ethanol, and be 1.10 clear paste when being concentrated into 80 ℃ of relative densities; Radix Angelicae Sinensis powder is broken into coarse powder, makes solvent with 70% ethanol, floods after 96 hours slowly percolation, collects percolate 1200ml, is 1.10 clear paste when reclaiming ethanol and being concentrated into 80 ℃ of relative densities; Fructus Zanthoxyli Dissiti, Caulis Mahoniae two flavors decoct with water secondary, add 6 times of decoctings for the first time and boil 3 hours, add 6 times of decoctings for the second time and boil 2.5 hours, and collecting decoction filters, and filtrate is 1.10 clear paste when being concentrated into 80 ℃ of relative densities; All the other Radix Flemingiae Philippinensiss etc. four flavor decocts with water secondary, adds 6 times of decoctings to boil 2 hours at every turn, and the medicinal residues that add above-mentioned Herba Andrographis and Radix Angelicae Sinensis when decocting for the second time decoct together, and collecting decoction filters, and filtrate is 1.10 clear paste when being concentrated into 80 ℃ of relative densities; Merge above-mentioned four kinds of clear paste, mixing, the qinghuo reagent portion, a and polyoxyethylene monostearate S-40 portion of PEG4000, mix homogeneously fuses in the water-bath, stirs evenly, and drips to become ball in dimethicone, promptly.

7 parts of embodiments of the invention 12 Radix Angelicae Sinensis, 7 parts of Radix Codonopsis, 7 parts of Herba Andrographis, 7 parts of Fructus Zanthoxyli Dissiti, 14 parts of Radix Rosae Laevigataes, 14 parts of Caulis Spatholobis, 14 parts of Caulis Mahoniaes, 14 parts of Radix Flemingiae Philippinensiss, get Herba Andrographis and be ground into coarse powder, spend the night with 85% soak with ethanol, then heating and refluxing extraction secondary, 6 times of amount ethanol for the first time, measure ethanol for 5 times for the second time, each three hours, merge extractive liquid, filtered, filtrate recycling ethanol, and be 1.10 clear paste when being concentrated into 80 ℃ of relative densities; Radix Angelicae Sinensis powder is broken into coarse powder, makes solvent with 70% ethanol, floods after 96 hours slowly percolation, collects percolate 1200ml, is 1.10 clear paste when reclaiming ethanol and being concentrated into 80 ℃ of relative densities; Fructus Zanthoxyli Dissiti, Caulis Mahoniae two flavors decoct with water secondary, add 6 times of decoctings for the first time and boil 3 hours, add 6 times of decoctings for the second time and boil 2.5 hours, and collecting decoction filters, and filtrate is 1.10 clear paste when being concentrated into 80 ℃ of relative densities; All the other Radix Flemingiae Philippinensiss etc. four flavor decocts with water secondary, adds 6 times of decoctings to boil 2 hours at every turn, and the medicinal residues that add above-mentioned Herba Andrographis and Radix Angelicae Sinensis when decocting for the second time decoct together, and collecting decoction filters, and filtrate is 1.10 clear paste when being concentrated into 80 ℃ of relative densities; Merge above-mentioned four kinds of clear paste, mixing, qinghuo reagent portion, a and polyoxyethylene monostearate S-40 portion of PEG4000, mix homogeneously, fuse in the water-bath, stir evenly, drip and in dimethicone, to become ball, drip apart from 5cm drip footpath 2.5mm/2mm, mix 80 ℃ of ointment temperature, liquid coolant height 80cm, promptly.

7 parts of embodiments of the invention 13 Radix Angelicae Sinensis, 7 parts of Radix Codonopsis, 7 parts of Herba Andrographis, 7 parts of Fructus Zanthoxyli Dissiti, 14 parts of Radix Rosae Laevigataes, 14 parts of Caulis Spatholobis, 14 parts of Caulis Mahoniaes, 14 parts of Radix Flemingiae Philippinensiss, get Herba Andrographis, Radix Angelicae Sinensis, Caulis Mahoniae, Caulis Spatholobi and Fructus Zanthoxyli Dissiti and be ground into coarse powder, use ethanol extraction, filter, filtrate recycling ethanol concentrates; Radix Rosae Laevigatae, Radix Flemingiae Philippinensis and Radix Codonopsis decoct with water, and collecting decoction filters, and filtrate concentrates; Merge above-mentioned two kinds of clear paste, evenly, add carrageenan, make gel.

7 parts of embodiments of the invention 14 Radix Angelicae Sinensis, 7 parts of Radix Codonopsis, 7 parts of Herba Andrographis, 7 parts of Fructus Zanthoxyli Dissiti, 14 parts of Radix Rosae Laevigataes, 14 parts of Caulis Spatholobis, 14 parts of Caulis Mahoniaes, 14 parts of Radix Flemingiae Philippinensiss, get Herba Andrographis, Radix Angelicae Sinensis, Caulis Mahoniae, Caulis Spatholobi and Fructus Zanthoxyli Dissiti and be ground into coarse powder, with 8 times of amount 70% alcohol reflux secondaries, each 2 hours, merge extractive liquid,, filter, filtrate recycling ethanol, and relative density is 1.05～1.15 clear paste when being concentrated into 80 ℃; Radix Rosae Laevigatae, Radix Flemingiae Philippinensis and Radix Codonopsis decoct with water secondary, add 6 times of water gagings decocted 2 hours at every turn, the medicinal residues that add when decocting for the second time after Herba Andrographis, Radix Angelicae Sinensis, Caulis Mahoniae, Caulis Spatholobi and Fructus Zanthoxyli Dissiti extract decoct together, collecting decoction, filter, relative density was 1.055～1.15 clear paste when filtrate was concentrated into 80 ℃; Merge above-mentioned two kinds of clear paste, evenly, add distilled water, make oral liquid.

7 parts of embodiments of the invention 15 Radix Angelicae Sinensis, 7 parts of Radix Codonopsis, 7 parts of Herba Andrographis, 7 parts of Fructus Zanthoxyli Dissiti, 14 parts of Radix Rosae Laevigataes, 14 parts of Caulis Spatholobis, 14 parts of Caulis Mahoniaes, 14 parts of Radix Flemingiae Philippinensiss, get Herba Andrographis, Radix Angelicae Sinensis, Caulis Mahoniae, Caulis Spatholobi and Fructus Zanthoxyli Dissiti and be ground into coarse powder, with 8 times of amount 70% alcohol reflux secondaries, each 2 hours, merge extractive liquid,, filter, filtrate recycling ethanol, and relative density is 1.05～1.15 clear paste when being concentrated into 80 ℃; Radix Rosae Laevigatae, Radix Flemingiae Philippinensis and Radix Codonopsis decoct with water secondary, add 6 times of water gagings decocted 2 hours at every turn, the medicinal residues that add when decocting for the second time after Herba Andrographis, Radix Angelicae Sinensis, Caulis Mahoniae, Caulis Spatholobi and Fructus Zanthoxyli Dissiti extract decoct together, collecting decoction, filter, relative density was 1.055～1.15 clear paste when filtrate was concentrated into 80 ℃; Merge above-mentioned two kinds of clear paste, evenly, drying under reduced pressure gets dry extract; Dried cream powder is broken into fine powder, adds microcrystalline Cellulose 25g, uses 85% alcohol granulation, drying, and granulate adds magnesium stearate 1g, mixing, tabletting, coating is made 1000, promptly gets tablet.

7 parts of embodiments of the invention 16 Radix Angelicae Sinensis, 7 parts of Radix Codonopsis, 7 parts of Herba Andrographis, 7 parts of Fructus Zanthoxyli Dissiti, 14 parts of Radix Rosae Laevigataes, 14 parts of Caulis Spatholobis, 14 parts of Caulis Mahoniaes, 14 parts of Radix Flemingiae Philippinensiss, get Herba Andrographis, Radix Angelicae Sinensis, Caulis Mahoniae, Caulis Spatholobi and Fructus Zanthoxyli Dissiti and be ground into coarse powder, with 8 times of amount 70% alcohol reflux secondaries, each 2 hours, merge extractive liquid,, filter, filtrate recycling ethanol, and relative density is 1.05～1.15 clear paste when being concentrated into 80 ℃; Radix Rosae Laevigatae, Radix Flemingiae Philippinensis and Radix Codonopsis decoct with water secondary, add 6 times of water gagings decocted 2 hours at every turn, the medicinal residues that add when decocting for the second time after Herba Andrographis, Radix Angelicae Sinensis, Caulis Mahoniae, Caulis Spatholobi and Fructus Zanthoxyli Dissiti extract decoct together, collecting decoction, filter, relative density was 1.055～1.15 clear paste when filtrate was concentrated into 80 ℃; Merge above-mentioned two kinds of clear paste, evenly, drying under reduced pressure, dry extract is broken into fine powder, adds starch and adjusts total amount, and mix homogeneously is granulated, 50～60 ℃ of dryings, the granulate that sieves incapsulates, and makes 1000, promptly gets capsule.

7 parts of embodiments of the invention 17 Radix Angelicae Sinensis, 7 parts of Radix Codonopsis, 7 parts of Herba Andrographis, 7 parts of Fructus Zanthoxyli Dissiti, 14 parts of Radix Rosae Laevigataes, 14 parts of Caulis Spatholobis, 14 parts of Caulis Mahoniaes, 14 parts of Radix Flemingiae Philippinensiss, get Herba Andrographis, Radix Angelicae Sinensis, Caulis Mahoniae, Caulis Spatholobi and Fructus Zanthoxyli Dissiti and be ground into coarse powder, with 8 times of amount 70% alcohol reflux secondaries, each 2 hours, merge extractive liquid,, filter, filtrate recycling ethanol, and relative density is 1.05～1.15 clear paste when being concentrated into 80 ℃; Radix Rosae Laevigatae, Radix Flemingiae Philippinensis and Radix Codonopsis decoct with water secondary, add 6 times of water gagings decocted 2 hours at every turn, the medicinal residues that add when decocting for the second time after Herba Andrographis, Radix Angelicae Sinensis, Caulis Mahoniae, Caulis Spatholobi and Fructus Zanthoxyli Dissiti extract decoct together, collecting decoction, filter, relative density was 1.055～1.15 clear paste when filtrate was concentrated into 80 ℃; Merge above-mentioned two kinds of clear paste, evenly, merge above-mentioned four kinds of clear paste, mixing, it is an amount of to add aspartame 15g and dextrin, and mixing is got about 3/4 medicine liquid spray drying, makes extract powder, get the residue medicinal liquid again and do binding agent, boiling granulating in fluid bed is made 1000g, promptly gets granule.

7 parts of embodiments of the invention 18 Radix Angelicae Sinensis, 7 parts of Radix Codonopsis, 7 parts of Herba Andrographis, 7 parts of Fructus Zanthoxyli Dissiti, 14 parts of Radix Rosae Laevigataes, 14 parts of Caulis Spatholobis, 14 parts of Caulis Mahoniaes, 14 parts of Radix Flemingiae Philippinensiss, get Herba Andrographis, Radix Angelicae Sinensis, Caulis Mahoniae, Caulis Spatholobi and Fructus Zanthoxyli Dissiti and be ground into coarse powder, with 8 times of amount 70% alcohol reflux secondaries, each 2 hours, merge extractive liquid,, filter, filtrate recycling ethanol, and relative density is 1.05～1.15 clear paste when being concentrated into 80 ℃; Radix Rosae Laevigatae, Radix Flemingiae Philippinensis and Radix Codonopsis decoct with water secondary, add 6 times of water gagings decocted 2 hours at every turn, the medicinal residues that add when decocting for the second time after Herba Andrographis, Radix Angelicae Sinensis, Caulis Mahoniae, Caulis Spatholobi and Fructus Zanthoxyli Dissiti extract decoct together, collecting decoction, filter, relative density was 1.055～1.15 clear paste when filtrate was concentrated into 80 ℃; Merge clear paste, mixing at 60～70 ℃ of vacuum dryings, is pulverized, and adds an amount of starch, with 80% ethanol and soybean oil system soft material, and extruding-round as a ball pill or the general ball of making of employing coating pan, drying promptly gets pellet.

7 parts of embodiments of the invention 19 Radix Angelicae Sinensis, 7 parts of Radix Codonopsis, 7 parts of Herba Andrographis, 7 parts of Fructus Zanthoxyli Dissiti, 14 parts of Radix Rosae Laevigataes, 14 parts of Caulis Spatholobis, 14 parts of Caulis Mahoniaes, 14 parts of Radix Flemingiae Philippinensiss, get Herba Andrographis, Radix Angelicae Sinensis, Caulis Mahoniae, Caulis Spatholobi and Fructus Zanthoxyli Dissiti and be ground into coarse powder, with 8 times of amount 70% alcohol reflux secondaries, each 2 hours, merge extractive liquid,, filter, filtrate recycling ethanol, and relative density is 1.05～1.15 clear paste when being concentrated into 80 ℃; Radix Rosae Laevigatae, Radix Flemingiae Philippinensis and Radix Codonopsis decoct with water secondary, add 6 times of water gagings decocted 2 hours at every turn, the medicinal residues that add when decocting for the second time after Herba Andrographis, Radix Angelicae Sinensis, Caulis Mahoniae, Caulis Spatholobi and Fructus Zanthoxyli Dissiti extract decoct together, collecting decoction, filter, relative density was 1.055～1.15 clear paste when filtrate was concentrated into 80 ℃; Merge above-mentioned two kinds of clear paste, evenly, the qinghuo reagent portion, two parts of PEG4000 and polyoxyethylene monostearate S-40 portion, mix homogeneously fuses in the water-bath, stirs evenly, and drips to become ball in dimethicone, promptly gets drop pill.

7 parts of embodiments of the invention 20 Radix Angelicae Sinensis, 7 parts of Radix Codonopsis, 7 parts of Herba Andrographis, 7 parts of Fructus Zanthoxyli Dissiti, 14 parts of Radix Rosae Laevigataes, 14 parts of Caulis Spatholobis, 14 parts of Caulis Mahoniaes, 14 parts of Radix Flemingiae Philippinensiss, Herba Andrographis, Radix Angelicae Sinensis, Caulis Mahoniae, Caulis Spatholobi and Fructus Zanthoxyli Dissiti are ground into coarse powder, with 8 times of amount 70% alcohol reflux secondaries, each 2 hours, merge extractive liquid,, filter, filtrate recycling ethanol, and relative density is 1.05～1.15 clear paste when being concentrated into 80 ℃; Radix Rosae Laevigatae, Radix Flemingiae Philippinensis and Radix Codonopsis decoct with water secondary, add 6 times of water gagings decocted 2 hours at every turn, the medicinal residues that add when decocting for the second time after Herba Andrographis, Radix Angelicae Sinensis, Caulis Mahoniae, Caulis Spatholobi and Fructus Zanthoxyli Dissiti extract decoct together, collecting decoction, filter, relative density was 1.055～1.15 clear paste when filtrate was concentrated into 80 ℃; Merge above-mentioned two kinds of clear paste, dry, pulverize, get extract powder, select crospolyvinylpyrrolidone (PVPP) or crosslinked carboxymethyl fecula sodium (CCMS-Na) or cross-linking sodium carboxymethyl cellulose (CCMC-Na), micropowder silica gel, polyvinylpyrrolidone (PVP-K ₃₀), in the mannitol, carboxymethyl starch sodium (CMC-Na), microcrystalline Cellulose, sodium bicarbonate, lactose two or more are as adjuvant, according to extract powder: the ratio of adjuvant=1: 0.8-1.5, the mixing that sieves, tabletting, promptly.

7 parts of embodiments of the invention 21 Radix Angelicae Sinensis, 7 parts of Radix Codonopsis, 7 parts of Herba Andrographis, 7 parts of Fructus Zanthoxyli Dissiti, 14 parts of Radix Rosae Laevigataes, 14 parts of Caulis Spatholobis, 14 parts of Caulis Mahoniaes, 14 parts of Radix Flemingiae Philippinensiss, get Herba Andrographis, Radix Angelicae Sinensis, Caulis Mahoniae, Caulis Spatholobi and Fructus Zanthoxyli Dissiti and be ground into coarse powder, with 8 times of amount 70% alcohol reflux secondaries, each 2 hours, merge extractive liquid,, filter, filtrate recycling ethanol, and relative density is 1.05～1.15 clear paste when being concentrated into 80 ℃; Radix Rosae Laevigatae, Radix Flemingiae Philippinensis and Radix Codonopsis decoct with water secondary, add 6 times of water gagings decocted 2 hours at every turn, the medicinal residues that add when decocting for the second time after Herba Andrographis, Radix Angelicae Sinensis, Caulis Mahoniae, Caulis Spatholobi and Fructus Zanthoxyli Dissiti extract decoct together, collecting decoction, filter, relative density was 1.055～1.15 clear paste when filtrate was concentrated into 80 ℃; Merge clear paste, drying is pulverized, and crosses 80 mesh sieves, and the adding soybean oil is an amount of, and mixing is pressed into 1000 of soft capsules, promptly gets soft capsule.

Claims (22)

1, a kind of Chinese medicine preparation for the treatment of gynaecopathia, it is characterized in that: calculate according to components by weight percent, it is with 7～11 parts of Radix Angelicae Sinensis, 7～11 parts of Radix Codonopsis, 7～11 parts of Herba Andrographis, 7～11 parts of Fructus Zanthoxyli Dissiti, 14～18 parts of Radix Rosae Laevigataes, 14～18 parts of Caulis Spatholobis, all acceptable dosage forms on 14～18 parts of Caulis Mahoniaes and 14～18 parts of pharmaceuticss that are made of Radix Flemingiae Philippinensis comprise: injection, the powder pin, freeze-dried powder, tablet, dispersible tablet, capsule, soft capsule, microcapsule, granule, pill, micropill, powder, drop pill, slow releasing preparation, controlled release preparation, gel, oral liquid, soft extract, extractum and membrane.

2, according to the Chinese medicine preparation of the described treatment gynaecopathia of claim 1, it is characterized in that: described preparation is dispersible tablet, soft capsule, granule, micropill, gel, oral liquid, drop pill, sustained-release preparation, tablet, effervescent tablet or capsule.

3, the preparation method of the Chinese medicine preparation of treatment gynaecopathia as claimed in claim 1 or 2, it is characterized in that: get Herba Andrographis, add 85% alcohol reflux 2 times after soaked overnight or direct the pulverizing, the 1st 6 times of amounts, the 2nd 5 times of amounts, each 3 hours, merge extractive liquid,, filter, reclaim ethanol and be condensed into extractum; Get Radix Angelicae Sinensis, add 70% alcohol dipping 96 hours after the pulverizing, percolation extracts, and collects percolate, reclaims ethanol and is condensed into extractum; Get Fructus Zanthoxyli Dissiti, Caulis Mahoniae, add 8 times of water gagings and decoct 2 times, the 1st time 3 hours, the 2nd time 2.5 hours, collecting decoction filtered, and filtrate is condensed into extractum; Get Radix Flemingiae Philippinensis, Radix Codonopsis, Radix Rosae Laevigatae, Caulis Spatholobi, add 10 times of water gagings for the 1st time and decocted 2 hours, the 2nd filtering residue with Herba Andrographis, Radix Angelicae Sinensis adds 8 times of water gagings and decocted 2 hours, filters, and is condensed into extractum, and merging extractum is made different preparations then respectively.

4, according to the preparation method of the Chinese medicine preparation of the described treatment gynaecopathia of claim 3, it is characterized in that: the granule in the described preparation prepares like this: Herba Andrographis is ground into coarse powder, extract secondary with 85% alcohol heating reflux, 6 times of amount ethanol are measured ethanol, each 3 hours for 5 times for the second time for the first time, merge extractive liquid,, filter, filtrate recycling ethanol, and be 1.10 clear paste when being concentrated into 80 ℃ of relative densities; Radix Angelicae Sinensis powder is broken into coarse powder, makes solvent with 70% ethanol, floods after 96 hours slowly percolation, collects percolate 2400ml, is 1.10 clear paste when reclaiming ethanol and being concentrated into 80 ℃ of relative densities; Fructus Zanthoxyli Dissiti, Caulis Mahoniae two flavors decoct with water secondary, and 3 hours for the first time, 2.5 hours for the second time, collecting decoction filtered, and filtrate is 1.10 clear paste when being concentrated into 80 ℃ of relative densities; All the other Radix Flemingiae Philippinensiss etc. four flavor decocts with water secondary, and each 2 hours, the medicinal residues that add above-mentioned Herba Andrographis and Radix Angelicae Sinensis when decocting for the second time decocted together, and collecting decoction filters, and filtrate is 1.10 clear paste when being concentrated into 80 ℃ of relative densities; Merge above-mentioned four kinds of clear paste, mixing, it is an amount of to add aspartame 20g and dextrin, and mixing is got about 2/3 medicinal liquid drying, makes extract powder, gets the residue medicinal liquid again and does binding agent, granulates, and makes 1000g, promptly.

5, according to the preparation method of the Chinese medicine preparation of the described treatment gynaecopathia of claim 4, it is characterized in that: the granule in the described preparation prepares like this: Herba Andrographis is ground into coarse powder, extract secondary with 85% alcohol heating reflux, 6 times of amount ethanol are measured ethanol, each 3 hours for 5 times for the second time for the first time, merge extractive liquid,, filter, filtrate recycling ethanol, and be 1.10 clear paste when being concentrated into 80 ℃ of relative densities; Radix Angelicae Sinensis powder is broken into coarse powder, makes solvent with 70% ethanol, floods after 96 hours slowly percolation, collects percolate 2400ml, is 1.10 clear paste when reclaiming ethanol and being concentrated into 80 ℃ of relative densities; Fructus Zanthoxyli Dissiti, Caulis Mahoniae two flavors decoct with water secondary, and 3 hours for the first time, 2.5 hours for the second time, collecting decoction filtered, and filtrate is 1.10 clear paste when being concentrated into 80 ℃ of relative densities; All the other Radix Flemingiae Philippinensiss etc. four flavor decocts with water secondary, and each 2 hours, the medicinal residues that add above-mentioned Herba Andrographis and Radix Angelicae Sinensis when decocting for the second time decocted together, and collecting decoction filters, and filtrate is 1.10 clear paste when being concentrated into 80 ℃ of relative densities; Merge above-mentioned four kinds of clear paste, mixing, it is an amount of to add aspartame 20g and dextrin, and mixing is got about 2/3 medicine liquid spray drying, makes extract powder, gets the residue medicinal liquid again and does binding agent, boiling granulating in fluid bed, feed liquor speed 50～55ml/min; Atomisation pressure 0.15Mpa; 55～60 ℃ of temperature of charge; 80～100 ℃ of inlet temperature; 60～65 ℃ of leaving air temps, when granulation, packing, storage, envionmental humidity should be controlled at below 67%, promptly.

6, according to the preparation method of the Chinese medicine preparation of the described treatment gynaecopathia of claim 3, it is characterized in that: the dispersible tablet in the described preparation prepares like this: Herba Andrographis is ground into coarse powder, spend the night with 85% soak with ethanol, then heating and refluxing extraction secondary, 6 times of amount ethanol for the first time, measure ethanol for 5 times for the second time, each three hours, merge extractive liquid, filtered, filtrate recycling ethanol, and be 1.10 clear paste when being concentrated into 80 ℃ of relative densities; Radix Angelicae Sinensis powder is broken into coarse powder, makes solvent with 70% ethanol, floods after 96 hours slowly percolation, collects percolate 1200ml, is 1.10 clear paste when reclaiming ethanol and being concentrated into 80 ℃ of relative densities; Fructus Zanthoxyli Dissiti, Caulis Mahoniae two flavors decoct with water secondary, add 6 times of decoctings for the first time and boil 3 hours, add 6 times of decoctings for the second time and boil 2.5 hours, and collecting decoction filters, and filtrate is 1.10 clear paste when being concentrated into 80 ℃ of relative densities; All the other Radix Flemingiae Philippinensiss etc. four flavor decocts with water secondary, adds 6 times of decoctings to boil 2 hours at every turn, and the medicinal residues that add above-mentioned Herba Andrographis and Radix Angelicae Sinensis when decocting for the second time decoct together, and collecting decoction filters, and filtrate is 1.10 clear paste when being concentrated into 80 ℃ of relative densities; Merge above-mentioned four kinds of clear paste, it when continuing to be concentrated into 80 ℃ of relative densities 1.20 clear paste, merge extractum, dry, pulverize, extract powder, be disintegrating agent, be aided with micropowder silica gel, polyvinylpyrrolidone PVP-K with among crospolyvinylpyrrolidone PVPP or crosslinked carboxymethyl fecula sodium CCMS-Na or the cross-linking sodium carboxymethyl cellulose CCMC-Na one or more ₃₀, in the mannitol, carboxymethyl starch sodium CMC-Na, microcrystalline Cellulose, sodium bicarbonate, lactose two or more, add an amount of pigment again, as the pharmaceutical adjunct of dispersible tablet, according to extract powder: the ratio of pharmaceutical adjunct=1: 0.6-2, the mixing that sieves, tabletting, promptly.

7, according to the preparation method of the Chinese medicine preparation of the described treatment gynaecopathia of claim 6, it is characterized in that: the dispersible tablet in the described preparation prepares like this: Herba Andrographis is ground into coarse powder, spend the night with 85% soak with ethanol, then heating and refluxing extraction secondary, 6 times of amount ethanol for the first time, measure ethanol for 5 times for the second time, each three hours, merge extractive liquid, filtered, filtrate recycling ethanol, and be 1.10 clear paste when being concentrated into 80 ℃ of relative densities; Radix Angelicae Sinensis powder is broken into coarse powder, makes solvent with 70% ethanol, floods after 96 hours slowly percolation, collects percolate 1200ml, is 1.10 clear paste when reclaiming ethanol and being concentrated into 80 ℃ of relative densities; Fructus Zanthoxyli Dissiti, Caulis Mahoniae two flavors decoct with water secondary, add 6 times of decoctings for the first time and boil 3 hours, add 6 times of decoctings for the second time and boil 2.5 hours, and collecting decoction filters, and filtrate is 1.10 clear paste when being concentrated into 80 ℃ of relative densities; All the other Radix Flemingiae Philippinensiss etc. four flavor decocts with water secondary, adds 6 times of decoctings to boil 2 hours at every turn, and the medicinal residues that add above-mentioned Herba Andrographis and Radix Angelicae Sinensis when decocting for the second time decoct together, and collecting decoction filters, and filtrate is 1.10 clear paste when being concentrated into 80 ℃ of relative densities; Merging above-mentioned four kinds of clear paste, is 1.20 clear paste when continuing to be concentrated into 80 ℃ of relative densities; Merge extractum, drying is pulverized, and gets extract powder; Get CMC-Na: PVPP: mannitol: micropowder silica gel=1: 3-4: 1-3: 3-4 adds an amount of pigment mixing as pharmaceutical adjunct, gets 4/5 pharmaceutical adjunct and is equivalent to the extract powder mix homogeneously that CMC-Nal0 doubly measures, the PVP-K with 1.5% approximately ₃₀Anhydrous alcohol solution is made binding agent, and 40 order system material, granulate remain 1/5 pharmaceutical adjunct and an amount of caramel color mixing, be added on outward in the particle that makes, and tabletting, promptly.

8, according to the preparation method of the Chinese medicine preparation of the described treatment gynaecopathia of claim 3, it is characterized in that: the pellet in the described preparation prepares like this: Herba Andrographis is ground into coarse powder, extract secondary with 85% alcohol heating reflux, 6 times of amount ethanol for the first time, 5 times of amounts for the second time, each three hours, merge extractive liquid,, filter, filtrate recycling ethanol, and be 1.10 clear paste when being concentrated into 80 ℃ of relative densities; Radix Angelicae Sinensis powder is broken into coarse powder, makes solvent with 70% ethanol, floods after 96 hours slowly percolation, collects percolate 4800ml, is 1.10 clear paste when reclaiming ethanol and being concentrated into 80 ℃ of relative densities; Fructus Zanthoxyli Dissiti, Caulis Mahoniae two flavors decoct with water secondary, and 3 hours for the first time, 2.5 hours for the second time, collecting decoction filtered, and filtrate is 1.10 clear paste when being concentrated into 80 ℃ of relative densities; All the other Radix Flemingiae Philippinensiss etc. four flavor decocts with water secondary, and each 2 hours, the medicinal residues that add above-mentioned Herba Andrographis and Radix Angelicae Sinensis when decocting for the second time decocted together, and collecting decoction filters, and filtrate is 1.10 clear paste when being concentrated into 80 ℃ of relative densities; Merge above-mentioned four kinds of clear paste, mixing at 60～70 ℃ of vacuum dryings, is pulverized, and adds an amount of starch, and with 75% ethanol and soybean oil system soft material, push a round as a ball pill or adopt the general ball of making of coating pan, drying, promptly.

9, according to the preparation method of the Chinese medicine preparation of the described treatment gynaecopathia of claim 8, it is characterized in that: the pellet in the described preparation prepares like this: Herba Andrographis is ground into coarse powder, extract secondary with 85% alcohol heating reflux, 6 times of amount ethanol for the first time, 5 times of amounts for the second time, each three hours, merge extractive liquid,, filter, filtrate recycling ethanol, and be 1.10 clear paste when being concentrated into 80 ℃ of relative densities; Radix Angelicae Sinensis powder is broken into coarse powder, makes solvent with 70% ethanol, floods after 96 hours slowly percolation, collects percolate 4800ml, is 1.10 clear paste when reclaiming ethanol and being concentrated into 80 ℃ of relative densities; Fructus Zanthoxyli Dissiti, Caulis Mahoniae two flavors decoct with water secondary, and 3 hours for the first time, 2.5 hours for the second time, collecting decoction filtered, and filtrate is 1.10 clear paste when being concentrated into 80 ℃ of relative densities; All the other Radix Flemingiae Philippinensiss etc. four flavor decocts with water secondary, and each 2 hours, the medicinal residues that add above-mentioned Herba Andrographis and Radix Angelicae Sinensis when decocting for the second time decocted together, and collecting decoction filters, and filtrate is 1.10 clear paste when being concentrated into 80 ℃ of relative densities; Merge above-mentioned four kinds of clear paste, mixing, at 60～70 ℃ of vacuum dryings, pulverize, add an amount of starch, with 75% ethanol and 1.5% soybean oil system soft material, the soft material that makes micropill mechanism ball, wet feed pushed the 0.8mm sieve aperture, and the wet grain of strip cuts off round as a ball, 50～60 ℃ of drying and mouldings, crossing 16～20 mesh sieves selects ball or merges above-mentioned four kinds of clear paste, spray drying, wet-milling granulation molding places mould to add the great achievement ball in the coating pan, medicated powder: water is 1: 1, the coating pan rotating speed is 40r/min, and capping selects ball; When granulation, packing, storage, envionmental humidity should be controlled at below 54%, promptly.

10, according to the preparation method of the Chinese medicine preparation of the described treatment gynaecopathia of claim 3, it is characterized in that: the soft capsule in the described preparation prepares like this: Herba Andrographis is ground into coarse powder, spend the night with 85% soak with ethanol, then heating and refluxing extraction secondary, 6 times of amount ethanol for the first time, measure ethanol for 5 times for the second time, each three hours, merge extractive liquid, filtered, filtrate recycling ethanol, and be 1.10 clear paste when being concentrated into 80 ℃ of relative densities; Radix Angelicae Sinensis powder is broken into coarse powder, makes solvent with 70% ethanol, floods after 96 hours slowly percolation, collects percolate 1200ml, is 1.10 clear paste when reclaiming ethanol and being concentrated into 80 ℃ of relative densities; Fructus Zanthoxyli Dissiti, Caulis Mahoniae two flavors decoct with water secondary, add 6 times of decoctings for the first time and boil 3 hours, add 6 times of decoctings for the second time and boil 2.5 hours, and collecting decoction filters, and filtrate is 1.10 clear paste when being concentrated into 80 ℃ of relative densities; All the other Radix Flemingiae Philippinensiss etc. four flavor decocts with water secondary, adds 6 times of decoctings to boil 2 hours at every turn, and the medicinal residues that add above-mentioned Herba Andrographis and Radix Angelicae Sinensis when decocting for the second time decoct together, and collecting decoction filters, and filtrate is concentrated into that relative density surveys in the time of 80 ℃ be 1.10 clear paste; Merging above-mentioned four kinds of clear paste, is 1.20 clear paste when continuing to be concentrated into 80 ℃ of relative densities, and drying is pulverized, and crosses 80 mesh sieves, and it is an amount of to add soybean oil, and mixing is pressed into 1000 of soft capsules, promptly.

11, according to the preparation method of the Chinese medicine preparation of the described treatment gynaecopathia of claim 10, it is characterized in that: the soft capsule in the described preparation prepares like this: Herba Andrographis is ground into coarse powder, spend the night with 85% soak with ethanol, then heating and refluxing extraction secondary, 6 times of amount ethanol for the first time, measure ethanol for 5 times for the second time, each three hours, merge extractive liquid, filtered, filtrate recycling ethanol, and be 1.10 clear paste when being concentrated into 80 ℃ of relative densities; Radix Angelicae Sinensis powder is broken into coarse powder, makes solvent with 70% ethanol, floods after 96 hours slowly percolation, collects percolate 1200ml, is 1.10 clear paste when reclaiming ethanol and being concentrated into 80 ℃ of relative densities; Fructus Zanthoxyli Dissiti, Caulis Mahoniae two flavors decoct with water secondary, add 6 times of decoctings for the first time and boil 3 hours, add 6 times of decoctings for the second time and boil 2.5 hours, and collecting decoction filters, and filtrate is 1.10 clear paste when being concentrated into 80 ℃ of relative densities; All the other Radix Flemingiae Philippinensiss etc. four flavor decocts with water secondary, adds 6 times of decoctings to boil 2 hours at every turn, and the medicinal residues that add above-mentioned Herba Andrographis and Radix Angelicae Sinensis when decocting for the second time decoct together, and collecting decoction filters, and filtrate is 1.10 clear paste when being concentrated into 80 ℃ of relative densities; Merging above-mentioned four kinds of clear paste, is 1.20 clear paste when continuing to be concentrated into 80 ℃ of relative densities, and drying is pulverized, and crosses 80 mesh sieves, and by medication amount: substrate amount=1: 1.5 adds soybean oil, mixing; The prescription of rubber is a gelatin: glycerol: water: titanium dioxide=100g: 45g: 100g: 1g, batchingization adhesive tape part is: weigh batching, in the inputization glue jar, merceration is warming up to 65 ± 5 ℃ gradually after 30 minutes, stirred 5 hours and simultaneously evacuation remove bubble, treat evenly back blowing of sizing material, incapsulate after the filtration in the sizing material bucket of machine; The debugging pellet press, 65 ℃ of gelatin box temperature controls, mould rotating speed 2.0 is rolled in 45 ℃ of sprinkler body temperature controls, rubber thickness 0.8mm, 18～25 ℃ of indoor temperatures, relative humidity＜40%, pelleting; The dry typing drying of rolling that adopts combined with two steps of tray dried, dry 2 hours of the typing of rolling, and 22 ℃ of baking temperatures, dry relative humidity should be lower than 40%, and drying time is at 24～48 hours, promptly.

12, according to the preparation method of the Chinese medicine preparation of the described treatment gynaecopathia of claim 3, it is characterized in that: the drop pill in the described preparation prepares like this: Herba Andrographis is ground into coarse powder, spend the night with 85% soak with ethanol, then heating and refluxing extraction secondary, 6 times of amount ethanol for the first time, measure ethanol for 5 times for the second time, each three hours, merge extractive liquid, filtered, filtrate recycling ethanol, and be 1.10 clear paste when being concentrated into 80 ℃ of relative densities; Radix Angelicae Sinensis powder is broken into coarse powder, makes solvent with 70% ethanol, floods after 96 hours slowly percolation, collects percolate 1200ml, is 1.10 clear paste when reclaiming ethanol and being concentrated into 80 ℃ of relative densities; Fructus Zanthoxyli Dissiti, Caulis Mahoniae two flavors decoct with water secondary, add 6 times of decoctings for the first time and boil 3 hours, add 6 times of decoctings for the second time and boil 2.5 hours, and collecting decoction filters, and filtrate is 1.10 clear paste when being concentrated into 80 ℃ of relative densities; All the other Radix Flemingiae Philippinensiss etc. four flavor decocts with water secondary, adds 6 times of decoctings to boil 2 hours at every turn, and the medicinal residues that add above-mentioned Herba Andrographis and Radix Angelicae Sinensis when decocting for the second time decoct together, and collecting decoction filters, and filtrate is 1.10 clear paste when being concentrated into 80 ℃ of relative densities; Merge above-mentioned four kinds of clear paste, mixing, qinghuo reagent and 1.5-2.5 water-soluble base mix homogeneously doubly, fusion in the water-bath stirs evenly, and drips to become ball in dimethicone or other fat-soluble coolants, promptly.

13, according to the preparation method of the Chinese medicine preparation of the described treatment gynaecopathia of claim 12, it is characterized in that: the drop pill in the described preparation prepares like this: Herba Andrographis is ground into coarse powder, spend the night with 85% soak with ethanol, then heating and refluxing extraction secondary, 6 times of amount ethanol for the first time, measure ethanol for 5 times for the second time, each three hours, merge extractive liquid, filtered, filtrate recycling ethanol, and be 1.10 clear paste when being concentrated into 80 ℃ of relative densities; Radix Angelicae Sinensis powder is broken into coarse powder, makes solvent with 70% ethanol, floods after 96 hours slowly percolation, collects percolate 1200ml, is 1.10 clear paste when reclaiming ethanol and being concentrated into 80 ℃ of relative densities; Fructus Zanthoxyli Dissiti, Caulis Mahoniae two flavors decoct with water secondary, add 6 times of decoctings for the first time and boil 3 hours, add 6 times of decoctings for the second time and boil 2.5 hours, and collecting decoction filters, and filtrate is 1.10 clear paste when being concentrated into 80 ℃ of relative densities; All the other Radix Flemingiae Philippinensiss etc. four flavor decocts with water secondary, adds 6 times of decoctings to boil 2 hours at every turn, and the medicinal residues that add above-mentioned Herba Andrographis and Radix Angelicae Sinensis when decocting for the second time decoct together, and collecting decoction filters, and filtrate is 1.10 clear paste when being concentrated into 80 ℃ of relative densities; Merge above-mentioned four kinds of clear paste, mixing, qinghuo reagent portion, a and polyoxyethylene monostearate S-40 portion of PEG4000, mix homogeneously, fuse in the water-bath, stir evenly, drip and in dimethicone, to become ball, drip apart from 5cm drip footpath 2.5mm/2mm, mix 80 ℃ of ointment temperature, liquid coolant height 80cm, promptly.

14, the preparation method of the Chinese medicine preparation of treatment gynaecopathia as claimed in claim 1 or 2 is characterized in that: Herba Andrographis, Radix Angelicae Sinensis, Caulis Mahoniae, Caulis Spatholobi and Fructus Zanthoxyli Dissiti are ground into coarse powder, use ethanol extraction, filter, and filtrate recycling ethanol concentrates; Radix Rosae Laevigatae, Radix Flemingiae Philippinensis and Radix Codonopsis decoct with water, and collecting decoction filters, and filtrate concentrates; Merge above-mentioned two kinds of clear paste, mixing adds adjuvant and makes different dosage form.

15, according to the preparation method of the Chinese medicine preparation of the described treatment gynaecopathia of claim 14, it is characterized in that: Herba Andrographis, Radix Angelicae Sinensis, Caulis Mahoniae, Caulis Spatholobi and Fructus Zanthoxyli Dissiti are ground into coarse powder, with 8 times of amount 70% alcohol reflux secondaries, each 2 hours, merge extractive liquid,, filter, filtrate recycling ethanol, and relative density is 1.05～1.15 clear paste when being concentrated into 80 ℃; Radix Rosae Laevigatae, Radix Flemingiae Philippinensis and Radix Codonopsis decoct with water secondary, add 6 times of water gagings decocted 2 hours at every turn, the medicinal residues that add when decocting for the second time after Herba Andrographis, Radix Angelicae Sinensis, Caulis Mahoniae, Caulis Spatholobi and Fructus Zanthoxyli Dissiti extract decoct together, collecting decoction, filter, relative density was 1.055～1.15 clear paste when filtrate was concentrated into 80 ℃; Merge above-mentioned two kinds of clear paste, evenly, add adjuvant and make different dosage form.

16, according to the preparation method of the Chinese medicine preparation of claim 14 or 15 described treatment gynaecopathias, it is characterized in that: the tablet in the described preparation prepares like this: Herba Andrographis, Radix Angelicae Sinensis, Caulis Mahoniae, Caulis Spatholobi and Fructus Zanthoxyli Dissiti are ground into coarse powder, with 8 times of amount 70% alcohol reflux secondaries, each 2 hours, merge extractive liquid,, filter, filtrate recycling ethanol, and relative density is 1.05～1.15 clear paste when being concentrated into 80 ℃; Radix Rosae Laevigatae, Radix Flemingiae Philippinensis and Radix Codonopsis decoct with water secondary, add 6 times of water gagings decocted 2 hours at every turn, the medicinal residues that add when decocting for the second time after Herba Andrographis, Radix Angelicae Sinensis, Caulis Mahoniae, Caulis Spatholobi and Fructus Zanthoxyli Dissiti extract decoct together, collecting decoction, filter, relative density was 1.055～1.15 clear paste when filtrate was concentrated into 80 ℃; Merge above-mentioned two kinds of clear paste, evenly, drying under reduced pressure gets dry extract; Dried cream powder is broken into fine powder, adds microcrystalline Cellulose 25g, uses 85% alcohol granulation, drying, and granulate adds magnesium stearate 1g, mixing, tabletting, coating is made 1000, promptly.

17, according to the preparation method of the Chinese medicine preparation of claim 14 or 15 described treatment gynaecopathias, it is characterized in that: the capsule in the described preparation prepares like this: Herba Andrographis, Radix Angelicae Sinensis, Caulis Mahoniae, Caulis Spatholobi and Fructus Zanthoxyli Dissiti are ground into coarse powder, with 8 times of amount 70% alcohol reflux secondaries, each 2 hours, merge extractive liquid,, filter, filtrate recycling ethanol, and relative density is 1.05～1.15 clear paste when being concentrated into 80 ℃; Radix Rosae Laevigatae, Radix Flemingiae Philippinensis and Radix Codonopsis decoct with water secondary, add 6 times of water gagings decocted 2 hours at every turn, the medicinal residues that add when decocting for the second time after Herba Andrographis, Radix Angelicae Sinensis, Caulis Mahoniae, Caulis Spatholobi and Fructus Zanthoxyli Dissiti extract decoct together, collecting decoction, filter, relative density was 1.055～1.15 clear paste when filtrate was concentrated into 80 ℃; Merge above-mentioned two kinds of clear paste, evenly, drying under reduced pressure, dry extract is broken into fine powder, adds starch and adjusts total amount, and mix homogeneously is granulated, 50～60 ℃ of dryings, the granulate that sieves incapsulates, and makes 1000, promptly.

18, according to the preparation method of the Chinese medicine preparation of claim 14 or 15 described treatment gynaecopathias, it is characterized in that: the granule in the described preparation prepares like this: Herba Andrographis, Radix Angelicae Sinensis, Caulis Mahoniae, Caulis Spatholobi and Fructus Zanthoxyli Dissiti are ground into coarse powder, with 8 times of amount 70% alcohol reflux secondaries, each 2 hours, merge extractive liquid,, filter, filtrate recycling ethanol, and relative density is 1.05～1.15 clear paste when being concentrated into 80 ℃; Radix Rosae Laevigatae, Radix Flemingiae Philippinensis and Radix Codonopsis decoct with water secondary, add 6 times of water gagings decocted 2 hours at every turn, the medicinal residues that add when decocting for the second time after Herba Andrographis, Radix Angelicae Sinensis, Caulis Mahoniae, Caulis Spatholobi and Fructus Zanthoxyli Dissiti extract decoct together, collecting decoction, filter, relative density was 1.055～1.15 clear paste when filtrate was concentrated into 80 ℃; Merge above-mentioned two kinds of clear paste, evenly, merge above-mentioned four kinds of clear paste, mixing, it is an amount of to add aspartame 15g and dextrin, and mixing is got about 3/4 medicine liquid spray drying, makes extract powder, get the residue medicinal liquid again and do binding agent, boiling granulating in fluid bed is made 1000g, promptly.

19, according to the preparation method of the Chinese medicine preparation of claim 14 or 15 described treatment gynaecopathias, it is characterized in that: the pellet in the described preparation prepares like this: Herba Andrographis, Radix Angelicae Sinensis, Caulis Mahoniae, Caulis Spatholobi and Fructus Zanthoxyli Dissiti are ground into coarse powder, with 8 times of amount 70% alcohol reflux secondaries, each 2 hours, merge extractive liquid,, filter, filtrate recycling ethanol, and relative density is 1.05～1.15 clear paste when being concentrated into 80 ℃; Radix Rosae Laevigatae, Radix Flemingiae Philippinensis and Radix Codonopsis decoct with water secondary, add 6 times of water gagings decocted 2 hours at every turn, the medicinal residues that add when decocting for the second time after Herba Andrographis, Radix Angelicae Sinensis, Caulis Mahoniae, Caulis Spatholobi and Fructus Zanthoxyli Dissiti extract decoct together, collecting decoction, filter, relative density was 1.055～1.15 clear paste when filtrate was concentrated into 80 ℃; Merge clear paste, mixing at 60～70 ℃ of vacuum dryings, is pulverized, and adds an amount of starch, with 80% ethanol and soybean oil system soft material, and extruding-round as a ball pill or the general ball of making of employing coating pan, drying, promptly.

20, according to the preparation method of the Chinese medicine preparation of claim 14 or 15 described treatment gynaecopathias, it is characterized in that: the drop pill in the described preparation prepares like this: Herba Andrographis, Radix Angelicae Sinensis, Caulis Mahoniae, Caulis Spatholobi and Fructus Zanthoxyli Dissiti are ground into coarse powder, with 8 times of amount 70% alcohol reflux secondaries, each 2 hours, merge extractive liquid,, filter, filtrate recycling ethanol, and relative density is 1.05～1.15 clear paste when being concentrated into 80 ℃; Radix Rosae Laevigatae, Radix Flemingiae Philippinensis and Radix Codonopsis decoct with water secondary, add 6 times of water gagings decocted 2 hours at every turn, the medicinal residues that add when decocting for the second time after Herba Andrographis, Radix Angelicae Sinensis, Caulis Mahoniae, Caulis Spatholobi and Fructus Zanthoxyli Dissiti extract decoct together, collecting decoction, filter, relative density was 1.055～1.15 clear paste when filtrate was concentrated into 80 ℃; Merge above-mentioned two kinds of clear paste, evenly, the qinghuo reagent portion, two parts of PEG4000 and polyoxyethylene monostearate S-40 portion, mix homogeneously fuses in the water-bath, stirs evenly, and drips to become ball in dimethicone, promptly.

21, according to the preparation method of the Chinese medicine preparation of claim 14 or 15 described treatment gynaecopathias, it is characterized in that: the dispersible tablet in the described preparation prepares like this: Herba Andrographis, Radix Angelicae Sinensis, Caulis Mahoniae, Caulis Spatholobi and Fructus Zanthoxyli Dissiti are ground into coarse powder, with 8 times of amount 70% alcohol reflux secondaries, each 2 hours, merge extractive liquid,, filter, filtrate recycling ethanol, and relative density is 1.05～1.15 clear paste when being concentrated into 80 ℃; Radix Rosae Laevigatae, Radix Flemingiae Philippinensis and Radix Codonopsis decoct with water secondary, add 6 times of water gagings decocted 2 hours at every turn, the medicinal residues that add when decocting for the second time after Herba Andrographis, Radix Angelicae Sinensis, Caulis Mahoniae, Caulis Spatholobi and Fructus Zanthoxyli Dissiti extract decoct together, collecting decoction, filter, relative density was 1.055～1.15 clear paste when filtrate was concentrated into 80 ℃; Merge above-mentioned two kinds of clear paste, drying is pulverized, and gets extract powder, selects crospolyvinylpyrrolidone PVPP or crosslinked carboxymethyl fecula sodium CCMS-Na or cross-linking sodium carboxymethyl cellulose CCMC-Na, micropowder silica gel, polyvinylpyrrolidone PVP-K ₃₀, in the mannitol, carboxymethyl starch sodium CMC-Na, microcrystalline Cellulose, sodium bicarbonate, lactose two or more are as adjuvant, according to extract powder: the ratio of adjuvant=1: 0.8-1.5, the mixing that sieves, tabletting, promptly.

22, according to the preparation method of the Chinese medicine preparation of claim 14 or 15 described treatment gynaecopathias, it is characterized in that: the soft capsule in the described preparation prepares like this: Herba Andrographis, Radix Angelicae Sinensis, Caulis Mahoniae, Caulis Spatholobi and Fructus Zanthoxyli Dissiti are ground into coarse powder, with 8 times of amount 70% alcohol reflux secondaries, each 2 hours, merge extractive liquid,, filter, filtrate recycling ethanol, and relative density is 1.05～1.15 clear paste when being concentrated into 80 ℃; Radix Rosae Laevigatae, Radix Flemingiae Philippinensis and Radix Codonopsis decoct with water secondary, add 6 times of water gagings decocted 2 hours at every turn, the medicinal residues that add when decocting for the second time after Herba Andrographis, Radix Angelicae Sinensis, Caulis Mahoniae, Caulis Spatholobi and Fructus Zanthoxyli Dissiti extract decoct together, collecting decoction, filter, relative density was 1.055～1.15 clear paste when filtrate was concentrated into 80 ℃; Merge clear paste, drying is pulverized, and crosses 80 mesh sieves, and the adding soybean oil is an amount of, and mixing is pressed into 1000 of soft capsules, promptly.