CN103239653B - Traditional Chinese medicine composition for psoriasis and preparation method thereof - Google Patents
Traditional Chinese medicine composition for psoriasis and preparation method thereof Download PDFInfo
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- CN103239653B CN103239653B CN201210030826.3A CN201210030826A CN103239653B CN 103239653 B CN103239653 B CN 103239653B CN 201210030826 A CN201210030826 A CN 201210030826A CN 103239653 B CN103239653 B CN 103239653B
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Abstract
The invention relates to a traditional Chinese medicine composition for psoriasis and a preparation method thereof. The traditional Chinese medicine composition is prepared by two medicines of rhizoma smilacis glabrae and smilax china L.. The composition has an effect of expelling wind and detoxifying, and is mainly used for treating psoriasis. Compared with the prior art, the composition is advanced in technology, clinical pharmacodynamic test results of the composition is improved significantly, the bioavailability is high, and the composition has no any side effects.
Description
Technical field
The present invention relates to a kind ofly for psoriatic Chinese medicine composition and preparation method thereof, belong to pharmaceutical technology field.
Technical background
Psoriasis is a kind of common dermatosis, has a strong impact on patient's daily life and work.At present, treat psoriatic Chinese patent medicine a lot, but curative effect is undesirable mostly, cure rate is low, and easily recurrence.Under the tenth WS3-B-2033-95 item of ministry standard < < Traditional Chinese medicine historical preparation > >, " silver bits electuary " is a kind of pure Chinese medicinal preparation, this medicine, through clinical application for many years, is being obtained certain curative effect aspect treatment psoriasis; But the defects such as we find that its curative effect is desirable not enough in the middle of clinical application, exist cure rate low, easily recur, and technique is thicker; Granule is containing Icing Sugar, and diabetic can not be taken, and adaptation population is restricted.
For solving the existing defect of prior art, in the time in recent years, we are by excavating the abundant Chinese medicine resource of motherland, and in conjunction with a large amount of Study on clinical pharmacodynamics, we are on the basis of original " silver bits electuary " technique, by a large amount of experiments, grope, discovery makes the water extraction in original technique into Rhizoma Smilacis Chinensis ethanol percolation, and after medicinal residues decoct with water with Rhizoma Smilacis Glabrae again, its clinical pharmacodynamic experiment effect significantly improves, have good stability, and without any side effects; We routinely technique made: capsule, tablet and granule.
Summary of the invention
The object of the invention is to: provide a kind of for psoriatic Chinese medicine composition and preparation method thereof.
For achieving the above object, the technical solution used in the present invention is:
Prescription proportioning:
Rhizoma Smilacis Glabrae 3375g Rhizoma Smilacis Chinensis 3375g.
Preparation method is: above two tastes, Rhizoma Smilacis Chinensis is ground into coarse powder, percolation secondary, with 8 times, measure 85% ethanol for the first time, with the ethanol of 8 times of amounts 60%, carry out percolation for the second time, percolation speed is 5ml/min, merges above percolate, it is that the clear paste of 1.05-1.10 (60 ℃ ± 1) is standby that decompression recycling ethanol (0.08Mpa, 70 ℃) is concentrated into relative density; After Rhizoma Smilacis Chinensis percolation, medicinal residues and Rhizoma Smilacis Glabrae decoct with water three times, add for the first time 12 times of water gagings, decoct 3 hours, second and third time respectively adds 10 times of water gagings, decoct respectively 2 hours, collecting decoction, filters, and filtrate decompression concentrates (0.08MPa, 80 ℃) to relative density, be the clear paste of 1.05-1.10 (60 ℃ ± 1), merge mix homogeneously, dry (150 ℃-170 ℃ of the inlet temperature of spraying with above-mentioned clear paste, leaving air temp 70-75 ℃), add each dosage form proper auxiliary materials, mix, by each dosage form common process, make capsule, tablet or granule.Preparation method of the present invention is:
1, capsule of the present invention:
Prescription proportioning:
Rhizoma Smilacis Glabrae 3375g Rhizoma Smilacis Chinensis 3375g;
Preparation method is: above two tastes, Rhizoma Smilacis Chinensis is ground into coarse powder, percolation secondary, with 8 times, measure 85% ethanol for the first time, with the ethanol of 8 times of amounts 60%, carry out percolation for the second time, percolation speed is 5ml/min, merges above percolate, it is that the clear paste of 1.05-1.10 (60 ℃ ± 1) is standby that decompression recycling ethanol (0.08Mpa, 70 ℃) is concentrated into relative density; After Rhizoma Smilacis Chinensis percolation, medicinal residues and Rhizoma Smilacis Glabrae decoct with water three times, add for the first time 12 times of water gagings, decoct 3 hours, second and third time respectively adds 10 times of water gagings, decoct respectively 2 hours, collecting decoction, filters, and filtrate decompression concentrates (0.08MPa, 80 ℃) to relative density, be the clear paste of 1.05-1.10 (60 ℃ ± 1), merge mix homogeneously, dry (150 ℃-170 ℃ of the inlet temperature of spraying with above-mentioned clear paste, leaving air temp 70-75 ℃), add appropriate amount of starch, mix, granulate, dry, granulate, encapsulated, obtain capsule.
2, tablet of the present invention:
Rhizoma Smilacis Glabrae 3375g Rhizoma Smilacis Chinensis 3375g;
Preparation method is: above two tastes, Rhizoma Smilacis Chinensis is ground into coarse powder, percolation secondary, with 8 times, measure 85% ethanol for the first time, with the ethanol of 8 times of amounts 60%, carry out percolation for the second time, percolation speed is 5ml/min, merges above percolate, it is that the clear paste of 1.05-1.10 (60 ℃ ± 1) is standby that decompression recycling ethanol (0.08Mpa, 70 ℃) is concentrated into relative density; After Rhizoma Smilacis Chinensis percolation, medicinal residues and Rhizoma Smilacis Glabrae decoct with water three times, add for the first time 12 times of water gagings, decoct 3 hours, second and third time respectively adds 10 times of water gagings, decocts respectively collecting decoction 2 hours, filter, filtrate decompression concentrated (0.08MPa, 80 ℃) is the clear paste of 1.05-1.10 (60 ℃ ± 1) to relative density, merges with above-mentioned clear paste, mix homogeneously, spraying dry (150 ℃-170 ℃ of inlet temperature, leaving air temp 70-75 ℃), adds appropriate amount of starch, mix, granulate, dry, granulate, add appropriate magnesium stearate, mix, tabletting, obtains tablet.
3, granule of the present invention:
Rhizoma Smilacis Glabrae 3375g Rhizoma Smilacis Chinensis 3375g;
Preparation method is: above two tastes, Rhizoma Smilacis Chinensis is ground into coarse powder, percolation secondary, with 8 times, measure 85% ethanol for the first time, with the ethanol of 8 times of amounts 60%, carry out percolation for the second time, percolation speed is 5ml/min, merges above percolate, it is that the clear paste of 1.05-1.10 (60 ℃ ± 1) is standby that decompression recycling ethanol (0.08Mpa, 70 ℃) is concentrated into relative density; After Rhizoma Smilacis Chinensis percolation, medicinal residues and Rhizoma Smilacis Glabrae decoct with water three times, add for the first time 12 times of water gagings, decoct 3 hours, second and third time respectively adds 10 times of water gagings, decoct respectively 2 hours, collecting decoction, filters, and filtrate decompression concentrates (0.08MPa, 80 ℃) to relative density, be the clear paste of 1.05-1.10 (60 ℃ ± 1), merge mix homogeneously, dry (150 ℃-170 ℃ of the inlet temperature of spraying with above-mentioned clear paste, leaving air temp 70-75 ℃), add appropriate dextrin, mix, granulate, dry, granulate, pack, obtains granule.
The present invention program is through inventor's repetition test repeatedly, updates summary out, and the preparation method of above-mentioned Chinese medicine composition medicine is best preparation method, and clinical pharmacodynamic experiment effect significantly improves.
Under the tenth WS3-B-2033-95 item of Chinese medicine capsules contrast ministry standard < < Traditional Chinese medicine historical preparation > > of preparing with the present invention " silver bits electuary ", its Pharmacodynamics is described below:
Pharmacodynamics experiment
Experiment purpose: by pharmacological experiment studies such as antiinflammatory, cell proliferation and the keratinization of capsule of the present invention and silver bits electuary, antipruritic, antiallergic and immunity of organism, capsule of the present invention and silver bits electuary are contrasted, observe the power of its pharmacological action.
Test method: the impact of capsule of the present invention and silver bits electuary xylol induced mice auricle edema; Impact on mouse skin capillary permeability; On the mitotic impact of mouse vagina epithelial cell; Impact on mouse tail scale keratinization; Histamine phosphate is caused to Cavia porcellus causes the impact of the reaction of itching; Impact on mice hemolysin content; Dinitrofluorobenzene is brought out to the impact of delayed hypersensitivity.
Experimental result: capsule of the present invention and silver bits electuary obviously suppress dimethylbenzene induced mice auricle edema; To mouse skin capillary permeability is hyperfunction, there is a remarkable inhibitory action; Can obviously suppress the mitotic activity of mouse vagina epithelial cell, there is antiproliferative effect; Mouse tail scale granular layer is formed to number and significantly improve, obviously promote the keratinization of mouse tail skin of back scale; Can obviously improve the itch-threshold that histamine phosphate causes Cavia porcellus pruritus; Can obviously reduce mice hemolysin content; Can obviously suppress dinitrofluorobenzene and bring out mice delayed hypersensitivity.
Conclusion: capsule of the present invention than the antiinflammatory of silver bits electuary, suppress cell proliferation, promote that the pharmacological actions such as the keratinization of cell, antipruritic, antiallergic and raising immunity of organisms are strong, therefore, capsule of the present invention is better than the psoriatic clinical efficacy of silver bits Chongji for Treatment.
The preparation of trial drug:
1, capsule of the present invention makes according to the method for embodiment 1.
2, silver bits electuary is that market is bought.
One, the impact of xylol induced mice auricle edema
Experiment material
1, animal: Kunming mouse, body weight 18～22g.
2, medicine: silver bits electuary 27g crude drug/bag; Large, medium and small three the dosage group 6.75g crude drug/grains of capsule of the present invention.Medicine configures with normal saline before experiment, gastric infusion.
Experimental technique
50 of Kunming mouses, male and female half and half, body weight 18～22g, is divided into 5 groups at random, 10 every group.The normal saline of matched group gavage same volume; Capsule group of the present invention is gastric infusion 21.6,10.8,5.4g crude drug/kg respectively; Silver bits electuary group gastric infusion 21.6g crude drug/kg.Successive administration 7d, every day 1 time, after last administration 1h, with 100% dimethylbenzene 0.03ml/, be only applied to two sides inside and outside auris dextra, left ear is not done any processing, after 0.5h, mice etherization is put to death, subtract lower ears and at the same position of mice, lay round auricle respectively with 9mm diameter macropore device, weigh.Calculate mice ear degree (mice ear degree=auris dextra sheet weight-left auricle weight).
Experimental result: in Table 1
The impact of table 1 on swelling due to Mice Auricle dimethylbenzene
Compare * * P < 0.01 with matched group; Consider electuary group to be worth doing than △ P < 0.05 with silver.
Result shows: capsule group of the present invention and silver bits electuary group xylol induced mice auricle edema have significant inhibitory action, have compared utmost point significant difference (P < 0.01) with matched group; The heavy dose of significant difference (P < 0.05) of having compared with silver bits electuary group of organizing of capsule of the present invention.Visible, capsule group of the present invention is stronger than silver bits electuary group antiinflammatory action.
Two, the impact on mouse skin capillary permeability
Experiment material
1, animal: Kunming mouse, body weight 18～22g.
2, medicine: silver bits electuary 27g crude drug/bag; Large, medium and small three the dosage group 6.75g crude drug/grains of capsule of the present invention.Medicine configures with normal saline before experiment, gastric infusion.
Experimental technique
50 of Kunming mouses, male and female half and half, body weight 18～22g, is divided into 5 groups at random, 10 every group.The normal saline of matched group gavage same volume; Capsule group of the present invention is gastric infusion 21.6,10.8,5.4g crude drug/kg respectively; Silver bits electuary group gastric infusion 21.6g crude drug/kg.Successive administration 7d, after last administration 1h, every tail vein injection 0.5% azovan blue 0.2ml/10g, is only coated with dimethylbenzene 0.04ml/ in abdominal part depilation place after 15min, puts to death mice after 15min, gets indigo plant and dyes skin and suitably shred.Put acetone: in normal saline (7: 3) liquid, soak 48h.After centrifugal, get supernatant in spectrophotometer wavelength 610nm place's colorimetric determination trap (OD) value.Experimental result: in Table 2
The impact of table 2 on mouse skin capillary permeability
Compare * * P < 0.01 with matched group; Consider electuary group to be worth doing than △ P < 0.05 with silver.
Result: capsule group of the present invention and silver bits electuary group have a remarkable inhibitory action to mouse skin capillary permeability is hyperfunction, compare have the difference of utmost point significance (P < 0.01) with matched group; The heavy dose of significant difference (P < 0.05) of having compared with silver bits electuary group of organizing of capsule of the present invention.Visible, the inhibitory action that capsule group of the present invention is oozed out edema inflammation than silver bits electuary group is strong.
Three, on the mitotic impact of mouse vagina epithelial cell
Experiment material
1, animal: Kunming mouse, body weight 18～22g.
2, medicine: silver bits electuary 27g crude drug/bag; Large, medium and small three the dosage group 6.75g crude drug/grains of capsule of the present invention.Medicine configures with normal saline before experiment, gastric infusion.
Experimental technique
50 of Kunming kind female mices, body weight 18～22g, is divided into 5 groups at random, 10 every group.The normal saline of matched group gavage same volume; Capsule group of the present invention is gastric infusion 21.6,10.8,5.4g crude drug/kg respectively; Silver bits electuary group gastric infusion 21.6g crude drug/kg.Successive administration 7d, every day 1 time.Before self administration of medication, 3d starts lumbar injection diethylstilbestrol, and each 0.2mg/ only, every day 1 time, injects 3d continuously.For avoiding the impact of the Circadian rhythm of cell mitogen on data, last 1 administration is unified in 8:00 in the morning, the morning 9:00 lumbar injection colchicine 3mg/kg, make mitosis stop at the mid-term of M phase and be convenient to counting.In last administration 2:00 that afternoon, put to death mice, get conventional fixing, the embedding of vagina specimen, HE dyeing.With optics microscope observing cell mitosis, count the mitosis number in 500 basal cells, the mitosis number of calculating every 100 basal cells is mitotic index.Experimental result: in Table 3
Table 3 is on the mitotic impact of mouse vagina epithelial cell
Compare * * P < 0.01 with matched group; Consider electuary group to be worth doing than △ P < 0.05 with silver.
Result: capsule group of the present invention and silver bits electuary group can obviously suppress the mitotic activity of mouse vagina epithelial cell, have obvious antiproliferative effect, relatively have utmost point significant difference (P < 0.01) with matched group; The heavy dose of significant difference (P < 0.05) of having compared with silver bits electuary group of organizing of capsule of the present invention.Visible, it is strong that capsule group of the present invention suppresses cel l proliferation than silver bits electuary group.
Four, the impact on mouse tail scale keratinization
Experiment material
1, animal: Kunming mouse, body weight 18～22g.
2, medicine: silver bits electuary 27g crude drug/bag; Large, medium and small three the dosage group 6.75g crude drug/grains of capsule of the present invention.Medicine configures with normal saline before experiment, gastric infusion.
Experimental technique
50 of Kunming mouses, male and female half and half, body weight 18～22g, is divided into 5 groups at random, 10 every group.The normal saline of matched group gavage same volume; Capsule group of the present invention is gastric infusion 21.6,10.8,5.4g crude drug/kg respectively; Silver bits electuary group gastric infusion 21.6g crude drug/kg.Successive administration 7d, every day 1 time.Last administration next day, de-cervical vertebra was put to death mice, got afterbody rectangular apart from root of the tail about 2cm place back side skin one, and conventional fixing, embedding, HE dye, at the tail scale of every mice of optical microphotograph Microscopic observation.The granular layer cell person that every scale has connection to embark on journey, is called the scale that has granular layer.Count the scale number that has granular layer in every 100 scales.
Experimental result: in Table 4
The impact of table 4 on mouse tail scale keratinization
Compare * * P < 0.01 with matched group; Consider electuary group to be worth doing than △ P < 0.05 with silver.
Result: capsule group of the present invention and silver bits electuary group form number to mouse tail scale granular layer and significantly improve, and obviously promote the keratinization of mouse tail skin of back scale, relatively have utmost point significant difference (P < 0.01) with matched group; The heavy dose of significant difference (P < 0.05) of having compared with silver bits electuary group of organizing of capsule of the present invention.Visible, capsule group of the present invention promotes that than silver bits electuary group the cornified effect of skin impressions is strong.
Five, histamine phosphate is caused to Cavia porcellus causes the impact of the reaction of itching
Experiment material
1, animal: Cavia porcellus, body weight 220～250g.
2, medicine: silver bits electuary 27g crude drug/bag; Large, medium and small three the dosage group 6.75g crude drug/grains of capsule of the present invention.Medicine configures with normal saline before experiment, gastric infusion.
Experimental technique
50 of healthy guinea pigs, male and female half and half, body weight 220～250g, is divided into 5 groups at random, 10 every group.The normal saline of matched group gavage same volume; Capsule group of the present invention is gastric infusion 12.8,6.4,3.2g crude drug/kg respectively; Silver bits electuary group gastric infusion 12.8g crude drug/kg.Successive administration 7d, every day 1 time.In administration, within the 7th day, with shears, cut off Cavia porcellus thigh lateral hair, the about 1cm of area
2, with shaver, shave clean fine hair, then abrade to oozing of blood with coarse sandpaper.1h after last administration, starts at wound surface Chu Di 0.01% 0.05ml/ of histamine phosphate only, after this every 3min, to comply with 0.02%, 0.03%, 0.04% ... progressive concentration is only 0.05ml/ at every turn.Until occur that Cavia porcellus later licks abrasion, the histamine phosphate total amount that the Cavia porcellus that causes of take occurs later licking right thigh lateral and given is itch-threshold, asks each cell mean.Experimental result: in Table 5
Table 5 causes that on histamine phosphate Cavia porcellus causes the impact of the reaction of itching
Compare * * P < 0.01 with matched group; Consider electuary group to be worth doing than △ P < 0.05 with silver.
Result: capsule group of the present invention and silver bits electuary group can obviously improve the itch-threshold that histamine phosphate causes Cavia porcellus pruritus, relatively have utmost point significant difference (P < 0.01) with matched group; The heavy dose of significant difference (P < 0.05) of having compared with silver bits electuary group of organizing of capsule of the present invention.Visible, capsule group of the present invention is stronger than the itching-relieving action of silver bits electuary group.
Six, the impact on mice hemolysin content
Experiment material
1, animal: Kunming mouse, body weight 18～22g.
2, medicine: silver bits electuary 27g crude drug/bag; Large, medium and small three the dosage group 6.75g crude drug/grains of capsule of the present invention.Medicine configures with normal saline before experiment, gastric infusion.。
Experimental technique
50 of Kunming mouses, male and female half and half, body weight 18～22g, is divided into 5 groups at random, 10 every group.The normal saline of matched group gavage same volume; Capsule group of the present invention is gastric infusion 21.6,10.8,5.4g crude drug/kg respectively; Silver bits electuary group gastric infusion 21.6g crude drug/kg.Successive administration 7d, animal is put to death in last administration next day.4d before putting to death animal, every mouse peritoneal injection sheep red blood cell (SRBC) (SRBC) suspension 0.2ml (approximately 400,000,000 cells) carries out immunity.Pluck eyeball and get blood, place after 30min, the centrifugal 10min of 2000r/min, diluted serum with normal saline by 1: 300.By the mice serum 1ml after dilution, SRBC liquid 0.5ml adds in test tube, then adds the mice serum 1ml through normal saline dilution in 1: 10.Matched group is with equal-volume physiologic saline for substitute mice serum.Test tube is placed in after 37 ℃ of water-bath 10min, is placed in immediately ice bath with cessation reaction, cooling rear centrifugal.Get supernatant 1ml, Dou Shi liquid 3ml adds in test tube, mixes rear standing 10min, measures trap value at 540nm place.
Separately in a test tube, add 0.25mlSRBC and Dou Shi liquid 3.75ml, the trap value while measuring SRBC HD50.
Sample half hemolysis value=(trap value during absorption of sample degree value/SRBC HD50) * serum diluting multiple
Experimental result: in Table 6
The impact of table 6 on mice hemolysin content
Compare * * P < 0.01 with matched group; Consider electuary group to be worth doing than △ P < 0.05 with silver.
Result: capsule group of the present invention and silver bits electuary group can obviously reduce mice hemolysin content, compare have the difference of utmost point significance (P < 0.01) with matched group; The heavy dose of significant difference (P < 0.05) of having compared with silver bits electuary group of organizing of capsule of the present invention.Visible, capsule group of the present invention is stronger than silver bits electuary group raising immunization.
Seven, dinitrofluorobenzene is brought out the impact of delayed hypersensitivity
Experiment material
1, animal: Kunming mouse, body weight 18～22g.
2, medicine: silver bits electuary 27g crude drug/bag; Large, medium and small three the dosage group 6.75g crude drug/grains of capsule of the present invention.Medicine configures with normal saline before experiment, gastric infusion.
Experimental technique
50 of Kunming mouses, male and female half and half, body weight 18～22g, is divided into 5 groups at random, 10 every group.
Each organizes mouse web portion unhairing, and scope is 3cm * 3cm, and evenly smears sensitization with 1% dinitrofluorobenzene solution 100 μ l, and sensitization started gastric infusion the same day.The normal saline of matched group gavage same volume; Capsule group of the present invention is gastric infusion 21.6,10.8,5.4g crude drug/kg respectively; Silver bits electuary group gastric infusion 21.6g crude drug/kg.Successive administration 7d, every day 1 time, capacity is 0.2ml/10g body weight.Before last administration, 1% dinitrofluorobenzene solution, 10 μ l being evenly applied in to mouse right ear (two sides) attacks, attack after 24h, put to death animal, with the card punch of diameter 9mm, ears are cut with position, with electronic balance, weigh, the difference of left and right auricle weight of take is swelling, calculates and respectively organizes swelling.Experimental result: in Table 7
The impact of table 7 on mice delayed hypersensitivity
Compare * * P < 0.01 with matched group; Consider electuary group to be worth doing than △ P < 0.05 with silver.
Result: capsule group of the present invention and silver bits electuary group can obviously suppress dinitrofluorobenzene and bring out mice delayed hypersensitivity, relatively have utmost point significant difference (P < 0.01) with matched group; The heavy dose of significant difference (P < 0.05) of having compared with silver bits electuary group of organizing of capsule of the present invention.Visible, capsule group of the present invention is stronger than the immunization of the anti-skin allergy of silver bits electuary group.
Experimental result: capsule of the present invention and silver bits electuary obviously suppress dimethylbenzene induced mice auricle edema; To mouse skin capillary permeability is hyperfunction, there is a remarkable inhibitory action; Can obviously suppress the mitotic activity of mouse vagina epithelial cell, there is antiproliferative effect; Mouse tail scale granular layer is formed to number and significantly improve, obviously promote the keratinization of mouse tail skin of back scale; Can obviously improve the itch-threshold that histamine phosphate causes Cavia porcellus pruritus; Can obviously reduce mice hemolysin content; Can obviously suppress dinitrofluorobenzene and bring out mice delayed hypersensitivity.
Conclusion: capsule of the present invention than the antiinflammatory of silver bits electuary, suppress cell proliferation, promote that the pharmacological actions such as the keratinization of cell, antipruritic, antiallergic and raising immunity of organisms are strong, therefore, capsule of the present invention is better than the psoriatic clinical efficacy of silver bits Chongji for Treatment.
Toxicological experiment:
Acute toxicity testing result shows: by capsule Cmax of the present invention, maximum volume gastric infusion, in 24h, successive administration is 3 times, every minor tick 4h, and accumulation medicine total amount reaches 120g crude drug/kg, is equivalent to 155.6 times of the clinical plan consumption of people.After administration in 7d, mice is movable, feed, excretion are all normal, well-grown, and hair color light, its average body weight average increases with the prolongation of test period.Every mice perusal heart of 8d place post mortem, liver, spleen, lung, kidney, brain, thymus, stomach, intestinal etc. are not all found color and paramophia, fail to measure LD
50.Show that capsule of the present invention is without acute toxic reaction.
Long term toxicity test result shows: capsule component of the present invention is that basic, normal, high dosage is respectively 15,30,60g crude drug/kg/d, be equivalent to 19.4,38.9,77.8 times of clinical dosage, after gastric infusion 12 weeks, capsule of the present invention is on the general status of animal, hematological indices, blood parameters all without significantly impact, and system dissection, organ coefficient and histopathological examination be no abnormal pathological change also.Drug withdrawal also has no obvious change for 2 weeks.Capsule of the present invention, in long term toxicity test, is not found overt toxicity reaction and delayed toxicity reaction.Visible, capsule non-toxic reaction of the present invention, long-term prescription is safe and reliable.
The specific embodiment of the invention:
The embodiment of the present invention 1:
Prescription proportioning:
Rhizoma Smilacis Glabrae 3375g Rhizoma Smilacis Chinensis 3375g;
Preparation method is: above two tastes, Rhizoma Smilacis Chinensis is ground into coarse powder, percolation secondary, with 8 times, measure 85% ethanol for the first time, with the ethanol of 8 times of amounts 60%, carry out percolation for the second time, percolation speed is 5ml/min, merges above percolate, it is that the clear paste of 1.05-1.10 (60 ℃ ± 1) is standby that decompression recycling ethanol (0.08Mpa, 70 ℃) is concentrated into relative density; After Rhizoma Smilacis Chinensis percolation, medicinal residues and Rhizoma Smilacis Glabrae decoct with water three times, add for the first time 12 times of water gagings, decoct 3 hours, second and third time respectively adds 10 times of water gagings, decoct respectively 2 hours, collecting decoction, filters, and filtrate decompression concentrates (0.08MPa, 80 ℃) to relative density, be the clear paste of 1.05-1.10 (60 ℃ ± 1), merge mix homogeneously, dry (150 ℃-170 ℃ of the inlet temperature of spraying with above-mentioned clear paste, leaving air temp 70-75 ℃), add appropriate amount of starch, mix, granulate, dry, granulate, encapsulated, obtain capsule.
The embodiment of the present invention 2:
Prescription proportioning:
Rhizoma Smilacis Glabrae 3375g Rhizoma Smilacis Chinensis 3375g;
Preparation method is: above two tastes, Rhizoma Smilacis Chinensis is ground into coarse powder, percolation secondary, with 8 times, measure 85% ethanol for the first time, with the ethanol of 8 times of amounts 60%, carry out percolation for the second time, percolation speed is 5ml/min, merges above percolate, it is that the clear paste of 1.05-1.10 (60 ℃ ± 1) is standby that decompression recycling ethanol (0.08Mpa, 70 ℃) is concentrated into relative density; After Rhizoma Smilacis Chinensis percolation, medicinal residues and Rhizoma Smilacis Glabrae decoct with water three times, add for the first time 12 times of water gagings, decoct 3 hours, second and third time respectively adds 10 times of water gagings, decocts respectively collecting decoction 2 hours, filter, filtrate decompression concentrated (0.08MPa, 80 ℃) is the clear paste of 1.05-1.10 (60 ℃ ± 1) to relative density, merges with above-mentioned clear paste, mix homogeneously, spraying dry (150 ℃-170 ℃ of inlet temperature, leaving air temp 70-75 ℃), adds appropriate amount of starch, mix, granulate, dry, granulate, add appropriate magnesium stearate, mix, tabletting, obtains tablet.
The embodiment of the present invention 3:
Prescription proportioning:
Rhizoma Smilacis Glabrae 3375g Rhizoma Smilacis Chinensis 3375g;
Preparation method is: above two tastes, Rhizoma Smilacis Chinensis is ground into coarse powder, percolation secondary, with 8 times, measure 85% ethanol for the first time, with the ethanol of 8 times of amounts 60%, carry out percolation for the second time, percolation speed is 5ml/min, merges above percolate, it is that the clear paste of 1.05-1.10 (60 ℃ ± 1) is standby that decompression recycling ethanol (0.08Mpa, 70 ℃) is concentrated into relative density; After Rhizoma Smilacis Chinensis percolation, medicinal residues and Rhizoma Smilacis Glabrae decoct with water three times, add for the first time 12 times of water gagings, decoct 3 hours, second and third time respectively adds 10 times of water gagings, decoct respectively 2 hours, collecting decoction, filters, and filtrate decompression concentrates (0.08MPa, 80 ℃) to relative density, be the clear paste of 1.05-1.10 (60 ℃ ± 1), merge mix homogeneously, dry (150 ℃-170 ℃ of the inlet temperature of spraying with above-mentioned clear paste, leaving air temp 70-75 ℃), add appropriate dextrin, mix, granulate, dry, granulate, pack, obtains granule.
Claims (4)
1. for a psoriatic Chinese medicine composition, it is characterized in that: the formula of described Chinese medicine composition consists of:
Rhizoma Smilacis Glabrae 3375g Rhizoma Smilacis Chinensis 3375g;
Preparation method is: above two tastes, Rhizoma Smilacis Chinensis is ground into coarse powder, percolation secondary, with 8 times, measure 85% ethanol for the first time, with the ethanol of 8 times of amounts 60%, carry out percolation for the second time, percolation speed is 5ml/min, merges above percolate, and under the condition of 70 ℃ of time-0.08Mpa, to be concentrated into and to record relative density at 60 ℃ ± 1 o'clock be that the clear paste of 1.05-1.10 is standby to decompression recycling ethanol; After Rhizoma Smilacis Chinensis percolation, medicinal residues and Rhizoma Smilacis Glabrae decoct with water three times, add for the first time 12 times of water gagings, decoct 3 hours, second and third time respectively adds 10 times of water gagings, decoct respectively 2 hours, collecting decoction, filter, filtrate is evaporated at 60 ℃ ± 1 o'clock and records the clear paste that relative density is 1.05-1.10 under the condition of 80 ℃ of time-0.08Mpa, merges mix homogeneously with above-mentioned clear paste, in inlet temperature, being 150 ℃-170 ℃, to go out pathogenic wind-warm be that under the condition of 70-75 ℃, spraying is dry, add each dosage form proper auxiliary materials, mix, by each dosage form common process, make capsule, tablet or granule.
2. Chinese medicinal composition capsules agent according to claim 1, is characterized in that: the formula of described Chinese medicine composition consists of:
Rhizoma Smilacis Glabrae 3375g Rhizoma Smilacis Chinensis 3375g;
Preparation method is: above two tastes, Rhizoma Smilacis Chinensis is ground into coarse powder, percolation secondary, with 8 times, measure 85% ethanol for the first time, with the ethanol of 8 times of amounts 60%, carry out percolation for the second time, percolation speed is 5ml/min, merges above percolate, and under the condition of 70 ℃ of time-0.08Mpa, to be concentrated into and to record relative density at 60 ℃ ± 1 o'clock be that the clear paste of 1.05-1.10 is standby to decompression recycling ethanol; After Rhizoma Smilacis Chinensis percolation, medicinal residues and Rhizoma Smilacis Glabrae decoct with water three times, add for the first time 12 times of water gagings, decoct 3 hours, second and third time respectively adds 10 times of water gagings, decocts respectively collecting decoction 2 hours, filter, filtrate is evaporated at 60 ℃ ± 1 o'clock and records the clear paste that relative density is 1.05-1.10 under the condition of 80 ℃ of time-0.08Mpa, merges mix homogeneously with above-mentioned clear paste, in inlet temperature, being 150 ℃-170 ℃, to go out pathogenic wind-warm be that under the condition of 70-75 ℃, spraying is dry, add appropriate amount of starch, mix, granulate, dry, granulate, encapsulated, obtain capsule.
3. Chinese medicine composition tablet according to claim 1, is characterized in that: the formula of described Chinese medicine composition consists of:
Rhizoma Smilacis Glabrae 3375g Rhizoma Smilacis Chinensis 3375g;
Preparation method is: above two tastes, Rhizoma Smilacis Chinensis is ground into coarse powder, percolation secondary, with 8 times, measure 85% ethanol for the first time, with the ethanol of 8 times of amounts 60%, carry out percolation for the second time, percolation speed is 5ml/min, merges above percolate, and under the condition of 70 ℃ of time-0.08Mpa, to be concentrated into and to record relative density at 60 ℃ ± 1 o'clock be that the clear paste of 1.05-1.10 is standby to decompression recycling ethanol, after Rhizoma Smilacis Chinensis percolation, medicinal residues and Rhizoma Smilacis Glabrae decoct with water three times, add for the first time 12 times of water gagings, decoct 3 hours, second, respectively add 10 times of water gagings for three times, decoct respectively 2 hours, collecting decoction, filter, filtrate is evaporated at 60 ℃ ± 1 o'clock and records the clear paste that relative density is 1.05-1.10 under the condition of 80 ℃ of time-0.08Mpa, merge with above-mentioned clear paste, mix homogeneously, in inlet temperature, being 150 ℃-170 ℃, to go out pathogenic wind-warm be that under the condition of 70-75 ℃, spraying is dry, add appropriate amount of starch, mix, granulate, dry, granulate, add appropriate magnesium stearate, mix, tabletting, obtain tablet.
4. Chinese medicinal composition granules according to claim 1, is characterized in that: the formula of described Chinese medicine composition consists of:
Rhizoma Smilacis Glabrae 3375g Rhizoma Smilacis Chinensis 3375g;
Preparation method is: above two tastes, Rhizoma Smilacis Chinensis is ground into coarse powder, percolation secondary, with 8 times, measure 85% ethanol for the first time, with the ethanol of 8 times of amounts 60%, carry out percolation for the second time, percolation speed is 5ml/min, merges above percolate, and under the condition of 70 ℃ of time-0.08Mpa, to be concentrated into and to record relative density at 60 ℃ ± 1 o'clock be that the clear paste of 1.05-1.10 is standby to decompression recycling ethanol; After Rhizoma Smilacis Chinensis percolation, medicinal residues and Rhizoma Smilacis Glabrae decoct with water three times, add for the first time 12 times of water gagings, decoct 3 hours, second and third time respectively adds 10 times of water gagings, decocts respectively collecting decoction 2 hours, filter, filtrate is evaporated at 60 ℃ ± 1 o'clock and records the clear paste that relative density is 1.05-1.10 under the condition of 80 ℃ of time-0.08Mpa, merges mix homogeneously with above-mentioned clear paste, in inlet temperature, being 150 ℃-170 ℃, to go out pathogenic wind-warm be that under the condition of 70-75 ℃, spraying is dry, add appropriate dextrin, mix, granulate, dry, granulate, pack, obtains granule.
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| CN1686521A (en) * | 2005-03-28 | 2005-10-26 | 北京正大绿洲医药科技有限公司 | Psoriasis drip pill and its preparation method |
| CN101648936A (en) * | 2009-09-17 | 2010-02-17 | 山东鲁泰环中制药有限公司 | Chemical composition separation method of traditional Chinese medicine smilax composition and clinical application thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1686521A (en) * | 2005-03-28 | 2005-10-26 | 北京正大绿洲医药科技有限公司 | Psoriasis drip pill and its preparation method |
| CN101648936A (en) * | 2009-09-17 | 2010-02-17 | 山东鲁泰环中制药有限公司 | Chemical composition separation method of traditional Chinese medicine smilax composition and clinical application thereof |
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| 菝葜、土茯苓治疗银屑病108例疗效观察;孙佑勤;《北镇医学院学报》;19821231(第1期);46-50 * |
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Denomination of invention: A traditional Chinese medicine composition for psoriasis and its preparation method Effective date of registration: 20200810 Granted publication date: 20141112 Pledgee: Xi'an innovation financing Company limited by guarantee Pledgor: XINGBANG PHARMACEUTICAL Co.,Ltd. Registration number: Y2020990000904 |
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Date of cancellation: 20220414 Granted publication date: 20141112 Pledgee: Xi'an innovation financing Company limited by guarantee Pledgor: XINGBANG PHARMACEUTICAL Co.,Ltd. Registration number: Y2020990000904 |
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Effective date of registration: 20220729 Address after: 710304 No. 18, Caotang 4th Road, Caotang science and technology industry base, high tech Zone, Xi'an, Shaanxi Province Patentee after: Shaanxi Hantang Pharmaceutical Co.,Ltd. Address before: 710201 Jinghe Industrial Park, Xi'an Economic and Technological Development Zone, Shaanxi Province Patentee before: XINGBANG PHARMACEUTICAL Co.,Ltd. |