WO2005074952A1 - Medicament chinois pour le traitement du syndrome du colon irritable ainsi que preparation de celui-ci - Google Patents

Medicament chinois pour le traitement du syndrome du colon irritable ainsi que preparation de celui-ci Download PDF

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Publication number
WO2005074952A1
WO2005074952A1 PCT/CN2005/000155 CN2005000155W WO2005074952A1 WO 2005074952 A1 WO2005074952 A1 WO 2005074952A1 CN 2005000155 W CN2005000155 W CN 2005000155W WO 2005074952 A1 WO2005074952 A1 WO 2005074952A1
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parts
soft
add
chinese medicine
traditional chinese
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PCT/CN2005/000155
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English (en)
Chinese (zh)
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Zunhong Ke
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Chengdu Kanghong Technology Enterprises (Group) Co., Ltd.
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Publication of WO2005074952A1 publication Critical patent/WO2005074952A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/65—Paeoniaceae (Peony family), e.g. Chinese peony
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system

Definitions

  • the invention relates to the field of pharmaceutical preparations, in particular to a traditional Chinese medicine for treating irritable bowel syndrome and a preparation method thereof. Background technique
  • IBS Irritable bowel syndrome
  • traditional Chinese medicine classifies irritable bowel syndrome in the categories of diarrhea, constipation, abdominal pain, stagnation, depression, gathering, intestinal dysfunction, etc. It is believed that it can be caused by exogenous evil qi, internal injury diet, and weak body. Caused by chronic diseases, overwork and other causes, liver stagnation, spleen deficiency, kidney deficiency, stasis, blood stasis and other syndromes are common clinically, and there are many mixed syndromes, but they have different emphasis. According to different classifications, it can be divided into two, three or eight syndrome types, which are usually divided into diarrhea type, constipation type and mixed type three types, among which the diarrhea type is the most common.
  • the present invention aims to provide a new Chinese medicine for treating irritable bowel syndrome, which has the advantages of strong pertinence, good curative effect, non-toxic side effects, and convenient taking and carrying. Summary of the invention
  • the purpose of the present invention is to provide a new traditional Chinese medicine prescription for treating irritable bowel syndrome.
  • the medicine has definite effect on diarrhea-type irritable bowel syndrome, has small side effects, good safety, and is convenient to take and carry.
  • Another object of the present invention is to provide a new traditional Chinese medicine preparation prepared by the formula.
  • Another object of the present invention is to provide a method for preparing the above-mentioned traditional Chinese medicine preparation.
  • the raw materials with the following weight ratios are provided: 1 part of peppermint oil and 80-180 parts of white peony / red peony.
  • the weight ratio of the drug substance contained in the Chinese herbal medicine formula of Shangmi is: 1 part of lutein oil and 100-160 parts of white peony / red peony. Further preferred weight ratio is: 1 part of peppermint oil and 130 parts of white peony / red peony.
  • the Chinese medicinal preparation according to the present invention is obtained by mixing an extract obtained by treating white peony / red peony with a conventional extraction method and 1 part of peppermint oil.
  • the above extract is an extract powder obtained by water extraction and purification.
  • the traditional Chinese medicine preparation according to the present invention is preferably a tablet, a hard gel liniment or a soft gel liniment.
  • the above-mentioned traditional Chinese medicine preparation for treating irritable bowel syndrome may also contain medicinal excipients required for preparing different dosage forms of medicines, such as lubricants such as magnesium stearate, talc, and polymer when preparing tablets or hard capsules.
  • lubricants such as magnesium stearate, talc, and polymer when preparing tablets or hard capsules.
  • Glycols, etc. fillers such as starch, dextrin, sucrose, lactose, mannitol, calcium sulfate, etc., disintegrating agents such as microcrystalline cellulose, low-substituted hydroxypropyl cellulose, etc., binders such as Ethylcellulose, povidone, hydroxypropylmethylcellulose, sodium carboxymethylcellulose, gelatin, ethanol, modified starch, etc.
  • Paeonia lactiflora / paeonia lactiflora in the method for preparing a Chinese medicinal preparation according to the present invention can be extracted by conventional methods, for example, water extraction method, organic solvent extraction method, supercritical extraction method and the like.
  • the white peony / red peony is extracted and purified with water to obtain an extract powder. It includes the following steps:
  • Extracting white peony / red peony take the white peony or red peony medicinal materials in the proportion, add 6 to 10 times the amount of water to cook and extract 2-4 times, each time for 3 hours, filter, and filter the combined filtrate Concentrated to a relative density of about 1. 10-1. 20, adding 2-4 times the amount of an 80-95% ethanol solution, standing the precipitate for 12-48 hours, filtering, recovering the filtrate to ethanol and concentrating to a relative density of about 1. 10 -1.
  • the content of paeoniflorin in the peony / red peony extract powder obtained in the above step (1) can reach more than 30% (g / g).
  • other methods can be used to further refine it.
  • the dosage form of the Chinese medicine for treating irritable bowel syndrome is more preferably a soft gel tincture, which consists of a soft gel tin content containing the above-mentioned peppermint oil and white tincture / red tincture extract powder and a soft gel tin covering the surface
  • the shell composition; and the contents of the soft gum tincture also contain any one or more medicinal excipients selected from vegetable oil, soybean phospholipids, beeswax, glycerin, polyethylene glycol, propylene glycol, and isopropanol; Contains gelatin, glycerin and water.
  • the soft gelatin shell can also contain sorbic acid, acrylic resin II, acrylic resin III, water, titanium dioxide, sodium hydroxide, sucrose, ethyl paraben, paraben and propyl paraben. Any one or more.
  • the preferred components of the above soft gum tincture wherein the contents of the soft gum tincture contain the following weight ratio components: 1 part of peppermint oil, extract powder obtained from 100-160 parts of white tincture / red tincture, 1.5 -3 parts of soybean oil, 0.02-0.08 parts of soybean phospholipids, and 0.02-0.08 parts of beeswax; the components of the soft gelatin shell are: 3 parts gelatin, 1. 2-1. 8 parts glycerin, 0 ⁇ 6-1. 0 parts acrylic resin II, 0. 2- 0. 6 parts acrylic resin III, 0. 008- 0. 012 parts of paraben ethyl ester, 0. 18- 0. 24 parts sodium hydroxide, 2-3 parts of water.
  • the content of a further preferred soft gum tincture contains the following weight ratio components: 1 part of peppermint oil, extract powder obtained from 130 parts of white peony / red peony, 2.2 parts of soybean oil, 0.05 parts of soybeans Phospholipids and 0.05 Parts of beeswax; the components of the soft gum shell are: 3 parts of gelatin, 1.5 parts of glycerin, 0.8 parts of acrylic resin II, 0.4 parts of acrylic resin III, 0.01 parts of paraben ethyl ester, 0. 21 parts of sodium hydroxide, 2.5 parts of water.
  • an enteric film coating may be coated on the surface of the soft gelatin tincture to form an enteric soft gel tincture.
  • enteric coating materials there are many reviews in the literature and reports, commonly used and necessary ingredients ⁇ "Enteric acrylic resins such as domestic I, II, III, respectively, are equivalent For imported Eudragit t L30D, L100D, S100, this kind of material does not dissolve in gastric juice, but dissolves into salt in intestinal fluid with higher pH value; among them, widely used are II, III (commonly used a certain proportion of their mixture );
  • some cellulose derivatives such as hydroxypropyl fluorenyl cellulose, ethyl cellulose, propyl cellulose, and polyvinylpyrrolidone can be optionally added.
  • the above materials are commercially available.
  • the preparation method of the traditional Chinese medicine soft tincture for treating irritable bowel syndrome includes the following steps:
  • Extracting white scallion / red scallion take the ratio of white scallion or scallion medicinal materials, add 6-10 times the amount of water to decoction and extract 2 to 4 times, each time 1-3 hours, after ⁇ , combine the filtrate And concentrated the filtrate to a relative density of about 1.10-1.20, added 2-4 times the amount of an 80-95% ethanol solution, left the precipitate for 12-48 hours, filtered, recovered the filtrate and concentrated the ethanol to a relative density About 1. 10- 1. 20, add equal amounts
  • an enteric-type film coating can also be coated on the surface of the soft gelatin capsules prepared above according to a conventional coating process to form an enteric soft gelatin capsule.
  • the menthol oil mentioned in the present invention is a volatile oil obtained from fresh stems or leaves of Labiatae mint (Mentha haplocalyx Bi-iq.) After being steam-steamed, frozen, and partially de-brained, namely Chinese Pharmacopoeia 2000 A contained mint oil. Its quality should comply with Chinese Pharmacopoeia standards: the total alcohol content is calculated according to menthol (d. H 2.0 ), and it should not be less than 50.0% (g / g).
  • Peppermint oil can be purchased from legal API manufacturers, or it can be prepared from the Chinese herbal medicine peppermint according to the method described above.
  • the white peony / red peony refers to white peony, red peony, or a mixture of white peony and red peony.
  • the Paeonia lactiflora referred to in the present invention is processed from the roots of Paeonia lactiflora Pall., And the processing method is as follows: after removing the head and tail and the fibrous roots, scrape off the skin, and cook in boiling water until thoroughly Remove the heart, soak it in cold water, and take it out for drying (or cook it first, then scrape the skin, and then dry it);
  • the red scallion mentioned in the present invention is Paeonia lactiflora Pall. Or Sichuan red Dried root of Paeonia (Paeonia veitchii Lynch.).
  • paeonia lactiflora C i U must not be less than 0.80% (g / g)
  • paeoniflorin C 23 H 2S 0 u
  • red peony must not be less than 1.80% (g / g).
  • the beneficial effects of the present invention are: (1).
  • Chinese patent medicine the invention uses for the first time a scientific formula of peppermint oil and paeonia lactiflora / red peony as a raw material medicine, and is composed of a certain weight ratio. It has been proven by animal tests and clinical trials to have liver relieving depression, analgesic and anti-inflammatory properties. The effects such as regulating qi and stopping diarrhea are used for prevention and treatment of diarrhea-type irritable bowel syndrome, and the effect is precise; especially the optimized formula has particularly excellent effect.
  • the menthol oil and paeonia lactiflora and radix paeoniae in the medicine of the present invention are commonly used traditional Chinese medicines, and have been proven by pharmacological and toxicological tests to have small toxic and side effects, good safety, and low cost. The cost of treatment is low.
  • Menthol oil mainly contains menthol (Menthol, 40-60%), menthol (Menthone) and other ingredients: It has the effects of expelling wind, regulating qi, depressing, anti-inflammatory, analgesic, etc. It has the effects of excitement, anti-vomiting and anti-depression.
  • the main components of Paeonia lactiflora and Paeonia lactiflora are Paeoniflorin, which have good effects of dilating blood vessels, analgesic and sedative, anti-inflammatory and anti-ulcer, antipyretic and spasm, and diuretic.
  • the medicament of the present invention combines peppermint oil with paeonia lactiflora and paeonia lactiflora in a scientific combination, and plays a role in relieving liver and stagnation, analgesic and anti-inflammatory, and regulating qi and diarrhea.
  • the medicament of the present invention made with different drug substance ratios is homemade and diluted with edible oil.
  • the positive control drug Yimengling (Luobutamide hydrochloride) was a product of Xi'an Yangsen Pharmaceutical Co., Ltd.
  • the rats were randomly divided into 8 groups of 8 rats each, namely the blank control group (injected with edible oil Iml / lOOg), the positive drug group (2 mg / kg Yimeng stop), peppermint oil, and peony / red
  • the composition ratio of the drug substance is 1: 100 (white peony), 1: 130 (white peony), 1: 160 (white peony), 1: 130 (red peony).
  • a peppermint oil group ( ⁇ 5 group) and a white) group ( ⁇ 6 group are prepared according to the method for extracting white ⁇ / red ⁇ in the present invention). 10 times of the intended clinical dose was administered orally once a day for 6 consecutive days.
  • a diarrhea model of irritable bowel syndrome (IBS) in rats with restraint stress was made. See Table 1:
  • Each group of the medicine of the present invention can significantly prolong the incubation period of diarrhea caused by castor oil in rats, significantly reduce the cumulative number of diarrhea, and the effect can be maintained to a minimum of 2 hours after the medicine; the effect of reducing the loose stool rate can be maintained to 6 hours after the medicine. Compared with the blank group, the difference is significant (P ⁇ 0.05).
  • the results are shown in Tables 2 and 3.
  • the medicine of the present invention has an inhibitory effect on diarrhea model of irritable bowel syndrome in rats caused by castor oil,
  • the effect of peppermint oil alone or paeony is better, and it is equivalent to that of the positive control drug Yimeng stop, suggesting that this product has a good effect in treating irritable bowel syndrome.
  • test results are as follows:
  • the toxicity of peppermint oil is very low, and LD 5 cannot be detected when given by gavage.
  • mice by intravenous injection and intraperitoneal injection of Paeonia lactiflora extract (prepared according to the method of extracting Paeonia lactiflora / Red paeony in the preparation method of the present invention, the same applies hereinafter).
  • Paeonia lactiflora extract prepared according to the method of extracting Paeonia lactiflora / Red paeony in the preparation method of the present invention, the same applies hereinafter.
  • 159mg / kg (equivalent to approximately 12.2g / kg of raw medicinal materials)
  • 230mg / kg equivalent to approximately of raw medicinal materials)
  • mice Feeding mice with paeony extract about 3000 mg / kg (equivalent to about 230g / kg of raw medicinal materials), no obvious symptoms of poisoning and no death.
  • the results of chronic toxicology studies showed that: it has no obvious toxicity to important organs of mice. Rats and dogs were given 3 different doses of Paeonia lactiflora extract (50 mg / kg, 1,000 mg / kg, 2000 mg / kg per day, equivalent to 5 to 200 times the highest adult dose) for 30 and 90 days. No obvious toxic damage, indicating that the drug has low toxicity and a large safety range.
  • Red peony extract prepared according to the method for extracting white peony / red peony in the medicine preparation method of the present invention
  • the maximum tolerated amount for intravenous injection in mice is greater than 50g / kg (raw medicine), and the maximum tolerated for mice by intragastric administration The amount is greater than 280 g / kg (raw herbs).
  • Fiber colonoscopy is normal, some patients have hyperkinesia, increased mucus, no obvious mucosal abnormalities, and histological examination is basically normal.
  • the treatment group was administered the drug of the present invention (the raw drug composition of the drug is: 100g of peppermint oil, 13000g of white peony, 220g of soybean oil, 5g of soybean phospholipid, 5g of beeswax, and 1000 soft capsules were made) Oral, 3 times a day, 2 capsules / time; the control group was given an equal dose of soft gelatin made of monomenthol oil, orally, 3 times a day, 2 capsules / time, the course of treatment was 1 month.
  • the raw drug composition of the drug is: 100g of peppermint oil, 13000g of white peony, 220g of soybean oil, 5g of soybean phospholipid, 5g of beeswax, and 1000 soft capsules were made
  • Oral 3 times a day, 2 capsules / time
  • the control group was given an equal dose of soft gelatin made of monomenthol oil, orally, 3 times a day, 2 capsules / time, the course of treatment was 1 month.
  • Points ratio points before treatment-points after treatment X 100%
  • the present invention is the pharmaceutical treatment of irritable bowel syndrome (diarrhea type) of the total effective rate was 95% efficacy alone and peppermint oil has a significant statistical difference compared. It shows that the medicine of the present invention has obvious therapeutic effect on irritable bowel syndrome (diarrhea type).
  • Example one is a hard gum tincture, and the raw material components of the contents of the gum tincture are: 1 part of peppermint oil and 130 parts of white tincture.
  • Extracting Paeonia lactiflora Take the medicinal materials of Paeonia lactiflora and add 10 times the amount of water to decoction and extract 4 times for 2 hours each time, filter, combine the filtrates, and concentrate the filtrates to a relative density of about 1.10, add 2 An 80% ethanol solution was doubled, and the precipitate was left standing for 12 hours, filtered, and the filtrate was recovered to ethanol and concentrated to a density of about 1.10.
  • This example is an enteric hard gelatin tincture.
  • the raw material ingredients of the gelatin capsule are: 1 part of peppermint oil, 160 parts of white tincture, and 0.01 part of magnesium stearate.
  • An enteric hard gel tincture is prepared by a method that includes the following steps:
  • Extracting Paeonia lactiflora Take the ratio of Paeonia lactiflora and add 6 times the amount of water to decoction to extract 3 Huan, each 3 hours, filter, combine the filtrate, and concentrate the filtrate to a relative density of about 1.20, add 4 Double the amount of 95% ethanol solution, leave it to stand for 48 hours, and filter. The filtrate is recovered and concentrated to a mesh density of about 1.20. An equal amount of 0.2mol / L NaHC0 3 solution is added. Stir to dissolve. Add 5 times the amount.
  • This embodiment is an enteric hard gelatin tincture.
  • the raw material ingredients of the gelatin capsule are: 1 part of mint t oil and 80 parts of red tincture.
  • An enteric hard gel tincture is prepared by a method that includes the following steps:
  • Extracting red scallion Take the red scallion medicinal materials with the proportion and add 8 times the amount of water to cook and extract 2: twice for 1 hour each time, filter, combine the filtrates, and concentrate the filtrates to a relative density of about 1.15, add 3 times the amount of 85% ethanol solution, left standing for 16 hours, filtered, the filtrate was recovered ethanol and concentrated to a mesh density of about 1.15, the same amount of 0.2mol / L NaHC0 3 solution was added, stirred to dissolve, added 4 times the amount Extract 3 times with ethyl acetate, combine the ethyl acetate extracts, recover the ethyl acetate to near dryness, add 5 times the amount of 75% ethanol solution to dissolve, filter, then recover the filtrate to ethanol and concentrate to a relative density of about 1.10, spray Dried to obtain red chrysalis extract powder;
  • This embodiment is a film-coated tablet, and the raw material components of the core are: 1 part of peppermint oil, 180 parts of white peony, and 5 parts of corn starch.
  • Tablets are made by a method that includes the following steps:
  • Extracting Paeonia lactiflora Take the medicinal materials of Paeonia lactiflora and add 7 times the amount of water to decoction and extract 3 times, 3 hours for the first time, 1.5 hours for the second and third times, filter, combine the filtrates, and The filtrate was concentrated to a relative density of about 1.15, 3 times the amount of a 90% ethanol solution was added, and the precipitate was left to stand for 18 hours, filtered, the filtrate was recovered to ethanol and concentrated to a relative density of about 1.15, and an equal amount of a 0.2mol / L NaHC0 3 solution was added.
  • This embodiment is an enteric film-coated tablet.
  • the raw material components of the tablet core are: 1 part of peppermint oil and 100 parts of red pepper.
  • Tablets are made by a method that includes the following steps:
  • Extracting red scallion Take the red scallion medicinal materials with the proportion, add 9 times the amount of water to cook and extract twice, 1.5 hours each time, filter, combine the filtrates, and concentrate the filtrates to a relative density of about 1.18, add 4 90% ethanol solution, settle for 24 hours, and filter. The filtrate was recovered and concentrated to a relative density of about 1.15. An equal amount of 0.2mol / L NaHC0 3 solution was added, stirred to dissolve, and 5 times the amount of acetic acid was added.
  • Extract twice with ethyl acetate combine the ethyl acetate extracts, recover the ethyl acetate to near dryness, add 3 times the amount of 80% ethanol solution to dissolve, filter, and then recover the filtrate to ethanol and concentrate to a relative density of about 1.15, spray-dried To get red chrysanthemum extract powder;
  • This embodiment is a soft gel tincture, where:
  • the drug substance components of the contents of the soft gum tincture are: 1 part of peppermint oil, 150 parts of white tincture, and 2.6 parts of tea oil.
  • the soft film is composed of the following weight ratio components: 3 parts of gelatin, 1 part of glycerin, 0.09 part of paraben, 1.6 parts of water.
  • This embodiment is a soft gel tincture, where:
  • the drug substance components of the contents of the soft capsules are: 1 part of peppermint oil, 140 parts of peony, 2.4 parts of soybean oil, 0.07 parts of soybean phospholipids, and 0.03 parts of beeswax.
  • the soft film is composed of the following weight ratio components: 3 parts gelatin, 1.5 parts glycerin, 1 part water. Make a soft gel tincture by a method that includes the following steps:
  • Extracting white peony take the ratio of white peony, add 10 times the amount of water to cook and extract 4 times, 2 hours each time, filter, combine the filtrate, and concentrate the filtrate to a relative density of about 1. 20, 3 times the amount of 85% ethanol solution was added, and the precipitate was allowed to stand for 36 hours, filtered, and the filtrate was recovered into ethanol and concentrated to a relative amount.
  • Density is about 1.12, add an equal amount of 0.2mol / L NaHC0 3 solution, stir to dissolve, add 5 times the amount of ethyl acetate to extract twice, combine the ethyl acetate extracts, recover the ethyl acetate to near dry, and then add 2 times The amount of 85% ethanol solution was dissolved, filtered, and then the filtrate was recovered ethanol and concentrated to a relative density of about 1.18, and spray-dried to obtain Baiji extract powder;
  • This embodiment is a soft gel tincture, where:
  • the drug substance components of the contents of the soft capsules are: 1 part of peppermint oil, 130 parts of peony, 2.2 parts of soybean oil, 0.05 parts of soybean phospholipids, and 0.05 parts of beeswax.
  • the soft film is composed of the following weight ratio components: 3 parts of gelatin, 1.5 parts of glycerin, 0.8 parts of acrylic resin II, 0.4 parts of acrylic resin III, 0.01 parts of paraben ethyl ester, 0.21 parts of sodium hydroxide, 2.5 parts of water.
  • Extracting Paeonia lactiflora Take the medicinal materials of Paeonia lactiflora and add 8 times the amount of water to decoction and extract it twice, the first time is 2 hours, and the second time is 1 hour. Filter, combine the filtrates, and concentrate the filtrates to The relative density is about 1, 15, 3 times the amount of 85% ethanol solution is added, the precipitate is left for 16 hours, filtered, the filtrate is recovered ethanol and concentrated to a relative density of about 1.15, and an equal amount of a 0.2mol / L NaHC0 3 solution is added.
  • This embodiment is a soft gel tincture, where:
  • the drug substance components of the contents of the soft capsule are: 1 part of peppermint oil, 100 parts of red pepper, 2.4 parts of soybean oil, 0.07 parts of soybean phospholipid, and 0.03 parts of beeswax.
  • the soft film is composed of the following weight ratio components: 3 parts of gelatin, 1.8 parts of glycerin, 0.9 parts of acrylic resin II, 0.5 parts of acrylic resin III, 0.09 parts of paraben ethyl ester, 0. 20 parts sodium hydroxide, 2.6 parts water.
  • Extracting red scallion take the ratio of red scallion medicinal materials, add 6 times the amount of water to cook and extract 4 times, 1.5 hours each time, filter, combine the filtrates, and concentrate the filtrate to a relative density of about 1. 12, add 4 times the amount of 80% ethanol solution, leave the precipitate for 12 hours, filter, recover the filtrate and concentrate the ethanol to a relative density of about 1.
  • This embodiment is a soft gel tincture, where:
  • the drug substance components of the contents of the soft capsule are: 1 part of peppermint oil, 160 parts of peony, 3 parts of soybean oil, 0.02 parts of soybean phospholipid, and 0.02 parts of beeswax.
  • the soft film is composed of the following weight ratio components: 3 parts of gelatin, 2.4 parts of glycerin, 0.6 parts of acrylic resin II, 0.3 parts of acrylic resin III, 0.008 parts of paraben propyl, 0. 24 parts of sodium hydroxide, 2.4 parts of water.
  • This embodiment is a soft gel tincture, where:
  • the drug substance components of the contents of the soft capsule are: 1 part of peppermint oil, 120 parts of peony, 2 parts of soybean oil, 0.03 parts of soybean phospholipid, and 0.08 parts of beeswax.
  • the soft film is composed of the following weight ratio components: 3 parts of gelatin, 0.8 parts of glycerin, 0.7 parts of acrylic resin II, 0.6 parts of acrylic resin III, 0.011 parts of paraben ethyl ester, 0. 18 parts of sodium hydroxide, 1 part of water.
  • the glue solution is made into a soft film with uniform thickness and a certain elasticity according to a conventional process for use;
  • Embodiment 12 This embodiment is an enteric soft gel liniment, where:
  • the drug substance components of the contents of the soft gum tincture are: 1 part of peppermint oil, 180 parts of peony, 1.5 parts of soybean oil, 0.08 parts of soybean phospholipids, and 0.007 parts of beeswax.
  • the soft film is composed of the following weight ratio components: 3 parts of gelatin, 1.2 parts of glycerin, 1 part of acrylic resin II, 0.2 parts of acrylic resin III, 0.012 parts of paraben ethyl ester, 0.18 parts Sodium hydroxide, 3 parts of water.
  • the surface of the preparation is also coated with an enteric film coating.
  • An enteric soft gel tincture is prepared by a method that includes the following steps:
  • the glue solution is made into a thin film with a uniform thickness and a certain elasticity according to a conventional process for use;
  • This embodiment is an enteric soft gel liniment, where:
  • the drug substance components of the contents of the soft capsule are: 1 part of peppermint oil, 80 parts of red pepper, 2.2 parts of peanut oil, 0. 05 parts of soybean phospholipid, Q. 05 parts of beeswax.
  • the soft film is composed of the following weight ratio components: 3 parts of gelatin, 1.5 parts of glycerin, 0.8 parts of acrylic resin II, 0.4 parts of acrylic resin III, 0.01 parts of paraben ethyl ester, 0. 21 parts sodium hydroxide, 2.5 parts water.
  • the surface of the preparation is also coated with an enteric film coating.
  • An enteric soft gel tincture is prepared by a method that includes the following steps:
  • Extracting red scallion take the ratio of red scallion medicinal materials, add 9 times the amount of water to cook and extract twice, the first 2.5 hours, the second 1.5 hours, filter, combine the filtrates, and Lmol
  • the filtrate was concentrated to a relative density of about 1.17, 4 times the amount of 80% ethanol solution was added, the precipitate was left for 32 hours, filtered, the filtrate was recovered ethanol and concentrated to a relative density of about 1.17, and an equal amount of 0.1 lmol was added.
  • the glue solution is made into a soft film with a uniform thickness and a certain elasticity according to a conventional process.
  • enteric soft gelatin capsules Made of enteric soft gelatin capsules: The contents of the soft gelatin capsules and the soft capsules on a soft capsule press are pressed into a soft gel capsule of 0.5g / granule, and then the surface is coated with a conventional coating process for one An enteric film coating is sufficient.
  • This embodiment is a soft gum tincture, wherein: the raw material medicine components of the soft gum tincture are: 1 part of peppermint oil, 100 parts of peony, 2.5 parts of soybean vegetable oil, 0.1 part of soybean phospholipid, 0.1 Portions of beeswax.
  • the soft film is composed of the following weight ratio components: 3 parts gelatin, 1.5 parts glycerin, 1 part water.
  • step (2) taking the ratio of soybean vegetable oil, heating it to about 55 ° C, adding the ratio of soybean phospholipid and beeswax, dissolving and mixing the mixture, adding the ratio of mint oil, and mixing, Add the Paeonia lactiflora powder obtained in step (1) while stirring, and continue to stir for about 30 minutes after the addition is complete, so that the mixture is homogeneous, and let stand for more than 12 hours for use;
  • This embodiment is a soft gel tincture, where:
  • the drug substance components of the contents of soft capsules are: 1 part of peppermint oil, 80 parts of peony, 2.0 parts of soybean vegetable oil, and 0.1 part of beeswax.
  • the soft film is composed of the following weight ratio components: 3 parts gelatin, 1.6 parts glycerin, 0.9 parts water. Preparation:
  • This embodiment is a soft gel tincture, where:
  • the drug substance components of the contents of soft capsules are: 1 part of peppermint oil, 130 parts of red pepper, 3 parts of soybean plant Oil.
  • the soft film consists of the following weight ratio components: 3 parts gelatin, 1.2 parts glycerin, 0.5 parts water. Preparation:
  • step (2) Take the proportion of soybean vegetable oil, heat it to about 55 ° C, add the proportion of menthol oil, mix well, and then add the red scallion extract powder obtained in step (1) while stirring, Continue to stir for about 30 minutes after the addition is complete, make the mixture uniform, and let it stand for more than 12 hours;
  • This embodiment is a soft gel tincture, where:
  • the drug substance components of the contents of soft capsules are: 1 part of peppermint oil, 160 parts of red pepper, 2.8 parts of soybean vegetable oil.
  • the soft film is composed of the following weight ratio components: 3 parts of gelatin, 1.2 parts of glycerin, 0.5 parts of water, 0.01 parts of paraben ethyl ester.
  • step (2) taking the proportion of soybean vegetable oil, heating it to about 55 ° C, adding the proportion of menthol oil, mixing well, and then adding the red chrysanthemum extract powder obtained in step (1) while stirring, Continue to stir for about 30 minutes after the addition is complete, make the mixture uniform, and let it stand for more than 12 hours;
  • Embodiment 18 This embodiment is a soft gel tincture, where:
  • the drug substance components of the contents of soft capsules are: 1 part of peppermint oil, 180 parts of red peony, and 2 parts of soybean vegetable oil.
  • the soft film is composed of the following weight ratio components: 3 parts gelatin, 1.2 parts glycerin, 0.5 parts water, 0.02 parts sorbic acid.
  • step (2) taking the proportion of soybean vegetable oil, heating it to about 55 ° C, adding the proportion of menthol oil, mixing well, and then adding the red chrysanthemum extract powder obtained in step (1) while stirring, Continue to stir for about 30 minutes after the addition is complete, make the mixture uniform, and let it stand for more than 12 hours;
  • This embodiment is a soft gel tincture, where:
  • the drug substance components of the contents of soft capsules are: 1 part mint oil, 100 parts white peony, 80 parts red peony,
  • the soft film is composed of the following weight ratio components: 3 parts of gelatin, 1.2 parts of glycerin, 0.4 parts of water, 0.01 parts of paraben.
  • step (2) Take the proportion of soybean vegetable oil, heat it to about 55 ° C, add the proportion of menthol oil, mix well, and then add the chitin extract powder obtained in step (1) while stirring, Continue to stir for about 30 minutes after the addition is complete, make the mixture uniform, and let it stand for more than 12 hours;
  • the pharmaceutical excipients used in the above examples were purchased from legal excipient manufacturers, among which: magnesium stearate is a product of Shanghai Yuanji Chemical Co., Ltd .; corn starch is a product of Zhenyu Huanyu Pharmaceutical Excipients Factory in Jiangsu; gelatin is Qinghai Products of Gelatin Co., Ltd .; glycerin is a product of Hangzhou Asia-Pacific Chemical Equipment Co., Ltd .; paraben, ethyl paraben and ethyl paraben are products of Xinke Chemical Co., Ltd.
  • the enteric film coating used in each of the above examples was an enteric film coating premix obtained from Chengdu Taishan Film Coating Factory.

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Abstract

L'invention concerne un médicament chinois efficace destiné à traiter le syndrome du côlon irritable, lequel comprend Pennyroyal ainsi que Radix Paeoniae Alba ou Radix Paeonia Rubra dans un rapport 1:80-180. Cette invention concerne également le procédé de préparation de ce médicament.
PCT/CN2005/000155 2004-02-05 2005-02-04 Medicament chinois pour le traitement du syndrome du colon irritable ainsi que preparation de celui-ci WO2005074952A1 (fr)

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CN200410021765.X 2004-02-05
CN200410021765 2004-02-05
CN2004100796671A CN1660259A (zh) 2004-02-05 2004-12-22 一种治疗肠易激综合征的中药及其制备方法
CN200410079667.1 2004-12-22

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EP3263114A4 (fr) * 2015-02-26 2018-09-05 Zuoguang Zhang Albiflorine ou son sel pharmaceutiquement acceptable et/ou son utilisation pour le traitement du syndrome du côlon irritable

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CN103585289B (zh) * 2012-08-15 2016-09-28 四川济生堂药业有限公司 一种预防或治疗肠易激综合征的药物组合物
CN107510716B (zh) * 2016-06-17 2020-06-30 上海凯宝药业股份有限公司 一种治疗肠易激综合症的药物组合物及其制备方法和用途
CN106177062A (zh) * 2016-08-30 2016-12-07 山西亿科宏泰生物科技有限公司 一种治疗肠易激综合征的药物组合物及其制备方法
IT201700082310A1 (it) * 2017-07-20 2017-10-20 Gianfranco Caramelli “Trattamento della complessa sintomatologia gastrointestinale connessa con IBS (Sindrome dell’intestino irritabile) tramite olio essenziale di Menta Piperita microincapsulato associato a principi naturali”
CN109260309A (zh) * 2018-11-20 2019-01-25 山东罗欣乐康制药有限公司 一种温中止痛的中药组合物颗粒剂的制备方法

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3263114A4 (fr) * 2015-02-26 2018-09-05 Zuoguang Zhang Albiflorine ou son sel pharmaceutiquement acceptable et/ou son utilisation pour le traitement du syndrome du côlon irritable
US10350230B2 (en) 2015-02-26 2019-07-16 Zuoguang Zhang Use of albiflorin or pharmaceutically acceptable salt for prevention and/or treatment of irritable bowel syndrome
AU2015384083B2 (en) * 2015-02-26 2021-02-18 Zuoguang Zhang Use of albiflorin or pharmaceutically acceptable salt for prevention and/or treatment of irritable bowel syndrome

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