WO2020187018A1 - Composition de médecine traditionnelle chinoise pour relaxer les intestins dans le but de soulager la constipation, son procédé de préparation et son utilisation - Google Patents

Composition de médecine traditionnelle chinoise pour relaxer les intestins dans le but de soulager la constipation, son procédé de préparation et son utilisation Download PDF

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WO2020187018A1
WO2020187018A1 PCT/CN2020/077630 CN2020077630W WO2020187018A1 WO 2020187018 A1 WO2020187018 A1 WO 2020187018A1 CN 2020077630 W CN2020077630 W CN 2020077630W WO 2020187018 A1 WO2020187018 A1 WO 2020187018A1
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chinese medicine
medicine composition
traditional chinese
extraction
extract
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PCT/CN2020/077630
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Chinese (zh)
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杜成强
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清华德人西安幸福制药有限公司
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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)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/896—Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
    • 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)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/896—Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
    • A61K36/8968—Ophiopogon (Lilyturf)
    • 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
    • A61P1/10—Laxatives

Definitions

  • the present invention relates to the technical field of traditional Chinese medicine, in particular to a traditional Chinese medicine composition for moisturizing the intestines and laxative, its preparation method and application.
  • Constipation is a common clinical symptom, which mainly refers to a decrease in the frequency of bowel movements, a decrease in stool volume, dry stool, and laborious defecation. When two or more of the above symptoms are present, it can be diagnosed as symptomatic constipation. It is usually based on the reduction of defecation frequency, generally defecation once every 2 to 3 days or longer (or ⁇ 3 times a week) is constipation.
  • the present invention aims to provide a traditional Chinese medicine composition for moisturizing the bowel and laxative, its preparation method and application, so as to reduce the risk of side effects after taking the medicine.
  • a Chinese medicinal composition for moisturizing the bowel and laxative is provided.
  • the active ingredient of the traditional Chinese medicine composition is made from the extract of the raw material medicine, and the raw material medicine is composed of aloe and Ophiopogon japonicus with a mass ratio of 2-5:1.5-12.
  • the raw material medicine is composed of aloe and Ophiopogon japonicus with a mass ratio of 5:9.
  • the traditional Chinese medicine composition also includes pharmaceutically acceptable excipients.
  • the dosage forms of the Chinese medicine composition are tablets, granules, capsules, pills, suppositories, powders, ointments, drops, aerosols, powder mists, solutions, suspensions, syrups, mixtures, wines Medicine, tea, lozenge, freeze-dried powder injection, or emulsion.
  • the traditional Chinese medicine composition is prepared by the following steps: S1, taking aloe and Ophiopogon japonicus with a mass ratio of 2-5:1.5-12 in an extraction tank for water extraction, and the vapor pressure of extraction is 0.25-0.35 MPa , The temperature is 70 ⁇ 90°C, the extract is obtained after the extraction is completed; S2, the extract is concentrated under reduced pressure, the vacuum degree of the reduced pressure concentration is -0.08 ⁇ -0.06MPa, the vapor pressure is 0.25 ⁇ 0.35MPa, The temperature is 60-70°C to obtain a clear ointment; and S3, the clear ointment is used as an active ingredient to prepare a traditional Chinese medicine composition for moisturizing and laxative.
  • the extraction is carried out in 2 or more times.
  • the leaching includes: adding 6-10 times the amount of water for the first time, leaching for 4 hours; and the second time 4-8 times the amount of water, leaching for 3 hours; the first leaching obtained from the first leaching
  • the extract and the second extract obtained from the second extraction are combined and filtered to obtain the extract.
  • S3 also includes drying and pulverizing the clear ointment to obtain a dry ointment powder, and then using the dry ointment powder as an effective ingredient to prepare a laxative Chinese medicine composition.
  • a method for preparing the above-mentioned traditional Chinese medicine composition includes the following steps: S1, taking aloe and Ophiopogon japonicus with a mass ratio of 2 to 5: 1.5 to 12 and placing them in an extraction tank for water extraction.
  • the vapor pressure of the extraction is 0.25 ⁇ 0.35 MPa, and the temperature is 70 ⁇
  • the extract is obtained after the extraction is completed;
  • the extract is concentrated under reduced pressure, the vacuum degree of the reduced pressure concentration is -0.08 ⁇ -0.06MPa, the vapor pressure is 0.25 ⁇ 0.35MPa, and the temperature is 60 ⁇ 70 °C to obtain a clear ointment;
  • the clear ointment is used as an active ingredient to prepare a laxative Chinese medicine composition;
  • the extraction is carried out in 2 or more times; more preferably, the extraction includes: the first time Add 6-10 times the amount of water and extract for 4 hours; and for the second time 4-8 times the amount of water, extract for 3 hours; combine the first extract obtained from the first extraction with the second extract The second extract is combined and filtered to obtain the extract; further preferably, S3 also includes drying and pulverizing the clear ointment to obtain a dry ointment powder, which is then used as an active ingredient to
  • the composition of the traditional Chinese medicine composition for moisturizing and laxative bowel movement is simple, and the active ingredients are extracted from aloe vera and Ophiopogon japonicus, avoiding excessive reactions between the components of complex components, and significantly reducing medication There is a risk of side effects afterwards, and it has a good laxative effect.
  • a traditional Chinese medicine composition for moisturizing the intestines and laxative is provided.
  • the active ingredients of the Chinese medicine composition are made of extracts of raw materials, and the mass ratio of the raw materials is 2-5: 1.5-12.
  • Composition of aloe and Ophiopogon japonicus is provided.
  • the composition of the traditional Chinese medicine composition for moisturizing and laxative bowel movement is simple, and the active ingredients are extracted from aloe vera and Ophiopogon japonicus, avoiding excessive reactions between the components of complex components, and significantly reducing medication There is a risk of side effects afterwards, and it has a good laxative effect.
  • the raw material medicine is composed of aloe and Ophiopogon japonicus with a mass ratio of 5:9.
  • the traditional Chinese medicine composition further includes pharmaceutically acceptable auxiliary materials.
  • the dosage form of the traditional Chinese medicine composition is tablet, granule, capsule, pill, suppository, powder, ointment, drops, aerosol Medicine, powder mist, solution, suspension, syrup, mixture, wine, tea, lozenge, lyophilized powder injection, or emulsion. It can be ordinary formulations, sustained-release formulations, controlled-release formulations, and various particle delivery systems.
  • the pharmaceutical carrier familiar to those skilled in the art can be used to prepare the traditional Chinese medicine pharmaceutical composition of the present invention containing an effective dose.
  • oral preparations such as tablets, capsules, solutions or suspensions
  • injectable preparations such as injectable solutions or suspensions, or injectable dry powders. Add water for injection immediately before injection use).
  • the carrier in the pharmaceutical composition includes: binders used in oral preparations (such as starch, usually corn, wheat or rice starch, gelatin, methylcellulose, sodium carboxymethylcellulose and/or polyvinylpyrrolidone), diluents (Such as lactose, dextrose, sucrose, mannitol, sorbitol, cellulose, and/or glycerin), lubricants (such as silicon dioxide, talc, stearic acid or its salts, usually magnesium stearate or hard Calcium fatty acid, and/or polyethylene glycol), and if necessary, also containing disintegrating agents, such as starch, agar, alginic acid or its salts, usually sodium alginate, and/or effervescent mixtures, co-solvents, Stabilizers, suspending agents, non-coloring, flavoring agents, etc., preservatives, solubilizers, stabilizers, etc.
  • binders used in oral preparations such as starch
  • compositions can be administered orally or parenterally (for example, intravenously, subcutaneously, intraperitoneally or topically). If certain drugs are unstable under gastric conditions, they can be formulated into enteric-coated tablets.
  • the phrase "effective dose" of the Chinese medicine pharmaceutical composition of the present invention refers to a compound in a sufficient amount to treat a disorder with a reasonable effect/risk ratio suitable for any medical treatment and/or prevention.
  • the total daily dosage of the traditional Chinese medicine composition of the present invention must be determined by the attending physician within the scope of reliable medical judgment.
  • the specific therapeutically effective dose level must be determined based on a variety of factors, including the disorder being treated and the severity of the disorder; the activity of the specific compound used; the specific composition used; The age, weight, general health, gender, and diet of the patient; the time of administration, route of administration and excretion rate of the specific compound used; duration of treatment; drugs used in combination or concurrently with the specific compound used; and Similar factors well known in the medical field.
  • the practice in the art is that the dosage of the traditional Chinese medicine composition starts from a level lower than the level required to obtain the desired therapeutic effect, and gradually increases the dosage until the desired effect is obtained.
  • the dosage of the traditional Chinese medicine composition of the present invention for mammals, especially humans can range from 42 to 128 mg/kg ⁇ day (60 kg for adults).
  • the traditional Chinese medicine composition is prepared by the following steps: S1, taking aloe vera and Ophiopogon japonicus with a mass ratio of 2-5:1.5-12 in an extraction tank for water extraction.
  • the vapor pressure is 0.25 ⁇ 0.35MPa, the temperature is 70 ⁇ 90°C, the leaching liquid is obtained after the extraction is completed; S2, the leaching liquid is concentrated under reduced pressure, and the vacuum degree of the vacuum concentration is -0.08 ⁇ -0.06MPa.
  • the pressure is 0.25-0.35 MPa and the temperature is 60-70°C to obtain a clear ointment; and S3, the clear ointment is used as an active ingredient to prepare a laxative Chinese medicine composition.
  • the extraction is carried out in two or more times. More preferably, the leaching includes: adding 6-10 times the amount of water for the first time, leaching for 4 hours; and the second time 4-8 times the amount of water, leaching for 3 hours; The extract and the second extract obtained from the second extraction are combined and filtered to obtain the extract.
  • S3 further includes drying and pulverizing the clear ointment to obtain a dry ointment powder, and then using the dry ointment powder as an active ingredient to prepare a laxative Chinese medicine composition. This is more convenient for the storage and industrial production of effective ingredients.
  • a method for preparing the above-mentioned traditional Chinese medicine composition includes the following steps: S1, taking aloe and Ophiopogon japonicus with a mass ratio of 2 to 5: 1.5 to 12 and placing them in an extraction tank for water extraction.
  • the vapor pressure of the extraction is 0.25 ⁇ 0.35 MPa, and the temperature is 70 ⁇
  • the extract is obtained after the extraction is completed;
  • the extract is concentrated under reduced pressure, the vacuum degree of the reduced pressure concentration is -0.08 ⁇ -0.06MPa, the vapor pressure is 0.25 ⁇ 0.35MPa, and the temperature is 60 ⁇ 70 °C to obtain a clear ointment;
  • the clear ointment is used as an active ingredient to prepare a laxative Chinese medicine composition;
  • the extraction is carried out in 2 or more times; more preferably, the extraction includes: the first time Add 6-10 times the amount of water and extract for 4 hours; and for the second time 4-8 times the amount of water, extract for 3 hours; combine the first extract obtained from the first extraction with the second extract The second extract is combined and filtered to obtain the extract; further preferably, S3 also includes drying and pulverizing the clear ointment to obtain a dry ointment powder, which is then used as an active ingredient to
  • the compound diphenoxylate was given by oral gavage to establish a mouse small intestinal peristalsis inhibition model, calculate the ink advance rate of the small intestine within a certain period of time, and judge the gastrointestinal peristalsis function of the model mice.
  • Sample #1 Provided by Tsinghua Deren Xi’an Xingfu Pharmaceutical Co., Ltd. (Aloe-Ophiopogon japonicus is fed at 5:9, decocted and extracted with a proper amount of water, and concentrated to 500ml, which is called the original solution).
  • the crude drug amount is 0.4844g.
  • the medium dose is 2.40ml/20ml/kg, take 2.40ml stock solution and add distilled water to 20ml.
  • mice The administration volume of mice is 20ml/kg, once a day.
  • Compound diphenoxylate tablets each containing 2.5mg compound diphenoxylate tablets, take 25mg (10 tablets) of compound diphenoxylate tablets, grind with a mortar to form a powder, add water to 100ml, and prepare before use.
  • mice 60 Kunming male mice weighing 18-22 g were purchased from the Experimental Animal Center of Xi'an Jiaotong University.
  • mice According to the weight of the mice, they were randomly divided into blank control group, model control group, and 1# sample small, medium and high-dose groups, a total of 5 groups, each with 12 mice.
  • the blank control group and the model control group were given distilled water by gavage, and the test sample was given in the same way.
  • the administration volume was 20ml/Kg, once a day for 10 consecutive days.
  • mice After the mice were given gastric administration for 10 days, the mice in each group were fasted without water for 16 hours.
  • the model control group and each dose group of the sample were given compound diphenoxylate (5mg/kg BW) by gavage, and the blank control group was given distilled water.
  • the dose groups were given the ink containing the corresponding test sample (containing 5% activated carbon powder, 10% gum arabic) by intragastric administration, and the blank and model control groups were given ink.
  • the animal was killed by removing the cervical vertebrae immediately, opening the abdominal cavity to separate the mesentery, cutting the upper end of the intestine from the pylorus, lower end to the ileocecal, and placing it on the tray, gently pulling the small intestine into a straight line, and measuring the length of the intestine as "total length of small intestine" , From the pylorus to the ink preface is "the length of ink advancing".
  • the data can be counted using the analysis of variance and the pairwise comparison of the means of multiple experimental groups and a control group. See Table 1 below for details.
  • the ink advancing rate of the model control group was extremely statistically significant (P ⁇ 0.01), indicating that the model preparation was established.
  • the ink advancing rate of sample 1# in each dose group increased, and the ink advancing rate of the medium-dose group and the high-dose group had significant statistical significance (P ⁇ 0.05).
  • the modeling drug compound diphenoxylate was administered orally orally to establish a mouse model of constipation, and the time to the first black stool, the number of black stools and the weight of black stool discharged in 6 hours were measured, and the model mice were reflected Your bowel movements.
  • Sample #1 Provided by Tsinghua Deren Xi'an Fortune Pharmaceutical Co., Ltd. (Aloe-Ophiopogon is fed at 5:9, decocted and extracted with an appropriate amount of water, and concentrated to 500ml). Each 1ml is equivalent to 0.4844g of total crude drug.
  • the medium dose is 2.40ml/20ml/kg, take 2.40ml stock solution and add distilled water to 20ml.
  • mice The administration volume of mice is 20ml/kg, once a day.
  • Compound diphenoxylate tablets each containing 2.5mg compound diphenoxylate tablets, take 50mg (20 tablets) of compound diphenoxylate tablets, grind in a mortar and add distilled water to 100ml, and prepare before use.
  • mice 60 Kunming male mice weighing 18-22 g were purchased from the Experimental Animal Center of Xi'an Jiaotong University.
  • mice According to the weight of the mice, they were randomly divided into blank control group, model control group, and 1# sample small, medium, and high-dose groups, a total of 5 groups, each with 12 mice.
  • the blank control group and the model control group were given distilled water by gavage, and the test sample was given in the same way.
  • the administration volume was 20ml/Kg, once a day for 10 consecutive days.
  • mice After the mice were given gastric administration for 10 days, the mice in each group were fasted without water for 16 hours.
  • the model control group and 1# sample each dose group were given compound diphenoxylate (5mg/kg BW) by gavage, and the blank control group was given distilled water.
  • mice in the negative control group and the model control group were gavaged with ink, and the dose group was given the ink containing the test sample.
  • the animals were raised in single cages and drank and ate normally.
  • the data can be counted by the analysis of variance and the pairwise comparison of the means of multiple experimental groups and a control group. See Table 2, Table 3, and Table 4 for details.
  • the model control group's first black stool time has extremely significant statistical significance (P ⁇ 0.01), indicating that the model preparation is established.
  • P ⁇ 0.01 the time of first defecation in each dose group of 1# sample was shortened, but there was no statistical significance.
  • the test result can be determined as positive.
  • the 1# sample has significant statistical significance on intestinal peristalsis and defecation in mice (P ⁇ 0.05).
  • mice The model drug compound diphenoxylate was given by oral gavage to establish a mouse small intestinal peristalsis inhibition model, calculate the ink advancement rate of the small intestine within a certain period of time, and judge the gastrointestinal peristalsis function of the model mice.
  • mice defecation experiment The model drug compound diphenoxylate was given by oral gavage to establish a mouse model of constipation, and the time of the first defecation of the mice, the number of black defecation and black defecation within 6 hours were measured The weight reflects the defecation of the model mice.
  • Proportion I sample aloe-Ophiopogon japonicus was fed at a ratio of 3:1, and an appropriate amount of water was added to decocting to extract, and then concentrated to 500ml, which was called the original liquid I. Each 1ml is equivalent to 0.4844g of the total crude drug.
  • Proportion II sample Aloe-Ophiopogon japonicus is fed at a ratio of 5:9, decocted and extracted with an appropriate amount of water, and concentrated to 500 ml, which is called the original liquid II. Each 1ml is equivalent to 0.4844g of the total crude drug.
  • Proportion III sample Aloe-Ophiopogon japonicus is fed at a ratio of 1:6, decocted and extracted with an appropriate amount of water, and concentrated to 500ml, which is called the original solution III. Each 1ml is equivalent to 0.4844g of the total crude drug.
  • the original solution I, the original solution II, and the original solution III are prepared according to the small, medium and large doses respectively.
  • the method is as follows:
  • mice The administration volume of mice is 20ml/kg, once a day.
  • compound diphenoxylate solution take 10 compound diphenoxylate tablets (each tablet contains 2.5mg compound diphenoxylate), grind in a mortar and add distilled water to 100ml, and prepare before use.
  • compound diphenoxylate solution take 20 compound diphenoxylate tablets (each tablet contains 2.5 mg compound diphenoxylate), grind with a mortar and add distilled water to 100ml, and prepare before use.
  • the blank control group and the model control group were given distilled water by gavage, and the test sample was given in the same way.
  • the administration volume was 20ml/Kg, once a day for 10 consecutive days.
  • mice After the mice were given gastric administration for 10 days, the mice in each group were fasted without water for 16 hours.
  • the model control group and each dose group of the sample were given 0.025% compound diphenoxylate solution (5mg/kg BW) by gavage, and the blank control group was given distilled water.
  • the dose groups were given the ink containing the corresponding test sample (containing 5% activated carbon powder, 10% gum arabic) by intragastric administration, and the blank and model control groups were given ink.
  • the animal was killed by removing the cervical vertebrae immediately, opening the abdominal cavity to separate the mesentery, cutting the upper end of the intestine from the pylorus, lower end to the ileocecal, and placing it on the tray, gently pulling the small intestine into a straight line, and measuring the length of the intestine as "total length of small intestine" , From the pylorus to the ink preface is "the length of ink advancing".
  • the data was calculated by analysis of variance, a pairwise comparison method of the means of multiple experimental groups and a control group. See Table 5 below for details.
  • the ink advancing rate of the model control group was extremely statistically significant (P ⁇ 0.01), indicating that the model preparation was established.
  • the ink advancing rate of each dose group of the sample increased.
  • the proportion I sample medium and high dose group, the proportion II sample medium and high dose group, and the proportion III sample high dose group had significant statistical significance. (P ⁇ 0.05).
  • the blank control group and the model control group were given distilled water by gavage, and the test sample was given in the same way.
  • the administration volume was 20ml/Kg, once a day for 10 consecutive days.
  • mice After the mice were given gastric administration for 10 days, the mice in each group were fasted without water for 16 hours.
  • the model control group and each dose group of the samples were given 0.05% compound diphenoxylate solution (5mg/kg BW) by gavage, and the blank control group was given distilled water.
  • the data can be counted using the analysis of variance and the pairwise comparison of the means of multiple experimental groups and a control group. For details, see Table 6, Table 7 and Table 8.
  • the model control group's first black stool time has extremely significant statistical significance (P ⁇ 0.01), indicating that the model preparation is established.
  • P ⁇ 0.01 the proportion of samples I, II, and III samples in the middle-dose group and the high-dose group shortened the time of first defecation, but there was no statistical significance.
  • the test result can be determined as positive.
  • the ratio I (3:1), the ratio II (5:9), and the ratio III (1:6) all have a certain degree of laxative effect.
  • the intestinal laxative effect is ratio I (3:1)> ratio II (5:9)> ratio III (1:6).
  • the proportion of aloe should be appropriately reduced, so the ratio II (5:9) is the optimal ratio.
  • Aloe-Ophiopogon Chinese medicinal composition (sample 1 in Example 1), Aloe-Angelica-Ophiopogon japonicus-Fructus Aurantii Chinese medicinal composition (for the preparation method see patent: A Chinese medicinal composition for improving gastrointestinal function and Its preparation, patent number: ZL201110317780.9) It is confirmed by mouse functional experiments that the medium and large doses of each composition have the effect of moistening bowel and laxative. The daily intake of crude drugs in each group of mice (calculated as 20g) was calculated and calculated (see Table 9).
  • Aloe vera accounted for 35.7% in the aloe-Ophiopogon japonicus Chinese medicinal composition, and aloe vera accounted for 50.9% in the aloe-angelica-Ophiopogon japonicus-Fructus Aurantii Chinese medicinal composition. Reduce the risk of side effects after taking the medicine.

Abstract

L'invention concerne une composition de médecine traditionnelle chinoise pour relaxer les intestins dans le but de soulager la constipation, son procédé de préparation et son utilisation. La composition de médecine traditionnelle chinoise est préparée par extraction à partir d'aloe et d'Ophiopogonis radix avec un rapport de masse de 2 à 5 : 1,5 à 12.
PCT/CN2020/077630 2019-03-21 2020-03-03 Composition de médecine traditionnelle chinoise pour relaxer les intestins dans le but de soulager la constipation, son procédé de préparation et son utilisation WO2020187018A1 (fr)

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CN109939175A (zh) * 2019-03-21 2019-06-28 清华德人西安幸福制药有限公司 润肠通便的中药组合物、其制备方法及应用

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