CN116966238A - Traditional Chinese medicine composition for relaxing bowel, preparation method and application - Google Patents
Traditional Chinese medicine composition for relaxing bowel, preparation method and application Download PDFInfo
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- CN116966238A CN116966238A CN202310921480.4A CN202310921480A CN116966238A CN 116966238 A CN116966238 A CN 116966238A CN 202310921480 A CN202310921480 A CN 202310921480A CN 116966238 A CN116966238 A CN 116966238A
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Classifications
-
- 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)
- A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
- A61K36/232—Angelica
-
- 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)
- A61K36/886—Aloeaceae (Aloe family), e.g. aloe vera
-
- 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
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
Landscapes
- Health & Medical Sciences (AREA)
- Natural Medicines & Medicinal Plants (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Chemical & Material Sciences (AREA)
- Microbiology (AREA)
- Medical Informatics (AREA)
- Epidemiology (AREA)
- Botany (AREA)
- Mycology (AREA)
- Alternative & Traditional Medicine (AREA)
- Biotechnology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Organic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Medicines Containing Plant Substances (AREA)
- Medicinal Preparation (AREA)
Abstract
The application belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for relaxing bowel, a preparation method and application thereof. The traditional Chinese medicine composition comprises aloe and Chinese angelica with the mass ratio of 4.5-5:1.5-9; the preparation method comprises soaking Aloe and radix Angelicae sinensis in water to obtain extractive solution; concentrating to obtain fluid extract. The traditional Chinese medicine composition for relaxing bowel has simple components, the effective components are specifically extracted from aloe and angelica, excessive reaction possibly existing between the components of complex components is avoided, the risk of side effects after taking medicine is obviously reduced, and the traditional Chinese medicine composition has good relaxing bowel effect.
Description
The application relates to a traditional Chinese medicine composition with the application date of 2019, 03 month and 21 days, the application number of 201910216954.9 and the name of ' relaxing bowel ', a preparation method and application ' and a divisional application of a patent application.
Technical Field
The application relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for relaxing bowel, a preparation method and application thereof.
Background
Constipation is a common clinical symptom, mainly referring to the reduction of defecation times, the reduction of fecal quantity, dry and hard defecation and the like. When the above symptoms are present in combination with 2 or more, symptomatic constipation can be diagnosed. Constipation is usually the predominant reduction in the frequency of bowel movements, typically once every 2-3 days or longer (or < 3 times per week).
Modern life style is greatly changed before, a few people sit for a long time, diet tests are not boring, ingested cellulose is less and less, some people drink too much, various reasons cause digestion dysfunction, and constipation of the large intestine is the most common phenomenon, so that the people are hard to say, and the health of the body is affected.
At present, a plurality of traditional Chinese medicine compositions for relaxing bowel exist on the market, but generally, the traditional Chinese medicine compositions have a plurality of medicine components and complex ingredients, and the traditional Chinese medicine composition is commonly known as three-component drug, so that the risk of side effects after taking the medicine composition is increased to a certain extent.
Disclosure of Invention
The application aims to provide a traditional Chinese medicine composition for relaxing bowel, a preparation method and application thereof, so as to reduce the risk of side effects after taking medicine.
In order to achieve the above object, according to one aspect of the present application, there is provided a traditional Chinese medicine composition for relaxing bowel. The active ingredients of the traditional Chinese medicine composition are prepared from extracts of raw materials, wherein the mass ratio of the raw materials is 2-5: 1.5 to 12 portions of aloe and angelica.
Preferably, the raw materials of the traditional Chinese medicine composition comprise aloe and angelica with the mass ratio of 4.5-5:1.5-9; the preparation method of the composition comprises the following steps:
s1, placing aloe and Chinese angelica into an extraction tank for water extraction, wherein the air pressure of the extraction is 0.25-0.35 MPa, the temperature is 80 ℃, and the extraction liquid is obtained after the extraction is completed;
s2, concentrating the leaching liquor under reduced pressure, wherein the vacuum degree of the reduced pressure concentration is-0.08 to-0.06 MPa, the air pressure is 0.25 to 0.35MPa, and the temperature is 60 to 70 ℃ to obtain clear paste; and
s3, preparing the traditional Chinese medicine composition for relaxing bowel by taking the clear paste as an effective component.
Preferably, the mass ratio of aloe to angelica is 3:1.
Preferably, the mass ratio of aloe to angelica is 5:9.
the application also provides a preparation method of the traditional Chinese medicine composition, which comprises the following steps:
s1, placing aloe and Chinese angelica into an extraction tank for water extraction, wherein the air pressure of the extraction is 0.25-0.35 MPa, the temperature is 80 ℃, and the extraction liquid is obtained after the extraction is completed;
s2, concentrating the leaching liquor under reduced pressure, wherein the vacuum degree of the reduced pressure concentration is-0.08 to-0.06 MPa, the air pressure is 0.25 to 0.35MPa, and the temperature is 60 to 70 ℃ to obtain clear paste; and
s3, preparing the traditional Chinese medicine composition for relaxing bowel by taking the clear paste as an effective component.
Preferably, the leaching in S1 is performed in two steps, the 1 st step is added with 6-10 times of water for 4 hours, the second step is added with 4-8 times of water for 3 hours.
The application also aims to provide a pharmaceutical preparation, which comprises the traditional Chinese medicine composition and pharmaceutical excipients.
Preferably, the dosage form of the pharmaceutical preparation is selected from tablets, granules, capsules, pills, suppositories, powders, ointments, drops, aerosols, powder mists, solutions, suspensions, syrups, mixtures, wines, teas, buccal tablets, freeze-dried powder injection or emulsions.
The application also aims to provide an application of the traditional Chinese medicine composition in preparing a medicine for relaxing bowel.
Preferably, the Chinese medicinal composition can improve small intestine peristalsis.
Preferably, the Chinese medicinal composition can shorten defecation time and/or improve defecation amount.
By applying the technical scheme of the application, the traditional Chinese medicine composition for relaxing bowel has simple components, the active ingredients are extracted from aloe and angelica, excessive reaction possibly existing between the components of complex ingredients is avoided, the risk of side effects after taking medicine is obviously reduced, and the traditional Chinese medicine composition has good effect of relaxing bowel.
Detailed Description
It should be noted that, without conflict, the embodiments of the present application and features of the embodiments may be combined with each other. The present application will be described in detail with reference to examples.
The traditional Chinese medicine composition for relaxing bowel exists in the existing market, but generally has a plurality of medicine components and complex ingredients, which increases the risk of side effects after taking medicine to some extent. In order to reduce this risk, the inventors of the present application have conducted intensive studies on a bowel relaxing traditional Chinese medicine composition. In the research process, it is unexpectedly found that good effects can be achieved by only preparing aloe and angelica according to a specific proportion as extracts of the raw materials, so that excessive reactions possibly existing between components of complex components can be avoided, the risk of side effects after taking the medicine is obviously reduced, and unexpected effects are obtained.
According to a typical embodiment of the application, a traditional Chinese medicine composition for relaxing bowel is provided, wherein the effective components of the traditional Chinese medicine composition are prepared from extracts of raw materials, and the mass ratio of the raw materials is (2-5): 1.5 to 12 portions of aloe and angelica.
By applying the technical scheme of the application, the traditional Chinese medicine composition for relaxing bowel has simple components, the active ingredients are extracted from aloe and angelica, excessive reaction possibly existing between the components of complex ingredients is avoided, the risk of side effects after taking medicine is obviously reduced, and the traditional Chinese medicine composition has good effect of relaxing bowel.
According to a typical embodiment of the application, the traditional Chinese medicine composition further comprises pharmaceutically acceptable auxiliary materials, and the dosage form of the traditional Chinese medicine composition is tablets, granules, capsules, pills, suppositories, powders, ointments, drops, aerosols, powder mists, solutions, suspensions, syrups, mixtures, wines, teas, buccal tablets, freeze-dried powder injection or emulsions. Can be common preparation, slow release preparation, controlled release preparation and various microparticle administration systems.
The pharmaceutical carrier familiar to those skilled in the art can be used to prepare the pharmaceutical composition containing an effective dose of the traditional Chinese medicine. For example, oral formulations (e.g., tablets, capsules, solutions or suspensions); injectable formulations (e.g., injectable solutions or suspensions, or injectable dry powders) can be administered immediately prior to injection by addition of injection water. The carrier in the pharmaceutical composition comprises: binders for oral formulations (e.g. starches, typically corn, wheat or rice starch, gelatin, methylcellulose, sodium carboxymethylcellulose and/or polyvinylpyrrolidone), diluents (e.g. lactose, dextrose, sucrose, mannitol, sorbitol, cellulose, and/or glycerol), lubricants (e.g. silica, talc, stearic acid or salts thereof, typically magnesium or calcium stearate, and/or polyethylene glycol), and, if desired, disintegrants, e.g. starches, agar, alginic acid or salts thereof, typically sodium alginate, and/or effervescent mixtures, co-solvents, stabilizers, suspending agents, non-pigments, flavoring agents, and the like, preservatives, solubilizers, stabilizers, and the like for injectable formulations; matrix for topical formulations, diluents, lubricants, preservatives and the like. Pharmaceutical formulations may be administered orally or parenterally (e.g., intravenously, subcutaneously, intraperitoneally, or topically), and if some drugs are unstable under gastric conditions, they may be formulated as enteric coated tablets.
The word "effective dose" of a pharmaceutical composition of the present application refers to a sufficient amount of a compound to treat a disorder at a reasonable effect/risk ratio applicable to any medical treatment and/or prophylaxis. It will be appreciated that the total daily dose of the pharmaceutical composition of the present application must be determined by the physician within the scope of sound medical judgment. For any particular patient, the particular therapeutically effective dose level will depend on a variety of factors including the disorder being treated and the severity of the disorder; the activity of the particular compound employed; the specific composition employed; age, weight, general health, sex and diet of the patient; the time of administration, route of administration and rate of excretion of the particular compound employed; duration of treatment; a medicament for use in combination with or simultaneously with the particular compound employed; and similar factors well known in the medical arts. For example, it is common in the art to start doses of a pharmaceutical composition of a traditional Chinese medicine at levels below that required to obtain the desired therapeutic effect and gradually increase the dosage until the desired effect is obtained. In general, the dosage of the pharmaceutical composition of the present application for mammals, especially humans, may be 42 to 128 mg/kg-day (adult in 60 kg).
According to an exemplary embodiment of the present application, the Chinese medicinal composition is prepared by the following steps: s1, taking a mass ratio of 2-5: 1.5-12 aloe and angelica are placed in an extraction tank for water extraction, the air pressure of the extraction is 0.25-0.35 MPa, the temperature is 70-90 ℃, and the extraction liquid is obtained after the extraction is completed; s2, concentrating the leaching solution under reduced pressure, wherein the vacuum degree of the reduced pressure concentration is-0.08 to-0.06 MPa, the air pressure is 0.25 to 0.35MPa, and the temperature is 60 to 70 ℃ to obtain clear paste; and S3, preparing the fluid extract as an effective component into a traditional Chinese medicine composition for relaxing bowel.
Although all the components and the contents thereof in the fluid extract obtained by the above steps cannot be clarified, the inventors found that the Chinese medicinal composition obtained by the above steps has a good therapeutic effect, and at the same time, because the raw material components are simple, because the risk of side effects which may occur is greatly reduced.
In order to obtain sufficient leaching of the active ingredient, it is preferable that the leaching is performed in 2 or more times. More preferably, the leaching comprises: adding 6-10 times of water for the first time, leaching for 4 hours; and leaching for 3 hours with water of which the second time is 4-8 times that of the water; combining the first leaching solution obtained by the first leaching with the second leaching solution obtained by the second leaching, and filtering to obtain leaching solution.
According to a typical embodiment of the present application, S3 further comprises drying and pulverizing the fluid extract to obtain dry extract powder, and then preparing the dry extract powder into the traditional Chinese medicine composition for relaxing bowel. Thus, the storage and the industrial production of the effective components are more convenient.
According to an exemplary embodiment of the present application, a method for preparing the above-mentioned Chinese medicinal composition is provided. The preparation method comprises the following steps: s1, taking a mass ratio of 2-5: 1.5-12 aloe and angelica are placed in an extraction tank for water extraction, the air pressure of the extraction is 0.25-0.35 MPa, the temperature is 70-90 ℃, and the extraction liquid is obtained after the extraction is completed; s2, concentrating the leaching solution under reduced pressure, wherein the vacuum degree of the reduced pressure concentration is-0.08 to-0.06 MPa, the air pressure is 0.25 to 0.35MPa, and the temperature is 60 to 70 ℃ to obtain clear paste; s3, preparing the clear paste as an effective component into a traditional Chinese medicine composition for relaxing bowel; preferably, the leaching is performed 2 times or more; more preferably, the leaching comprises: adding 6-10 times of water for the first time, leaching for 4 hours; and leaching for 3 hours with water of which the second time is 4-8 times that of the water; combining and filtering the first leaching solution obtained by the first leaching with the second leaching solution obtained by the second leaching to obtain leaching solution; further preferably, S3 further comprises drying and pulverizing the fluid extract to obtain dry extract powder, and preparing the dry extract powder as an active ingredient into a traditional Chinese medicine composition for relaxing bowel.
Although all the components and the contents thereof in the fluid extract obtained by the above steps cannot be clarified, the inventors found that the Chinese medicinal composition obtained by the above steps has a good therapeutic effect, and at the same time, because the raw material components are simple, because the risk of side effects which may occur is greatly reduced.
According to an exemplary embodiment of the application, the application of the traditional Chinese medicine composition for relaxing bowel in preparation of medicines for relaxing bowel is provided.
The advantageous effects of the present application will be further described below with reference to examples.
Example 1
1. Influence of the Chinese medicinal composition on the peristalsis of mice
1. Principle of: the method comprises the steps of orally and intragastrically administering a modeling drug compound diphenoxylate, establishing a mouse small intestine peristalsis inhibition model, calculating the ink propelling rate of small intestine within a certain time, and judging the gastrointestinal peristalsis function of the model mouse.
2. Sample and instrument
2.1 samples and instruments
2.1.1 Sample # 1: is provided by Qinghua De's Sian happiness pharmacy Co., ltd (aloe-Chinese angelica is added in a ratio of 5:9, and is decocted and extracted by adding proper amount of water, and is concentrated to 500ml, namely, a stock solution), and each 1ml is equivalent to 0.4844g of total crude drug.
The preparation method of the stock solution comprises the following steps:
taking aloe and angelica, placing the aloe and the angelica into a multifunctional extraction tank at the same time, adding 6-10 times of water for leaching for 4 hours, adding 4-8 times of water for leaching for 3 hours, wherein the air pressure is 0.25-0.35 MPa, the temperature is 80 ℃, filtering, merging filtrate, concentrating under reduced pressure, the vacuum degree is-0.06-0.08 MPa, the air pressure is 0.25-0.35 MPa, the temperature is 60-70 ℃, and concentrating to 500ml, namely, the stock solution.
2.1.2 instruments: surgical scissors, ophthalmic forceps, ruler, syringe, activated carbon powder, gum arabic, compound diphenoxylate, measuring cylinder, distilled water, tray and timer.
2.2 preparation of reagents
2.2.1 Preparation of sample 1#
Small dosage of 0.24ml/20ml/kg, and distilled water is added into 0.24ml stock solution to 20ml.
The medium dosage is 2.40ml/20ml/kg, and distilled water is added into 2.40ml of stock solution to 20ml.
7.20ml/20ml/kg of large dose, 7.20ml of stock solution is taken and distilled water is added to 20ml.
The administration volume of the mice is 20ml/kg, and the mice are 1 time per day.
2.2.2 preparation of ink
Accurately weighing 50g of gum arabic, adding 400ml of water, boiling until the solution is transparent, weighing 25g of active carbon (powder) and adding into the solution, boiling for three times, cooling the solution, adding water to 500ml, keeping at 4deg.C in a refrigerator, and shaking.
2.2.3 preparation of Compound diphenoxylate at concentration of 0.025%
The compound diphenoxylate tablet contains 2.5mg of compound diphenoxylate, 25mg (10 tablets) of compound diphenoxylate tablet is taken, ground into powder by a mortar, added with water to 100ml, and prepared just before use.
3. Experimental method
3.1 laboratory animals
60 male Kunming mice, 18-22 g in weight, were purchased from the university of Western An traffic laboratory animal center.
3.2 Experimental procedure
3.2.1 grouping and administration of laboratory animals
The mice were randomly stratified into blank control group, model control group, small, medium and large dose group of sample 1# and 5 groups of 12 mice each. The blank control group and the model control group were filled with distilled water, and the test sample was administered by the same route, with a volume of 20ml/Kg, for 10 consecutive days, 1 time per day.
3.2.2 modeling
After 10 days of gastric lavage, each group of mice fasted without water for 16h. The model control and sample each dose group were given a compound diphenoxylate (5 mg/kg BW) by gavage and the blank control was given distilled water.
3.2.3 specific method for index determination
After 0.5 hour of compound diphenoxylate administration, the dose groups were respectively given by gavage with ink (5% active carbon powder, 10% gum arabic) of the corresponding test samples, and the blank and model control groups were given ink. Immediately after 25 minutes, the animals were sacrificed by cervical vertebra removal, the celiac separation mesentery was opened, the upper end from the pylorus, the lower end to the ileocecum were cut off, the intestinal canal was placed on a tray, the small intestine was gently pulled into a straight line, the length of the intestinal canal was measured as the "total length of the small intestine", and the length from pylorus to ink was measured as the "ink pushing length". The ink push rate (%) was calculated as follows:
4. data processing
The data were counted by a two-by-two comparison of the mean of the experimental groups and a control group using analysis of variance, as detailed in table 1 below.
Table 11 influence of sample on mouse intestinal peristalsisn＝12)
Note that: comparison with the Normal group △ P<0.01; comparison with model group ** P<0.01; comparison with model group * P<0.05.
5. Experimental results
Compared with the normal control group, the ink propulsion rate of the model control group has extremely remarkable statistical significance (P is less than 0.01), which indicates that the model is prepared. The ink push rate of each dose group of the 1# sample was increased compared with the model control group, and the ink push rates of the medium dose group and the large dose group were significantly statistically significant (P < 0.05).
Effect of sample # 1 on urination and defecation in mice
1. Principle of
The molding drug compound diphenoxylate is administrated by oral gastric lavage, a constipation model of the mice is established, and the first granule of the mice is tested for black stool discharge time, the number of black stool discharge granules in 6 hours and the weight of black stool discharge, and the defecation condition of the mice is reflected by the reaction model.
2. Sample and instrument
2.1 samples and instruments
2.1.1 Sample # 1: is provided by Qinghua De's Sian happiness pharmacy Co., ltd (aloe-Chinese angelica is added in a ratio of 5:9, and is decocted and extracted by adding proper amount of water, and is concentrated to 500ml, namely, a stock solution), and each 1ml is equivalent to 0.4844g of total crude drug.
The preparation method of the stock solution comprises the following steps:
taking aloe and angelica, placing the aloe and the angelica into a multifunctional extraction tank at the same time, adding 6-10 times of water for leaching for 4 hours, adding 4-8 times of water for leaching for 3 hours, wherein the air pressure is 0.25-0.35 MPa, the temperature is 80 ℃, filtering, merging filtrate, concentrating under reduced pressure, the vacuum degree is-0.06-0.08 MPa, the air pressure is 0.25-0.35 MPa, the temperature is 60-70 ℃, and concentrating to 500ml, namely, the stock solution.
2.1.2 instruments: surgical scissors, ophthalmic forceps, ruler, syringe, activated carbon powder, gum arabic, compound diphenoxylate, measuring cylinder, distilled water, tray and timer.
2.2 preparation of reagents
2.2.1 Preparation of sample 1#
Small dosage of 0.24ml/20ml/kg, and distilled water is added into 0.24ml stock solution to 20ml.
The medium dosage is 2.40ml/20ml/kg, and distilled water is added into 2.40ml of stock solution to 20ml.
7.20ml/20ml/kg of large dose, 7.20ml of stock solution is taken and distilled water is added to 20ml.
The administration volume of the mice is 20ml/kg, and the mice are 1 time per day.
2.2.2 preparation of ink
Accurately weighing 50g of gum arabic, adding 400ml of water, boiling until the solution is transparent, weighing 25g of active carbon (powder) and adding into the solution, boiling for three times, cooling the solution, adding water to 500ml, keeping at 4deg.C in a refrigerator, and shaking.
2.2.3 preparation of Compound diphenoxylate with concentration of 0.05%
The compound diphenoxylate tablet contains 2.5mg of compound diphenoxylate, 50mg (20 tablets) of compound diphenoxylate tablet is taken, ground by a mortar, added with distilled water to 100ml, and prepared just before use.
3. Experimental method
3.1 laboratory animals
60 male Kunming mice, 18-22 g in weight, were purchased from the university of Western An traffic laboratory animal center.
3.2 Experimental procedure
3.2.1 grouping and administration of laboratory animals
The mice were randomly stratified into blank control group, model control group, small, medium and large dose group of sample # 1, 5 groups of 12 mice each. The blank control group and the model control group were filled with distilled water, and the test sample was administered by the same route, with a volume of 20ml/Kg, for 10 consecutive days, 1 time per day.
3.2.2 modeling
After 10 days of gastric lavage, each group of mice fasted without water for 16h. The model control and 1# samples were given to compound diphenoxylate (5 mg/kg BW) by gavage in each dose group and distilled water in the blank group.
3.2.3 specific method for index determination
After 0.5 hour of compound diphenoxylate, mice in the blank control group and model control group were filled with ink, and the dose group was given ink containing the test sample, and animals were fed in single cages with normal drinking water.
From the ink filling, the black stool discharge time of the first grains of each animal, the number of black stool discharge grains in 6 hours and the weight are recorded.
4. Data processing and result determination
The data can be counted by a two-by-two comparison of the mean of the various experimental groups and a control group using analysis of variance, as detailed in tables 2, 3 and 4 below.
Influence of sample 21 # on the first grain urination and defecation time of micen＝12)
| Group of | Dosage/mg.kg －1 | Black stool time (seconds) | P value |
| Normal control group | － | 61.8.8±35.7 | |
| Model control group | － | 166.5±73.9 △ | 0.0002 |
| Group of small doses | 0.24 | 166.8±76.4 | 0.993 |
| Medium dose group | 2.40 | 147.8±50.4 | 0.475 |
| Large dose group | 7.20 | 119.9±76.0 | 0.142 |
Note that: comparison with the Normal group △ P<0.01; comparison with model group ** P<0.01; comparison with model group * P<0.05.
Compared with the normal control group, the first granule urination and defecation time of the model control group has extremely remarkable statistical significance (P is less than 0.01), which proves that the model is prepared. The first granule of the dose group and the high dose group in the 1# sample had a shortened stool blacking time compared to the model control group, but was not statistically significant.
Table 31 influence of sample on the number of black excrement particles discharged from micen＝12)
| Group of | Dosage/mg.kg －1 | Number of black excrement particles | P value |
| Normal control group | － | 34.9±6.52 | |
| Model control group | － | 27.4±10.5 △ | 0.047 |
| Group of small doses | 0.24 | 37.3±13.3 | 0.057 |
| Medium dose group | 2.40 | 36.1±9.9 * | 0.049 |
| Large dose group | 7.20 | 36.1±8.56 * | 0.038 |
Note that: comparison with the Normal group △ P<0.05; comparison with model group ** P<0.01; comparison with model group * P<0.05.
Compared with the normal control group, the black stool particle number of the model control group has obvious statistical significance (P is less than 0.05), which indicates that the model preparation is successful. The number of black bowel movements was significantly increased for each dose group of sample # 1 compared to the model control group, with significant statistical significance (P < 0.05) for the medium and large dose groups.
Table 4 1 influence of sample on the weight of black stool discharged from micen＝12)
| Group of | Dosage/ml.kg －1 | Black stool weight (g) | P value |
| Normal control group | － | 1.20±0.36 | |
| Model control group | － | 1.26±0.59 | 0.761 |
| Group of small doses | 0.24 | 1.38±0.50 | 0.593 |
| Medium dose group | 2.40 | 1.54±0.68 | 0.290 |
| Large dose group | 7.20 | 1.59±0.81 | 0.264 |
Note that: comparison with the Normal group △ P<0.01; comparison with model group ** P<0.01; comparison with model group * P<0.05.
The model control group had increased weight of black bowel movement compared to the normal control group, but no statistical difference (P > 0.05). The weight of the black bowel discharge was increased for each dose group for sample # 1 compared to the model control group, but with no statistical difference (P > 0.05).
And (3) result judgment:
the positive result can be judged according to the positive result of any one of the small intestine movement experiment and the defecation time, and the positive result of any one of the weight and the grain number of the black stool in 6 hours.
The results show that compared with a model control group, the ink propulsion rate of each dosage group of the 1# sample is increased, and the ink propulsion rates of the medium dosage group and the large dosage group have obvious statistical significance (P < 0.05); the number of black bowel movements was significantly increased for each dose group of sample # 1 compared to the model control group, with significant statistical significance (P < 0.05) for the medium and large dose groups.
Conclusion(s)
The sample 1 has obvious statistical significance (P < 0.05) on the peristalsis and defecation of mice.
Example 2
Effects of different proportions of Chinese medicinal composition on loosening bowel to relieve constipation
1 principle: the beneficial effects of the proportion of the traditional Chinese medicine composition (aloe and Chinese angelica) in the application are proved by the results of a gastrointestinal peristalsis experiment and a defecation experiment of mice.
1.1 mice gastrointestinal motility experiments: the method comprises the steps of orally and intragastrically administering a modeling drug compound diphenoxylate, establishing a mouse small intestine peristalsis inhibition model, calculating the ink propelling rate of small intestine within a certain time, and judging the gastrointestinal peristalsis function of the model mouse.
1.2 mice defecation experiment: the molding drug compound diphenoxylate is administrated by oral gastric lavage, a constipation model of the mice is established, and the first granule of the mice is tested for black stool discharge time, the number of black stool discharge granules in 6 hours and the weight of black stool discharge, and the defecation condition of the mice is reflected by the reaction model.
2 sample and instrument
2.1 samples and instruments
2.1.1 sample sources: qinghua De Siemens Happy pharmaceutical Co.
2.1.2 sample preparation
(1) Sample of ratio I: aloe-angelica is used as a main ingredient 3:1, adding a proper amount of water, decocting and extracting, and concentrating to 500ml, namely a stock solution I. Each 1ml corresponds to 0.4844g of the total crude drug.
(2) Proportion II sample: aloe-angelica is used in 5:9, adding a proper amount of water, decocting and extracting, and concentrating to 500ml, namely a stock solution II. Each 1ml corresponds to 0.4844g of the total crude drug.
(3) Sample of proportion III: aloe-angelica is used as a raw material 1: and 6, adding a proper amount of water, decocting and extracting, and concentrating to 500ml, namely the stock solution III. Each 1ml corresponds to 0.4844g of the total crude drug.
2.1.2 instruments: surgical scissors, ophthalmic forceps, ruler, syringe, activated carbon powder, gum arabic, compound diphenoxylate, measuring cylinder, distilled water, tray and timer.
2.2 preparation of reagents
2.2.1 dosing settings
The stock solution I, the stock solution II and the stock solution III are respectively prepared according to small, medium and large doses, and the method is as follows:
(1) Small dose: 0.24ml/20ml/kg, and distilled water was added to the 0.24ml stock solution to 20ml.
(2) Medium dose: 2.40ml/20ml/kg, and distilled water was added to 2.40ml of the stock solution to 20ml.
(3) High dose: 7.20ml/20ml/kg, 7.20ml of stock solution was taken and distilled water was added to 20ml.
The administration volume of the mice is 20ml/kg, and the mice are 1 time per day.
2.2.2 preparation of ink
Accurately weighing 50g of gum arabic, adding 400ml of water, boiling until the solution is transparent, weighing 25g of active carbon (powder) and adding into the solution, boiling for three times, cooling the solution, adding water to 500ml, keeping at 4deg.C in a refrigerator, and shaking.
2.2.3 preparation of Compound diphenoxylate solution
(1) 0.025% compound diphenoxylate solution: taking 10 tablets of compound diphenoxylate (each tablet contains 2.5mg of compound diphenoxylate), grinding with a mortar, adding distilled water to 100ml, and preparing the tablet immediately before use.
(2) 0.05% compound diphenoxylate solution: taking 20 tablets of compound diphenoxylate (each tablet contains 2.5mg of compound diphenoxylate), grinding with a mortar, adding distilled water to 100ml, and preparing the tablet immediately before use.
3 mice gastrointestinal peristalsis experiments
3.1 Experimental methods
3.1.1 laboratory animals
132 male mice, 18-22 g in weight, were purchased from the university of western amp traffic laboratory animal center.
3.1.2 Experimental procedure
3.1.2.1 groups of laboratory animals and administration
The mice are randomly layered into a blank control group, a model control group, a small, medium and large dose group of a proportion I sample, a small, medium and large dose group of a proportion II sample, and a small, medium and large dose group of a proportion III sample, which are 11 groups of 12 mice each. The blank control group and the model control group were filled with distilled water, and the test sample was administered by the same route, with a volume of 20ml/Kg, for 10 consecutive days, 1 time per day.
Construction of 3.1.2.2 model
After 10 days of gastric lavage, each group of mice fasted without water for 16h. The model control and sample each dose group were given a solution of 0.025% compound diphenoxylate (5 mg/kg BW) by gavage, and the blank group was given distilled water.
Specific method for 3.1.2.3 index determination
After 0.5 hour of compound diphenoxylate administration, the dose groups were respectively given by gavage with ink (5% active carbon powder, 10% gum arabic) of the corresponding test samples, and the blank and model control groups were given ink. Immediately after 25 minutes, the animals were sacrificed by cervical vertebra removal, the celiac separation mesentery was opened, the upper end from the pylorus, the lower end to the ileocecum were cut off, the intestinal canal was placed on a tray, the small intestine was gently pulled into a straight line, the length of the intestinal canal was measured as the "total length of the small intestine", and the length from pylorus to ink was measured as the "ink pushing length". The ink push rate (%) was calculated as follows:
3.2 data processing
The data were counted using a two-by-two comparison of the mean of the multiple experimental groups and one control group using analysis of variance, as detailed in table 5 below.
TABLE 5 influence of Chinese medicinal compositions in different proportions on the peristalsis of micen＝12)
Note that: comparison with the Normal group △ P<0.01; comparison with model group ** P<0.01; comparison with model group * P<0.05.
3.3 experimental results
Compared with the normal control group, the ink propulsion rate of the model control group has extremely remarkable statistical significance (P is less than 0.01), which indicates that the model is prepared. The ink push rate of each dose group of the samples is increased compared with the model control group, wherein the ink push rate of the medium and large dose groups of the sample in proportion I, the medium and large dose groups of the sample in proportion II and the large dose group of the sample in proportion III has obvious statistical significance (P is less than 0.05).
4 mice defecation experiment
4.1 Experimental methods
4.1.1 laboratory animals
132 male mice, 18-22 g in weight, were purchased from the university of western amp traffic laboratory animal center.
4.1.2 Experimental procedures
4.1.2.1 laboratory animals grouping and administration
The mice are randomly layered into blank control groups, model control groups, small, medium and large dose groups of samples in proportion I, small, medium and large dose groups of samples in proportion II, small, medium and large dose groups of samples in proportion III, 11 groups of samples in proportion III, and 12 groups of samples in each group. The blank control group and the model control group were filled with distilled water, and the test sample was administered by the same route, with a volume of 20ml/Kg, for 10 consecutive days, 1 time per day.
4.1.2.2 modeling
After 10 days of gastric lavage, each group of mice fasted without water for 16h. Model control and sample each dose group was given a 0.05% solution of compound diphenoxylate (5 mg/kg BW) by gavage, and the blank group was given distilled water.
Specific method for 4.1.2.3 index determination
After 0.5 hour of compound diphenoxylate, mice in the blank control group and model control group were filled with ink, and the dose group was given ink containing the test sample, and animals were fed in single cages with normal drinking water.
From the ink filling, the black stool discharge time of the first grains of each animal, the number of black stool discharge grains in 6 hours and the weight are recorded.
4.2 data processing and result determination
The data can be counted by a two-by-two comparison of the mean of the multiple experimental groups and one control group using analysis of variance, as detailed in tables 6, 7 and 8 below.
TABLE 6 influence of Chinese medicinal compositions in different proportions on the first grain urination and defecation time of micen＝12)
Note that: comparison with the Normal group △ P<0.01; comparison with model group ** P<0.01; comparison with model group * P<0.05.
Compared with the normal control group, the first granule urination and defecation time of the model control group has extremely remarkable statistical significance (P is less than 0.01), which proves that the model is prepared. Compared with the model control group, the first granule urination and defecation time of the dosage group and the high dosage group in the samples of the proportion I, II and III is shortened, but the method has no statistical significance.
TABLE 7 influence of Chinese medicinal compositions in different proportions on the number of black bowel movements discharged by micen＝12)/>
Note that: comparison with the Normal group △ P<0.05; comparison with model group ** P<0.01; comparison with model group * P<0.05.
Compared with the normal control group, the black stool particle number of the model control group has obvious statistical significance (P is less than 0.05), which indicates that the model preparation is successful. Compared with the model control group, the number of the black bowel movement discharged by each dosage group of the samples in the proportion I, II and III is obviously increased, and the medium dosage group and the large dosage group have obvious statistical significance (P is less than 0.05).
TABLE 8 influence of Chinese medicinal compositions in different proportions on the weight of black urine discharged by micen＝12)
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Note that: and (3) withNormal group comparison △ P<0.01; comparison with model group ** P<0.01; comparison with model group * P<0.05.
The model control group had increased weight of black bowel movement compared to the normal control group, but no statistical difference (P > 0.05). The weight of the black bowel movement was increased for each dose group of samples in proportions I, II, III, but with no statistical difference (P > 0.05) compared to the model control group.
4.3 experimental results
The positive result can be judged according to the positive result of any one of the small intestine movement experiment and the defecation time, and the positive result of any one of the weight and the grain number of the black stool in 6 hours.
The results show that compared with a model control group, the ink propulsion rate of each dosage group of the samples in the proportion I, II and III is increased, and the ink propulsion rates of the medium dosage group and the large dosage group have obvious statistical significance (P < 0.05); compared with the model control group, the number of the black bowel movement discharged by each dosage group of the samples in the proportion I, II and III is obviously increased, and the medium dosage group and the large dosage group have obvious statistical significance (P is less than 0.05).
Conclusion 5
As can be seen from the results of the gastrointestinal peristalsis experiments and the defecation experiments of mice, the proportion I (3:1), the proportion II (5:9) and the proportion III (1:6) have certain effect of relaxing bowel, and the effect of relaxing bowel is that the proportion I (3:1) is greater than the proportion II
(5:9) > ratio III (1:6).
Example 3
Comparison of advantages of traditional Chinese medicine composition on bowel relaxing effect
1. The aloe-angelica traditional Chinese medicine composition (sample 1 in example 1), the aloe-angelica-dwarf lilyturf tuber-bitter orange traditional Chinese medicine composition (the preparation method is referred to as a traditional Chinese medicine composition for improving gastrointestinal functions and the preparation thereof, and the patent number is ZL 201110317780.9) are proved by a mouse functional experiment, and the medium and large doses of each composition have the efficacy of relaxing bowel. The daily intake of the raw medicines of the mice (calculated by 20 g) of each group of samples is calculated and counted (see table 9), and the result shows that the daily intake of the raw medicines of the aloe-angelica sinensis-dwarf lilyturf tuber-bitter orange group is lower than that of the aloe-angelica sinensis-dwarf lilyturf tuber-bitter orange group on the premise of playing the role of relaxing bowel.
Table 9 daily intake of crude drug (g) in mice
| Group of | Aloe-angelica | Aloe-radix Angelicae sinensis-radix Ophiopogonis-fructus Aurantii |
| Medium dose group | 0.0232 | 0.0436 |
| Large dose group | 0.0696 | 0.0872 |
2. The aloe-Chinese angelica traditional medicine composition has the aloe accounting for 35.7 percent, the aloe-Chinese angelica-dwarf lilyturf tuber-bitter orange traditional Chinese medicine composition has the aloe accounting for 50.9 percent, the use proportion of the aloe is obviously reduced, the safety of the composition is improved, and the risk of side effects after taking medicine is reduced.
The above description is only of the preferred embodiments of the present application and is not intended to limit the present application, but various modifications and variations can be made to the present application by those skilled in the art. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application should be included in the protection scope of the present application.
Claims (10)
1. A traditional Chinese medicine composition for relaxing bowel is characterized by comprising aloe and Chinese angelica with the mass ratio of 4.5-5:1.5-9;
the preparation method of the composition comprises the following steps:
s1, placing aloe and Chinese angelica into an extraction tank for water extraction, wherein the air pressure of the extraction is 0.25-0.35 MPa, the temperature is 80 ℃, and the extraction liquid is obtained after the extraction is completed;
s2, concentrating the leaching liquor under reduced pressure, wherein the vacuum degree of the reduced pressure concentration is-0.08 to-0.06 MPa, the air pressure is 0.25 to 0.35MPa, and the temperature is 60 to 70 ℃ to obtain clear paste; and
s3, preparing the traditional Chinese medicine composition for relaxing bowel by taking the clear paste as an effective component.
2. The composition of claim 1, wherein the aloe and angelica are in a mass ratio of 3:1.
3. The composition of claim 1, wherein the aloe and angelica are present in a mass ratio of 5:9.
4. A method of preparing a Chinese medicinal composition according to any one of claims 1 to 3, comprising the steps of:
s1, placing aloe and Chinese angelica into an extraction tank for water extraction, wherein the air pressure of the extraction is 0.25-0.35 MPa, the temperature is 80 ℃, and the extraction liquid is obtained after the extraction is completed;
s2, concentrating the leaching liquor under reduced pressure, wherein the vacuum degree of the reduced pressure concentration is-0.08 to-0.06 MPa, the air pressure is 0.25 to 0.35MPa, and the temperature is 60 to 70 ℃ to obtain clear paste; and
s3, preparing the traditional Chinese medicine composition for relaxing bowel by taking the clear paste as an effective component.
5. The process of claim 4, wherein the leaching in S1 is performed in two steps, 1 st step with 6-10 times of water for 4 hours and second step with 4-8 times of water for 3 hours.
6. A pharmaceutical formulation comprising the traditional Chinese medicine composition of any one of claims 1-3 and pharmaceutical excipients.
7. The pharmaceutical formulation according to claim 6, wherein the pharmaceutical formulation is selected from the group consisting of tablets, granules, capsules, pills, suppositories, powders, ointments, drops, aerosols, powder mists, solutions, suspensions, syrups, mixtures, wines, teas, buccal tablets, lyophilized powder for injection or emulsions.
8. Use of a Chinese medicinal composition according to any one of claims 1-3 in the preparation of a medicament for relaxing bowel.
9. The use according to claim 8, wherein the Chinese medicinal composition is capable of improving small intestine peristalsis.
10. The use according to claim 8, wherein the Chinese medicinal composition shortens the defecation time and/or increases the defecation amount.
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| CN114259053A (en) * | 2021-12-30 | 2022-04-01 | 新乡绿健园药食同源研究院有限公司 | Fructus cannabis and radix angelicae sinensis soft capsule and preparation method thereof |
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