CN110179961A - Pharmaceutical composition, preparation method and application - Google Patents

Pharmaceutical composition, preparation method and application Download PDF

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CN110179961A
CN110179961A CN201910593029.8A CN201910593029A CN110179961A CN 110179961 A CN110179961 A CN 110179961A CN 201910593029 A CN201910593029 A CN 201910593029A CN 110179961 A CN110179961 A CN 110179961A
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pharmaceutical composition
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cloves
alcohol extract
nutmeg
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CN110179961B (en
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周滔
王洪
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Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital University of Medicine Sciences
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Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital University of Medicine Sciences
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
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    • A61K36/185Magnoliopsida (dicotyledons)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/54Lauraceae (Laurel family), e.g. cinnamon or sassafras
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
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    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/906Zingiberaceae (Ginger family)
    • A61K36/9068Zingiber, e.g. garden ginger
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation 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
    • A61K2236/30Extraction of the material
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331Extraction 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
    • AHUMAN NECESSITIES
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    • A61K2236/30Extraction of the material
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/333Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation 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
    • A61K2236/30Extraction of the material
    • A61K2236/39Complex extraction schemes, e.g. fractionation or repeated extraction steps

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Abstract

This application involves field of medicaments, in particular to a kind of pharmaceutical composition, preparation method and application.The raw material of pharmaceutical composition mainly includes cloves, baked ginger, simmers nutmeg, cortex cinnamomi and Chinese gall.The pharmaceutical composition is adjusted comprehensively based on tonifying spleen and kidney, to viscera function, and qi and blood is pushed to use, and is adjusted viscera function, is promoted the recovery of gastrointestinal function.Spleen, temperature male wind-supplying kidney are managed with baked ginger, cortex cinnamomi, nutmeg middle benefit gas;Baked ginger, cortex cinnamomi, warming spleen and stomach for dispelling cold, mends fire supporing yang;Nutmeg, Chinese gall relieving diarrhea with astringents, cloves middle benefit gas activating qi for lowering adverse qi.It can be effectively improved main clinic symptoms and the card marquis of patient, mitigate patient suffering, good effect can be achieved for treatment diarrhea-type irritability syndrome.

Description

Pharmaceutical composition, preparation method and application
Technical field
This application involves field of medicaments, in particular to a kind of pharmaceutical composition, preparation method and application.
Background technique
Irritable bowel syndrome (irritable bowel syndrome, IBS) is one group and continues or intermittently break out, with abdomen Bitterly, abdominal distension, bowl evacuation habit and (or) stool change into clinical manifestation, and lack gastrointestinal tract structure and biochemical abnormal enteron aisle Dysfunction disease.Chinese medicine divides IBS for the scorching card of large intestine, cold-heat complication card, weakness of the spleen and stomach, irritable bowel syndrome card, liver depression The cards type such as syndrome of qi stagnation achieves certain curative effect to the treatment of IBS by the methods of diagnosis and treatment, acupuncture, but there is still a need for into one Step research improves the curative effect of IBS.
Summary of the invention
The embodiment of the present application is designed to provide a kind of pharmaceutical composition, preparation method and application, is intended to provide A kind of drug for the curative effect that can improve IBS.
The application first aspect provides a kind of pharmaceutical composition, and the raw material of pharmaceutical composition mainly includes according to parts by weight Following components:
1-6 parts of cloves, 3-9 parts of baked ginger, nutmeg 3-9 parts of stewing, 1-6 parts of cortex cinnamomi and 6-12 parts of Chinese gall.
The pharmaceutical composition is started at all from the interpretation of the cause, onset and process of an illness of diarrhea-type irritability syndrome, based on tonifying spleen and kidney, to internal organs Full-featured adjusting pushes qi and blood to use, and adjusts viscera function, promotes the recovery of gastrointestinal function.With baked ginger, cortex cinnamomi, Pork and beans Cool middle benefit gas manages spleen, temperature male wind-supplying kidney;Baked ginger, cortex cinnamomi, warming spleen and stomach for dispelling cold, mends fire supporing yang;Nutmeg, Chinese gall relieving diarrhea with astringents, cloves temperature Middle activating qi for lowering adverse qi.It can be effectively improved main clinic symptoms and the card marquis of patient, mitigate the pain of patient, can be treatment diarrhea-type Irritable bowel syndrome achieves good effect.
In some embodiments of the application first aspect, the raw material of pharmaceutical composition mainly includes according to parts by weight Following components:
2-5 parts of cloves, 5-8 parts of baked ginger, nutmeg 5-8 parts of stewing, 2-5 parts of cortex cinnamomi and 8-10 parts of Chinese gall.
Pharmaceutical composition under the proportion has preferable drug effect.
In some embodiments of the application first aspect, pharmaceutical composition includes:
Volatile oil, Chinese gall powder, the alcohol extract of baked ginger, the myristic alcohol extract of stewing and the alcohol extracting of cortex cinnamomi of cloves Object.
The application second aspect provides a kind of preparation method of aforementioned pharmaceutical compositions, the preparation method packet of pharmaceutical composition It includes:
Distillation extracts cloves and obtains volatile oil, and alcohol extracting baked ginger, stewing nutmeg and cortex cinnamomi obtain alcohol extract.
Mixed chaotic sequences, alcohol extract and gallic powder.
Distillation extracts cloves and obtains volatile oil, enters the effective component in cloves in caryophyllus oil, non-in removal cloves to have Ingredient is imitated, alcohol extracting baked ginger, stewing nutmeg and cortex cinnamomi obtain alcohol extract;Effective component is extracted into alcohol extract, is then mixed again Close volatile oil, alcohol extract and gallic powder.It can reduce the volume for the pharmaceutical composition that identical crude drug amount obtains.
In some embodiments of the application second aspect, alcohol extracting baked ginger, stewing nutmeg and cortex cinnamomi obtain alcohol extract Step includes:
Using the ethanol water of 70-75vol% to baked ginger, stewing nutmeg and cortex cinnamomi alcohol extracting 2-3 times, merging filtrate Removal ethyl alcohol obtains alcohol extract afterwards.
Alcohol extracting is carried out using the above method and obtains alcohol extract, it is shorter that the alcohol extracting time can be taken into account, and makes as much as possible to have It imitates ingredient and alcohol extract is entered by ethyl alcohol leaching.
In some embodiments of the application second aspect, distillation extracts the step of cloves obtains volatile oil and includes:
Using extraction by steam distillation cloves 2-2.5 hours and volatile oil is collected, wherein the weight of water is cloves 10-12 times.
Volatile clove oil is extracted using the above method, the effective component of cloves can be entered into volatile oil as far as possible.
In some embodiments of the application second aspect, the step of Mixed chaotic sequences, alcohol extract and gallic powder Suddenly include:
It will volatilize oil, gallic powder, framework material, crosslinking agent and moisturizer and be mixed to get the first phase.
Alcohol extract, thickener, cross-linking regulator and water are mixed to get the second phase.
Mix the first phase and the second phase.
Using the available lotion of the above method;Big with dose, moisture retention is strong, the good advantage with the compatibility of skin.
In some embodiments of the application second aspect, alcohol extract, thickener, cross-linking regulator and water are mixed Include: to the step of the second phase
Aqueous solution, alcohol extract and the cross-linking regulator of mixing thickener obtain the second phase.
The aqueous solution of thickener is mixed with alcohol extract and cross-linking regulator can mix more evenly, can be to avoid because increasing Thick dose of viscosity and lead to that its dissolubility is poor, is not easy the shortcomings that mixing.
In some embodiments of the application second aspect, framework material includes Sodium Polyacrylate NP-700, crosslinking agent packet Dihydroxyaluminium Aminoacetate is included, moisturizer includes glycerol, and thickener includes PVP K-30, and cross-linking regulator includes citric acid.
The performance of keeping humidity of pharmaceutical composition and the persistence of drug effect can be increased using above-mentioned substrate.
The application third aspect provides a kind of purposes, the pharmaceutical composition that the application first aspect provides in preparation treatment or Prevent the application in diarrhea-type irritability syndrome drug.
The pharmaceutical composition that the application first aspect provides, which has, promotes that the recovery of gastrointestinal function, to facilitate viscera function complete The effect of face is adjusted can be effectively improved main clinic symptoms and the card marquis of patient, can be used in preparation and treat or prevent diarrhea Type irritable bowel syndrome drug.
Specific embodiment
It, below will be in the embodiment of the present application to keep the purposes, technical schemes and advantages of the embodiment of the present application clearer Technical solution be clearly and completely described.The person that is not specified actual conditions in embodiment, according to normal conditions or manufacturer builds The condition of view carries out.Reagents or instruments used without specified manufacturer is the conventional production that can be obtained by commercially available purchase Product.
The pharmaceutical composition of the embodiment of the present application, preparation method and application are specifically described below.
A kind of pharmaceutical composition, the raw material of pharmaceutical composition mainly include following components according to parts by weight:
1-6 parts of cloves, 3-9 parts of baked ginger, nutmeg 3-9 parts of stewing, 1-6 parts of cortex cinnamomi and 6-12 parts of Chinese gall.
Pharmaceutical composition provided by the present application is started at all from the interpretation of the cause, onset and process of an illness of diarrhea-type irritability syndrome, and the formula is with temperature compensation Based on spleen kidney, viscera function is adjusted comprehensively, qi and blood is pushed to use, adjusted viscera function, promote the recovery of gastrointestinal function.With Baked ginger, cortex cinnamomi, nutmeg middle benefit gas manage spleen, temperature male wind-supplying kidney;Baked ginger, cortex cinnamomi, warming spleen and stomach for dispelling cold, mends fire supporing yang;Nutmeg, Chinese gall are puckery Intestines antidiarrheal, cloves middle benefit gas activating qi for lowering adverse qi.It can be effectively improved main clinic symptoms and the card marquis of patient, mitigate patient body and the heart The pain of reason can achieve good effect for treatment diarrhea-type irritability syndrome.
Further, in embodiments herein, pharmaceutical composition includes the fourth that the cloves of above-mentioned 1-6 part is extracted Sesame oil, the Chinese gall powder (such as the partial size of powder can be less than 100 mesh) that 6-12 parts of Chinese gall is ground, 1-6 parts The alcohol extract of cortex cinnamomi that raises of cinnamyl alcohol, the alcohol extract for the baked ginger that 3-9 parts of baked ginger alcohol extracting obtains, 3-9 parts of stewing meat The myristic alcohol extract of the stewing that cardanol raises.
It is further possible to directly carry out purchase caryophyllus oil, Chinese gall powder, baked ginger alcohol extract, simmer it is myristic Alcohol extract and the alcohol extract of cortex cinnamomi.
Caryophyllus oil is conducive to the absorption to active drug, and the alcohol extract of baked ginger simmers myristic alcohol extract and cortex cinnamomi Alcohol extract also contributes to the utilization of drug effect,
In some embodiments of the application first aspect, the raw material of pharmaceutical composition mainly includes according to parts by weight Following components:
2-5 parts of cloves, 5-8 parts of baked ginger, nutmeg 5-8 parts of stewing, 2-5 parts of cortex cinnamomi and 8-10 parts of Chinese gall.
Pharmaceutical composition under the proportion has preferable drug effect.
The application second aspect provides a kind of preparation method of aforementioned pharmaceutical compositions, the preparation method packet of pharmaceutical composition It includes:
Distillation extracts cloves and obtains volatile oil, and alcohol extracting baked ginger, stewing nutmeg and cortex cinnamomi obtain alcohol extract;
Mixed chaotic sequences, alcohol extract and gallic powder.
The application also provides a kind of preparation method of aforementioned pharmaceutical compositions, and the preparation method of pharmaceutical composition includes:
Distillation extracts cloves and obtains volatile oil, and alcohol extracting baked ginger, stewing nutmeg and cortex cinnamomi obtain alcohol extract;
Mixed chaotic sequences, alcohol extract and gallic powder.
Distillation extracts cloves and obtains volatile oil, enters the effective component in cloves in caryophyllus oil, non-in removal cloves to have Ingredient is imitated, alcohol extracting baked ginger, stewing nutmeg and cortex cinnamomi obtain alcohol extract;Effective component is extracted into alcohol extract, is then mixed again Close volatile oil, alcohol extract and gallic powder.It can reduce the volume for the pharmaceutical composition that identical crude drug amount obtains.
It should be noted that the step of alcohol extracting baked ginger, stewing nutmeg and cortex cinnamomi obtain alcohol extract, it can be for respectively to big gun Ginger simmers nutmeg or cortex cinnamomi alcohol extracting and then is mixed to get alcohol extract.Or baked ginger, stewing nutmeg and cortex cinnamomi are mixed It closes object progress alcohol extracting and obtains alcohol extract.
Further, the step of alcohol extracting baked ginger, stewing nutmeg and cortex cinnamomi obtain alcohol extract includes: using 70- The ethanol water of 75vol% to baked ginger, simmer nutmeg and cortex cinnamomi alcohol extracting 2-3 time, remove ethyl alcohol after merging filtrate and obtain alcohol Extract.
Alcohol extracting is carried out using the above method and obtains alcohol extract, it is shorter that the alcohol extracting time can be taken into account, and makes as much as possible to have It imitates ingredient and alcohol extract is entered by ethyl alcohol leaching.
Further, in some embodiments of the present application, distillation extracts the step of cloves obtains volatile oil and includes:
Using extraction by steam distillation cloves 2-2.5 hours and volatile oil is collected, wherein the weight of water is cloves 10-12 times.
Volatile clove oil is extracted using the above method, the effective component of cloves can be entered into volatile oil as far as possible.
It should be noted that the preparation method of pharmaceutical composition may be will be each in the other embodiments of the application Raw material mixing carries out alcohol extracting, then removes ethyl alcohol.Alternatively, prepared by the method that can also boil each raw material using water.
Further, in some embodiments of the present application, cataplasm (also known as gel ointment) is made in pharmaceutical composition, Further, preparation method includes:
It will volatilize oil, gallic powder, framework material, crosslinking agent and moisturizer and be mixed to get the first phase.
Alcohol extract, thickener, cross-linking regulator and water are mixed to get the second phase.
Mix the first phase and the second phase.
Using the lotion of the available cataplasm of the above method;Big with dose, moisture retention is strong, good with the compatibility of skin The advantages of.
It further, include that the aqueous solution for mixing thickener, alcohol extract and crosslinking are adjusted the step of preparing the second phase Agent obtains the second phase.In other words, thickener is first dissolved in water and obtains aqueous solution, then mixed with alcohol extract and cross-linking regulator.
The aqueous solution of thickener is mixed with alcohol extract and cross-linking regulator can mix more evenly, can be to avoid because increasing Thick dose of viscosity and lead to that its dissolubility is poor, is not easy the shortcomings that mixing.
It should be noted that in the other embodiments of the application, can also in such a way that other make cataplasms system Obtain pharmaceutical composition.
For example, framework material includes Sodium Polyacrylate NP-700 in some embodiments of the present application, crosslinking agent includes Dihydroxyaluminium Aminoacetate, moisturizer include glycerol, and thickener includes PVP K-30, and cross-linking regulator includes citric acid.
The performance of keeping humidity of pharmaceutical composition and the persistence of drug effect can be increased using above-mentioned substrate.
As illustratively, in some embodiments of the present application, the proportion of above-mentioned substrate and pharmaceutical composition can be as Under:
Cloves 3-18g;Baked ginger 9-27g;Simmer nutmeg 9-27g;Cortex cinnamomi 3-18g;Chinese gall 18-36g;6- The Sodium Polyacrylate NP-700 60-70g of 8wt%;Dihydroxyaluminium Aminoacetate 6-8g;Citric acid 2-4g;Glycerol 250-280ml;Poly- dimension Ketone K-30 50-60g;Water 565-570ml.
It is understood that the proportion of raw material can be in speed according to said ratio in some embodiments of the present application Increase or and reduces.In addition, the dosage of the substrates such as Sodium Polyacrylate NP-700 can also in the other embodiments of the application To carry out ingredient as needed.
It should be noted that above-mentioned framework material may be carbomer etc. in the other embodiments of the application.Phase Ying Di, crosslinking agent, moisturizer, thickener, cross-linking regulator can also using other not with cloves, baked ginger, simmer nutmeg, cortex cinnamomi And Chinese gall generates the substance of reaction or drug effect conflict.
The application also provides a kind of purposes, and above-mentioned pharmaceutical composition treats or prevents diarrhea type irritable bowel synthesis in preparation Levy the application in drug.
From the above, pharmaceutical composition provided by the embodiments of the present application have promote gastrointestinal function recovery, facilitate it is dirty The effect of internal organs full-featured adjusting, can be effectively improved main clinic symptoms and the card marquis of patient, can be used in preparation treatment or Prevent diarrhea-type irritability syndrome drug.
The feature of the application and performance are described in further detail with reference to embodiments.
Embodiment 1
Present embodiments provide a kind of pharmaceutical composition.Mainly it is made by following steps:
Take raw material: 1 part of cloves, 3 parts of baked ginger, 3 parts of nutmeg of stewing, 1 part of cortex cinnamomi and 6 parts of Chinese gall.
Cloves is taken, 10 times of amount water are added, extraction by steam distillation 2h collects volatile oil.
Chinese gall crushes, and sieves with 100 mesh sieve.
Baked ginger, stewing nutmeg, cortex cinnamomi use ethanol water refluxing extraction 2 times of 70vol%;Wherein, add 7 times for the first time Ethanol water is measured, 1.5h is extracted, second plus 5 times of amount ethyl alcohol extract 1h, and extracting solution filtration merges, and recycle ethyl alcohol and are concentrated Primary dose 2g, which is equivalent to, to every milliliter obtains alcohol extract.
Merge alcohol extract, volatile oil and gallnut extract.
Embodiment 2
Present embodiments provide a kind of pharmaceutical composition.Mainly it is made by following steps:
Take raw material: 6 parts of cloves, 9 parts of baked ginger, 9 parts of nutmeg of stewing, 6 parts of cortex cinnamomi and 12 parts of Chinese gall.
Cloves is taken, 10 times of amount water are added, extraction by steam distillation 2h collects volatile oil.
Chinese gall crushes, and sieves with 100 mesh sieve.
Baked ginger, stewing nutmeg, cortex cinnamomi use ethanol water refluxing extraction 2 times of 75vol%;Wherein, add 7 times for the first time Ethanol water is measured, 1.5h is extracted, second plus 5 times of amount ethyl alcohol extract 1h, and extracting solution filtration merges, and recycle ethyl alcohol and are concentrated Primary dose 2g, which is equivalent to, to every milliliter obtains alcohol extract.
Merge alcohol extract, volatile oil and gallnut extract.
Embodiment 3
Present embodiments provide a kind of pharmaceutical composition.Mainly it is made by following steps:
Take raw material: 2 parts of cloves, 5 parts of baked ginger, 5 parts of nutmeg of stewing, 2 parts of cortex cinnamomi and 8 parts of Chinese gall.
Cloves is taken, 12 times of amount water are added, extraction by steam distillation 2.5h collects volatile oil.
Chinese gall crushes, and sieves with 100 mesh sieve.
Baked ginger, stewing nutmeg, cortex cinnamomi use ethanol water refluxing extraction 2 times of 72vol%;Wherein, add 7.5 for the first time Amount ethanol water again extracts 1.5h, and for the second time plus 6 times of amount ethyl alcohol, extraction 1h, extracting solution filtration merge, and recycling ethyl alcohol is simultaneously dense It is reduced to every milliliter and is equivalent to primary dose 2g and obtain alcohol extract.
Merge alcohol extract, volatile oil and gallnut extract.
Embodiment 4
Present embodiments provide a kind of pharmaceutical composition.Mainly it is made by following steps:
Take raw material: 5 parts of cloves, 8 parts of baked ginger, 8 parts of nutmeg of stewing, 5 parts of cortex cinnamomi and 10 parts of Chinese gall.
Cloves is taken, 11 times of amount water are added, extraction by steam distillation 2h collects volatile oil.
Chinese gall crushes, and sieves with 100 mesh sieve.
Baked ginger, stewing nutmeg, cortex cinnamomi use ethanol water refluxing extraction 2 times of 70vol%;Wherein, add 7.5 for the first time Amount ethanol water again extracts 1.5h, and for the second time plus 6 times of amount ethyl alcohol, extraction 1h, extracting solution filtration merge, and recycling ethyl alcohol is simultaneously dense It is reduced to every milliliter and is equivalent to primary dose 2g and obtain alcohol extract.
Merge alcohol extract, volatile oil and gallnut extract.
Embodiment 5
Take raw material: 5 parts of cloves, 8 parts of baked ginger, 8 parts of nutmeg of stewing, 5 parts of cortex cinnamomi and 10 parts of Chinese gall.
Cloves 3g;Baked ginger 9g;Simmer nutmeg 9g;Cortex cinnamomi 3g;Chinese gall 18g.
The Sodium Polyacrylate NP-700 60g of 6wt%;Dihydroxyaluminium Aminoacetate 6g;Citric acid 2g;Glycerol 250ml;PVP K-30 50g;Water 565ml.
Set PVP K-30 in beaker, water be added, stirring makes it completely dissolved, add citric acid and Medical fluid stirs evenly, and obtains the second phase.Sodium Polyacrylate NP-700, Dihydroxyaluminium Aminoacetate, gallnut extract are taken, is set in another beaker, is added Glycerol and volatile clove oil, stir evenly, and obtain the first phase.The first phase and the second phase are mixed, is uniformly mixed, 1000g is made, Coating.
Embodiment 6
Take raw material: 5 parts of cloves, 8 parts of baked ginger, 8 parts of nutmeg of stewing, 5 parts of cortex cinnamomi and 10 parts of Chinese gall.
Cloves 18g;Baked ginger 27g;Simmer nutmeg 27g;Cortex cinnamomi 18g;Chinese gall 36g;The Sodium Polyacrylate NP- of 8wt% 700 70g;Dihydroxyaluminium Aminoacetate 8g;Citric acid 4g;Glycerol 250ml;PVP K-30 60g;Water 570ml.
Set PVP K-30 in beaker, water be added, stirring makes it completely dissolved, add citric acid and Medical fluid stirs evenly, and obtains the second phase.Sodium Polyacrylate NP-700, Dihydroxyaluminium Aminoacetate, gallnut extract are taken, is set in another beaker, is added Glycerol and volatile clove oil, stir evenly, and obtain the first phase.The first phase and the second phase are mixed, is uniformly mixed, 1000g is made, Cataplasm is made in coating.
Test example
Clinical research is carried out using random, double blind, placebo.Treatment group is using the drug for sticking the offer of embodiment 6 Composition is intervened, and control group uses placebo, from change of illness state integral, semiotics, syndrome manifestations, quality of life various dimensions section Learning evaluation, it treats IBS-D (diarrhea-type irritability syndrome) curative effect and safety.
146 yang deficiency of spleen and stomache IBS-D patients are randomly divided into observation group and control group, and are provided respectively with embodiment 6 Pharmaceutical composition and placebo acupoint application treatment, the course for the treatment of 4 weeks, follow-up 4 weeks.After treating 4 weeks, observation group IBS-D patient's IBS-SSS integral is decreased obviously earlier above, and difference is statistically significant (P < 0.05), and is better than control group (P < 0.05).Treatment 4 Zhou Hou observation group Chinese medicine syndrome integrals are decreased obviously before relatively treating, and difference is statistically significant (P < 0.05), and better than control Group (P < 0.05).Treat that the most numbers of 4 Zhou Hou observation group defecations, number of days, the stool integral of defecation urgency sense are equal in 10 days Decline earlier above, difference is statistically significant (P < 0.05), and is better than control group (P < 0.05).Treat the life of 4 Zhou Hou observation groups Quality integral is significantly raised earlier above, and difference is statistically significant (P < 0.05), and is better than control group (P < 0.05).Observation group, Control group IBS-SSS total effective rate is respectively 93.24% and 50.68%, and tcm syndrome total effective rate is respectively 89.04% He 42.46%, stool total effective rate is respectively 87.67% and 35.61%, statistically significant (the P < of 2 group differences 0.05)。
Diagnostic criteria
Doctor trained in Western medicine diagnosis
Referring to Functional Gastrointestinal Disease Rome III standard.Using abdominal pain or abdominal discomfort as main clinical manifestation, abdominal pain or It is uncomfortable related with bowl evacuation habit, or with bowl evacuation habit change and abnormal defecation.Diagnostic criteria is the abdominal pain or not of recurrent exerbation It is suitable, and with following 2 or multinomial performance: 1. symptom improves when defecation;2. with the change of stool interval when breaking-out;3. breaking out When with fecal character change.Meet that functional bowel disorder is temporal to be defined jointly, i.e., requires the 1st paresthesia epilepsy on the time Time must already exceed 6 months, and nearly 3 months symptom duration >=3 day/month, show nearest state of an illness activity.IBS-D is answered Meet: arranging the ratio < 1/4 of ratio >=1/4 and hard or bulk of shapeless (paste) or watery stool just.
Chinese medical discrimination
It is formulated referring to " irritable bowel syndrome Chinese medicine diagnosis and treatment National Consensus ".Syndrome of yang deficiency of spleen and kidney: primary symptom: 1. abdominal pain is from morning It rushes down;2. abdomen crymodynia obtains warm pain and subtracts;The limb cold 3. shape is trembled with fear.Minor symptom: 1. soreness and weakness of waist and knees;2. do not feel like eating;3. pale tongue is fat, white,slippery and moist fur; 4. deep thready pulse.Primary symptom is indispensable, add minor symptom two or more it is i.e. diagnosable.
It is included in standard
(1) meet IBS-D doctor trained in Western medicine Rome III diagnostic criteria;(2) meet the CM syndrome differentiation criterion of Chinese medicine syndrome of yang deficiency of spleen and kidney;(3) Age is between 18-65 years old;(4) informed consent is volunteered tested.
Exclusion criteria
(1) infectious diarrhea patient;(2) diarrhea person caused by systemic disease, poisoning, malignant tumour;(3) merge heart and brain Blood vessel, liver kidney, endocrine, hemopoietic system severe primary disease patient;(4) gestation or late afternoon cream women;(5) allergic constitution person;(6) Suffer from mental disease or is not able to cooperate researcher.
Treatment method
Using random, double blind, placebo-controlled trial design, patient be pressed into group sequence by drug control person sequence open with Machine envelope, gets drug.
Observation group
The pharmaceutical composition provided using embodiment 6, one time a day, night paste umbilical region, remove from morning, and patch is stopped 1 day for 6 days.It treats Journey is 4 weeks.
Control group
Using placebo cataplasm, the content of pharmaceutical composition is the medicine group that embodiment 6 provides in placebo cataplasm The 1/10 of amount of substance is closed, one time a day, night pastes umbilical region, removes from morning, and patch is stopped 1 day for 6 days.The course for the treatment of is 4 weeks.
Observation index and method
Before treatment, the 2nd week and 1 change of illness state of the 4th week record, and follow-up in 4 weeks 1 time after treatment end, note Picture recording closes change of illness state.
IBS severity of symptom scale
It is formulated referring to IBS severity of symptom scale (IBS symptom severity scale, IBS-SSS), packet Include: abdominal pain degree, abdominal pain number of days, abdominal distension degree, defecation satisfaction, life 5 projects of interference, each project are divided into nothing, are not Very seriously, some are serious, serious, 5 grades very serious, respectively correspond 0 point, 25 points, 50 points, 75 points, 100 points, projects are always accumulated Divide up to 500 points.
TCM Syndrome Theories index (symptom integral)
Referring to " new Chinese medicine guideline of clinical investigations ", respectively to stool, diarrhea number, abdominal pain, abdominal distension, burnout Out of strength, abdomen crymodynia obtains that warm pain subtracts, shape is trembled with fear limb cold, soreness and weakness of waist and knees, loss of appetite, depressed emotion or irritable, sighing frequently, intestines Ring flatus, the fat white,slippery and moist fur of pale tongue, deep thready pulse are scored, by symptom be divided into it is light, in, severe, remember 1,2,3 point respectively, it is asymptomatic 0 point of note.It is syndrome integral by above each symptom sum.
IBS-D stool questionnaire (defection state questionnaire, DSQ)
It include most numbers of daily defecation including stool evaluation referring to the IBD-DSQ questionnaire of the designs such as Shen Yun (times/day), in 10 days defecation urgency sense the aspect of number of days and stool 3.Wherein stool Bristol stool Parting, point normal, dispersion agglomerate sample soft stool, mushy stool, 4 grades of watery stool, respectively corresponds 1,2,3,4 point.
IBS quality of life scale
Referring to quality of life scale (IBS quality of life, IBS- by establishments such as the PatrickD L in the U.S. QOL), scale by Chinesizing, including dysthymia, behavior disorder, self image, health worry, feed escape, social function, Sexual behaviour and relationship expand 34 entries composition of 8 dimensions, by symptom be divided into without, it is light, in, again, it is very heavy, remember 5 respectively, 4,3, 2,1 point, score is higher, and quality of life is higher.
Evaluation method
General symptom curative effect determinate standard
The IBS change of illness state table of integrals (IBS-SSS) points-scoring system is divided into 4 grades: (I) integrates < 75 as normal person's integral It is horizontal;(II) integral be 75~175 (75 " x < 175) are slight IBS symptom integral level;(III) integral is 175~300 (175 " x < 300) it is that moderate IBS symptom integral is horizontal;(IV) integral >=300 is horizontal for severe IBS symptom integral.
Efficacy determination is as follows:
(1) clinical recovery: patient's integral is less than 75 after treatment;(2) effective: after treatment patient integrate reduce by two ranks with On;(3) effectively: patient, which integrates, after treatment reduces a rank;(4) invalid: patient's integral is still in same rank or height after treatment In former stratification levels.
Therapeutic effect of syndrome (TCM symptom score) evaluation criteria
(referring to the efficacy assessment standard of " new Chinese medicine guideline of clinical investigations "): it is calculated using Nimodipine method.It treats Imitate index=(pre-treatment score-post treatment integral)/pre-treatment score × 100%).(1) clinic control: therapeutic index >= 95%.(2) effective: 70%≤therapeutic index < 95%.(3) effectively: 30%≤therapeutic index < 70%.(4) invalid: curative effect refers to Number < 30%.
Stool curative effect determinate standard:
Efficacy determination is as follows: (1) clinical recovery: stool restores normal after treatment.(2) effective: patient stool property after treatment Shape is to normal 2 ranks that improve.(3) effectively: patient's stool is to normal 1 rank that improves after treatment.(4) invalid: treatment Patient's stool is in same rank or defecates and develops to watery stool afterwards.
The pretherapy and post-treatment IBS-SSS individual event integral contrast of 2 groups of patients:
Treat uncomfortable preceding 2 groups of IBS-SSS abdominal pain, abdominal pain breaking-out number of days, abdominal distension, to defecation situation satisfaction, bowel symptoms Interference and total mark no significant difference (P > 0.05) to life.Compared with before treatment, after treatment and 2 when follow-up Group abdominal pain discomfort, abdominal pain breaking-out number of days, abdominal distension, interference and total mark to defecation situation satisfaction, bowel symptoms to life 2 groups of integrals integral of 2 weeks than treatment is low (P < 0.05) when being remarkably decreased (P < 0.05), and treating 4 weeks.With control group ratio Compared with it is more significant (P < 0.05) that observation group integrates reduction after the treatment.It is shown in Table 1.
The pretherapy and post-treatment IBS-SSS integral contrast of 12 groups of patients of table (point, X ± s)
With this group before treatment, * P < 0.05;Compared with being treated 2 weeks with this group, ▲ P < 0.05;With control group same period ratio Compared with △ P < 0.05
The group pretherapy and post-treatment IBS-SSS total mark of patient compares:
Treat preceding 2 groups of IBS-SSS integral no significant difference (P > 0.05).With treatment before compared with, after treatment and 2 groups of integrals are remarkably decreased (P < 0.05) when follow-up, and treat 4 weeks when 2 groups of integrals than treat 2 weeks integral it is (P < low 0.05).Compared with the control group, it is more significant (P < 0.05) to integrate reduction after the treatment for observation group.It is shown in Table 2.
The pretherapy and post-treatment IBS-SSS integral contrast of 22 groups of patients of table (point, X ± s)
With this group before treatment, * P < 0.05;Compared with being treated 2 weeks with this group, ▲ P < 0.05;With control group same period ratio Compared with △ P < 0.05
IBS-SSS curative effect
Observation group, control group IBS-SSS total effective rate are respectively 93.24% and 50.68%, and 2 group differences have statistics Meaning (P < 0.05).It is shown in Table 3.
The pretherapy and post-treatment IBS-SSS curative effect of 32 groups of patients of table compares [example (%)]
Compared with the control group, △ P < 0.05
The pretherapy and post-treatment individual event symptom of group patient and Chinese medicine syndrome integral compare
Treat preceding 2 groups of stools, diarrhea number, abdominal pain, abdominal distension integral no significant difference (P > 0.05).With Treatment before relatively, 2 groups of integrals are remarkably decreased (P < 0.05) after treatment and when follow-up, and treat 4 weeks when 2 groups of integrals than controlling It is low (P < 0.05) to treat 2 weeks integrals.Compared with the control group, it is more significant (P < 0.05) to integrate reduction after the treatment for observation group.
Treat preceding 2 groups of Chinese medicine syndrome integral no significant differences (P > 0.05).With treatment before compared with, after treatment and 2 groups of integrals are remarkably decreased (P < 0.05) when follow-up, and treat 4 weeks when 2 groups of integrals than treat 2 weeks integral it is (P < low 0.05).Compared with the control group, it is more significant (P < 0.05) to integrate reduction after the treatment for observation group.It is shown in Table 4.
The pretherapy and post-treatment individual event symptom of 42 groups of patients of table and Chinese medicine syndrome integral compare and (divide, X ± s)
With this group before treatment, * P < 0.05;Compared with being treated 2 weeks with this group, ▲ P < 0.05;With control group same period ratio Compared with △ P < 0.05
Tcm syndrome curative effect
Observation group, control group tcm syndrome total effective rate are respectively 89.04% and 42.46%, and 2 group differences have statistics Meaning (P < 0.05).It is shown in Table 5.
The pretherapy and post-treatment tcm syndrome curative effect of 52 groups of patients of table compares [example (%)]
Compared with the control group, △ P < 0.05
The pretherapy and post-treatment stool variation of 2 groups of patients is compared
Treat the most numbers of preceding 2 groups of defecations, in 10 days defecation urgency sense number of days, stool integral no statistical difference Meaning (P > 0.05).Compared with before treatment, 2 groups of integrals are remarkably decreased (P < 0.05) after treatment and when follow-up, and are treated 4 weeks When 2 groups of integrals than treatment 2 weeks integral it is low (P < 0.05).Compared with the control group, it is more aobvious to integrate reduction after the treatment for observation group It writes (P < 0.05).It is shown in Table 6.
62 groups of patients of table pretherapy and post-treatment stool variation compare (times/day, day, point;X±s)
With this group before treatment, * P < 0.05;Compared with being treated 2 weeks with this group, ▲ P < 0.05;With control group same period ratio Compared with △ P < 0.05
Stool curative effect
Observation group, control group stool total effective rate are respectively 87.67% and 35.61%, and 2 group differences have statistics Meaning (P < 0.05), is shown in Table 7.
The pretherapy and post-treatment stool curative effect of 72 groups of patients of table compares [example (%)]
Compared with the control group, △ P < 0.05
The pretherapy and post-treatment quality of life integral contrast of 2 groups of patients
Treat preceding 2 groups of qualities of life integral no significant difference (P > 0.05).Compared with before treatment, after treatment 4 weeks Observation group's quality of life integral is significantly raised earlier above, and difference is statistically significant (P < 0.05).Compared with the control group, observation group Integral increases more significant (P < 0.05) after the treatment.It is shown in Table 8.
The pretherapy and post-treatment quality of life integral contrast of 82 groups of patients of table (point, X ± s)
With this group before treatment, * P < 0.05;Compared with the control group same period, △ P < 0.05
Referring to table 1 to table 8 as can be seen that the pharmaceutical composition application method treatment IBS-D that embodiment 6 provides has well Clinical efficacy, can be obviously improved patient clinical symptoms, card marquis.
The foregoing is merely preferred embodiment of the present application, are not intended to limit this application, for the skill of this field For art personnel, various changes and changes are possible in this application.Within the spirit and principles of this application, made any to repair Change, equivalent replacement, improvement etc., should be included within the scope of protection of this application.

Claims (10)

1. a kind of pharmaceutical composition, which is characterized in that the raw material of described pharmaceutical composition mainly include according to parts by weight with Lower component:
1-6 parts of cloves, 3-9 parts of baked ginger, nutmeg 3-9 parts of stewing, 1-6 parts of cortex cinnamomi and 6-12 parts of Chinese gall.
2. pharmaceutical composition according to claim 1, which is characterized in that the raw material of described pharmaceutical composition mainly includes pressing The following components of parts by weight meter:
Described cloves 2-5 parts, it is baked ginger 5-8 parts described, 5-8 parts of the stewing nutmeg, cortex cinnamomi 2-5 parts and described five described 8-10 parts of gall nut.
3. pharmaceutical composition according to claim 1 or 2, which is characterized in that described pharmaceutical composition includes:
The volatile oil of the cloves, the Chinese gall powder, the baked ginger alcohol extract, it is described simmer myristic alcohol extract and The alcohol extract of the cortex cinnamomi.
4. the preparation method of the described in any item pharmaceutical compositions of claim 1-3, which is characterized in that described pharmaceutical composition Preparation method include:
Distillation extracts the cloves and obtains volatile oil, and baked ginger described in alcohol extracting, the stewing nutmeg and the cortex cinnamomi obtain alcohol extracting Object;
Mix the volatile oil, the alcohol extract and the gallic powder.
5. the preparation method of pharmaceutical composition according to claim 4, which is characterized in that baked ginger described in the alcohol extracting, institute It states and simmers the step of nutmeg and the cortex cinnamomi obtain alcohol extract and include:
Using the ethanol water of 70-75vol% to the baked ginger, the stewing nutmeg and cortex cinnamomi alcohol extracting 2-3 times described, Ethyl alcohol is removed after merging filtrate obtains the alcohol extract.
6. the preparation method of pharmaceutical composition according to claim 4, which is characterized in that the cloves is extracted in the distillation The step of obtaining volatile oil include:
Using cloves 2-2.5 hours described in extraction by steam distillation and the volatile oil is collected, wherein the weight of water is described 10-12 times of cloves.
7. the preparation method of pharmaceutical composition according to claim 4, which is characterized in that mix the volatile oil, described The step of alcohol extract and the gallic powder includes:
The volatile oil, the gallic powder, framework material, crosslinking agent and moisturizer are mixed to get the first phase;
The alcohol extract, thickener, cross-linking regulator and water are mixed to get the second phase;
Mix first phase and second phase.
8. the preparation method of pharmaceutical composition according to claim 7, which is characterized in that
The described the step of alcohol extract, thickener, cross-linking regulator and water are mixed to get the second phase includes:
The aqueous solution, the alcohol extract and the cross-linking regulator for mixing the thickener obtain second phase.
9. the preparation method of pharmaceutical composition according to claim 7 or 8, which is characterized in that
The framework material includes Sodium Polyacrylate NP-700, and the crosslinking agent includes Dihydroxyaluminium Aminoacetate, and the moisturizer includes sweet Oil, the thickener include PVP K-30, and the cross-linking regulator includes citric acid.
10. the described in any item pharmaceutical compositions of claim 1-3 treat or prevent diarrhea-type irritability syndrome medicine in preparation Application in object.
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