CN105853653A - Pharmaceutical composition for treating digestive system disease and preparation method thereof - Google Patents
Pharmaceutical composition for treating digestive system disease and preparation method thereof Download PDFInfo
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- CN105853653A CN105853653A CN201610259521.8A CN201610259521A CN105853653A CN 105853653 A CN105853653 A CN 105853653A CN 201610259521 A CN201610259521 A CN 201610259521A CN 105853653 A CN105853653 A CN 105853653A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/75—Rutaceae (Rue family)
- A61K36/754—Evodia
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/61—Myrtaceae (Myrtle family), e.g. teatree or eucalyptus
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/67—Piperaceae (Pepper family), e.g. Jamaican pepper or kava
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/89—Cyperaceae (Sedge family)
- A61K36/8905—Cyperus (flatsedge)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0014—Skin, i.e. galenical aspects of topical compositions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
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Abstract
The invention discloses a pharmaceutical composition, which is a preparation prepared from the following raw materials in parts by weight: 1 to 3 parts of fructus evodiae, 2 to 6 parts of pepper, 2 to 5 parts of bud of syzygium aromaticum and 1 to 4 parts of rhizoma cyperi. The invention also provides a preparation method and application of the pharmaceutical composition. The pharmaceutical composition provided by the invention can effectively treats chronic gastritis, is fewer in herbal medicine and small in dosage, is an external used medicine, is convenient to apply and easy to accept by patients, provides the new externally used medicine with high efficiency and safety, without toxicity and side effects, and suitable for being used for a long time for clinically treating chronic gastritis, is low in cost, and has wide market prospect.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition treating disease of digestive system and preparation method thereof, belong to doctor
Medicine field.
Background technology
Disease of digestive system includes the organic and functional of the internal organs such as oesophagus, stomach, intestines, liver, courage, pancreas
Disease, the most common, wherein the chronic gastritis incidence of disease ranks first in various stomach trouble.Chronic stomach
Inflammation means the stomach lining chronic inflammation that different pathogeny causes, since self-digestion scope is extensively applied, to this disease
Understanding is significantly improved.Often it is divided into superficial gastritis, atrophic gastritis and specific type gastritis three major types.
From the cause of disease, Hp infection is the main cause of chronic gastritis, and the chronic gastritis of more than 90% has Hp to feel
Dye；Corpus atrophy is that main chronic gastritis occurs on autoimmunity basis, also referred to as autoimmunity
Property gastritis, or A type atrophic gastritis；Additionally physical factor is as drunk strong tea, coffee, strong drink for a long time,
Eat overheated, supercooling or the most coarse food, cause stomach lining repeatedly to damage；Chemical factor is as long-term big
Amount takes non-steroid anti-inflammatory drug, the nicotine in tobacco, and bile regurgitation, pancreatic juice regurgitation etc. cause stomach to stick
Film chronic inflammation change etc..From pathological change, have mucous membrane chronic inflammation, body of gland atrophy, metaplasia and
Intraepithelial neoplasia (cin).
Chronic gastritis is a kind of chronic digestible tract disease.Clinical manifestation is asymptomatic or has disappearing of varying degree
Change ill symptoms such as upper abdomen secret anguish, lack appetite, post-prandial fullness, sour regurgitation, belch etc. of feeling sick.Seriously wither
Contracting gastritis sufferer have anaemia, become thin, glossitis, diarrhoea etc..
Doctor trained in Western medicine currently mainly with anti symptom treatment, eradicate Hp treatment, and change diet and life style is main.
General prognosis bona.But to part chronic gastritis, antibiotic can be produced drug resistance, and have certain poison
Side effect.The traditional Chinese medical science is more to the research of chronic gastritis, and the relevant report of all circles is many, demonstrates traditional Chinese medicine
Treatment chronic gastritis has certain advantage.Chinese medicine compound prescription is taken orally and controlled outward is the main of Chinese traditional treatment disease
One of approach, it is each that the advantages such as entirety is nursed one's health, prescription is flexible, bad reaction is little, cheap obtain the world
The highly recognition of state.
The patent application of Publication No. CN101890086A discloses a kind of medicine, including forging hedgehog skin 10
Part, pseudo-ginseng 10 parts, American Ginseng 10 parts, the coptis 10 parts, evodia rutaecarpa 5 parts, cuttlebone 15 parts, benefit
Intelligence benevolence 10 parts, cloves 10 parts, 10 parts of the rhizome of nutgrass flatsedge and 5 parts of pepper.But the many consumptions of the flavour of a drug of this medicine
Greatly, cause said preparation price, particularly with needing the patient of long-term prescription, add their economy
Burden.
Therefore, the medicine of the treatment chronic gastritis that a kind of drug effect is clear and definite, toxic and side effect is little and with low cost is developed
Thing, becomes a problem demanding prompt solution.
Summary of the invention
It is an object of the invention to provide a kind of pharmaceutical composition treating chronic gastritis and preparation method thereof.
The invention provides a kind of pharmaceutical composition, it is characterised in that: it is by following weight proportioning
The preparation that raw material is prepared from: evodia rutaecarpa 1-3 part, pepper 2-6 part, cloves 2-5 part, rhizoma cyperi 1-4 part.
Preferably, it is the preparation being prepared from by the raw material of following weight proportioning: evodia rutaecarpa 2 parts, recklessly
Green pepper 3 parts, cloves 5 parts, rhizoma cyperi 4 parts.
Preferably, it is the extract of primary medicinal powder, water or the organic solvent by each weight proportion bulk drug,
Add pharmaceutically acceptable auxiliary material or preparation that complementary composition is prepared from.
Preferably, described preparation is external preparation.It is further preferred that described preparation is powder agent.
Present invention also offers the preparation method of foregoing, comprise the steps: to take each weight proportion
Bulk drug, directly beat powder, or add water or Solvent Extract methods, add pharmaceutically acceptable auxiliary
Material or complementary composition, to obtain final product.
Present invention also offers foregoing pharmaceutical composition and prepare the use in the medicine treating disease of digestive system again
On the way.
Pharmaceutical composition of the present invention can effectively treat chronic gastritis, and flavour of a drug are few, and consumption is little, and is outward
With medicine, use conveniently, be easily accepted by patients, for clinical treatment chronic gastritis provide a kind of efficiently,
The external application novel drugs of safe and free of toxic and side effects, applicable Long-Time Service, and with low cost, have wide
Market prospects.
Obviously, according to the foregoing of the present invention, according to ordinary technical knowledge and the customary means of this area,
Without departing under the present invention above-mentioned basic fundamental thought premise, it is also possible to make other various ways amendment,
Replace or change.
The detailed description of the invention of form by the following examples, remakes the foregoing of the present invention further
Detailed description.But this should not being interpreted as, the scope of the above-mentioned theme of the present invention is only limitted to Examples below.
All technology realized based on foregoing of the present invention belong to the scope of the present invention.
Detailed description of the invention
The raw material, the equipment that use in the specific embodiment of the invention are known product, commercially available by buying
Product obtains.
The preparation of embodiment 1 pharmaceutical composition of the present invention
Raw material is weighed by following weight proportion:
Evodia rutaecarpa 2g, pepper 3g, cloves 5g, rhizoma cyperi 4g
Preparation method is as follows:
Weigh each medicinal material, clean, dry, pulverize, cross 100 mesh sieves, stirring, mix, be placed in
Drying receptacle, seals standby.
The preparation of embodiment 2 pharmaceutical composition of the present invention
Raw material is weighed by following weight proportion:
Evodia rutaecarpa 2g, pepper 4g, cloves 2g, rhizoma cyperi 3g
Preparation method is as follows:
Weigh each medicinal material, clean, dry, pulverize, cross 100 mesh sieves, stirring, mix, be placed in
Drying receptacle, seals standby.
The preparation of embodiment 3 pharmaceutical composition of the present invention
Raw material is weighed by following weight proportion:
Evodia rutaecarpa 1g, pepper 2g, cloves 3g, rhizoma cyperi 1g
Preparation method is as follows:
Weigh each medicinal material, clean, dry, pulverize, cross 100 mesh sieves, stirring, mix, be placed in
Drying receptacle, seals standby.
The preparation of embodiment 4 pharmaceutical composition of the present invention
Raw material is weighed by following weight proportion:
Evodia rutaecarpa 3g, pepper 6g, cloves 5g, rhizoma cyperi 4g
Preparation method is as follows:
Weigh each medicinal material, clean, dry, pulverize, cross 100 mesh sieves, stirring, mix, be placed in
Drying receptacle, seals standby.
Beneficial effects of the present invention is proved below by way of clinical testing.
The clinical trial of experimental example 1 medicine composite for curing of the present invention chronic gastritis
1. materials and methods
1.1 physical data
Collect patient 108 example meeting inclusive criteria
1.2. chronic gastritis (epigastric pain) diagnostic criteria
1.2.1 tcm diagnosis standard:
With reference to " atrophic gastritis traditional Chinese medical science diagnosis and treatment National Consensus ", (China Association of Traditional Chinese Medicine's the spleen-stomach diseases divides
Meeting), " chronic superficial gastritis traditional Chinese medical science diagnosis and treatment National Consensus " (the spleen-stomach diseases branch of China Association of Traditional Chinese Medicine,
2009, Shenzhen) and " new Chinese medicine guideline of clinical investigations " (2002)
Cardinal symptom: in various degree with the gastral cavilty portion pain of character.
Minor symptom: can have that gastral cavity is swollen concurrently, belch, vomit evil, indigestion and loss of appetite, acid regurgitation etc..
This disease is found in any age bracket, common with person in middle and old age.Often recurrent exerbation.
1.2.2 doctor trained in Western medicine diagnostic criteria:
With reference to " Chinese National Consensus on Chronic Gastritis ", (disease for digest branch of Chinese Medical Association whole nation Second Committee is chronic
Gastritis consensus conference, 2006, Shanghai).
Chronic gastritis common upper abdomen pain, abdominal distension, early satiety, appetite lowers, and diet reduces, or with
Heartburn pantothenic acid etc..Symptom lacks specific, makes a definite diagnosis and need to rely on endoscopy and pathology.
(1) endoscopic diagnosis:
Chronic superficial gastritis: visible erythema (point-like, strip, sheet) under scope, mucous membrane be rough,
Blutpunkte or blood spots, myxedema or ooze out.
Atrophic gastritis: under mucous membrane, visible mucous membrane is red and white, and with Bai Weizhu, mucosal fold flattens
Even disappearance, mucous membrane exposed vessel, mucous membrane is in granular form or nodositas.
As with bile regurgitation, erosion, mucous membrane internal haemorrhage etc., being described as atrophic gastritis or shallow stomach
Scorching companion bile regurgitation, erosion, mucous membrane internal haemorrhage etc..
(2) pathological diagnosis
The most desirable 2-5 block biopsy, pathology to HP, chronic inflammation, Active inflammation, wither
Contracting, intestinal metaplasia and dysplasia answer classification.
Chronic gastritis shows the atrophy of intrinsic gland according to biopsy, can be diagnosed as atrophic gastritis, it is not necessary to
Consider the atrophy block number of biopsy specimen and degree, clinician can binding of pathological result and endoscopic findings, do
Go out the judgement of extent of disease and degree.
1.3 methods for the treatment of
Treatment group: pharmaceutical composition of the present invention (preparing according to embodiment 1) is through percutaneous drug delivery；Dosage:
According to acupuncture point prescription, each point-application drug dose about 1g, per person pastes (acupuncture point, five basic acupuncture points
Including: the middle part of gastric cavity, Shangwan, blBilateral, PishuBilateral, ZusanliBilateralFive caves), paste 10 days, every day 1 time,
2-3 hour every time.
1.4 Syndrome Diagnostic
3) standardization: with reference to " atrophic gastritis traditional Chinese medical science diagnosis and treatment National Consensus " (China Association of Traditional Chinese Medicine
The spleen-stomach diseases branch), " chronic superficial gastritis traditional Chinese medical science diagnosis and treatment National Consensus " (China Association of Traditional Chinese Medicine's taste
Sick branch, 2009, Shenzhen), fix tentatively in conjunction with section office's clinical practice situation:
Main symptom type:
1. weakness of the spleen and stomach:
(1) deficiency of spleen-QI and stomach-QI: epigastric pain is indistinct, continuous or have pain of empty stomach very endlessly, must eat, delay, labor
Showing effect after Lei or increase the weight of, gastral cavity is swollen, and god is tired indigestion and loss of appetite, loose stool, pale tongue with white fur, deficient and weak pulse.
(2) deficiency-cold in spleen and stomach: epigastric pain is indistinct, pain exaggerated by catching cold obtains warm pain and subtracts, the cold loose stool of limb, and difference of receiving is weary
Power, general hydroptysis, show effect after fatigue or increase the weight of, pale tongue with white fur or whiten, forceless deep pulse or late.
2. deficiency of stomach-Yin card:
Gastral cavilty has a dull ache, anorexia, and dryness of the mouth and throat is dysphoria in chestpalms-soles, becomes thin weak, thirsty think of drink, greatly
The driest and the hardest, red tongue with a little fluid, thready rapid pulse.
3. syndrome of incoordination between liver and stomach:
(1) stagnation of liver-QI and stomach-QI (liver-qi attacking stomach): epigastric distension and distress, attacks support and has a pain, and extends to two sides of body, kind sigh,
Meeting the unsuccessful epigastric pain of feelings will to increase the weight of, belch is frequent, or has bitter taste, and stool is not smooth, pale tongue with white fur or the most greasy,
Arteries and veins string.
(2) syndrome of liver-stomach heat: epigastric pain gesture is urgent, has burning heat sensation；Dry mouth with bitter taste；Water brass, irritated easy
Anger, constipation, cool drink, red tongue body, tongue is yellow or yellow greasy, wiry and frequent pulse or arteries and veins string.
(3) stagnation of liver-QI with deficiency of the spleen: stomach secret anguish or distending pain, or pain and two sides of body, sighing frequently, mood is smooth, indigestion and loss of appetite abdomen
Swollen, loose stool is not well, and gas is vowed in borborygmus, or stomachache is intended to rush down, and after rushing down, pain subtracts, and tongue nature is light red, and tongue is thin white or white
Greasy；Arteries and veins string or weak.
4. intrinsic heat card (damp-heat brewing internally) in stomach:
Burning pain in the epigastrium, get Liang Ze subtracts, and obtains hot, weighs, or sees indigestion and loss of appetite, and gastral cavity abdomen ruffian is full, dry mouth with bitter taste, or yearningly likes
Cold drink, or have aphthae, or have halitosis, oliguria with yellow urine, time have evil of vomitting, big loose stool or knot, tongue is red,
Tongue is yellow or yellow greasy, the sliding or sliding number of arteries and veins.
Common accompanying symptoms:
1. dampness: gastral cavity ruffian is indigestion and loss of appetite, body weight the most sleepy, time have evils of vomitting, big loose stool, tongue is light, and tongue is greasy, arteries and veins cunning.
2. blood stasis: gastral cavilty ruffian expires or fixed pain, epigastric pain tenderness, or has melena, and complexion is the most stagnant, tongue
Matter is dark or has petechia, ecchymosis, and string seen from arteries and veins is puckery.
3. dyspepsia: after food, gastral cavity is swollen does not relaxes, rotten acid regurgitation, indigestion and loss of appetite apocleisis, tongue white rot is greasy, and arteries and veins is sliding.
4. the stagnation of the circulation of vital energy: gastral cavity is swollen substantially, belch is frequent, or vows that gas is many, and constipation is the most smooth.
1.5, the standard of curative effect evaluation:
Therapeutic evaluation is with reference to the spleen-stomach diseases branch of China Association of Traditional Chinese Medicine Patients with Chronic Gastritis diagnosis and treatment National Consensus
(2009)
Evaluation criterion
Cardinal symptom the standard of curative effect evaluation
The record of cardinal symptom (epigastric pain and turgor) and evaluation.Percentage=(before treatment is improved by symptom
Total mark after total mark-treatment) front total mark * 100% of/treatment, calculate cardinal symptom and improve percentage.
(1) recovery from illness: transference cure.
(2) effective: symptom improves percentage >=80%.
(3) progressive: 50%≤symptom improves percentage < 80%.
(4) invalid: symptom improves percentage < 50%.
Recovery from illness and effective case load calculate total effective rate.
1.6 observation index clinical symptoms improvement rates: the related symptoms before and after treatment is improved situation and carries out point
Analysis, such as stomachache, turgor.
1.7 statistical methods use the data that the form of survey draws, calculate in percentage terms.
2. result
Stomachache (effective 26 examples, effective 65 examples, invalid 17 examples) is efficient is 84.26
Turgor (effective 32 examples, effective 58 examples, invalid 18 examples) is efficient is 83.33
Total effective rate is added up: 83.80%.
Experimental result illustrates, pharmaceutical composition of the present invention can effectively treat chronic gastritis, and flavour of a drug are few,
Consumption is little, and is external used medicine, uses conveniently, is easily accepted by patients, and potential applicability in clinical practice is good.
Claims (8)
1. the pharmaceutical composition of a kind, it is characterised in that: it is by the raw material preparation of following weight proportioning
The preparation become: evodia rutaecarpa 1-3 part, pepper 2-6 part, cloves 2-5 part, rhizoma cyperi 1-4 part.
Pharmaceutical composition the most according to claim 1, it is characterised in that: it is to be joined by following weight
The preparation that the raw material of ratio is prepared from: evodia rutaecarpa 2 parts, 3 parts of pepper, cloves 5 parts, rhizoma cyperi 4 parts.
Pharmaceutical composition the most according to claim 1 and 2, it is characterised in that: it is by each weight
The extract of primary medicinal powder, water or the organic solvent of proportioning bulk drug, adds pharmaceutically acceptable auxiliary material
Or the preparation that complementary composition is prepared from.
Pharmaceutical composition the most according to claim 3, it is characterised in that: described preparation is external application
Preparation.
Pharmaceutical composition the most according to claim 4, it is characterised in that: described preparation is powder
Agent.
6. a preparation method for pharmaceutical composition described in Claims 1 to 5 any one, is characterized in that:
Comprise the steps: to take the bulk drug of each weight proportion, directly beat powder, or addition water or organic solvent carry
Take, add pharmaceutically acceptable auxiliary material or complementary composition, to obtain final product.
7. the pharmaceutical composition described in Claims 1 to 5 any one prepares treatment disease of digestive system again
Medicine in purposes.
Purposes the most according to claim 7, it is characterised in that: described medicine is treatment chronic gastritis
Medicine.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106421193A (en) * | 2016-08-31 | 2017-02-22 | 李海峰 | Medicinal liquor for treating tinea pedis and preparation method thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101991804A (en) * | 2009-08-18 | 2011-03-30 | 陈庭财 | Externally applied medicament for treating stomach illness |
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2016
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Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101991804A (en) * | 2009-08-18 | 2011-03-30 | 陈庭财 | Externally applied medicament for treating stomach illness |
Non-Patent Citations (2)
| Title |
|---|
| 原萍萍: "吴茱萸散敷脐治疗小儿泻泄", 《医学理论与实践》 * |
| 邓笑文等: "香附外用简介", 《福建中医药》 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106421193A (en) * | 2016-08-31 | 2017-02-22 | 李海峰 | Medicinal liquor for treating tinea pedis and preparation method thereof |
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| CN105853653B (en) | 2020-04-07 |
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