CN105853653B - Pharmaceutical composition for treating chronic gastritis and preparation method thereof - Google Patents

Pharmaceutical composition for treating chronic gastritis and preparation method thereof Download PDF

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CN105853653B
CN105853653B CN201610259521.8A CN201610259521A CN105853653B CN 105853653 B CN105853653 B CN 105853653B CN 201610259521 A CN201610259521 A CN 201610259521A CN 105853653 B CN105853653 B CN 105853653B
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pharmaceutical composition
preparation
chronic gastritis
gastritis
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CN105853653A (en
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王莹
闫爵
黄锐
陈贵全
蒲清荣
***
甘露
任桂林
刘建伟
曾强
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Affiliated Hospital of Traditional Chinese Medicine TCM of Southwest Medical University
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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
    • 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
    • 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
    • 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)
    • 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
    • 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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  • Health & Medical Sciences (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
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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: 1-3 parts of fructus evodiae, 2-6 parts of pepper, 2-5 parts of clove and 1-4 parts of rhizoma cyperi. The invention also provides a preparation method and application of the pharmaceutical composition. The pharmaceutical composition can effectively treat chronic gastritis, has the advantages of less medicinal flavor and small dosage, is an external medicament, is convenient to apply, is easy to accept by patients, provides a novel external medicament which is high-efficiency, safe, free of toxic and side effects, suitable for long-term use, low in cost and wide in market prospect, and is clinically used for treating chronic gastritis.

Description

Pharmaceutical composition for treating chronic gastritis and preparation method thereof
Technical Field
The invention relates to a pharmaceutical composition for treating digestive system diseases and a preparation method thereof, belonging to the field of medicines.
Background
Digestive system diseases comprise organic and functional diseases of organs such as esophagus, stomach, intestine, liver, gallbladder and pancreas, and are common clinically, wherein the incidence rate of chronic gastritis is the first of various stomach diseases. The chronic gastritis refers to chronic inflammation of gastric mucosa caused by different causes, and the understanding of the disease is obviously improved since the digestive endoscopy is widely applied. They are classified into superficial gastritis, atrophic gastritis and special gastritis. From the etiology, Hp infection is the main cause of chronic gastritis, and more than 90% of chronic gastritis is infected with Hp; chronic gastritis mainly caused by stomach atrophy is generated on the basis of autoimmunity and is also called autoimmune gastritis or A-type atrophic gastritis; in addition, physical factors such as long-term drinking of strong tea, coffee and strong wine and eating of overheated, overcooled or too coarse food cause repeated damage to gastric mucosa; chemical factors such as chronic inflammation of gastric mucosa caused by long-term taking of a large amount of non-steroidal anti-inflammatory drugs, nicotine in tobacco, bile reflux, pancreatic juice reflux and the like. Pathologically, there are chronic inflammation of mucous membrane, gland atrophy, metaplasia and intraepithelial neoplasia.
Chronic gastritis is a chronic digestive tract disease. The clinical manifestations are asymptomatic or have different degrees of dyspepsia symptoms such as epigastric dull pain, anorexia, postprandial fullness, acid regurgitation, nausea and belching. Patients with severe atrophic gastritis have anemia, emaciation, glossitis, diarrhea, etc.
Western medicine mainly treats the symptoms, eradicates Hp, and changes diet and life style at present. The prognosis is generally good. But for part of chronic gastritis, the medicine can generate drug resistance to antibiotics and has certain toxic and side effects. The traditional Chinese medicine has more researches on the chronic gastritis, and a plurality of reports are related in various circles, so that the traditional Chinese medicine has certain advantages in treating the chronic gastritis. The traditional Chinese medicine compound oral administration and external treatment are one of the main ways for treating diseases in traditional Chinese medicine, and have the advantages of integral conditioning, flexible formula, small adverse reaction, low price and the like, and are highly approved by various countries in the world.
The patent application with publication number CN101890086A discloses a medicine, which comprises 10 parts of calcined hedgehog skin, 10 parts of pseudo-ginseng, 10 parts of American ginseng, 10 parts of coptis root, 5 parts of evodia rutaecarpa, 15 parts of cuttlebone, 10 parts of sharpleaf galangal fruit, 10 parts of clove, 10 parts of cyperus rotundus and 5 parts of pepper. However, the medicine has a large amount of medicinal ingredients, so that the preparation is expensive, and particularly for patients needing long-term administration, the economic burden of the patients is increased.
Therefore, the development of a medicament for treating chronic gastritis with clear efficacy, small toxic and side effects and low cost is an urgent problem to be solved.
Disclosure of Invention
The invention aims to provide a pharmaceutical composition for treating chronic gastritis and a preparation method thereof.
The invention provides a pharmaceutical composition, which is characterized in that: the preparation is prepared from the following raw materials in parts by weight: 1-3 parts of fructus evodiae, 2-6 parts of pepper, 2-5 parts of clove and 1-4 parts of rhizoma cyperi.
Preferably, the preparation is prepared from the following raw materials in parts by weight: 2 parts of fructus evodiae, 3 parts of pepper, 5 parts of clove and 4 parts of rhizoma cyperi.
Preferably, the preparation is prepared by mixing crude drug powder of raw drug materials, water or an extract of an organic solvent in weight ratio and adding pharmaceutically acceptable auxiliary materials or auxiliary components.
Preferably, the formulation is an external formulation. Further preferably, the formulation is a powder.
The invention also provides a preparation method of the composition, which comprises the following steps: directly pulverizing the raw materials in weight ratio, or extracting with water or organic solvent, and adding pharmaceutically acceptable adjuvants or auxiliary components.
The invention also provides application of the pharmaceutical composition in preparation of a medicine for treating digestive system diseases.
The pharmaceutical composition can effectively treat chronic gastritis, has the advantages of less medicinal flavor and small dosage, is an external medicament, is convenient to apply, is easy to accept by patients, provides a novel external medicament which is high-efficiency, safe, free of toxic and side effects, suitable for long-term use, low in cost and wide in market prospect, and is clinically used for treating chronic gastritis.
Obviously, many modifications, substitutions, and variations are possible in light of the above teachings of the invention, without departing from the basic technical spirit of the invention, as defined by the following claims.
The present invention will be described in further detail with reference to the following examples. This should not be understood as limiting the scope of the above-described subject matter of the present invention to the following examples. All the technologies realized based on the above contents of the present invention belong to the scope of the present invention.
Detailed Description
The raw materials and equipment used in the embodiment of the present invention are known products and obtained by purchasing commercially available products.
EXAMPLE 1 preparation of a pharmaceutical composition of the invention
Weighing the following raw materials in parts by weight:
2g of fructus evodiae, 3g of pepper, 5g of clove and 4g of rhizoma cyperi
The preparation method comprises the following steps:
weighing the medicinal materials, cleaning, drying, pulverizing, sieving with 100 mesh sieve, stirring, mixing, placing in a drying container, and sealing for use.
EXAMPLE 2 preparation of pharmaceutical compositions of the invention
Weighing the following raw materials in parts by weight:
2g of fructus evodiae, 4g of pepper, 2g of clove and 3g of rhizoma cyperi
The preparation method comprises the following steps:
weighing the medicinal materials, cleaning, drying, pulverizing, sieving with 100 mesh sieve, stirring, mixing, placing in a drying container, and sealing for use.
EXAMPLE 3 preparation of a pharmaceutical composition of the invention
Weighing the following raw materials in parts by weight:
1g of fructus evodiae, 2g of pepper, 3g of clove and 1g of rhizoma cyperi
The preparation method comprises the following steps:
weighing the medicinal materials, cleaning, drying, pulverizing, sieving with 100 mesh sieve, stirring, mixing, placing in a drying container, and sealing for use.
EXAMPLE 4 preparation of a pharmaceutical composition of the invention
Weighing the following raw materials in parts by weight:
evodia rutaecarpa 3g, pepper 6g, clove 5g, cyperus rotundus 4g
The preparation method comprises the following steps:
weighing the medicinal materials, cleaning, drying, pulverizing, sieving with 100 mesh sieve, stirring, mixing, placing in a drying container, and sealing for use.
The beneficial effects of the present invention are demonstrated by clinical trials as follows.
Experimental example 1 clinical experiment of the pharmaceutical composition of the present invention for treating chronic gastritis
1. Materials and methods
1.1 general data
108 patients meeting inclusion criteria were collected
1.2. Diagnostic criteria for chronic gastritis (epigastric pain)
1.2.1 Chinese medicine diagnosis standard:
refer to the Chinese medicine diagnosis and treatment consensus opinion on chronic atrophic gastritis (the spleen and stomach diseases division of the Chinese medical society), the Chinese medicine diagnosis and treatment consensus opinion on chronic superficial gastritis (the spleen and stomach diseases division of the Chinese medical society, 2009, Shenzhen) and the Chinese medicine new drug clinical research guiding principle (2002)
The main symptoms are: various degrees and properties of epigastric pain.
Secondary symptoms: it is accompanied by gastric distention, belching, nausea, vomiting, anorexia, acid regurgitation, etc.
This disease is seen in any age group, and is common in the middle-aged and the elderly. The attacks are often repeated.
1.2.2 Western diagnostic criteria:
refer to the "Chinese consensus opinion on chronic gastritis" (the second conference on chronic gastritis in China, the digestive system of the Chinese medical society, 2006, Shanghai).
Chronic gastritis is often accompanied by abdominal pain, abdominal distension, early satiety, reduced appetite, reduced diet, or burning hearts and pantothenic acid. The symptoms lack specificity, and the diagnosis depends on endoscopy and pathology.
(1) Performing endoscopic diagnosis:
chronic superficial gastritis: erythema (dot, strip, sheet), roughness of mucosa, bleeding spot or spot, edema or exudation of mucosa can be seen under endoscope.
Chronic atrophic gastritis: the red and white of mucosa can be seen under the mucosa, mainly white, the mucosal fold is flattened or even disappears, the mucosal blood vessel is exposed, and the mucosa is granular or nodular.
Such as those associated with bile reflux, erosion, intra-mucosal hemorrhage, etc., and is described as atrophic gastritis or superficial gastritis with bile reflux, erosion, intra-mucosal hemorrhage, etc.
(2) Pathological diagnosis
2-5 biopsies can be taken as required, and the pathology should be graded for HP, chronic inflammation, active inflammation, atrophy, intestinal metaplasia and dysplasia.
The chronic gastritis can be diagnosed as atrophic gastritis by biopsy showing the atrophy of the inherent glands without considering the number and degree of atrophic blocks of the biopsy specimen, and a clinician can make a judgment on the range and degree of a pathological change by combining the pathological result and the endoscope.
1.3 methods of treatment
Treatment groups: the pharmaceutical compositions of the present invention (prepared as in example 1) are administered transdermally; administration dose: according to the acupoint formula, the dosage of the medicine is about 1g per acupoint, and five basic acupoints (acupoints including Zhongwan, Shangwan and Weishu) are applied once per personTwo sidesPishu, PishuTwo sidesZusanli (Zusanli)Two sidesFive acupoints), and the plaster is applied for 10 days 1 time per day for 2-3 hours each time.
1.4 syndrome diagnosis
3) And (3) diagnosis of the syndrome: the traditional Chinese medicine diagnosis and treatment consensus opinion for chronic atrophic gastritis (the spleen and stomach disease division of the Chinese medical science society) and the traditional Chinese medicine diagnosis and treatment consensus opinion for chronic superficial gastritis (the spleen and stomach disease division, 2009, Shenzhen of the Chinese medical science society) are tentatively determined by combining clinical practical conditions of departments:
the main syndrome type:
1. spleen-stomach deficiency syndrome:
(1) deficiency of spleen-stomach qi: dull epigastric pain, lingering and continuous, or empty abdominal pain, slow eating, attack or aggravation after fatigue, abdominal distention, mental fatigue, loss of appetite, loose stool, pale tongue with white coating, and weak pulse.
(2) Deficiency-cold of the spleen and stomach: gastric cavity pain is dull and pain is aggravated by cold, warmth and pain is relieved, limbs are cold and loose, poor appetite and hypodynamia are caused, clear water is spitted, the attack or aggravation is caused after fatigue, the tongue is pale, white or white and slippery coating, and the pulse is deep, weak or slow.
2. Stomach yin deficiency syndrome:
dull pain in the stomach, hunger without appetite, dry mouth and throat, feverish sensation in the chest, palms and soles, emaciation, hypodynamia, thirst with desire for water, dry stools, red tongue with little saliva, thready and rapid pulse.
3. Syndrome of disharmony between liver and stomach:
(1) stagnation of liver-stomach qi (liver qi attacking the stomach): distending and oppression in the stomach, distending pain in the chest and abdomen, prolonged pain in the hypochondrium, sighing, emotional distress, aggravated epigastric pain, frequent belching, bitter taste in the mouth, difficult defecation, pale tongue with white or white greasy coating, wiry pulse.
(2) Stagnated heat of the liver and stomach: epigastric pain is urgent with burning sensation; dry mouth and bitter taste; acid regurgitation, gastric upset, restlessness, irritability, constipation, preference for cold drink, red tongue with yellow or yellow greasy coating, wiry and rapid pulse or wiry pulse.
(3) Liver stagnation and spleen deficiency: dull or distending pain in the stomach, or pain in the hypochondrium, frequent sighing, poor mood, poor appetite, abdominal distension, loose stool, borborborygmus, or abdominal pain with desire to purge, pain relieved after purging, pale red tongue with thin white or white greasy coating; the pulse is wiry or weak.
4. Syndrome of intrinsic heat in stomach (intrinsic damp-heat syndrome):
the stomach cavity is burning pain, which is relieved when the stomach cavity is cold and serious when the stomach cavity is hot, or has the symptoms of anorexia, abdominal fullness and fullness, dry mouth and bitter taste, or thirst with desire for cold drinks, or sores on the mouth and tongue, or halitosis, yellow urine, nausea, vomiting, loose or knotted stool, red tongue, yellow or greasy coating, and slippery or rapid pulse.
Common concurrent syndrome:
1. wet resistance: gastric fullness, poor appetite, heaviness of the body, lassitude, nausea, loose stool, pale tongue with greasy coating, and slippery pulse.
2. Blood stasis: epigastric fullness or pain in the fixed area, epigastric pain with tenderness, dark stool, dark complexion, dark tongue or with petechia, ecchymosis, and wiry and unsmooth pulse.
3. Food retention: abdominal distention after eating, belching with fetid odor, acid regurgitation, anorexia, white and greasy tongue coating, and slippery pulse.
4. Qi stagnation: gastric distention, frequent belching or excessive discharge of qi, constipation.
1.5, curative effect evaluation standard:
the evaluation of the curative effect refers to the Chinese traditional medicine society of spleen and stomach diseases and chronic gastritis diagnosis and treatment consensus opinion (2009 year)
Evaluation criteria
Evaluation criteria for therapeutic effects of chief complaints
Recording and evaluation of the major symptoms (epigastric pain and fullness). Percent improvement of cardinal symptoms was calculated as percent improvement of symptoms (pre-treatment total score-post-treatment total score)/pre-treatment total score 100%.
(1) And (3) healing: the symptoms disappear.
(2) The effect is shown: the symptom improvement percentage is more than or equal to 80 percent.
(3) The improvement is as follows: the symptom improving percentage is more than or equal to 50 percent and less than 80 percent.
(4) And (4) invalidation: the percent improvement in symptoms was < 50%.
The total effective rate is calculated according to the number of cure and significant cases.
1.6 Observation indicators clinical symptom improvement rate: the improvement of related symptoms such as stomach ache and fullness before and after treatment is analyzed.
1.7 statistical methods data obtained in the form of questionnaires were calculated as percentages.
2. Results
The effective rate of the stomachache (26 cases with obvious effect, 65 cases with effect and 17 cases with no effect) is 84.26
The effective rate of the fullness (32 cases with effect, 58 cases with effect and 18 cases with no effect) is 83.33
And (3) counting the total effective rate: 83.80 percent.
The experimental result shows that the pharmaceutical composition can effectively treat chronic gastritis, has less medicinal flavor and small dosage, is an external medicament, is convenient to apply, is easy to accept by patients, and has good clinical application prospect.

Claims (5)

1. A pharmaceutical composition for treating chronic gastritis, which is characterized in that: the external preparation is prepared from the following raw materials in parts by weight: 2 parts of fructus evodiae, 3 parts of pepper, 5 parts of clove and 4 parts of rhizoma cyperi.
2. The pharmaceutical composition of claim 1, wherein: the external preparation is prepared by mixing crude drug powder of raw drug materials, water or an extract of an organic solvent in a weight ratio and adding pharmaceutically acceptable auxiliary materials or auxiliary components.
3. The pharmaceutical composition according to claim 1 or 2, characterized in that: the external preparation is powder.
4. A process for the preparation of a pharmaceutical composition according to any one of claims 1 to 3, characterized in that: the method comprises the following steps: directly pulverizing the raw materials in weight ratio, or extracting with water or organic solvent, and adding pharmaceutically acceptable adjuvants or auxiliary components.
5. Use of a pharmaceutical composition according to any one of claims 1 to 3 in the manufacture of a medicament for the treatment of chronic gastritis.
CN201610259521.8A 2016-04-22 2016-04-22 Pharmaceutical composition for treating chronic gastritis and preparation method thereof Active CN105853653B (en)

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