CN114903960B

CN114903960B - Traditional Chinese medicine composition for treating chronic gastritis and preparation method thereof

Info

Publication number: CN114903960B
Application number: CN202210513424.2A
Authority: CN
Inventors: 刘德喜; 戴好富; 刘建浩; 刘海涛; 梅文莉; 蔡翠珠; 汪洁; 刘莹
Original assignee: Individual
Current assignee: Individual
Priority date: 2022-05-12
Filing date: 2022-05-12
Publication date: 2023-08-29
Anticipated expiration: 2042-05-12
Also published as: CN114903960A

Abstract

The invention relates to a traditional Chinese medicine composition for treating chronic gastritis and a preparation method thereof. The Chinese medicine is prepared from lignum Aquilariae Resinatum, herba Agastaches, fructus Amomi rotundus, semen Arecae Preparatum, fructus Aurantii Immaturus, herba Taraxaci, radix Curcumae, and Glycyrrhrizae radix. And the like. The invention also provides a preparation method of the traditional Chinese medicine composition. The traditional Chinese medicine composition provided by the invention is mainly used for treating chronic gastritis.

Description

Traditional Chinese medicine composition for treating chronic gastritis and preparation method thereof

Technical Field

The invention relates to the field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for treating chronic gastritis and a preparation method thereof.

Background

Chronic gastritis is a common digestive tract disease, and is a chronic gastric mucosa inflammatory disease caused by a plurality of different causes. Part of patients can have gastric mucosa lamina propria gland atrophy and metaplasia in the later period, and then have intraepithelial neoplasia which is closely related to gastric cancer. Chronic gastritis can be divided into two major categories, chronic superficial gastritis (non-atrophic gastritis) and chronic atrophic gastritis.

The most common symptoms of chronic gastritis are epigastric pain and fullness. Compared with ulcer, the food is comfortable in empty stomach, and after meal discomfort can be caused by the relaxation dysfunction, and the food is not too much but is full. Patients often resort to "weak stomach" or "soft stomach". Symptoms are often caused or exacerbated by cold, hard, spicy or other irritating foods. These symptoms are not easily alleviated with antacids and spasmolytics. Most patients complain of inappetence.

In addition, bleeding is also one of the symptoms of chronic gastritis, especially in combination with erosion. Can be repeatedly and little bleeding or big bleeding. The emergency gastroscopy suggests that the acute and chronic gastritis accounts for 20-40% of the causes of upper gastrointestinal hemorrhage. Bleeding is usually seen in black, and usually occurs automatically after 3-4 days, and can occur after several months or years.

At present, the existing chronic gastritis drugs have a weak effect and are easy to relapse after treatment. Therefore, there is a need to develop a medicine for treating chronic gastritis with definite curative effect and good curative effect.

Disclosure of Invention

The invention aims to provide a traditional Chinese medicine composition for treating chronic gastritis;

the invention also aims to provide a preparation method of the traditional Chinese medicine composition for treating chronic gastritis.

The aim of the invention is realized by the following technical scheme:

the traditional Chinese medicine composition for treating chronic gastritis is prepared from the following traditional Chinese medicine raw materials in parts by weight:

5-12 parts of agilawood, 10-30 parts of wrinkled gianthyssop herb, 10-25 parts of fructus amomi, 10-25 parts of cardamom, 8-16 parts of charred betel nut, 8-16 parts of immature bitter orange, 5-15 parts of dandelion, 5-15 parts of radix curcumae and 3-10 parts of liquorice.

In a preferred scheme I, the active ingredients of the traditional Chinese medicine composition for treating chronic gastritis are prepared by the following method: drying the above materials, mixing, pulverizing into fine powder, and stirring.

In a second preferred scheme, the active ingredients of the traditional Chinese medicine composition for treating chronic gastritis are prepared by the following method: is prepared by water extraction or ethanol extraction with the volume percentage concentration of 40-80%.

In a third preferred embodiment, the active ingredients of the traditional Chinese medicine composition for treating chronic gastritis are prepared by the following method: mixing all the above materials, reflux-extracting with 40-80% ethanol for 2-3 times, each time with ethanol amount of 4-10 times of total amount of the materials for 1-4 hr, mixing extractive solutions, filtering, and concentrating the filtrate to obtain fluid extract with relative density of 1.15-1.20 at 70-80deg.C.

In a fourth preferred embodiment, the active ingredients of the traditional Chinese medicine composition for treating chronic gastritis are prepared by the following method: mixing all the medicinal materials, extracting with water for 2-3 times, each time with water amount of 6-12 times of total weight of the medicinal materials, each time for 1-3 hours, mixing extractive solutions, filtering, concentrating filtrate to fluid extract with relative density of 1.15-1.20 at 70-80deg.C, adding ethanol to make ethanol content 40-70%, standing for 12-24 hours, filtering, concentrating filtrate to extract with relative density of 1.10-1.25 at 70-80deg.C, and making into final product.

The traditional Chinese medicine composition for treating chronic gastritis can be matched with a carrier acceptable in medicine to prepare a traditional Chinese medicine preparation for improving metabolism and regulating functions.

Pharmaceutically acceptable carriers of the invention include, but are not limited to, the following:

oral preparation:

a diluent: starch, sugar powder, lactose, dextrin, microcrystalline cellulose, inorganic salts, sugar alcohols, etc.

Wetting agent and binder: purified water, ethanol, gelatin, polyethylene glycol, cellulose derivatives, and the like.

Disintegrating agent: starch, sodium carboxymethyl starch, cellulose derivatives, crospovidone, and the like.

And (3) a lubricant: magnesium stearate, silica gel micropowder, talcum powder, polyethylene glycol, etc.

Cosolvent: water, ethanol, glycerol, propylene glycol, liquid paraffin, vegetable oil, etc.

Flavoring agent: sucrose, monosaccharides, fragrances, and the like.

Preservative: benzoic acid, sorbic acid, methyl ester, ethyl ester, propyl ester, and the like.

Method 1: tablet formulation

Adding one of the active ingredients obtained in the first to fourth preferred schemes into common auxiliary materials of the tablet, and preparing the tablet according to the conventional production method.

The common auxiliary materials of the tablet comprise one or all of diluents, wetting agents, binders, disintegrants and lubricants.

Method 2: capsule preparation

Adding common auxiliary materials of the capsule into one of the active ingredients obtained in the first to fourth preferred schemes, and preparing the capsule according to a conventional production method.

The common auxiliary materials of the capsule comprise one or all of diluents, wetting agents, adhesives, disintegrants and lubricants.

Method 3: syrup preparation

Adding common auxiliary materials of the syrup into one of the active ingredients obtained in the second to fourth preferred schemes, and preparing the syrup according to the conventional production method.

The common auxiliary materials of the syrup comprise one or all of flavoring agents, preservatives and cosolvents.

Method 4: mixture of materials

Taking one of the active ingredients obtained in the second to fourth preferred schemes, adding common auxiliary materials of the mixture, and preparing the mixture according to a conventional production method.

The common auxiliary materials of the mixture comprise one or all of flavoring agents and preservatives.

Method 5: oral liquid

Taking one of the active ingredients obtained in the second to fourth schemes, purifying and concentrating after dissolving, adding common auxiliary materials of the oral liquid, and preparing the oral liquid according to a conventional production method.

The inventor considers that chronic gastritis is mostly caused by improper diet, binge eating, addiction and pungent food, drinking, eating and coolness or liver depression and qi stagnation, spleen and stomach lifting and pivoting dysfunction, damp turbidity and internal growth, along with tropical areas at Hainan places, coastal areas and astronomical people, damp heat evil is more easily generated, and symptoms caused by middle-jiao qi obstruction are mostly gastric cavity pain or distending and fullness and smoldering pain, tiredness and debilitation, frequent inappetence, eructation, nausea and vomiting, dry mouth and bitter taste and stool viscosity.

The invention is as follows:

the prescription of the invention is designed aiming at the pathogenesis of chronic gastritis, and the agastache rugosus has good curative effect for the patients with positive helicobacter pylori by the agastache rugosus with the effects of promoting qi circulation and relieving pain, and the agastache rugosus with the effects of eliminating dampness by aromatics, harmonizing middle-jiao and vomiting. The agilawood and the agastache contain volatile oil, the agilawood has the functions of reducing stomach qi and regulating middle energizer, and the agastache has the functions of ascending spleen and activating spleen, and the agastache is matched with the agastache to ascend and descend simultaneously, so that damp turbidity is removed and distention, fullness and pain of the stomach and abdominal distention are removed when spleen and stomach are normal.

Fructus Amomi has effects of eliminating dampness, promoting qi circulation, and relieving vomiting, and has fragrant smell, warm but not dry, and promoting qi circulation without breaking qi, and is essential for activating spleen and regulating stomach. The cardamom has the effects of resolving dampness, promoting qi circulation, stimulating appetite and promoting digestion, and modern pharmacological research proves that the cardamom mainly contains volatile oil, has an antibacterial effect, particularly has a remarkable inhibiting effect on bacillus dysenteriae, can invigorate stomach, dispel wind, promote gastric secretion and intestinal peristalsis, expel intestinal qi and inhibit abnormal fermentation in intestines, and has good spleen and stomach strengthening and vomiting stopping effects. Fructus Amomi and fructus Amomi rotundus both contain volatile oil, both enter spleen and stomach channels, and are used together to further cooperate with monarch drug to dispel dampness and harmonize stomach, regulate qi and harmonize middle energizer.

Hainan-jiao betel is entered into stomach and large intestine meridian to promote digestion and remove food stagnation, and is indicated for indigestion. Immature bitter orange enters the large intestine channel of spleen and stomach, breaks qi, eliminates food retention, eliminates phlegm and removes distension and fullness. Hainan charred betel nut and immature bitter orange both enter the large intestine channel of spleen and stomach, and are combined to enhance gastrointestinal motility and further eliminate stomach and abdomen distending pain. Dandelion has the actions of clearing heat and removing toxicity, relieving swelling and resolving hard mass, and clearing damp-heat toxin in stomach and intestine. Radix Curcumae enters heart, liver and gallbladder meridians, soothes liver, regulate qi, relieve depression, clear heat, promote diuresis and alleviate pain. The four are combined to promote digestion and remove stagnation, clear damp-heat, sooth liver and regulate qi, and are assistant. Modern pharmacological researches have found that dandelion has a certain bactericidal effect on staphylococcus, hemolytic streptococcus, pseudomonas aeruginosa, diphtheria bacillus, shigella dysenteriae and typhoid bacillus, and has been reported to have the effect of killing helicobacter pylori. Glycyrrhrizae radix has effects of clearing heat and detoxicating, relieving spasm and pain, and relieving drug property. The whole formula has the functions of regulating qi, resolving dampness, clearing turbid and harmonizing stomach.

The traditional Chinese medicine composition provided by the invention has the advantages of scientific and reasonable formula, simple preparation method, good effect and great popularization value, and is proved by an efficacy experiment.

Detailed Description

The invention is further illustrated by the following examples. It should be understood that the examples of the present invention are intended to illustrate the present invention and not to limit the present invention. Simple modifications of the invention in accordance with the essence of the invention are all within the scope of the invention as claimed. Unless otherwise indicated, the percentage of ethanol in the present invention is a volume percentage, and v/v represents the volume ratio of the solution.

Example 1

The traditional Chinese medicine composition for treating chronic gastritis comprises the following components:

agalloch eaglewood 5 kg, wrinkled gianthyssop 10 kg, amomum fruit 10 kg, cardamom 10 kg, betel nut 8 kg, immature bitter orange 8 kg, dandelion 5 kg, curcuma aromatica 5 kg, licorice root 3 kg.

The preparation method comprises the following steps:

drying the above materials, mixing, pulverizing into fine powder, and stirring.

Example 2

agalloch eaglewood 12 kg, wrinkled gianthyssop 30 kg, amomum fruit 25 kg, cardamom 25 kg, betel nut 16 kg, immature bitter orange 16 kg, dandelion 5 kg, curcuma aromatica 15 kg, licorice root 10 kg.

The preparation method comprises the following steps:

drying the above materials, mixing, pulverizing into fine powder, and stirring.

Example 3

agalloch eaglewood 8 kg, agastache 20 kg, amomum villosum 16 kg, cardamom 16 kg, betel nut 12 kg, immature bitter orange 12 kg, dandelion 10 kg, curcuma aromatica 10 kg, licorice 6 kg.

The preparation method comprises the following steps:

drying the above materials, mixing, pulverizing into fine powder, and stirring.

Example 4

agalloch eaglewood 6 kg, wrinkled gianthyssop 18 kg, amomum fruit 15 kg, cardamom 15 kg, betel nut 8 kg, immature bitter orange 8 kg, dandelion 10 kg, curcuma aromatica 0 kg, licorice root 5 kg.

The preparation method comprises the following steps:

mixing all the medicinal materials, reflux-extracting with 40% ethanol for 2 times, wherein the ethanol consumption is 4 times of the total amount of the medicinal materials, extracting for 1 hr, mixing the extractive solutions, filtering, and concentrating the filtrate to fluid extract with relative density of 1.15 at 70deg.C.

Example 5

agalloch eaglewood 7 kg, agastache 13 kg, amomum villosum 12 kg, cardamom 18 kg, betel nut 9 kg, immature bitter orange 9 kg, dandelion 12 kg, curcuma aromatica 13 kg, licorice 4 kg.

The preparation method comprises the following steps:

mixing all the above materials, reflux-extracting with 80% ethanol for 3 times, wherein the ethanol dosage is 10 times of the total amount of the materials, extracting for 4 hr, mixing the extractive solutions, filtering, and concentrating the filtrate to fluid extract with relative density of 1.20 at 80deg.C.

Example 6

10-kg-agalloch eaglewood, 25-kg-agastache rugosus, 15-kg-amomum villosum, 15-kg-cardamom, 15-kg-betel nut, 15-kg-immature bitter orange, 13-kg-dandelion, 8-kg-curcuma aromatica and 9-kg-liquorice.

The preparation method comprises the following steps:

mixing all the medicinal materials, reflux-extracting with 60% ethanol for 2 times, wherein the ethanol consumption is 6 times of the total amount of the medicinal materials, extracting for 3 hr, mixing the extractive solutions, filtering, and concentrating the filtrate to obtain fluid extract with relative density of 1.18 at 75deg.C.

Example 7

agalloch eaglewood 11 kg, agastache 27 kg, amomum villosum 13 kg, cardamom 13 kg, betel nut 13 kg, immature bitter orange 13 kg, dandelion 9 kg, curcuma aromatica 6 kg, licorice 8 kg.

The preparation method comprises the following steps:

mixing all the medicinal materials, extracting with water for 2 times, each time with water amount 6 times of total weight of the medicinal materials, each time for 1 hr, mixing the extractive solutions, filtering, concentrating the filtrate to fluid extract with relative density of 1.15 at 70deg.C, adding ethanol to ethanol content of 40%, standing for 12 hr, filtering, concentrating the filtrate to extract with relative density of 1.10 at 70deg.C.

Example 8

agalloch eaglewood 8 kg, wrinkled gianthyssop 12 kg, amomum fruit 12 kg, cardamom 12 kg, betel nut 13 kg, immature bitter orange 14 kg, dandelion 11 kg, curcuma aromatica 11 kg, licorice root 8 kg.

The preparation method comprises the following steps:

mixing all the medicinal materials, extracting with water for 3 times, each time with water amount of 12 times of total weight of the medicinal materials, each time for 3 hours, mixing the extractive solutions, filtering, concentrating the filtrate to fluid extract with relative density of 1.20 at 80deg.C, adding ethanol to ethanol content of 70%, standing for 24 hours, filtering, concentrating the filtrate to extract with relative density of 1.25 at 80deg.C, and obtaining the final product.

Example 9

agalloch eaglewood 9 kg, agastache rugosus 16 kg, amomum villosum 22 kg, cardamom 21 kg, betel nut 10 kg, immature bitter orange 13 kg, dandelion 7 kg, curcuma aromatica 7 kg, licorice 5 kg.

The preparation method comprises the following steps:

mixing all the medicinal materials, extracting with water for 3 times, each time with water amount 8 times of total weight of the medicinal materials, each time for 2 hr, mixing the extractive solutions, filtering, concentrating the filtrate to fluid extract with relative density of 1.16 at 80deg.C, adding ethanol to alcohol content of 55%, standing for 18 hr, filtering, concentrating the filtrate to extract with relative density of 1.20 at 80deg.C, and making into final product.

Example 10

Summary of clinical trials

1. General data: the study was approved by the ethical committee of the third-party hospital (lot number ZYFY 20160536). The study was carried out on 160 patients as study subjects, and all the study subjects were from department of gastroenterology outpatient department of three-city middle-aged hospitals, and the study time was from 6 months in 2019 to 6 months in 2021. The control group and the observation group were each 80 cases divided into 1:1 by the random number table method. Control group of 48 men and 32 women, age of 31-65 years, average (46.79 + -8.27) years, disease course of 6 months-12 years, average 4.87+ -0.52) years, pathological atrophic gastritis of 30 cases, and non-atrophic gastritis of 50 cases. During the test, 6 cases are dropped and lost, 3 cases are removed against the scheme, and 71 cases are completed. 45 men and 35 women in the observation group, 30-64 years of age, average (46.05+/-9.58) years of age, 9 months-14 years of disease course, average (5.15+/-0.64) years, 32 cases of pathological atrophic gastritis and 48 cases of non-atrophic gastritis. During the test, 4 cases are dropped and lost, 1 case is removed against the scheme, and 75 cases are completed. The comparison of the baseline data of more than two groups of patients shows that the difference has no statistical significance and is comparable.

2. Diagnostic criteria (1) diagnostic criteria for chronic gastritis criteria were formulated with reference to the consensus opinion for chronic gastritis in China (2017, shanghai). Can have nonspecific dyspepsia symptom, and can be detected as CAG or CNAG by endoscope and pathology examination. Hp detection A gastroscopically biopsied test was performed with reference to the fifth national helicobacter pylori infection treatment consensus report, using a rapid urease test, and a 14C-urea expiration test was performed simultaneously. (2) The traditional Chinese medicine dialectical standard refers to spleen and stomach damp-heat syndrome in "chronic gastritis traditional Chinese medicine diagnosis and treatment expert consensus opinion (2017)". (1) The main symptoms are epigastric pain or distending pain, debilitation and incoordination, and constipation. (2) The secondary symptoms are bitter taste, bad breath, bad appetite, nausea and vomiting. (3) A red tongue with yellow coating, slippery pulse or rapid pulse.

3. The method comprises the steps of taking the standard (1) for treating chronic gastritis with obvious dyspepsia symptoms through endoscopy and pathological examination, (2) for detecting Hp as positive through a rapid urease test and a 14C-urea expiration test, (3) for conforming to spleen and stomach damp heat syndrome differentiation standard, (4) for 20-65 years old and unlimited in sex, and (5) for patients to agree with the scheme for treatment and obtaining signed informed consent.

4. Excluding standard (1) gastritis caused by taking nonsteroidal anti-inflammatory drugs for a long time and ethanol intake, and other types of gastritis such as autoimmune gastritis, (2) patients with digestive tract operation history, (3) patients with peptic ulcer, gastric polyp and digestive tract tumor, (4) patients with severe liver, kidney and heart and lung dysfunction and other internal surgical diseases needing urgent treatment, (5) women in gestational period or lactation period, (6) patients with psychosis and depression, and patients with cognitive dysfunction, (7) patients with severe allergic constitution, and patients with allergic components of known medicines in the study, (8) patients with other traditional Chinese medicines in the same period, and affecting clinical efficacy evaluation.

5. The treatment method comprises the following steps: the control group used the Hp eradication scheme, and was referred to the literature oral Esomeprazole magnesium enteric coated tablet, america pharmaceutical Co., ltd., national drug standard H20046379), 20 mg/time, 1 time/d, and bismuth potassium citrate tablets (0.3 g/tablet, lizhu group Lizhu pharmaceutical Co., national drug standard H10900084), 1 tablet/time, 2 times/d, and Amoxicillin capsule (0.5 g/granule, harrow pharmaceutical Co., national drug standard H23020932), 2 granules/time, 2 times/d, and Furazolidone tablets (0.1 g/tablet, beijing double Crane pharmaceutical Co., ltd., national drug standard H11020698), 1 tablet/time, 2 times/d. The treatment course is 14-d of continuous treatment. The observation group is administered with lignum Aquilariae Resinatum and stomach pill (three-city middle-hospital preparation) based on control group treatment, and comprises lignum Aquilariae Resinatum 8 g, herba Agastaches 20 g, fructus Amomi 16 g, fructus Amomi rotundus 16 g, semen Arecae Preparata 12 g, fructus Aurantii Immaturus 12 g, herba Taraxaci 10 g, radix Curcumae 10 g, and Glycyrrhrizae radix 6 g;6 g/time, 3/d, orally.

6. The curative effect evaluation of the curative effect standard (1) refers to the consensus opinion (2017) of traditional Chinese medical science medical specialists for chronic gastritis, wherein the recovery is that the main symptoms and the signs disappear or basically disappear, the curative effect index is more than or equal to 95%, the obvious effect is that the main symptoms and the signs are obviously improved, the curative effect index is more than or equal to 70% and less than or equal to 95%, the effective effect is that the main symptoms and the signs are obviously improved, the curative effect index is more than or equal to 30% and less than 70%, the ineffective effect is that the main symptoms and the signs are not obviously improved or even aggravated, and the curative effect index is less than 30%. (2) The clinical efficacy evaluation refers to the "combination of traditional Chinese and western medicine with diagnosis and treatment consensus opinion (Tianjin in 2011)" and is judged according to gastroscope and pathological examination results, and is classified into 4 grades of cure, obvious effect, effective and ineffective.

7. Results

Comparison of Hp negative transfer conditions in two groups of patients: the Hp negative conversion rate of the observation group is (70/75) 93.33%, which is higher than that of the control group (58/71) 81.69%, and the comparison difference between the groups is statistically significant.

Comparison of the efficacy of the traditional Chinese medical conditions in two groups of patients, 75 observations: the cure 58 is obvious, the effect 10 is effective, and the effect 6 is ineffective 1. Control 71 cases: cure 43 significant 14 effective 10 ineffective 4. The curative effect of the traditional Chinese medicine symptoms of the two groups of patients after treatment is analyzed by rank sum test, and the observation group is superior to the control group.

The comparison of the two groups of patients in the four aspects of Hp negative conversion condition, traditional Chinese medicine syndrome curative effect, clinical curative effect and spleen and stomach damp-heat syndrome integral shows that the observation groups are better than the control group, and the accurate curative effect of the combination of agilawood and gastritis for treating Hp gastritis by four-way therapy is shown.

While the invention has been described in detail in the foregoing general description, embodiments and experiments, it will be apparent to those skilled in the art that modifications and improvements can be made thereto. Accordingly, such modifications or improvements may be made without departing from the spirit of the invention and are intended to be within the scope of the invention as claimed.

Claims

1. The traditional Chinese medicine composition for treating chronic gastritis is characterized by being prepared from the following traditional Chinese medicine raw materials in parts by weight:

2. The traditional Chinese medicine composition for treating chronic gastritis according to claim 1, wherein the active ingredients are prepared by the following method:

drying the above materials, mixing, pulverizing into fine powder, and stirring.

3. The traditional Chinese medicine composition for treating chronic gastritis according to claim 1, wherein the active ingredients are prepared by the following method:

is prepared by water extraction or ethanol extraction with the volume percentage concentration of 40-80%.

4. The traditional Chinese medicine composition for treating chronic gastritis according to claim 3, wherein the active ingredients are prepared by the following method: mixing all the above materials, reflux-extracting with 40-80% ethanol for 2-3 times, each time with ethanol amount of 4-10 times of total amount of the materials for 1-4 hr, mixing extractive solutions, filtering, and concentrating the filtrate to obtain fluid extract with relative density of 1.15-1.20 at 70-80deg.C.

5. The traditional Chinese medicine composition for treating chronic gastritis according to claim 3, wherein the active ingredients are prepared by the following method: mixing all the medicinal materials, extracting with water for 2-3 times, each time with water amount of 6-12 times of total weight of the medicinal materials, each time for 1-3 hours, mixing extractive solutions, filtering, concentrating filtrate to fluid extract with relative density of 1.15-1.20 at 70-80deg.C, adding ethanol to make ethanol content 40-70%, standing for 12-24 hours, filtering, concentrating filtrate to extract with relative density of 1.10-1.25 at 70-80deg.C, and making into final product.

6. A preparation for treating chronic gastritis, which is prepared by matching the traditional Chinese medicine composition for treating chronic gastritis according to any one of claims 1-5 with a pharmaceutically acceptable carrier.