CN116920057B - Traditional Chinese medicine composition for treating acute and chronic gastritis and application thereof - Google Patents
Traditional Chinese medicine composition for treating acute and chronic gastritis and application thereof Download PDFInfo
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Abstract
The invention relates to a traditional Chinese medicine composition for treating abdominal distension, belch and inappetence caused by acute and chronic gastritis, which is prepared from the following raw materials in parts by weight: 6-14 parts of raw rice sprouts, 6-14 parts of raw malt, 6-14 parts of dried orange peel, 9-21 parts of citron, 3-7 parts of elecampane, 3-7 parts of perilla leaves, 3-7 parts of wrinkled gianthyssop and 9-21 parts of betel nuts. The invention also provides the application of the medicine in preparing medicines for treating acute and chronic gastritis. The advantages are that: the traditional Chinese medicine composition provided by the invention is composed of natural plant raw materials, is scientifically proportioned, and can regulate qi, harmonize stomach, invigorate spleen, sooth liver, relieve depression and relieve distention after long-term use.
Description
[ Field of technology ]
The invention relates to a traditional Chinese medicine composition for treating abdominal distention, belch and inappetence caused by acute and chronic gastritis and application thereof, in particular to a Chinese patent medicine prepared from Chinese herbal medicines serving as raw materials.
[ Background Art ]
Chronic gastritis (Chronic gastritis) refers to a persistent chronic inflammatory condition in which the gastric mucosal epithelium is repeatedly affected by various pathogenic factors. Chronic gastritis is classified into Chronic atrophic gastritis and Chronic non-atrophic gastritis (chronically non-atrophic gastritis, CNAG) according to gastroscopy and histopathological examination, with the incidence of Chronic non-atrophic gastritis being the leading one among various stomach diseases. The clinical manifestation of the disease is atypical, and partial patients can have dyspepsia symptoms such as upper abdominal distension, and the presence or absence of the dyspepsia symptoms is obviously not related to gastroscopy and gastric mucosa pathological tissue classification. Some patients may develop chronic atrophic gastritis and even gastric cancer, so prevention and treatment of chronic non-atrophic gastritis should be regarded as important.
The cause of the chronic non-atrophic gastritis is not completely clear, and the main principle of the current Western medicine for treating the chronic non-atrophic gastritis is to eliminate or weaken attack factors, strengthen the defending function of gastric mucosa, promote gastrointestinal motility and the like. The main treatment methods at present are proton pump inhibitor treatment (such as lansoprazole); colloidal bismuth agents (such as bismuth potassium citrate); antibiotic drugs (such as amoxicillin); other adjunctive treatments (e.g., adjusting lifestyle and diet). However, many chronic gastritis patients still have symptoms that are not improved well by the treatment, or symptoms are improved during the administration period, but symptoms are easy to relapse after stopping the administration.
In traditional Chinese medicine, chronic non-atrophic gastritis belongs to the categories of symptoms such as stomach ache, distention and fullness, noisy and the like, and the symptoms are located in spleen and stomach and closely related to liver and gallbladder, and are mostly caused by disorder of spleen and stomach qi due to various internal factors, external factors, no internal and external factors and the like. With the increasing development of modern biological-psychological-social medical modes, heart and body diseases are increasingly common in clinical departments, especially internal medicine, and chronic gastritis is gradually considered as a typical heart and body disease, after systematic evaluation, the clinical chronic gastritis patients with anxiety and depression emotion are subjected to combined conventional treatment, and the patients can be effectively controlled and relieved by administration of anxiolytic and antidepressant medicaments, however, the problems of more side effects, long-term administration, difficulty in withdrawal, poor patient compliance and the like exist. The disease is usually manifested by symptoms of epigastric fullness, anorexia, belch, emotional depression or dysphoria.
The Chinese patent document CN201510391298.8 discloses a Chinese medicinal preparation for treating chronic atrophic gastritis and a preparation method thereof, wherein the preparation comprises the following raw materials in parts by weight: 9-18 parts of codonopsis pilosula, 6-15 parts of fried bighead atractylodes rhizome, 6-15 parts of poria cocos, 3-12 parts of dried orange peel, 3-12 parts of honey-fried licorice root, 3-12 parts of prepared pinellia tuber, 2-11 parts of dried ginger, 3-12 parts of cassia twig, 9-18 parts of fried white peony root, 3-12 parts of caulis perllae, 12-21 parts of cuttlefish bone, 6-15 parts of fried malt, 6-15 parts of fried rice sprout and 2-5 parts of coptis chinensis. The traditional Chinese medicine preparation has the advantages of definite curative effect, less toxic and side effects, convenient administration, lower price than similar medicines in the market and good patient compliance in treating chronic atrophic gastritis and precancerous lesions. The Chinese patent document CN201010186122.6 discloses a Chinese medicinal composition for treating belch and a preparation method thereof, and the Chinese medicinal composition mainly comprises the following raw material medicaments: radish seed, green tangerine peel, dried orange peel, curcuma aromatica, immature bitter orange, storax, benzoin, holy basil, grassleaf sweelflag rhizome, prepared rhubarb, red sage root, pseudo-ginseng, medicated leaven, rice sprout, motherwort herb, peach seed, safflower, magnolia bark, cowherb seed, ground beeltle, pangolin scales, aspongopus, common burreed rhizome, zedoary, snakegourd fruit seed, agilawood, sandalwood and the like; the invention can obviously improve: the Chinese medicinal composition has the symptoms of belching, short breath, asthma, chest distress, fullness, depressed mood, low emotion, debilitation, drowsiness and the like, and has definite clinical curative effect, obvious curative effect and quick response.
Many traditional Chinese medicine compositions for treating abdominal distension, eructation and inappetence caused by acute and chronic gastritis have more or less disadvantages, such as excessive medicine taste, difficult material obtaining and high price; has no obvious drug effect, poor treatment effect, etc. Therefore, a medicine which has obvious effect on treating acute and chronic gastritis, has few medicine flavors and is convenient to prepare is needed.
[ Invention ]
The invention aims at overcoming the defects in the prior art and provides a traditional Chinese medicine composition for treating acute and chronic gastritis.
It is a further object of the present invention to provide a use of the above medicament.
In order to achieve the above purpose, the technical scheme adopted by the invention is as follows:
A traditional Chinese medicine composition for treating acute and chronic gastritis is prepared from the following raw materials in parts by weight: 6-14 parts of raw rice sprouts, 6-14 parts of raw malt, 6-14 parts of dried orange peel, 9-21 parts of citron, 3-7 parts of elecampane, 3-7 parts of perilla leaves, 3-7 parts of wrinkled gianthyssop and 9-21 parts of betel nuts.
Preferably, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 8-12 parts of raw rice sprouts, 8-12 parts of raw malt, 8-12 parts of dried orange peel, 12-18 parts of citron, 4-6 parts of elecampane, 4-6 parts of perilla leaves, 4-6 parts of wrinkled gianthyssop and 12-18 parts of betel nuts.
More preferably, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 10 parts of raw rice sprouts, 10 parts of raw malt, 10 parts of dried orange peel, 15 parts of citron, 5 parts of costustoot, 5 parts of perilla leaves, 5 parts of wrinkled gianthyssop and 15 parts of betel nuts.
The medicament of the medicament is mixture, capsule, granule, tablet, oral liquid or syrup.
Preferably, the preparation method of the drug mixture comprises the following steps: taking 2kg of raw rice sprouts, 2kg of raw malt, 2kg of dried orange peel, 3kg of citron, 1kg of costustoot, 3kg of betel nuts, 1kg of perilla leaves and 1kg of wrinkled giant hyssop; adding water, decocting for 3 hr, and filtering to obtain decoction; adding water, decocting for 3 hr, filtering to obtain decoction, mixing the two decoctions, standing, filtering to obtain supernatant, concentrating, cooling, adding 3.5 times of ethanol, and stirring to precipitate overnight; collecting supernatant, concentrating to obtain soft extract; adding proper pharmaceutical auxiliary materials, and preparing 20000ml of mixture.
In order to achieve the second purpose, the invention adopts the following technical scheme:
the invention provides an application of the traditional Chinese medicine composition in preparing medicines for treating acute and chronic gastritis.
Preferably, the acute and chronic gastritis is spleen deficiency and qi stagnation type chronic non-atrophic gastritis.
Preferably, the symptoms of acute and chronic gastritis as described above are abdominal distension, eructation and inappetence.
The invention has the advantages that:
The traditional Chinese medicine composition (distention-eliminating mixture) consists of raw rice sprouts, raw malt, dried orange peel, citron, costustoot, perilla leaves, wrinkled giant hyssop and betel nuts, and is used for treating abdominal distention, belch, inappetence and the like caused by acute and chronic gastritis. The raw rice sprouts and the raw malt in the recipe are monarch drugs, and are used for regulating qi, strengthening spleen, eliminating food stagnation, regulating stomach, and strengthening spleen and stimulating appetite, wherein the raw rice sprouts are sweet in nature, warm in nature, enter spleen and stomach channels, promote digestion, regulate stomach, and invigorate spleen; raw malt is sweet in taste and neutral in nature, and has the effects of invigorating spleen and stomach meridian, promoting qi circulation, promoting digestion, strengthening spleen and stimulating appetite. Pericarpium Citri Tangerinae, fructus Citri parched with Mel, radix aucklandiae, and folium Perillae as ministerial drugs, and has effects of regulating qi-flowing and relieving flatulence, and pericarpium Citri Tangerinae has bitter and pungent taste, and has effects of warming nature, invigorating lung and spleen channel, regulating qi-flowing and invigorating spleen; the citron fried with the honey has pungent, slightly bitter and sour taste, warm nature, and liver, spleen, stomach and lung channels, and has the effects of soothing liver, relieving depression, regulating qi and relieving the middle warmer; the woody flavor is pungent and bitter, warm in nature, and enters spleen, stomach, large intestine, triple energizer and gallbladder channel, and has the effects of promoting qi circulation, relieving pain, strengthening spleen and promoting digestion; perillae herba She Weixin has warm nature, and can enter lung and spleen meridians, relieve exterior syndrome, dispel cold, promote qi circulation and harmonize stomach. Herba Pogostemonis and semen Arecae are adjuvant drugs, and are effective in eliminating dampness and invigorating spleen, and dispersing stagnated liver qi for relieving qi stagnation. The whole formula is combined to play the roles of regulating qi, harmonizing stomach, strengthening spleen, soothing liver, relieving depression and relieving distension.
[ Detailed description ] of the invention
The application is further described below in conjunction with the detailed description. It is to be understood that these examples are illustrative of the present application and are not intended to limit the scope of the present application. Further, it is understood that various changes and modifications of the present application may be made by those skilled in the art after reading the description of the present application, and such equivalents are intended to fall within the scope of the application as defined in the appended claims.
EXAMPLE 1 preparation of a medicament for treating acute and chronic gastritis (I)
10 Parts of raw rice sprouts, 10 parts of raw malt, 10 parts of dried orange peel, 15 parts of citron, 5 parts of costustoot, 5 parts of perilla leaves, 5 parts of wrinkled gianthyssop and 15 parts of betel nuts.
EXAMPLE 2 preparation of a drug for treating acute and chronic gastritis (II)
10 Parts of raw rice sprouts, 8 parts of raw malt, 12 parts of dried orange peel, 9 parts of citron, 7 parts of costustoot, 5 parts of perilla leaves, 4 parts of wrinkled gianthyssop and 18 parts of betel nuts.
EXAMPLE 3 preparation of a medicament for treating acute and chronic gastritis (III)
8 Parts of raw rice sprouts, 12 parts of raw malt, 6 parts of dried orange peel, 21 parts of citron, 5 parts of costustoot, 4 parts of perilla leaves, 6 parts of wrinkled gianthyssop and 9 parts of betel nuts.
EXAMPLE 4 preparation of a drug for treating acute and chronic gastritis (IV)
12 Parts of raw rice sprouts, 6 parts of raw malt, 14 parts of dried orange peel, 15 parts of citron, 4 parts of costustoot, 6 parts of perilla leaves, 3 parts of wrinkled gianthyssop herb and 21 parts of betel nuts.
EXAMPLE 5 preparation of a drug for treating acute and chronic gastritis (five)
6 Parts of raw rice sprout, 14 parts of raw malt, 10 parts of dried orange peel, 12 parts of citron, 6 parts of costustoot, 3 parts of perilla leaf, 7 parts of wrinkled gianthyssop herb and 15 parts of betel nut.
EXAMPLE 6 preparation of drug for treating acute and chronic gastritis (six)
14 Parts of raw rice sprouts, 10 parts of raw malt, 8 parts of dried orange peel, 18 parts of citron, 3 parts of costustoot, 7 parts of perilla leaves, 5 parts of wrinkled gianthyssop and 12 parts of betel nuts.
EXAMPLE 7 preparation of a drug for treating acute and chronic gastritis (seven)
10 Parts of raw rice sprouts, 12 parts of raw malt, 6 parts of dried orange peel, 21 parts of citron, 5 parts of costustoot, 4 parts of perilla leaves, 6 parts of wrinkled gianthyssop and 9 parts of betel nuts.
EXAMPLE 8 preparation of a medicament for treating acute and chronic gastritis (eight)
8 Parts of raw rice sprout, 6 parts of raw malt, 14 parts of dried orange peel, 15 parts of citron, 4 parts of costustoot, 6 parts of perilla leaf, 3 parts of wrinkled gianthyssop herb and 21 parts of betel nut.
EXAMPLE 9 preparation of a drug for treating acute and chronic gastritis (nine)
12 Parts of raw rice sprouts, 14 parts of raw malt, 10 parts of dried orange peel, 12 parts of citron, 6 parts of costustoot, 3 parts of perilla leaves, 7 parts of wrinkled gianthyssop and 15 parts of betel nuts.
EXAMPLE 10 preparation of a medicament for treating acute and chronic gastritis (Ten)
6 Parts of raw rice sprout, 10 parts of raw malt, 8 parts of dried orange peel, 18 parts of citron, 3 parts of costustoot, 7 parts of perilla leaf, 5 parts of wrinkled gianthyssop herb and 12 parts of betel nut.
EXAMPLE 11 preparation of a drug for treating acute and chronic gastritis (eleven)
14 Parts of raw rice sprouts, 8 parts of raw malt, 12 parts of dried orange peel, 9 parts of citron, 7 parts of costustoot, 5 parts of perilla leaves, 4 parts of wrinkled gianthyssop and 18 parts of betel nuts.
EXAMPLE 12 preparation of pharmaceutical tablet/Capsule for treating acute and chronic gastritis
Taking the medicine in any one of the embodiments 1-11, adding 9-11 times of water, decocting for 2-3.5 hours, and filtering out the medicine juice. Adding 9 times of water, decocting for 2.5 hr, filtering to obtain decoction, mixing the two decoctions, standing, filtering to obtain supernatant, concentrating, cooling, adding 3 times of ethanol, and stirring to precipitate overnight. Collecting supernatant, concentrating to obtain soft extract; adding pharmaceutical adjuvants, vacuum drying, pulverizing, granulating, and making into tablet or capsule.
EXAMPLE 13 preparation of pharmaceutical granules for treating acute and chronic gastritis
Taking the medicine in any one of the embodiments 1-11, adding 8-10 times of water, decocting for 3 hours, and filtering out the medicine juice. Adding 10 times of water, decocting for 2.5 hr, filtering to obtain decoction, mixing the two decoctions, standing, filtering to obtain supernatant, concentrating, cooling, adding 2 times of ethanol, and stirring to precipitate overnight. Collecting supernatant, concentrating to obtain soft extract; adding proper pharmaceutical adjuvants, granulating, drying, grading to obtain 20g granule, and packaging into 10 g/bag.
EXAMPLE 14 preparation of pharmaceutical mixture/oral liquid/syrup for treating acute and chronic gastritis
Taking the medicine in any one of the embodiments 1-11, adding 8-11 times of water, decocting for 3 hours, and filtering out the medicine juice. Adding 8 times of water, decocting for 3 hr, filtering to obtain decoction, mixing the two decoctions, standing, filtering to obtain supernatant, concentrating, cooling, adding 3.5 times of ethanol, and stirring to precipitate overnight. Collecting supernatant, concentrating to obtain soft extract; adding proper pharmaceutical adjuvants, and making into mixture, oral liquid or syrup.
Example 15 animal experiment
1. Experimental materials
1.1 Medicaments
The first traditional Chinese medicine group: 10 parts of raw rice sprouts, 10 parts of raw malt, 10 parts of dried orange peel, 15 parts of citron, 5 parts of costustoot, 5 parts of perilla leaves, 5 parts of wrinkled gianthyssop and 15 parts of betel nuts;
the invention discloses a traditional Chinese medicine group II: 8 parts of raw rice sprouts, 12 parts of raw malt, 6 parts of dried orange peel, 21 parts of citron, 5 parts of costustoot, 4 parts of perilla leaves, 6 parts of wrinkled gianthyssop and 9 parts of betel nuts;
control group one: 10 parts of raw rice sprouts, 10 parts of raw malt, 10 parts of dried orange peel, 15 parts of fructus aurantii, 5 parts of elecampane, 5 parts of mulberry leaves, 5 parts of wrinkled gianthyssop and 15 parts of chinaberry bark;
control group two: 8 parts of raw rice sprouts, 12 parts of raw malt, 6 parts of mulberry branches, 21 parts of citron, 5 parts of nutgrass galingale rhizome, 4 parts of schizonepeta, 6 parts of wrinkled gianthyssop and 9 parts of betel nuts;
Western medicine group: sanjiuweitai granule;
Model group: physiological saline;
Blank group: physiological saline.
1.2 Animals
SPF SD rats with a mass of 180-200g and 70 male and female halves are provided by Shanghai Bai Yi Biotechnology Co.
1.3 Reagents and instruments
Uratam, ethanol, sodium deoxycholate (beijing solibao technologies limited), superoxide dismutase (SOD) kit, malondialdehyde (MDA) kit (institute of bioengineering, built in south kying); rat serum Gastrin (GAS) ELISA kit, rat pepsin activity (PP) detection ELISA kit (Shanghai Ji biosciences, inc.) and centrifuge (sammer femto technology, usa).
2. Method of
2.1 Modeling and packet administration
And (3) adopting a multi-factor method to mould: 10 rats were used as a blank group, and the remaining 60 rats were prepared into a spleen deficiency qi stagnation chronic non-atrophic gastritis model. The rats are orally administrated with 60% ethanol solution 1 time (empty stomach), 2mL each time, 1 time every 5 days in 1 month, 1 time every 7 days in 2 months, and the sodium deoxycholate solution with pH of 7.0-7.8 and 20mmoL/L is used for replacing water to drink at will. Hunger-saturation disorders were matched during the first two months: the feed is fed in sufficient quantity for 2 days, fasted for 1 day and unlimited in feeding day. The 30% ethanol solution and 20mmoL/L sodium deoxycholate solution are used in 3 months, and the water is replaced for 1 time to drink freely every 3 days. And starting in the third month, rats were restrained with the modified mineral water bottle for 1.5h each day, swim for 10min, and eat every other day until the modeling is completed. At the end of the molding, 5 rats died due to improper handling. Molding success standard: the rats had no luster, no movement, binding and piling, no activity, and irritability, and then were low, the diet was gradually reduced, and the rats were easy to wake, tired and recumbent, and the stool was slightly dry to loose. After the model is successfully prepared, 54 rats are selected and equally divided into a treatment group I, a treatment group II, a control group I, a control group II, a model group and a western medicine group. Continuous gastric lavage administration is started for 30 days after grouping, and the treatment group and the control group are subjected to gastric lavage according to the dosage of 10mL/kg, the western medicine group is subjected to gastric lavage according to the dosage of 5.33g/kg, and the model group and the blank group are subjected to gastric lavage by using normal saline with the same dosage.
2.2 Obtaining materials
After 30 days of administration, rats were anesthetized with 10% uratam after 24 hours of fasting, and the abdomen was opened, pylorus ligated, sutured, and closed. The extracted stomach was dissected along the large stomach curve, the gastric juice was poured out into a centrifuge tube, centrifuged at 3000g for 10min, and the supernatant was taken. And removing the supernatant after centrifugation by using a precision pipette, taking a proper amount of gastric juice, and respectively measuring GAS and PP according to the operation of ELISA kit instructions.
The extracted stomach is dissected along the large stomach curve, the extracted stomach tissue is rinsed by ice normal saline to remove gastric contents, filter paper is sucked dry, 0.2g of stomach tissue is sheared and put into a 5mL centrifuge tube, 9 times of ice normal saline is added, a homogenizer is homogenized, 10% homogenate is prepared, 3000 Xg is centrifuged for 10min, supernatant is taken for SOD and MDA measurement, and the measurement method is strictly carried out according to the instruction of a kit.
2.3 Detection index
(1) Comparing the rat GAS and PP results;
(2) Comparing SOD activity and MDA content of rat gastric mucosa tissue.
2.4 Statistical methods
All statistical analyses were performed using GRAPHPAD PRISM software. Results are expressed as mean ± standard deviation. Paired and unpaired data were evaluated using the Student-t test. The multiple sets of comparisons were evaluated using one-way AONVA. P <0.05 is statistically significant for the differences.
3. Results
3.1 Comparison of rat GAS and PP results for each group
The results are shown in Table 1. Compared to the blank group, the rats in the model group had elevated GAS, PP (p < 0.05). Compared with the model group, the GAS and PP of the first and second rats of the treatment group are obviously reduced (p < 0.01), the GAS and the PP of the rats of the western medicine group are reduced (p < 0.05), and the PP is not obviously reduced (p > 0.05); whereas the rats in the control group had no significant decrease in GAS or PP (p > 0.05).
Table 1 comparison of rat GAS and PP results for each group
Note that: # compared to blank, p <0.05; comparison with model group, p <0.05, p <0.01.
3.2 Comparison of SOD Activity and MDA content of gastric mucosal tissue of rat
Compared with the blank group, the SOD activity of the rats in the model group is reduced (P < 0.05), and the MDA content is increased (P < 0.05). Compared with the model group, the SOD activity and MDA content of the western medicine group rats have no significant difference (p > 0.05); the SOD activity of the first and second rats of the control group is increased (p < 0.05), and the MDA content has no significant difference (p > 0.05); the SOD activity of the treated group one and two rats was significantly increased (P < 0.01) and MDA content was decreased (P < 0.05).
TABLE 2 comparison of SOD Activity and MDA content in gastric mucosal tissue of rats
Note that: # compared to blank, p <0.05; comparison with model group, p <0.05, p <0.01.
The results show that the treatment group I and the treatment group II have obviously better effects than the control group I and the control group II. The western medicine group and the model group have almost no obvious difference, which indicates that the western medicine has no obvious effect on spleen deficiency and qi stagnation chronic non-atrophic gastritis.
Example 16 clinical trials
1. Research data
1.1 Medical record Material
120 Outpatients or inpatients with a doctor of seventh people's hospital in Shanghai city, 5 months 2019-2021, 12 months.
1.2 Inclusion criteria
① Meets the diagnostic standard of CNAG, but has no atrophy, intestinal epithelial dysplasia and no helicobacter pylori infection detected by a C14 expiration test method;
② The differentiation and classification of the traditional Chinese medicine accords with spleen deficiency and qi stagnation standards;
③ The age is 18-75 years old;
④ Agreeing and being able to receive treatment, observation and various inspectors.
1.3 Diagnostic criteria
(1) Western diagnostic criteria: the Chinese medical society digestive endoscopy department of Chinese chronic gastritis is referred to for formulation of the Chinese medical society digestive endoscopy department of Chinese chronic gastritis endoscope classification standard and treatment trial opinion.
① The disease course is prolonged, and symptoms such as epigastric pain, distension and fullness, acid regurgitation, anorexia, nausea, upper abdominal pain related to eating and the like can be caused by slight upper left abdominal tenderness.
② Can confirm diagnosis according to CNAG gastroscope diagnosis standard and pathological examination diagnosis standard: erythema (punctate, striped, flaky), rough and uneven mucous membranes, bleeding points or spots, oedema or exudation of mucous membranes can be seen under the endoscope. Pathological diagnosis includes chronic inflammatory severity, active inflammation, atrophy, intestinal metaplasia and dysplasia should be graded. The chronic gastritis biopsy shows that the atrophic gastritis can be diagnosed by the atrophy of the intrinsic glands, and the occurrence of atrophy, intestinal epithelial metaplasia, abnormal hyperplasia and the like do not belong to the research scope.
(2) The differentiation and typing standard of traditional Chinese medicine: according to the established diagnosis standard of spleen deficiency and qi stagnation syndrome: anorexia, epigastric distending pain, belch, nausea and vomiting, loose stool, listlessness, less qi and no desire to speak, sallow complexion, pale tongue with white coating, slow weak pulse or wiry and thin pulse.
1.4 Exclusion criteria:
① Combining peptic ulcer, erosive gastritis, atrophic gastritis, history of abdominal operation, severe dysplasia of gastric mucosa or malignant lesions in pathological diagnosis;
② Overlap syndrome complicated with gastroesophageal reflux disease and irritable bowel syndrome;
③ Women in gestation and lactation;
④ Patients suspected or sure to have a history of alcohol, drug abuse or be in a major anxiety depression state, with a suicidal tendency;
⑤ Patients with serious primary diseases such as cardiovascular diseases, liver diseases, kidney diseases, hematopoietic systems, etc.;
⑥ At the discretion of the investigator, it was considered unsuitable for patients into the group.
2. Research method
2.1 Grouping method
Patients diagnosed with CNAG were randomized into control and test groups of 60 cases each.
2.2 Methods of treatment
Control group: the stomach-strengthening granule (Jiangsu pharmaceutical Co., ltd.) is taken after meals 3 times a day in 1 bag each time for 4 weeks.
Test group: "Xiaobang" formula: 10g of raw rice sprouts, 10g of raw malt, 10g of dried orange peel, 15g of citron, 5g of costustoot, 5g of perilla leaves, 5g of wrinkled gianthyssop and 15g of betel nuts. 1 dose per day, and is decocted with water for 400ml twice per day, and is orally taken for 4 weeks.
2.3 Observations index
(1) Symptomatic observation: the changes of the main symptoms before and after the treatment of the observed cases are observed and recorded. Symptom score was expressed using a hierarchical score method: severe (3 points), moderate (2 points), mild (1 point), asymptomatic (0). Scoring the symptoms of epigastric or abdominal distention, epigastric pain, diet reduction, belch, hiccup, bitter taste, dry mouth, fatigue, weakness, nausea, vomiting, gastric upset, chest distress, heavy weight, drowsiness and loose stool, and taking the sum of the symptoms as the integral of the symptoms.
(2) Electronic gastroscopy: the gastroscopic mucosal phases (congestion, edema, erosion, bleeding, etc.) were observed and recorded within 1-2 weeks before and after treatment of all observed cases.
(3) Histopathological examination: in vivo histopathological examination, when gastroscopy is performed within 1-2 weeks before and after treatment of all observed cases, 5 biopsies are taken and respectively: the antrum 2 is taken from the greater curvature and lesser curvature at a distance of 2-3 cm from the pylorus, the body 2 is taken from the greater curvature at a distance of 8cm from the cardia (about the greater curvature middle) and the lesser curvature at a distance of 4cm proximal to the angle of the stomach, the angle of the stomach is 1. When the gastroscope is reexamined after treatment, tissue is clamped at the original biopsy position as much as possible, and the gastroscope and pathological examination are required to be carried out by special persons. The change in the condition of the degree of inflammation was observed. The gastroscope is clamped at the original position as much as possible during the reexamination after the treatment, and the gastroscope and the pathological examination need to be taken charge of special persons.
(4) Safety index: general physical examination. Blood and urine are conventional, and stool is conventional; electrocardiogram, liver function, kidney function; type, extent, incidence of adverse events.
2.4 Statistical methods
SPSS24 software package is used for statistics, grade data is checked by Ridit, count data is checked by X 2, and metering data is checked by t.
2.5 Standard of efficacy
(1) Traditional Chinese medicine syndrome curative effect evaluation standard
Efficacy index = (pre-treatment integral-post-treatment integral)/pre-treatment integral x 100%. Clinical control: the clinical symptoms and physical signs disappear, and the curative effect index is more than or equal to 90%; the effect is shown: the clinical symptoms and physical signs are obviously improved, and the curative effect index is more than or equal to 70% and less than 90%; the method is effective: the clinical symptoms and physical signs are improved, and the curative effect index is less than 70% and is more than or equal to 30%; invalidation: the clinical symptoms and physical signs are not changed or aggravated, and the curative effect index is less than 30 percent.
(2) Pathological curative effect judgment standard
And (3) curing: gastroscopy review gastric mucosal congestion and disappearance of edema signs; the inflammatory infiltration is basically disappeared in pathological examination, and the active inflammation is disappeared;
the effect is shown: the gastroscope is obviously improved in the symptoms of gastric mucosa congestion, edema and the like; the active inflammation and the severity of the inflammation are reduced by more than 1 grade in pathological examination;
The method is effective: the gastroscope re-examination of gastric mucosa has improved symptoms such as congestion and edema; pathological examination of active inflammation or reduction of inflammation severity by 1 grade;
Invalidation: the effective standard is not met but not deteriorated.
3. Results
3.1 Comparison of curative effects of 2 groups of Chinese medicinal symptoms
See table 3. The obvious efficiency of the treatment group is 45.0%, the obvious efficiency of the control group is 18.3%, and the difference has very significant significance (P is less than 0.01) when compared with the 2 groups; the total effective rate of the treatment group is 86.7%, the total effective rate of the control group is 65.0%, and the difference has very significant significance (P is less than 0.01) compared with the comparison of the 2 groups, which proves that the clinical curative effect of the compound medicine for treating spleen deficiency and qi stagnation type chronic non-atrophic gastritis is obviously better than that of the control group.
Table 32 comparative curative effects of Chinese traditional medicine syndrome (%)
Note that: the test group was compared with the control group, and P < 0.01. Total effectiveness= (clinical control + effectiveness)/total case count 100%.
3.2 Comparison of pathological changes results of group 2
See table 4. The obvious effect and total effective rate of the pathological changes after treatment of the 2 groups are tested by rank sum, and the difference of the 2 groups has very significant significance (P is less than 0.01), which indicates that the test group is obviously superior to the control group in the aspect of pathological curative effect.
Table 42 comparative results of pathological changes (%)
3.3 Drug safety observations
During the treatment period of taking medicine, detection of safety indexes such as blood routine, urine routine, stool routine, electrocardiogram, liver function, kidney function and the like of patients before and after treatment shows that no damage or three routine abnormalities of liver and kidney function occur to the patients.
4. Conclusion(s)
CNAG belongs to the categories of epigastric pain, distention and fullness, acid regurgitation, vomiting and the like in traditional Chinese medicine. The pathogenesis of traditional Chinese medicine is known as "stomach-qi depression". In the compound combination, the raw rice sprouts and the raw malt are monarch drugs, the qi-flowing and spleen-invigorating, the digestion-promoting and stomach-harmonizing functions are realized, the dried orange peel, the honey-fried citron, the elecampane and the perilla leaf are ministerial drugs, the qi-flowing and distention-eliminating functions are enhanced, the wrinkled gianthyssop herb and the betel nut are adjuvant drugs, the wrinkled gianthyssop herb and the betel nut are capable of eliminating dampness and strengthening the spleen, the betel nut is capable of soothing liver and relieving depression, and the qi-flowing and stagnation-eliminating functions are realized. The whole formula is combined to play the roles of regulating qi, harmonizing stomach, strengthening spleen, soothing liver, relieving depression and relieving distension.
Clinical research results show that the traditional Chinese medicine composition can obviously improve symptoms such as abdominal distension, eructation, inappetence and the like caused by chronic non-atrophic gastritis.
The foregoing is merely a preferred embodiment of the present invention, and it should be noted that modifications and additions may be made to those skilled in the art without departing from the method of the present invention, which modifications and additions are also to be considered as within the scope of the present invention.
Claims (6)
1. The traditional Chinese medicine composition for treating spleen deficiency and qi stagnation type chronic non-atrophic gastritis is characterized by being prepared from the following raw materials in parts by weight: 6-14 parts of raw rice sprouts, 6-14 parts of raw malt, 6-14 parts of dried orange peel, 9-21 parts of citron, 3-7 parts of elecampane, 3-7 parts of perilla leaves, 3-7 parts of wrinkled gianthyssop and 9-21 parts of betel nuts.
2. The traditional Chinese medicine composition according to claim 1, which is prepared from the following raw materials in parts by weight: 8-12 parts of raw rice sprouts, 8-12 parts of raw malt, 8-12 parts of dried orange peel, 12-18 parts of citron, 4-6 parts of elecampane, 4-6 parts of perilla leaves, 4-6 parts of wrinkled gianthyssop and 12-18 parts of betel nuts.
3. The traditional Chinese medicine composition according to claim 2, which is characterized by being prepared from the following raw materials in parts by weight: 10 parts of raw rice sprouts, 10 parts of raw malt, 10 parts of dried orange peel, 15 parts of citron, 5 parts of costustoot, 5 parts of perilla leaves, 5 parts of wrinkled gianthyssop and 15 parts of betel nuts.
4. A Chinese medicinal composition according to any one of claims 1 to 3, wherein the composition is in the form of a mixture, capsule, granule, tablet or syrup.
5. The traditional Chinese medicine composition according to claim 4, wherein the preparation method of the mixture comprises the following steps: taking 2kg of raw rice sprouts, 2kg of raw malt, 2kg of dried orange peel, 3kg of citron, 1kg of costustoot, 3kg of betel nuts, 1kg of perilla leaves and 1kg of wrinkled giant hyssop; adding water, decocting for 3 hr, and filtering to obtain decoction; adding water, decocting for 3 hr, filtering to obtain decoction, mixing the two decoctions, standing, filtering to obtain supernatant, concentrating, cooling, adding 3.5 times of ethanol, and stirring to precipitate overnight; collecting supernatant, concentrating to obtain soft extract; adding proper pharmaceutical auxiliary materials, and preparing 20000ml of mixture.
6. The use of a Chinese medicinal composition according to any one of claims 1-5 in the preparation of a medicament for treating spleen deficiency and qi stagnation type chronic non-atrophic gastritis.
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