Traditional Chinese medicine composition for treating chronic gastritis

Abstract

The invention discloses a traditional Chinese medicine composition for treating chronic gastritis, and relates to the technical field of traditional Chinese medicines. The main functional component of the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 10-20 parts of radix bupleuri, 10-20 parts of parched white peony root, 10-20 parts of radix curcumae, 6-15 parts of radix aucklandiae, 3-9 parts of fructus amomi, 5-15 parts of fructus evodiae, 15-25 parts of cuttlebone, 10-20 parts of astragalus membranaceus, 10-20 parts of codonopsis pilosula, 10-20 parts of pericarpium citri reticulatae, 10-20 parts of pinellia ternate, 15-25 parts of poria cocos, 10-20 parts of roasted rhizoma atractylodis macrocephalae, 10-20 parts of cassia twig and 3-9 parts of honey-fried licorice root. The compatibility of the traditional Chinese medicine composition conforms to the principle of'monarch, minister, assistant and guide 'of traditional Chinese medicines, and all the medicines are synergistic to strengthen the spleen, treat root causes, regulate qi to alleviate pain and simultaneously regulate the liver and the spleen; the effects of reducing phlegm and dampness, harmonizing the stomach, dispelling cold and treating both symptoms and root causes are achieved. The traditional Chinese medicine is high in clinical gastritis patient treatment efficiency, safe and free of side effects.

Description

TECHNICAL FIELD

[0001] The application relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for treating chronic gastritis. BACKGROUND

[0002] Chronic gastritis is the most common disease in the digestive system, the disease starts slowly, the healing time is long, and it is easy to relapse, and its incidence rate ranks first among various digestive system diseases, accounting for about 90% of patients receiving gastroscopy. It refers to various chronic gastric mucosa diseases caused by different causes, and is commonly manifested as upper abdominal discomfort, dull pain, nausea, vomiting and other symptoms. Diagnosis is divided into three categories: non-atrophic (previously known as superficial), atrophic and special types. At present, it is believed that the occurrence of chronic gastritis is closely related to helicobacter pylori infection, gastroesophageal reflux, psychoneurotic factors, diet and drug factors. However, the entire pathogenesis cannot be explained at present.

[0003] For the clinical treatment of chronic gastritis, western medicine often adds tranquilizing and hypnotic drugs, anti-anxiety, anti-depression and other drugs on the basis of anti-inflammatory, acid suppression, sterilization and protection of gastric mucosa. The symptoms are improved when the drugs are taken, but it is easy to relapse after the drugs are stopped. Moreover, if the patient does not receive regular treatment for a long time, not only will the drug resistance be increased and the treatment difficulty be increased, but also toxic side effects will be produced.

[0004] Chronic gastritis belongs to the category of "stomachache", "fullness" and "dyspepsia" in traditional Chinese medicine. The Inner Classic points out three main causes of stomachache, that is, external invasion of pathogenic factors, invasion of liver qi into the stomach and internal injury of diet. The Treatise on Pains states: "Cold pathogen invading between the intestines and stomach, below the membrane origin, blood cannot be dispersed, small collaterals are drawn urgently, so pain. Cold pathogen invading the intestines and stomach, and the upper part of the pernicious yin, so pain and vomiting." The Treatise on Pains also involves the syndrome differentiation of stomachache, such as "pulse number and slip are real, there is food retention, and it is better to be down"; "loose stool and no desire to eat are food retention, and it should be down"; "food retention is in the upper epigastric region, and it should be vomited"; and "abdominal fullness is virtual and real, such as "virtual is not painful, and real is painful", which are all applicable to the syndrome differentiation of stomachache. According to the discussion of ancient medical doctors on the etiology and pathogenesis of stomachache, it is believed that the occurrence of the disease is caused by qi stagnation and blood stasis, damp-heat accumulation, stomach failure and stomach collateral damage due to six exogenous factors, diet injury to the spleen, invasion of liver qi into the stomach and spleen and stomach weakness. The disease is located in the stomach, and is closely related to the liver and the spleen. The pathogenesis changes can be manifested as deficiency in the root and excess in the branch, and deficiency and excess mixed together; in the early stage, it is in qi, and over time, it involves blood, and cold, heat, deficiency and excess can be transformed into each other in the course of the disease.

[0005] Traditional Chinese medicine has certain advantages in the treatment of chronic gastritis, not only can it regulate the inflammatory factor level of patients with gastritis through multiple pathways and multiple targets, but also can improve the prognosis and treatment of recurrence, and has small side effects, no drug dependence and good safety.

[0006] Therefore, it is still an urgent problem for those skilled in the art to provide a Chinese medicine preparation for effectively treating chronic gastritis. SUMMARY

[0007] Therefore, the present application provides a Chinese medicine composition for treating chronic gastritis.

[0008] In order to achieve the above-mentioned purpose, the present application adopts the following technical solutions.

[0009] A Chinese medicine composition, the main effective components of which are composed of the following raw materials in parts by weight: Radix Bupleuri 10-20 parts, Fried Radix Paeoniae Alba 10-20 parts, Radix Curcumae 10-20 parts, Radix Aucklandiae 6-15 parts, Fructus Amomi Rotundus 3-9 parts, Fructus Evodiae 5-15 parts, Concha Arcae 15-25 parts, Radix Paeoniae Alba 10-20 parts, Radix Paeoniae Rubra 10-20 parts, Pericarpium Citri Reticulatae 10-20 parts, Rhizoma Pinelliae 10-20 parts, Poria 15-25 parts, Fried Radix Paeoniae Alba 10-20 parts, Ramulus Cinnamomi 10-20 parts, and Radix Glycyrrhizae 3-9 parts.

[0010] The Chinese medicine composition of the present application takes Radix Bupleuri, Radix Paeoniae Rubra and Radix Paeoniae Alba as monarch drugs: Radix Bupleuri: soothing liver and relieving depression, regulating qi movement, aiming at stomachache caused by liver depression; Radix Paeoniae Rubra and Radix Paeoniae Alba: tonifying qi and invigorating spleen, enhancing the function of spleen and stomach, aiming at weak spleen and stomach. Fried Radix Paeoniae Alba, Radix Curcumae, Radix Aucklandiae and Concha Arcae are used as ministerial drugs: Fried Radix Paeoniae Alba: nourishing blood and soothing liver, relieving pain, combined with Radix Bupleuri, soothing liver without damaging yin; Radix Curcumae and Radix Aucklandiae: promoting qi and relieving depression, assisting Radix Bupleuri in soothing liver and regulating qi, relieving stomachache; Concha Arcae: relieving acid and pain, protecting gastric mucosa, aiming at excessive gastric acid of gastritis. Pericarpium Citri Reticulatae, Rhizoma Pinelliae, Poria, Fried Radix Paeoniae Alba, Fructus Evodiae, Fructus Amomi Rotundus and Ramulus Cinnamomi are used as auxiliary drugs: Pericarpium Citri Reticulatae, Rhizoma Pinelliae, Poria and Fried Radix Paeoniae Alba: invigorating spleen and eliminating dampness, regulating qi and harmonizing stomach, preventing liver depression from damaging spleen; Fructus Evodiae: warming middle and descending, relieving vomiting, aiming at cold and damp or stomach qi upward; Fructus Amomi Rotundus: eliminating dampness and promoting qi, warming middle and invigorating spleen, enhancing the function of spleen and stomach; Ramulus Cinnamomi: warming yang qi, assisting qi movement, relieving cold and pain. Radix Glycyrrhizae is used as ministerial drug: Radix Glycyrrhizae: regulating all drugs, relieving pain, tonifying middle qi at the same time.

[0011] The present application can support spleen and treat the root, regulate qi and relieve pain, and harmonize liver and spleen; it can also eliminate dampness and harmonize stomach, relieve cold, and treat both the root and the branch, and warm middle and relieve acid, which is suitable for gastritis with multiple syndromes or complex syndrome elements. It includes:

[0012] Gastritis of liver depression and spleen deficiency: liver depression and spleen deficiency with dampness, which is manifested as stomachache, loss of appetite, fatigue, etc.

[0013] Gastritis of spleen and stomach deficiency: cold and dampness blocking in the middle, stomach qi upward, which is manifested as stomach cold pain, vomiting and acid regurgitation, loose stool, etc.

[0014] Gastritis of qi stagnation and blood stasis: liver depression and qi stagnation, blood stasis, which is manifested as stomachache, dark tongue, etc.

[0015] Preferably, the efficacy principal component is composed of the following raw materials by weight: Radix Bupleuri 15 parts, Fried Radix Paeoniae Alba 15 parts, Radix Curcumae 15 parts, Radix Aucklandiae 10 parts, Fructus Amomi Rotundus 6 parts, Fructus Evodiae 10 parts, Concha Arcae 20 parts, Radix Astragali 15 parts, Radix Codonopsis 15 parts, Pericarpium Citri Reticulatae 12 parts, Rhizoma Pinelliae 15 parts, Poria 20 parts, Fried Radix Paeoniae Alba 15 parts, Ramulus Cinnamomi 12 parts and Radix Glycyrrhizae 6 parts.

[0016] Preferably, the traditional Chinese medicine composition further comprises a pharmaceutically acceptable excipient or carrier.

[0017] More preferably, the dosage form of the traditional Chinese medicine composition is a decoction, granules, tablets, powder, powder, capsules, oral liquid or dripping pills.

[0018] Another object of the present application is to provide a preparation method of the above-mentioned traditional Chinese medicine composition, wherein Radix Bupleuri, Fried Radix Paeoniae Alba, Radix Curcumae, Radix Aucklandiae, Fructus Evodiae, Concha Arcae, Radix Astragali, Radix Codonopsis, Pericarpium Citri Reticulatae, Rhizoma Pinelliae, Poria, Fried Radix Paeoniae Alba, Ramulus Cinnamomi and Radix Glycyrrhizae in the traditional Chinese medicine prescription are washed with water, then 5-10 times the amount of water is added to soak in a container for more than 2 hours, boiled under normal pressure with large fire and then boiled under small fire for 20 minutes, Fructus Amomi Rotundus is added and boiled for 15 minutes, the medicinal liquid is filtered out to obtain water decoction I, 2-3 times the amount of water is added again, boiled under normal pressure with large fire and then boiled under small fire for 35 minutes, the medicinal liquid is filtered out to obtain water decoction II, water decoction I and II are mixed and evenly distributed, and then divided into two parts for morning and evening administration.

[0019] Preferably, the obtained water decoction is added to a pharmaceutically acceptable excipient or carrier, and a conventional preparation method is used to prepare the corresponding pharmaceutical preparation.

[0020] Still another object of the present application is to provide the use of the above-mentioned traditional Chinese medicine composition in the preparation of a medicine for treating gastritis.

[0021] Beneficial effects: The traditional Chinese medicine composition of the present application is in accordance with the principle of "lord, minister, assistant and messenger" of traditional Chinese medicine, and the various medicinal ingredients are synergistic, which can support the spleen, regulate qi and relieve pain, and harmonize the liver and spleen, and also can resolve phlegm and dampness, harmonize the stomach and dispel cold, and achieve the effect of treating the root and the branch. It has high effective rate and no side effects for the treatment of clinical gastritis patients. DETAILED DESCRIPTION

[0022] The technical solutions in the embodiments of the present application will be described clearly and completely below. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative work fall within the protection scope of the present application.

[0023] The embodiments of the present application disclose a traditional Chinese medicine composition for treating chronic gastritis. The raw materials used are commercially available, and their sources are not specifically limited. The methods involved are conventional methods, and will not be described one by one here.

[0024] Example 1

[0025] A traditional Chinese medicine composition for chronic gastritis

[0026] Take 15g of Radix Bupleuri, 15g of Radix Paeoniae Alba, 15g of Radix Curcumae, 10g of Radix Aucklandiae, 6g of Amomum villosum (added later), 10g of Fructus Evodiae, 20g of Concha Arcae, 15g of Radix Astragali, 15g of Radix Codonopsis, 12g of Pericarpium Citri Reticulatae, 15g of Rhizoma Pinelliae, 20g of Poria cocos, 15g of Radix Paeoniae Alba, 12g of Ramulus Cinnamomi, and 6g of Radix Glycyrrhizae.

[0027] The above Chinese herbal medicines are washed with water, then soaked in 5-10 times the amount of water in a container for more than 2 hours, boiled with high heat under normal pressure, and then simmered for 20 minutes with low heat. Amomum villosum is added and simmered for another 15 minutes. The medicinal liquid is filtered out to obtain water decoction one. Then 2-3 times the amount of water is added, boiled with high heat under normal pressure, and then simmered for 35 minutes with low heat. The medicinal liquid is filtered out to obtain water decoction two. The water decoctions one and two are mixed and adjusted to obtain the water decoction of the traditional Chinese medicine composition.

[0028] Further, on the basis of the water decoction, pharmaceutically acceptable excipients or carriers are added, and conventional preparation methods are used to prepare the corresponding pharmaceutical preparations (including but not limited to granules, tablets, powders, capsules, oral liquid, or dripping pills).

[0029] Example 2

[0030] A traditional Chinese medicine composition for chronic gastritis

[0031] Take 10g of Radix Bupleuri, 20g of Radix Paeoniae Alba, 20g of Radix Curcumae, 6g of Radix Aucklandiae, 9g of Amomum villosum (added later), 15g of Fructus Evodiae, 25g of Concha Arcae, 10g of Radix Astragali, 20g of Radix Codonopsis, 10g of Pericarpium Citri Reticulatae, 10g of Rhizoma Pinelliae, 15g of Poria cocos, 15g of Radix Paeoniae Alba, 10g of Ramulus Cinnamomi, and 6g of Radix Glycyrrhizae.

[0032] The preparation method is the same as that of Example 1.

[0033] Example 3

[0034] A traditional Chinese medicine composition for chronic gastritis

[0035] Take 20g of Radix Bupleuri, 10g of Radix Paeoniae Alba, 10g of Radix Curcumae, 15g of Radix Aucklandiae, 3g of Amomum villosum (added later), 5g of Fructus Evodiae, 15g of Concha Arcae, 20g of Radix Astragali, 10g of Radix Codonopsis, 20g of Pericarpium Citri Reticulatae, 15g of Rhizoma Pinelliae, 25g of Poria cocos, 10g of Radix Paeoniae Alba, 20g of Ramulus Cinnamomi, and 3g of Radix Glycyrrhizae.

[0036] The preparation method is the same as that of Example 1.

[0037] Example 4

[0038] Animal experiment of traditional Chinese medicine composition for treating chronic gastritis

[0039] Healthy male 9-week-old, KM mice 60, in SPF level environment, room temperature control in 20~26℃, relative humidity in 40%~70%, ordinary feed feeding. After 3 days of adaptive feeding, the mice were randomly divided into 6 groups, 10 in each group, namely normal group, model group, western medicine group, gastritis recipe 1, 2, 3 group (corresponding to example 1-3 respectively).

[0040] Except for the normal group, the model group, the western medicine group and the gastritis recipe group were given 2% sodium salicylate 2 mL / d / one, combined with the factor of fasting and gorging, and the mice were modeled by gavage for 6 weeks. The mice were normally fed for the first 3 weeks, and then were fed with food every other day for the last 3 weeks without water. After modeling, the gastritis recipe group and the western medicine group were given gastritis recipe 1, 2, 3 group (corresponding to example 1-3 respectively, the dosage of the drug used was 26.13 g / kg according to the equivalent dose ratio between humans and animals based on body surface area), and the suspension of vitamin enzyme (0.33 mg / kg) was given by gavage. The normal group and the model group were given the same volume of deionized water once a day, for a total of 28 days. Note: The dosages of the animals in the gastritis recipe 1, 2, 3 groups were 26.13 g / kg according to the equivalent dose ratio between humans and animals based on body surface area.

[0041] After the last administration, the mice were taken and the gastric tissue was taken to prepare pathological sections for HE staining; the expression of inflammatory factors interleukin-6 (IL-6) and tumor necrosis factor-α (TNF-α) in the serum of the mice was detected by enzyme-linked immunosorbent assay (ELISA).

[0042] The results of HE staining showed that there were no inflammatory cells in the gastric tissue of the normal group, and the gastric mucosa structure was complete; there were a large number of inflammatory cell infiltrates in the model group, the gastric mucosa was thin, the folds disappeared or became shallow, and the glands were disordered; the inflammatory cell infiltration of the gastric mucosa in the gastritis recipe 1, 2, 3 groups was lighter than that in the model group; the inflammatory cell infiltration in the western medicine group was lighter than that in the model group.

[0043] The results of ELISA detection showed that the expression levels of IL-6 and TNF-α in the serum of the model group were higher than those in the normal group, and the expression levels of IL-6 and TNF-α in the gastritis recipe 1, 2, 3 groups were lower than those in the model group (P<0.05), as shown in Table 1; Conclusion: The gastritis recipe can significantly reduce the pathological damage of the gastric mucosa of the mice with chronic gastritis; reduce the expression of inflammatory factors in the serum, and has good anti-inflammatory and protective effect on the gastric mucosa.

[0044] Table 1: The levels of IL-6 and TNF-α in the serum of mice (pg / mL, x±s)

[0045]

[0046]

[0047] Note: * Compared with the normal group, P<0.05, △ Compared with the model group, P<0.05.

[0048] Example 5

[0049] Clinical efficacy confirmation of traditional Chinese medicine composition in treating chronic gastritis

[0050] Through the development of clinical trials, the effectiveness and safety of the invention Weiyang prescription in treating chronic gastritis are evaluated.

[0051] Case source: Cases were collected from January 2019 to June 2021 in the outpatient department of Chinese medicine internal medicine of the First Affiliated Hospital of the Navy Medical University, and the outpatients diagnosed as chronic gastritis by gastroscope, a total of 200 cases were included. All patients were fully communicated and signed the informed consent form.

[0052] Inclusion criteria: (1) Patients met the diagnostic criteria developed by the Chinese Consensus on Chronic Gastritis. Chronic gastritis is divided into two types of non-atrophic gastritis and atrophic gastritis under endoscopy. Chronic non-atrophic gastritis can be seen under endoscopy mucosal erythema, mucosal hemorrhagic spots or patches, rough mucosa with or without edema, hyperemia and exudation, etc. Chronic atrophic gastritis can be seen under endoscopy mucosal red and white interlaced, white phase-based, wrinkle flat even disappear, part of the mucosal blood vessels exposed; can be accompanied by mucosal granules or nodules, etc. (2) Age 18-70 years old. (3) Accepting the use of Weiyang prescription treatment.

[0053] Exclusion criteria: (1) Patients with gastric epithelial intraepithelial neoplasia and gastric cancer diagnosed by gastroscope biopsy; (2) Patients with history of gastric surgery; (3) Patients with severe heart, brain, liver, kidney and other underlying diseases; (4) Pregnant or lactating women.

[0054] Treatment method: 200 cases of traditional Chinese medicine were given the traditional Chinese medicine composition decoction (Example 1), 1 dose per day, decocted with water, about 500 mL, taken in the morning and evening, 4 weeks as a course of treatment, 3 consecutive courses.

[0055] Efficacy evaluation: The efficacy of traditional Chinese medicine symptoms after 2 weeks and 4 weeks of treatment and the gastroscope pathological efficacy after 12 weeks were observed, and the safety evaluation was also conducted.

[0056] Evaluation criteria:

[0057] (1) Pathological score: According to the Chinese Consensus on Diagnosis and Treatment of Chronic Atrophic Gastritis and the Guiding Principles for Clinical Research of New Drugs of Traditional Chinese Medicine, atrophy and intestinalization are divided into no, mild, moderate and severe, respectively, 0, 3, 6 and 9 points; According to the degree of chronic inflammation and activity, it is divided into no, mild, moderate and severe, respectively, 0, 1, 2 and 3 points.

[0058] (2) Clinical symptom efficacy:

[0059] (1) Disease symptom efficacy: ① Clinical recovery: main symptoms disappear, secondary symptoms basically disappear or disappear, and the efficacy index is ≥95%; ② Marked effect: main symptoms and secondary symptoms are obviously improved, and 70%≤efficacy index<95%; ③ Effective: main symptoms and secondary symptoms are obviously improved, and 30%≤efficacy index<70%; ④ Ineffective: main symptoms and secondary symptoms have no obvious improvement, and the efficacy index is <30%. The efficacy index calculation formula is: [(pre-treatment score-post-treatment score) / pre-treatment score]×100%. The score standard is: the symptoms such as abdominal pain, abdominal distension, acid reflux, belching, poor appetite, etc. are scored, no symptoms are 0 points, mild (can recall symptoms after prompting) is 1 point, moderate (symptoms are complained, but do not affect daily life) is 2 points, and severe (symptoms affect daily life) is 3 points.

[0060] (2) Single symptom efficacy: ① Disappearance: the symptom disappears, and the score is reduced to 0; ② Marked effect: the symptom is obviously improved, and the score is reduced by 2 levels, but not 0; ③ Effective: the symptom is improved, and the score is reduced by 1 level, but not 0; ④ Ineffective: the symptom is not improved or aggravated, and the score is not reduced or increased. Clinical recovery+marked effect is total effect, and clinical recovery+marked effect+effective is total effect.

[0061] Treatment results:

[0062] (1) Pathological change evaluation:

[0063] Compared with before treatment, the pathological atrophy, intestinal epithelial metaplasia, chronic inflammation and active pathological change scores of the patients after 12 weeks of treatment were significantly lower than those before treatment (P<0.01) (see Table 2). The Weiyangfang has good effects on improving gastric tissue atrophy, intestinal metaplasia, reducing chronic inflammation and reducing activity in patients with gastritis.

[0064] Table 2 Evaluation of gastric pathological changes before and after treatment

[0065]

[0066] △ P<0.01 compared with before treatment

[0067] (2) Symptom change evaluation: compared with before treatment, the total effective rate of clinical symptom improvement of Weiyangfang after 2 weeks of treatment was 72.5%, and the total effective rate of clinical symptom improvement after 4 weeks of treatment was 86.0%, as shown in Table 3. The symptoms of stomachache, stomach fullness, loss of appetite, acid reflux and belching of the patients were improved after 4 weeks of treatment with Weiyangfang, as shown in Table 4. It shows that the traditional Chinese medicine composition in the present application has a certain therapeutic effect on patients with chronic gastritis.

[0068] Table 3 Clinical efficacy before and after treatment

[0069]

[0070] Table 4 Clinical efficacy of single symptom before and after 4 weeks of treatment (n=200 cases)

[0071]

[0072]

[0073] Example 6

[0074] Clinical efficacy verification of the traditional Chinese medicine composition and its disassembled prescriptions combined with triple therapy in the present application

[0075] Gastritis has the characteristics of deficiency in the root and excess in the branches, and deficiency and excess mixed together. The single treatment method of regulating qi to stop pain and invigorating the spleen to harmonize the center does not have ideal clinical effects. The Gastritis Recipe in the present application takes into account the complex pathogenesis of the disease, and considers multiple factors to simultaneously solve multiple problems, and has good clinical effects. The present embodiment aims to compare the clinical effects of the Gastritis Recipe and its disassembled prescriptions (invigorating the spleen and harmonizing the center medicine and regulating qi medicine) combined with triple therapy, and evaluate the synergistic effects of the Gastritis Recipe and triple therapy.

[0076] Case source: The cases were collected from January 2020 to December 2021 in the outpatient department of the Department of Traditional Chinese Medicine of the First Affiliated Hospital of the Navy Medical University, and the outpatients diagnosed with chronic gastritis by gastroscope, a total of 120 cases were included and divided into an observation group (Gastritis Recipe group, invigorating the spleen and harmonizing the center group and regulating qi group) and a control group. All patients were fully communicated and signed the informed consent form.

[0077] Inclusion criteria: (1) The patient meets the diagnostic criteria formulated in the Chinese Consensus on Chronic Gastritis. Chronic gastritis is divided into two types of non-atrophic gastritis and atrophic gastritis under endoscopy. Chronic non-atrophic gastritis can be seen under endoscopy mucosal erythema, mucosal hemorrhagic spots or patches, rough mucosa with or without edema, hyperemia and exudation, etc. Chronic atrophic gastritis can be seen under endoscopy with red and white interlaced, mainly white, with flat or even disappeared folds, and part of the mucosal blood vessels are exposed; It can be accompanied by mucosal granules or nodules, etc. (2) Age 18-70 years old. (3) Willing to accept the treatment of Gastritis Recipe or its disassembled prescriptions.

[0078] Exclusion criteria: (1) Patients with gastric epithelial intraepithelial neoplasia and gastric cancer diagnosed by gastroscope biopsy pathology; (2) Patients with a history of gastric surgery; (3) Patients with severe heart, brain, liver, kidney and other underlying diseases; (4) Pregnant or lactating women.

[0079] Treatment method: 30 cases in the control group were treated with triple therapy (omeprazole 20 mg, Bid, clarithromycin 0.5 g, Bid, amoxicillin 1 g each time, Bid). The observation group took the traditional Chinese medicine decoction on the basis of the control group. Specifically, 30 cases in the stomach inflammation group were given the traditional Chinese medicine composition decoction (Example 1), 1 dose per day, decocted with water, about 500 mL, taken twice a day in the morning and evening, 4 weeks as a course of treatment, 3 consecutive courses. 30 cases in the spleen and middle group were given the spleen and middle composition decoction (Radix Astragali 15 g, Radix Codonopsis 15 g, Pericarpium Citri Reticulatae 12 g, Rhizoma Pinelliae 15 g, Poria 20 g, Fried Atractylodes 15 g), 1 dose per day, decocted with water, about 500 mL, taken twice a day in the morning and evening, 4 weeks as a course of treatment, 3 consecutive courses. 30 cases in the qi group were given the qi composition decoction (Radix Bupleuri 15 g, Fried Radix Paeoniae 15 g, Radix Curcumae 15 g, Radix Aucklandiae 10 g, Amomum (added later) 6 g), 1 dose per day, decocted with water, about 500 mL, taken twice a day in the morning and evening, 4 weeks as a course of treatment, 3 consecutive courses.

[0080] Efficacy evaluation: The clinical efficacy of the observation group and the control group after 12 weeks of treatment was compared, and the clinical efficacy evaluation standard was the same as that of Example 5.

[0081] Treatment results:

[0082] Compared with the control group, the total effective rate of clinical symptoms improvement of the stomach inflammation group after 12 weeks of treatment was 93.3%, which was better than that of the spleen and middle group, the qi group and the control group, as shown in Table 5, which showed that the traditional Chinese medicine composition of the application was compatible and had a definite therapeutic effect on patients with chronic gastritis.

[0083] Table 5 Clinical efficacy of stomach inflammation and its disassembled formula combined with triple therapy

[0084]

[0085] △ P<0.05 compared with the control group

[0086] Example 7

[0087] Comparison of clinical efficacy and safety of different dosage forms of stomach inflammation

[0088] This study retrospectively analyzed the case data of patients treated with stomach inflammation in our hospital, and compared the clinical efficacy and safety of traditional Chinese medicine decoction and traditional Chinese medicine granules.

[0089] Case source: Outpatient patients diagnosed with chronic gastritis by gastroscopy and treated with stomach inflammation in the Department of Internal Medicine of the First Affiliated Hospital of the Navy Medical University from January 2021 to December 2021.

[0090] Inclusion criteria: (1) complete clinical data; (2) treated with Weiyangan during the visit, treatment time ≥ 12 weeks; exclusion criteria: (1) incomplete clinical data; (2) using Weiyangan decoction or granules other than the dosage form; (3) treatment time < 12 weeks. According to the inclusion and exclusion criteria, 300 cases of case data were finally selected for analysis. According to the different dosage forms of Weiyangan, they were divided into Weiyangan decoction group and Weiyangan granule group. In Weiyangan decoction group, 150 cases, including 85 males and 65 females; age 18-70 years, average 43.5 years; disease course 4 months-20 years. In Weiyangan granule group, 150 cases, including 82 males and 68 females; age 17-69 years, average 41.5 years; disease course 6 months-18 years. The gender, age and disease course of the patients in the two groups were similar and had comparability.

[0091] The preparation method of Weiyangan decoction is the same as that of Example 1.

[0092] The preparation method of Weiyangan granules is as follows: the water extract is obtained by decocting according to the preparation method of decoction, then concentrated, added with dextrin and sugar powder, mixed evenly; the soft material is prepared with 70% ethanol, sieved with No. 1 sieve, granulated at 50°C for 2 hours, the dried granules are sieved with 12-14 mesh sieve, packaged, and obtained.

[0093] Observation index: The improvement of clinical symptoms (abdominal pain, abdominal distension, acid reflux, belching, poor appetite, etc.) and safety of the patients in the two groups were compared according to the clinical case data. Clinical efficacy criteria: marked effect: the above symptoms were obviously relieved or disappeared; effect: the above symptoms were relieved, and part of the symptoms still existed; no effect: the above symptoms were not relieved or aggravated. Total effective rate = marked effect + effect.

[0094] Clinical effect: The improvement of clinical symptoms of the patients in the two groups was compared, and the results showed that after treatment, the clinical symptoms of the patients in the two groups were effectively relieved, and in terms of clinical effective rate, the total effective rate of Weiyangan decoction group was 91.3% (47 cases of marked effect, 90 cases of effect, and 13 cases of no effect), and the total effective rate of Weiyangan granule group was 90.7% (51 cases of marked effect, 85 cases of effect, and 14 cases of no effect), and there was no significant difference between the two groups (P>0.05). During the treatment, there was no liver and kidney function damage and serious adverse reactions in the two groups, indicating that the composition was safe, had good compliance, and had stable and reliable curative effect.

[0095] Each embodiment in the specification is described in a progressive manner, and each embodiment focuses on the difference from other embodiments. The same and similar parts of each embodiment can be referred to each other.

[0096] The foregoing description of the disclosed embodiments enables a person skilled in the art to make or use the application. Modifications of these embodiments will occur to persons of skill in the art, and that the appended claims are intended to cover all such modifications that do not depart from the true spirit and scope of the application. Therefore, the application is not limited to the embodiments shown but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A traditional Chinese medicine composition, characterized in that, The main active ingredients are composed of the following raw materials in parts by weight: Bupleurum chinense 10-20 parts, stir-fried Paeonia lactiflora 10-20 parts, Curcuma longa 10-20 parts, Aucklandia lappa 6-15 parts, Amomum villosum 3-9 parts, Evodia rutaecarpa 5-15 parts, Cuttlebone 15-25 parts, Astragalus membranaceus 10-20 parts, Codonopsis pilosula 10-20 parts, Citrus reticulata peel 10-20 parts, Pinellia ternata 10-20 parts, Poria cocos 15-25 parts, stir-fried Atractylodes macrocephala 10-20 parts, Cinnamomum cassia 10-20 parts, and prepared Glycyrrhiza uralensis 3-9 parts.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The main active ingredients are composed of the following raw materials in parts by weight: Bupleurum chinense 15 parts, stir-fried white peony root 15 parts, turmeric 15 parts, costus root 10 parts, amomum villosum 6 parts, evodia rutaecarpa 10 parts, cuttlebone 20 parts, astragalus membranaceus 15 parts, codonopsis pilosula 15 parts, tangerine peel 12 parts, pinellia ternata 15 parts, poria cocos 20 parts, stir-fried atractylodes macrocephala 15 parts, cinnamon twig 12 parts, and prepared licorice root 6 parts.

3. The traditional Chinese medicine composition according to claim 1 or 2, characterized in that, The traditional Chinese medicine composition also includes pharmaceutically acceptable excipients or carriers.

4. The traditional Chinese medicine composition according to claim 3, characterized in that, The dosage form of the traditional Chinese medicine composition is decoction, granules, tablets, powders, capsules, oral liquids, or pills.

5. The method for preparing the traditional Chinese medicine composition according to any one of claims 1-4, characterized in that, After rinsing the following herbs in the traditional Chinese medicine formula—Bupleurum, stir-fried white peony root, turmeric, costus root, evodia fruit, cuttlebone, astragalus root, codonopsis root, tangerine peel, pinellia tuber, poria cocos, stir-fried atractylodes macrocephala, cinnamon twig, and prepared licorice root—with water, add 5-10 times the amount of water to a container and soak for at least 2 hours. Bring to a boil over high heat under normal pressure, then simmer over low heat for 20 minutes. Add amomum villosum and continue simmering for 15 minutes. Filter out the liquid to obtain decoction one. Add 2-3 times the amount of water again, bring to a boil over high heat under normal pressure, then simmer over low heat for 35 minutes. Filter out the liquid to obtain decoction two. Mix decoction one and decoction two thoroughly, divide into two portions, and take one portion in the morning and one in the evening.

6. The method for preparing the traditional Chinese medicine composition according to claim 5, characterized in that, The obtained decoction is added to pharmaceutically acceptable excipients or carriers, and the corresponding drug preparation is obtained by conventional preparation methods.

7. The use of the traditional Chinese medicine composition according to any one of claims 1-4 in the preparation of a drug for treating gastritis.

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