Traditional Chinese medicine composition for chronic active-atrophic gastritis and preparation method thereof

Abstract

The application discloses a traditional Chinese medicine composition for chronic active-atrophic gastritis and a preparation method thereof, and belongs to the technical field of traditional Chinese medicines, aiming at solving the technical problems that there is no traditional Chinese medicine composition for treating Hp infection in combination of traditional Chinese medicine and western medicine or the treatment effect is poor. The traditional Chinese medicine composition for chronic active-atrophic gastritis is prepared from the following traditional Chinese medicinal materials according to weight parts: Fructus Aurantii 10-15 parts, Rhizoma Pinelliae Praeparatum 8-12 parts, Rhizoma Atractylodis Macrocephalae 10-20 parts, Radix Pseudostellariae 20-40 parts, Pericarpium Citri Reticulatae Viride 8-12 parts, Rhizoma Coptidis 5-8 parts, Radix Paeoniae Rubra 10-20 parts, Fritillariae Thunbergii 10-20 parts, Radix Glycyrrhizae 5-8 parts, Radix Rehmanniae Preparata 20-40 parts, Fructus Evodiae 1-3 parts and Herba Taraxaci 10-20 parts. The traditional Chinese medicine composition has the advantages of good curative effect, low drug resistance, and the like, and the combination of the traditional Chinese medicine composition and a conventional anti-Helicobacter pylori scheme can obviously alleviate the clinical symptoms of patients and improve the life quality of patients.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine, in particular to a traditional Chinese medicine composition for chronic active-atrophic gastritis and a preparation method. BACKGROUND

[0002] Chronic active-atrophic gastritis is a chronic gastritis caused by Helicobacter pylori (Hp) infection, which is characterized by mononuclear cell infiltration and neutrophil infiltration under endoscopy, and atrophy of the intrinsic glands and intestinal metaplasia caused by chronic changes. It is also a common precancerous disease of gastric cancer. China is one of the countries with high infection rate of Hp and high incidence of gastric cancer. Hp infection is the main risk factor for the incidence of gastric cancer in China, and eradication of Hp can reduce the risk of gastric cancer, which is the most important means to prevent the progression of precancerous diseases to gastric cancer.

[0003] Multiple Meta analyses have shown that eradication of Hp can reverse atrophy, although it cannot reverse intestinal metaplasia, but can delay the progression of intestinal metaplasia. Therefore, in addition to eradication of Hp and regular endoscopy, there is no other effective treatment recognized by the industry.

[0004] The 2022 China Helicobacter pylori Infection Treatment Guidelines recommend using bismuth quadruple regimen for the first and second eradication of Helicobacter pylori infection. Current studies show that the average Hp infection eradication rate of bismuth quadruple regimen is 81.3%. The drug resistance rate of clarithromycin and levofloxacin in China is 20%-40%, and the drug resistance rate of metronidazole is 60%-90%. The increase of antibiotic resistance rate poses a great challenge to the eradication of Helicobacter pylori infection. Due to differences in disease patterns, antibiotic resistance rates and treatment drug availability between regions, it is difficult to achieve satisfactory Hp eradication effect. Although the bacteriostatic and bactericidal effects of traditional Chinese medicine are difficult to compare with antibiotics, the composition and mechanism are complex, but it has unique advantages in improving the eradication rate, immune regulation, improving clinical symptoms, reducing Hp drug resistance, not easy to produce drug resistance, reducing antibiotic use, reducing adverse reactions and improving gastric mucosal lesions. Therefore, compared with simple Western medicine treatment or traditional Chinese medicine treatment, the combination of traditional Chinese and Western medicine treatment is an ideal treatment for Hp infection. Therefore, it is of great significance to study traditional Chinese medicine drugs for the combination of traditional Chinese and Western medicine treatment of Hp infection. SUMMARY

[0005] In view of the above problems in the prior art, the present application provides a traditional Chinese medicine composition for chronic active-atrophic gastritis and a preparation method, to solve the technical problems that there is a lack of traditional Chinese medicine composition for the combination of traditional Chinese and Western medicine treatment of Hp infection or the treatment effect is not good.

[0006] The technical scheme adopted by the present application is as follows:

[0007] The traditional Chinese medicine composition for chronic active-atrophic gastritis is prepared from the following traditional Chinese medicinal materials according to weight parts: Fructus Aurantii 10-15 parts, Rhizoma Pinelliae Praeparatum 8-12 parts, Rhizoma Atractylodis Macrocephalae 10-20 parts, Radix Pseudostellariae 20-40 parts, Pericarpium Citri Reticulatae 8-12 parts, Rhizoma Coptidis 5-8 parts, Radix Paeoniae Rubra 10-20 parts, Fritillariae Thunbergii 10-20 parts, Radix Glycyrrhizae 5-8 parts, Radix Rehmanniae Preparata 20-40 parts, Fructus Evodiae 1-3 parts, Herba Taraxaci 10-20 parts.

[0008] Hp pathogenesis is in line with the characteristics of damp-heat external evil invasion and pathogenesis, therefore, Hp is attributed to damp-heat evil in traditional Chinese medicine. Researches show that the proportion of spleen and stomach damp-heat syndrome in TCM syndrome types of chronic active-atrophic gastritis is relatively high, the traditional Chinese medicine composition designed according to the Hp pathogenic reason is simple in kind and remarkable in curative effect, and the traditional Chinese medicine ingredients can reduce drug resistance.

[0009] In the present application, Fructus Aurantii is pungent, bitter and warm, and is attributed to the spleen, stomach, large intestine, triple energizer and gallbladder meridians, and can promote qi circulation, relieve pain, invigorate the spleen and promote digestion.

[0010] Rhizoma Pinelliae Praeparatum is pungent and warm, and is attributed to the spleen, stomach and lung meridians, and can dry dampness, reduce phlegm, relieve vomiting, dissipate mass and resolve nodes.

[0011] Rhizoma Atractylodis Macrocephalae is sweet, bitter and warm, and is attributed to the spleen and stomach meridians, and can tonify qi, invigorate the spleen, dry dampness, benefit water, stop sweating and secure the fetus.

[0012] Radix Pseudostellariae is sweet, slightly bitter and neutral, and is attributed to the spleen and lung meridians, and can tonify qi, invigorate the spleen, produce fluid and moisten the lung.

[0013] Pericarpium Citri Reticulatae is bitter, pungent and warm, and is attributed to the spleen and lung meridians, and can regulate qi, invigorate the spleen, dry dampness and reduce phlegm.

[0014] Rhizoma Coptidis is bitter and cold, and is attributed to the heart, spleen, stomach, liver, gallbladder and large intestine meridians, and can clear heat and dry dampness, purge fire and detoxify.

[0015] Radix Paeoniae Rubra is bitter and cold, and is attributed to the liver meridian, and can clear heat, cool blood, dissipate stasis and relieve pain.

[0016] Fritillariae Thunbergii is bitter and cold, and is attributed to the lung and heart meridians, and can clear heat, reduce phlegm, relieve cough, detoxify, dissipate nodes and resolve abscesses.

[0017] Radix Glycyrrhizae is sweet and neutral, and is attributed to the heart, lung, spleen and stomach meridians, and can tonify the spleen, benefit qi, clear heat and detoxify, dispel phlegm and relieve cough, relieve pain and regulate various drugs.

[0018] Radix Rehmanniae Preparata is sweet, bland and cool, and is attributed to the spleen, stomach and lung meridians, and can benefit water, dissipate dampness, invigorate the spleen, stop diarrhea, remove obstruction, discharge pus, detoxify and dissipate nodes.

[0019] Fructus Evodiae is pungent, bitter and warm, and is attributed to the liver, spleen, stomach and kidney meridians, and can dissipate cold and relieve pain, reduce adverse flow and vomiting, and assist yang and stop diarrhea.

[0020] Herba Taraxaci is bitter, sweet and cold, and is attributed to the liver and stomach meridians, and can clear heat and detoxify, dissipate swelling and nodes, benefit dampness and relieve stranguria.

[0021] The design principle of the traditional Chinese medicine composition in the present application is that:

[0022] In the prescription, Taizipen and Baizhu are the monarchs for tonifying the spleen; Yiyiren is the minister for promoting water and removing dampness, detoxifying and resolving mass; Huanglian is the minister for clearing heat and removing dampness, purging fire and detoxifying; Fabanxia is the minister for promoting qi and opening the spleen; the three ministers together play the functions of detoxifying, resolving mass, clearing heat and removing dampness; Zhike is the minister for promoting qi and regulating the spleen, drying dampness and resolving phlegm; Zhebeimu is the minister for detoxifying and resolving mass; Chishao is the minister for clearing heat and detoxifying, soothing the liver and relieving depression; Wuzhuyu is the minister for soothing the liver and regulating the stomach, which cooperates with Huanglian to play the functions of soothing the liver and regulating the stomach, purging fire and relieving pain, and is the method for preventing the liver from being excessive and damaging the spleen; Pugongying is the assistant for clearing heat and detoxifying; Shi is the assistant for tonifying qi and regulating the center; and the above-mentioned traditional Chinese medicine materials are mixed to prepare the traditional Chinese medicine composition.

[0023] The pathogenesis of chronic active atrophic gastritis is spleen deficiency and failure to transport, and the micro-endoscopic manifestation is obvious congestion and edema of gastric mucosa, disappearance of collecting venules, and mass of mucus and turbid dampness obstructing the middle warmer. Therefore, the Yaweitiaozhong mixture is used to tonify the spleen, dry dampness, and harmonize the stomach and detoxify, so as to tonify the spleen and stomach, eradicate Helicobacter pylori, and reduce drug resistance.

[0024] The preferred traditional Chinese medicine composition for chronic active atrophic gastritis in the present application is prepared from the following traditional Chinese medicine materials according to weight parts: Zhike 12 parts, Fabanxia 10 parts, Baizhu 15 parts, Taizipen 30 parts, Chenpi 10 parts, Huanglian 6 parts, Chishao 15 parts, Zhebeimu 15 parts, Gancao 6 parts, Yiyiren 30 parts, Wuzhuyu 2 parts, and Pugongying 15 parts.

[0025] The traditional Chinese medicine composition with the above-mentioned ratio is obtained through multiple preparations, in which the amounts of the monarchs Taizipen and Baizhu are 30 parts and 15 parts respectively; the ministers are Yiyiren 30 parts, Fabanxia 10 parts, and Huanglian 6 parts; the assistants are Zhike 12 parts, Chenpi 10 parts, Zhebeimu 15 parts, Chishao 15 parts, Wuzhuyu 2 parts, and Pugongying 15 parts; and the assistant is Gancao 6 parts.

[0026] The preferred traditional Chinese medicine composition for chronic active atrophic gastritis in the present application is in the form of oral liquid or mixture.

[0027] The preferred traditional Chinese medicine composition for chronic active atrophic gastritis in the present application is in the form of pill, powder, tablet, granule or capsule.

[0028] The traditional Chinese medicine composition in the present application can be prepared into various dosage forms to meet different needs.

[0029] The preparation method of the traditional Chinese medicine composition for chronic active atrophic gastritis comprises the following steps:

[0030] Step 1: the above-mentioned traditional Chinese medicine materials are weighed according to weight parts;

[0031] Step 2: water is added for decoction twice, and the decoction is combined;

[0032] Step 3: filtering, adding auxiliary materials, and preparing oral liquid or mixture.

[0033] The present application can fully extract the effective components in the medicinal material by twice decocting the above-mentioned 12 raw materials.

[0034] In the preferred preparation method of the present application, the first decoction is performed for 2 hours, and the second decoction is performed for 1 hour.

[0035] In the present application, the first decoction is performed for a longer time to fully extract the effective components in the initial medicinal material, and after the first extraction, water is added to continue the decoction to further extract the remaining effective components in the medicinal material.

[0036] In the preferred preparation method of the present application, in step 3, the auxiliary material is sucrose, which is a sweetener that can improve the bitterness of the medicinal material, and also has the effects of tonifying qi and nourishing blood, thereby assisting the Chinese medicinal composition to have better effects.

[0037] The use of the Chinese medicinal composition for chronic active-atrophic gastritis, which is combined with western medicine to treat chronic active-atrophic gastritis.

[0038] The preferred use of the Chinese medicinal composition for chronic active-atrophic gastritis in the present application is for the syndrome type of spleen-stomach damp-heat.

[0039] In summary, compared with the prior art, the present application has the following advantages and beneficial effects:

[0040] 1. The present application selects 12 raw materials to treat Hp caused by invasion of damp-heat external pathogen, and obtains a Chinese medicinal composition with significant effects on Hp by reasonable combination of monarch, minister and assistant medicinal herbs.

[0041] 2. The Chinese medicinal composition of the present application is prepared by multiple decoctions and combined with sucrose to obtain oral liquid or mixture, which is simple to take and has significant effects.

[0042] 3. The Chinese medicinal composition of the present application is combined with the conventional anti-Helicobacter pylori scheme of modern medicine, and can be used as the initial treatment method and remedial treatment method for chronic atrophic gastritis patients with Helicobacter pylori infection. DETAILED DESCRIPTION

[0043] In order to make the purpose, technical scheme and advantages of the present application clearer, the present application is further described in detail below with examples, and the illustrative embodiments of the present application and their descriptions are only used to explain the present application, and do not limit the present application.

[0044] Example 1

[0045] The embodiment provides a traditional Chinese medicine composition, which is prepared from the following traditional Chinese medicinal materials according to weight parts: Fructus Aurantii 12 g, Radix Anemarrhenae 30 g, Rhizoma Atractylodis Macrocephalae 15 g, Radix Paeoniae Rubra 15 g, Rhizoma Pinelliae 10 g, Radix Bupleuri 2 g, Herba Artemisiae Scopariae 15 g, and Radix Paeoniae Rubra 15 g.

[0046] The preparation method of the traditional Chinese medicine composition is as follows:

[0047] The traditional Chinese medicine materials are weighed according to the above weight, boiled with water twice, the first time for 2 hours and the second time for 1 hour, the decoction is combined, filtered, and sucrose is added to prepare an oral solution.

[0048] The traditional Chinese medicine composition prepared in Example 1 is subjected to clinical experiments, and the situation is as follows:

[0049] 1. Materials and methods

[0050] 1.1. Research object

[0051] 1.2. Case selection

[0052] 1.2.1. TCM syndrome differentiation criteria (spleen-stomach dampness-heat syndrome): reference is made to the Adult Gastritis Caused by Helicobacter Pylori Expert Consensus on Collaborative Diagnosis and Treatment of Chinese and Western Medicine (2020, Beijing):

[0053] ① Main symptoms: 1) burning sensation or pain in the stomach; 2) sticky mouth or bad breath.

[0054] ② Secondary symptoms: 1) noisy acid regurgitation; 2) thirst without desire to drink; 3) poor appetite and nausea; 4) sticky and unsmooth stool; 5) heavy drowsiness. Tongue and pulse: red tongue, yellow and greasy or thick tongue fur; slippery and rapid pulse.

[0055] 2 items of main symptoms + 1 or 2 items of secondary symptoms can determine the syndrome type; tongue and pulse can be used as reference.

[0056] 1.2.2. Inclusion criteria:

[0057] ① Patients with chronic active-atrophic gastritis (with or without IM or dysplasia) who meet the diagnostic criteria for chronic active-atrophic gastritis, have 13C breath test and pathological diagnosis.

[0058] ② Age 18-75 years old, male and female.

[0059] ③ Patients with chronic active-atrophic gastritis of spleen-stomach dampness-heat syndrome according to the Adult Gastritis Caused by Helicobacter Pylori Expert Consensus on Collaborative Diagnosis and Treatment of Chinese and Western Medicine (2020, Beijing).

[0060] ④ No use of antibiotics, proton pump inhibitors (PPI), and bismuth agent in the past 1 month.

[0061] ⑤ Agree to sign the informed consent form.

[0062] 1.2.2. Exclusion criteria:

[0063] ① With severe atypical hyperplasia, suspected gastric cancer or other tumors.

[0064] ② History of gastric surgery.

[0065] ③ Severe systemic organic diseases, such as cardiovascular and cerebrovascular diseases, liver disease, blood, kidney disease, liver or lung disease, etc.

[0066] ④ Taking non-steroidal anti-inflammatory drugs.

[0067] ⑤ Pregnant and lactating women.

[0068] ⑥ Those who do not sign the informed consent form.

[0069] 1.2.3. Exclusion and dropout criteria:

[0070] ① Poor compliance, unable to take medicine according to the treatment course;

[0071] ② During treatment, change other treatment methods by themselves, which cannot judge the efficacy;

[0072] ③ End the treatment course by themselves, lose follow-up;

[0073] ④ During treatment, serious adverse reactions occur, which is not suitable for further treatment.

[0074] 1.2.4. Termination criteria: During the clinical observation, serious safety problems occur, which is not suitable for further treatment.

[0075] 1.3. Grouping and treatment method

[0076] 1.3.1. Patient source: Outpatient from January 2023 to November 2023 in the Department of Spleen and Stomach Diseases of Chongqing Hospital of Traditional Chinese Medicine.

[0077] 1.3.2. Grouping: A total of 60 cases were collected and randomly divided into treatment group and control group by random number method, 30 cases in each group.

[0078] 1.3.3. Treatment method

[0079] 1.3.3.1. Both groups of patients were given basic treatment, including diet management of patients, regular and quantitative, and avoiding overeating. The diet should be light, and fresh fruits and vegetables should be eaten. Stimulating foods such as spicy and greasy foods should be prohibited. During treatment, alcohol and smoking should be avoided, and psychological nursing intervention should be strengthened to enable patients to maintain a positive and optimistic treatment mentality, improve treatment compliance, and thus improve treatment effect.

[0080] 1.3.3.2 The control group was given a bismuth quadruple regimen (esomeprazole 20 mg 2 times / day, colloidal pectin bismuth capsules 0.2 g 3 times / day, amoxicillin capsules 1 g 2 times / day, furazolidone 100 mg 2 times / day) for 14 days for anti-Helicobacter pylori treatment.

[0081] 1.3.3.3 The treatment group was given the traditional Chinese medicine composition liquid provided in Example 1 on the basis of the control group: 3 times / day, 150 ml / time, 1 dose / day, for a course of 14 days.

[0082] 1.3.4 Follow-up records After treatment, the patients in both groups stopped taking the medicine, and the symptom relief of the patients in both groups before and after treatment was observed and recorded.

[0083] 1.4 Observation index

[0084] (1) Efficacy of TCM syndrome: The efficacy of TCM syndrome was determined according to the "Consensus on Diagnosis and Treatment of Chronic Atrophic Gastritis in Combination with Traditional Chinese and Western Medicine (2017):

[0085] ① Clinical cure: main symptoms and signs disappeared or basically disappeared, and the efficacy index was ≥95%;

[0086] ② Marked effect: main symptoms and signs improved significantly, and 70%≤efficacy index<95%;

[0087] ③ Effective: main symptoms and signs improved significantly, and 30%≤efficacy index<70%;

[0088] ④ Ineffective: main symptoms and signs did not improve significantly, or even worsened, and the efficacy index was <30%. The efficacy index = (pre-treatment score - post-treatment score) / pre-treatment score x 100%. All symptoms were divided into 4 grades: none, mild, moderate, and severe, with scores of 0, 2, 4, and 6 respectively, and the secondary symptoms were scored as 0, 1, 2, and 3 respectively.

[0089] (2) Hp eradication: 13C-urea breath test was performed 8 weeks after treatment to detect the Hp eradication of the patients in both groups, and the eradication rate was calculated.

[0090] 1.5 Statistical method: SPSS 25.0 statistical software was used for statistical analysis of the data. Measurement data was represented by

[0091] —mean ± standard deviation (x ± s), if the measurement data of the two groups met the normal distribution and homogeneity of variance, independent sample t test was used; if it did not meet the normal distribution, two independent sample rank sum test was used, and the median and interquartile range (M(P25, P75)) were used; chi-square test was used for comparison of count data; rank sum test was used for comparison of grade data of the two groups. P<0.05 was considered statistically significant.

[0092] 2Results

[0093] 2.1 Comparison of baseline data of two groups of patients: In the control group of 30 patients, 10 were male and 20 were female; age 27-74 years, average age (47.97±10.61) years; in the treatment group of 30 patients, 13 were male and 17 were female; age 31-73 years, average age (49.67±10.38) years.

[0094] 2.2 Comparison of baseline data such as gender, age, disease duration, and primary disease of two groups of patients, the difference was not statistically significant (P>0.05), which was comparable.

[0095] 2.3 Comparison of TCM syndrome efficacy in two groups of patients: Table 1 shows that after 2 months of treatment, the total effective rate of the treatment group was 93.3%, i.e. 28 of the 30 patients in the treatment group were effective (28 / 30), and the control group was 66.7%, i.e. 20 of the 30 patients in the treatment group were effective (20 / 30). Comparison between groups, the efficacy of the treatment group was significantly better than that of the control group, the difference was statistically significant (P<0.05).

[0096] Table 1 Comparison of TCM syndrome efficacy in two groups of patients

[0097] Group Clinical recovery Markedly effective Effective Ineffective Total effective rate (%) Control group 0 5 15 10 66.7 Treatment group 0 19 9 2 93.3*

[0098] Note: Compared with the control group, *p<0.05.

[0099] 2.4 Comparison of spleen and stomach dampness syndrome score in two groups of patients: see Table 2.

[0100] Table 2. Comparison of spleen and stomach dampness syndrome score in two groups of patients (M(P25, P75))

[0101]

[0102] Note: Compared with the treatment group before treatment, △p<0.05; compared with the control group, *p<0.05.

[0103] Before treatment, the main symptoms of two groups of patients: stomach burning or pain, sticky or bad breath, secondary symptoms: jumbled acid reflux, thirsty but not drinking, poor appetite and vomiting, sticky stool, heavy and tired, etc. There was no statistical difference in TCM syndrome performance (P>0.05), which was comparable.

[0104] After treatment, the main symptoms of the treatment group, such as stomach burning or pain score, sticky or bad breath score, compared with the control group, had statistical difference (p<0.05), the secondary symptoms of the treatment group, such as sticky stool score, heavy and tired score, compared with the control group, had statistical difference (p<0.05). After treatment, the scores of jumbled acid reflux, thirsty but not drinking, and poor appetite and vomiting in two groups had no statistical difference.

[0105] 2.5 Comparison of Hp eradication rates of the two groups of patients before and after treatment

[0106] The Hp eradication rate of the treatment group was 100%, i.e., the Hp of 30 patients in the treatment group was eradicated, and the Hp eradication rate of the control group was 90%, i.e., the Hp of 27 patients in the control group was eradicated, as shown in Table 3.

[0107] Table 3 Comparison of Hp eradication rates of the two groups of patients after treatment

[0108]

[0109] In summary, the traditional Chinese medicine composition provided by the present application has good therapeutic effect on patients with chronic active-atrophic gastritis of spleen-stomach dampness syndrome. The combination of the traditional Chinese medicine composition and the bismuth-containing quadruple regimen increases the Hp eradication rate from 90% to 100%, and can significantly relieve the clinical symptoms of the patients, such as stomach burning or pain, sticky or bad breath, sticky stool, heaviness and drowsiness, etc., and has good application prospect.

[0110] 3 Typical cases

[0111] Case 1: Treatment of a patient with chronic atrophic gastritis infected with Helicobacter pylori for the first time

[0112] Patient Pu, male, 31 years old, was diagnosed with chronic active-atrophic gastritis for 2 days on May 24, 2023, and the main clinical manifestation was postprandial abdominal distension. It was accompanied by bad breath, bitter taste in the mouth, and loose stool 1-2 times / day. The tongue was red, the tongue fur was yellow and greasy, and the pulse was slippery. Auxiliary examination: gastroscope showed chronic active-atrophic gastritis (Muro Takehoto classification O1); colonoscopy showed no abnormalities in the colonic mucosa; 13C breath test showed Hp positive.

[0113] The traditional Chinese medicine composition oral liquid provided in Example 1 was orally taken, combined with esomeprazole 20 mg 2 times / day, colloidal pectin bismuth capsules 0.2 g 3 times / day, amoxicillin capsules 1 g 2 times / day, and furazolidone 100 mg 2 times / day for 14 days. After 2 months of drug withdrawal, 13C breath test showed Hp negative.

[0114] After treatment, the symptoms of the patient, such as postprandial abdominal distension, bad breath, bitter taste in the mouth, and loose stool, were significantly improved, indicating that the traditional Chinese medicine composition provided by the present application has good effect on the initial treatment of chronic active-atrophic gastritis with Helicobacter pylori infection.

[0115] Case 2: Treatment of a patient with chronic atrophic gastritis with failed Helicobacter pylori eradication

[0116] Patient Guo, female, 58 years old, complained of upper abdominal pain for 3 months, intermittent, with acid reflux, heartburn, bitter mouth, belching, no other discomfort. Tongue red, greasy yellow fur, pulse slippery. Past medical history: 3 years of infection with Helicobacter pylori. 3 years ago, the patient underwent 13C breath test during physical examination and found Helicobacter pylori positive. She underwent 2 times of Helicobacter pylori eradication treatment. The first anti-Hp regimen was: Lijuzhui Sanlian (bismuth citrate potassium tablet / nitroimidazole tablet / clarithromycin tablet combination package) + omeprazole capsule. The second anti-Hp regimen was: amoxicillin capsule + levofloxacin + colloidal pectin bismuth + omeprazole capsule. 6 months ago, 13C breath test showed Hp positive, and no Hp eradication treatment was performed. Past drug sensitivity test showed that levofloxacin, clarithromycin and metronidazole were resistant, and the bacterial typing was type II. This time, gastroscopy showed chronic active-atrophic gastritis (C2), and C13 breath test showed Hp positive.

[0117] The traditional Chinese medicine composition oral liquid provided in Example 1 was used in combination with the bismuth quadruple regimen (Esomeprazole 20mg 2 times / day, colloidal pectin bismuth capsule 0.2g 3 times / day, amoxicillin capsule 1g 2 times / day, furazolidone 100mg 2 times / day) for 14 days for anti-Helicobacter pylori treatment.

[0118] After treatment, the patient's upper abdominal pain, acid reflux, heartburn, bitter mouth, belching and other discomforts were significantly reduced. After stopping the drug for 2 months, 13C breath test showed that Helicobacter pylori was negative.

[0119] The results show that the traditional Chinese medicine composition oral liquid provided in the present application can effectively reduce the clinical symptoms of patients with chronic active-atrophic gastritis who have failed Helicobacter pylori eradication, especially for improving the symptoms of bitter mouth, bad breath and other spleen deficiency and turbid qi disturbing symptoms, and can improve the Helicobacter pylori eradication rate, indicating that the traditional Chinese medicine composition oral liquid provided in the present application combined with the bismuth quadruple regimen can be used as a rescue treatment regimen for chronic atrophic gastritis with failed Helicobacter pylori eradication.

[0120] The above specific embodiments further illustrate the purpose, technical solutions and advantages of the present application. It should be understood that the above description is only a specific embodiment of the present application and is not used to limit the protection scope of the present application. Any modification, equivalent replacement, improvement, etc. made within the spirit and principles of the present application should be included in the protection scope of the present application.

Claims

1. A traditional Chinese medicine composition for chronic active-atrophic gastritis, characterized in that, The following Chinese medicinal materials were used in the preparation according to the following weight parts: 12 parts of Citrus aurantium, 10 parts of Pinellia ternata, 15 parts of Atractylodes macrocephala, 30 parts of Codonopsis pilosula, 10 parts of Citrus reticulata peel, 6 parts of Coptis chinensis, 15 parts of Paeonia lactiflora, 15 parts of Fritillaria thunbergii, 6 parts of Glycyrrhiza uralensis, 30 parts of Coix lacryma-jobi, 2 parts of Evodia rutaecarpa, and 15 parts of Taraxacum mongolicum. The chronic active-atrophic gastritis described was of the spleen and stomach damp-heat type and accompanied by Helicobacter pylori infection.

2. The traditional Chinese medicine composition for chronic active-atrophic gastritis according to claim 1, characterized in that, The dosage form of the traditional Chinese medicine composition is an oral liquid or a compound preparation.

3. The traditional Chinese medicine composition for chronic active-atrophic gastritis according to claim 1, characterized in that, The dosage form of the traditional Chinese medicine composition is pills, powders, tablets, granules, or capsules.

4. A method for preparing a traditional Chinese medicine composition for chronic active-atrophic gastritis, characterized in that, Includes the following steps: Step 1: Weigh the Chinese medicinal materials as described in claim 1 according to the specified weight proportions; Step 2: Add water and boil twice, then combine the decoctions; Step 3: Filter, add excipients, and prepare into oral liquid or compound.

5. The preparation method according to claim 4, characterized in that, In step 2, the first decoction is 2 hours long, and the second decoction is 1 hour long.

6. The preparation method according to claim 4 or 5, characterized in that, In step 3, the excipient is sucrose.

7. The use of the traditional Chinese medicine composition as described in claim 1 or 2 in the preparation of a medicament for treating chronic active atrophic gastritis, characterized in that, This traditional Chinese medicine composition, when combined with Western medicine, is used to treat chronic active atrophic gastritis.

8. The application according to claim 7, characterized in that, The syndrome of chronic active atrophic gastritis is classified as spleen and stomach damp-heat type.

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