External traditional Chinese medicine composition for treating liver-stomach disharmony type epigastric pain and application thereof

Abstract

The invention relates to an external traditional Chinese medicine composition for treating liver-stomach disharmony type epigastric pain, which is prepared from the following raw material medicines in parts by weight: 18-22 parts of fructus evodiae, 7-11 parts of cinnamon, 7-11 parts of ginger, 7-11 parts of clove, 10-14 parts of ligusticum wallichii, 13-17 parts of corydalis tuber and 13-17 parts of fingered citron. The invention provides application of a traditional Chinese medicine composition in preparation of a medicine for treating liver-stomach disharmony type epigastric pain. The invention further provides a pharmaceutical composition for treating liver-stomach disharmony type epigastric pain. The pharmaceutical composition is prepared from the traditional Chinese medicine composition, omeprazole enteric capsules and mosapride citrate tablets. The acupoint application can improve the traditional Chinese medicine syndromes of patients with liver-stomach disharmony type epigastric pain, reduce epigastric pain attack times and pain degree, inhibit inflammatory response and reduce the recurrence rate.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and specifically, to an external traditional Chinese medicine composition for treating epigastric pain of disharmony between the liver and stomach and its application. Background Art

[0002] In the course of modern medical diseases such as acute and chronic gastritis, peptic ulcer, dyspepsia, gastric cancer and other diseases, epigastric pain symptoms often occur. Therefore, diseases with such symptoms can be classified into the category of "epigastric pain" in traditional Chinese medicine. The modern medical diagnosis of the clinical cases included in this study was chronic non-atrophic gastritis. The etiology of chronic non-atrophic gastritis has not been clearly defined, but the existing etiologies currently include Helicobacter Pylori (HP) infection, smoking, alcohol consumption and the use of non-steroidal anti-inflammatory drugs, among which HP infection is the main etiology. At present, no drugs for improving or reversing the gastric mucosa pathology have been found in the western medicine treatment of chronic non-atrophic gastritis. The main treatment is to clear HP infection, that is, proton pump inhibitor + bismuth agent + two different antibiotics for 2 consecutive weeks to improve symptoms and reduce inflammatory reactions. With the extensive application of antibiotics and the like, the drug resistance of Hp has increased to a certain extent. If chronic non-atrophic gastritis is not treated regularly for a long time, it will lead to the Correa cascade reaction, that is, the gastric mucosa pathology begins to change from non-atrophic to atrophic, and then develops step by step to intestinal metaplasia and dysplasia, and finally forms gastric cancer. However, traditional Chinese medicine treatment of chronic non-atrophic gastritis can achieve good results, can improve the symptoms and signs of patients and gastric mucosa inflammation, etc., so as to improve the radical cure rate of Hp.

[0003] "Epigastric pain" is the description in traditional Chinese medicine for the pain in the epigastric region near the heart pit in the upper abdomen. The causes of this disease are complex. For example, invasion of the stomach by cold pathogens, exogenous damp pathogens, improper diet, internal injury caused by the seven emotions, and weakness of the spleen and stomach can all lead to the occurrence of this disease. Disharmony between the liver and the stomach is one of the syndromes of epigastric pain, and its pathogenesis lies in the stagnation of liver qi invading the stomach horizontally, resulting in the stagnation of stomach qi. At present, there are many treatment methods for epigastric pain of the disharmony between the liver and the stomach type in clinical practice, including western medicine, surgery, traditional Chinese medicine, acupuncture, acupoint application, etc. Among them, the principle of acupoint application in treating epigastric pain can be summarized as follows: it stimulates acupoints, thereby promoting the flow of meridian qi inside and outside the body. Through acupoints, the qi of the zang-fu organs and meridians is infused into the body surface inside and outside, achieving the effect of optimizing the flow of qi and blood in the body, acting on the whole body, soothing the liver and regulating the stomach, warming the middle-jiao and stopping pain. Taking the overall concept of traditional Chinese medicine as the guiding ideology of acupoint application therapy, and adopting the effects of stimulation and penetration, it can effectively adjust the balance of yin and yang and fully demonstrate the "meridian tropism" effect of drugs. During the application of acupoint application method, the operation is simple and patients are easy to accept. Usage of acupoint application: for external use, clean the application site and then apply it to the corresponding acupoints. Acupoint selection: Zhongwan, bilateral Tianshu, bilateral Zusanli. It is recommended to use each patch for 4 hours, once a day, 2 weeks as a course of treatment, and continue for 4 weeks. Zhongwan acupoint: It belongs to the Conception Vessel among the extraordinary meridians and is also one of the eight confluent points. The position of the Zhongwan acupoint is exactly the location of the gastric body in human anatomy. It corresponds to the epigastric region and is also a specific acupoint for treating epigastric pain. In clinical practice, using this acupoint can exert its nearby treatment effect. Tianshu acupoint: It is an acupoint of the Stomach Meridian, mainly treating diseases such as abdominal pain, abdominal distension, and diarrhea. Regular massage of this acupoint can promote intestinal peristalsis and has the function of regulating qi and relieving pain. "Qianjin Fang" records: "Tianshu, mainly treats diarrhea caused by repeated exposure to cold in winter, pain around the umbilicus, and wandering qi pain in the intestines and stomach." The Tianshu acupoint can be used to treat various diseases caused by disharmony of qi movement in the spleen and stomach and imbalance of yin and yang. Its combination with acupoints such as Zhongwan and Zusanli can strengthen the function of regulating the zang-fu organs and the ability to regulate qi movement. Zusanli acupoint: It is the lower he-sea point of the Stomach Meridian of Foot-Yangming. It can regulate the stomach qi and shows certain effects in relieving stomach pain and other aspects. It has the effects of generating stomach qi and drying dampness in the spleen. Regular massage can also enhance the generation of qi in the spleen and stomach. As a he-sea point, Zusanli undertakes the important function of the qi of all meridians in the body converging into the zang-fu organs, so it is considered an important health care acupoint for strengthening the body. At the same time, both the spleen and stomach and Zusanli belong to earth in the theory of the five elements in traditional Chinese medicine. Therefore, in clinical application, applying this acupoint can not only achieve the basic effects of generating stomach qi and dispelling cold and relieving pain, but also can be used as the hub for regulating the qi movement of the spleen and stomach and balancing the rise and fall of qi in the spleen and stomach. Precautions: During the application period, do not engage in strenuous activities to prevent a large amount of sweating from causing the drug to move or fall off. During acupoint application, avoid eating spicy and irritating foods, pay attention to rest, and avoid overexertion. During the application process, if there are situations such as local burning sensation, severe itching, pain and discomfort, remove the application in time.

[0004] Chinese patent document CN 118593663A discloses a traditional Chinese medicine for treating epigastric pain, specifically related to the technical field of traditional Chinese medicine. The traditional Chinese medicine for treating epigastric pain includes: Bupleurum chinense 10g, Scutellaria baicalensis 10g, Codonopsis pilosula 10g, Pinellia ternata (Thunb.) Breit. 9g, Salvia miltiorrhiza 15g, Pueraria lobata (Willd.) Ohwi 15g, Citrus reticulata Blanco 10g, Poria cocos 15 - 30g, Atractylodes macrocephala Koidz. stir-fried 10g, Atractylodes macrocephala Koidz. raw 10g, Atractylodes lancea (Thunb.) DC. stir-fried 10g, Cyperus rotundus L. vinegar-processed 10g, Perilla frutescens (L.) Britt. var. acuta (Thunb.) Kudo 10g, Coptis chinensis Franch. 6, Zingiber officinale Rosc. 6, Cinnamomum cassia Presl 10g, Paeonia lactiflora Pall. stir-fried 10g, Poncirus trifoliata (L.) Raf. stir-fried 6g, Sepia seu Sepiellae Os 20g, Fritillaria thunbergii Miq. 10g, Acorus tatarinowii Schott 6g, Glycyrrhiza glabra L. roasted 6g, Dioscorea opposita Thunb. stir-fried with bran 10 - 15g. The traditional Chinese medicine for treating epigastric pain provided by the present invention has a good therapeutic effect on epigastric pain.

[0005] Chinese patent document CN 105233126A discloses a traditional Chinese medicine composition for treating epigastric pain caused by deficiency-cold of the spleen and stomach, which is characterized by being made from the following Chinese medicine raw materials in parts by weight: Cyperus rotundus L. processed 9 - 20 parts, Alpinia officinarum Hance 4.5 - 15 parts, Gardenia jasminoides Ellis stir-fried 4 - 6 parts, Atractylodes macrocephala Koidz. raw 8 - 15 parts, Poria cocos 8 - 15 parts, Citrus reticulata Blanco 4 - 6 parts, Aucklandia lappa Decne. 5 - 7 parts, Paeonia lactiflora Pall. stir-fried 7 - 9 parts, Glycyrrhiza glabra L. raw 3 - 5 parts, Aspergillus oryzae (Ahlb.) Cohn stir-fried 4 - 6 parts, Codonopsis pilosula Franch. 8 - 15 parts. The beneficial effects of the present invention: The selected drug compatibility formula is mutually assisting in action, with the effects of soothing the liver and regulating qi, warming the middle-jiao and dispelling cold, invigorating the spleen and promoting digestion, promoting digestion and removing dampness, regulating the middle-jiao and inducing qi stagnation, and achieving both symptomatic and root treatment for epigastric pain caused by deficiency-cold of the spleen and stomach.

[0006] There are many such traditional Chinese medicine compositions for treating epigastric pain, but they all have more or less disadvantages. For example, there are too many medicinal flavors, it is difficult to obtain raw materials, and the price is expensive; the medicinal effect is not obvious, and the therapeutic effect is poor, etc. Therefore, there is an urgent need for a traditional Chinese medicine composition for treating epigastric pain with obvious effect, few medicinal flavors, practical operability, high compliance, safety and effectiveness. Summary of the Invention

[0007] The purpose of the present invention is to provide an external traditional Chinese medicine composition for treating epigastric pain of disharmony between the liver and stomach and its application in view of the deficiencies in the prior art.

[0008] In the first aspect, the present invention provides an external traditional Chinese medicine composition for treating epigastric pain of disharmony between the liver and stomach, and the traditional Chinese medicine composition is made from the following raw materials in parts by weight: Evodia rutaecarpa (Juss.) Benth. 18 - 22 parts, Cinnamomum cassia Presl 7 - 11 parts, Zingiber officinale Rosc. 7 - 11 parts, Eugenia caryophyllata Thunb. 7 - 11 parts, Ligusticum wallichii Franch. 10 - 14 parts, Corydalis yanhusuo W. T. Wang 13 - 17 parts, Citrus medica L. var. sarcodactylis Swingle 13 - 17 parts.

[0009] As a preferred example, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: Evodia rutaecarpa (Juss.) Benth. 19 - 21 parts, Cinnamomum cassia Presl 8 - 10 parts, Zingiber officinale Rosc. 8 - 10 parts, Eugenia caryophyllata Thunb. 8 - 10 parts, Ligusticum wallichii Franch. 11 - 13 parts, Corydalis yanhusuo W. T. Wang 14 - 16 parts, Citrus medica L. var. sarcodactylis Swingle 14 - 16 parts.

[0010] As another preferred example, the traditional Chinese medicine composition is made from the following raw medicinal materials in parts by weight: Evodia rutaecarpa 20 parts, Cinnamon 9 parts, Ginger 9 parts, Clove 9 parts, Chuanxiong rhizome 12 parts, Corydalis yanhusuo 15 parts, and Fructus citri sarcodactylis 15 parts.

[0011] As another preferred example, the traditional Chinese medicine composition is an ointment.

[0012] In a second aspect, the present invention provides a preparation method of an external-use traditional Chinese medicine composition for treating epigastric pain due to disharmony between the liver and stomach. The traditional Chinese medicine composition is taken and ground into powder uniformly, and then sesame oil, honey, and ginger juice are added and adjusted to an ointment state.

[0013] In a third aspect, the present invention provides the application of the traditional Chinese medicine composition in the preparation of a drug for treating epigastric pain due to disharmony between the liver and stomach.

[0014] In a fourth aspect, the present invention provides a pharmaceutical composition for treating epigastric pain due to disharmony between the liver and stomach. The pharmaceutical composition is composed of a traditional Chinese medicine composition, Omeprazole Enteric Capsules, and Mosapride Citrate Tablets.

[0015] As a preferred example, the mass ratio of the Omeprazole Enteric Capsules to the Mosapride Citrate Tablets is 40:15.

[0016] Clinically, patients with epigastric pain due to disharmony between the liver and stomach often have a constitution of deficiency-cold of the spleen and stomach, and the clinical manifestations include epigastric pain, preference for warmth and pressure, retching, expectoration of saliva, aggravation by cold, etc., and some are accompanied by cold pain at the vertex of the head, dizziness, belching, acid regurgitation, etc. Acupoint application therapy with the modified Evodia Decoction is given to achieve the purpose of soothing the liver and regulating the stomach, warming the middle-jiao and relieving pain. The traditional Chinese medicine composition of the present invention altogether contains seven traditional Chinese medicines.

[0017] Evodia rutaecarpa: Pungent and dispersing, bitter and purging, warm in nature and dispelling cold. Evodia rutaecarpa enters the liver meridian and is the main drug for treating various pains caused by liver cold and qi stagnation. Cinnamon is extremely warm in nature, pungent and sweet in taste, and has the effects of tonifying fire and assisting yang, guiding back the floating fire, and dispelling cold and relieving pain. The combination of Evodia rutaecarpa and Cinnamon can strengthen its effect of dispelling cold and relieving pain, and can also assist Cinnamon in tonifying yang. It can be used to treat epigastric distending pain, deficiency-cold diarrhea, etc. For patients with epigastric pain due to deficiency-cold of the spleen and stomach, the two can achieve the effects of dispelling cold and relieving pain, warming the channels and promoting blood circulation. The two together are the monarch drugs.

[0018] Ginger: Pungent and warm in nature, warming the stomach and dispelling cold, and is the ministerial drug. "Medical Formula Treatise" states that "Evodia rutaecarpa is strong in nature and good at descending. With the warm-dispersing property of ginger, it is used to dispel excessive yin qi." Ginger has the effects of sterilization, analgesia, and anti-inflammation, inhibits gastric juice secretion, can treat gastric ulcers, and also has the effect of killing Helicobacter pylori. Clove enters the liver, spleen, stomach, and kidney meridians, and is used for its effects of warming the middle-jiao and dispelling cold, promoting qi flow and relieving pain. The combination of the two can warm the stomach and dispel cold, and together they are the ministerial drugs.

[0019] Chuanxiong (Rhizoma Chuanxiong): It pertains to the Liver, Gallbladder, and Pericardium meridians, promoting blood circulation to remove stasis, regulating qi to relieve depression, and dispelling wind to alleviate pain. It ascends to the head, regulates menstruation downward, and relieves stagnation in the middle. It is a qi drug in blood. It has a pungent taste and a yang nature, with a qi that is good at running and not in a state of yin coagulation and stickiness. Although it enters the blood aspect, it can also dispel all kinds of wind and regulate all kinds of qi. Corydalis Rhizome: It has the efficacy of promoting blood circulation, regulating qi, and relieving pain, and can mainly treat epigastric pain. It mainly takes its effect of regulating qi to relieve pain and is an important analgesic drug. The combination of Chuanxiong and Corydalis Rhizome enhances the effect of promoting blood circulation, regulating qi, and relieving pain, and they are both adjuvant drugs.

[0020] Buddha's Hand: It has a pungent, bitter, and sour taste, a warm nature, and pertains to the Liver, Spleen, Stomach, and Lung meridians. It has the functions of soothing the liver and regulating qi, and harmonizing the stomach to relieve pain. It is often used to treat distension, pain, abdominal distension, food accumulation, etc. caused by liver-stomach qi stagnation, and is used as the guiding drug.

[0021] The advantages of the present invention are as follows:

[0022] (1) Comparison of the curative effects of traditional Chinese medicine syndrome scores: After 4 weeks of treatment, for the evaluation of the curative effects of traditional Chinese medicine syndromes, the effective rate of the treatment group was 83.87%, and the effective rate of the control group was 53.33%. The treatment group was significantly better than the control group (p < 0.01).

[0023] (2) Comparison of the attack frequency and pain degree of epigastric pain: Before treatment, there were no statistically significant differences in the attack frequency of epigastric pain and the VAS score between the two groups (p > 0.05). After treatment, the attack frequency of epigastric pain and the VAS score in the treatment group were lower than those in the control group (p < 0.05). When comparing within the group, the attack frequency of epigastric pain and the VAS in both the treatment group and the control group decreased significantly (p < 0.05).

[0024] (3) Comparison of inflammatory indicators: Before treatment, there were no statistically significant differences in CRP, IL-6, and TNF-α between the two groups (p > 0.05). After treatment, the levels of CRP, IL-6, and TNF-α in the treatment group were lower than those in the control group (p < 0.05). When comparing within the group, the levels of CRP, IL-6, and TNF-α in both the treatment group and the control group decreased significantly (p < 0.05).

[0025] (4) Comparison of the results of long-term follow-up: All patients were followed up for 6 months. There were no lost-to-follow-up cases in both groups. The recurrence rate of the treatment group was 9.68%, and the recurrence rate of the control group was 33.33%. The treatment group was significantly lower than the control group (p < 0.05).

[0026] (5) Safety observation: No obvious adverse reactions occurred in both groups during the treatment process.

[0027] In summary, acupoint application can improve the traditional Chinese medicine syndromes of patients with epigastric pain due to disharmony between the liver and stomach, reduce the attack frequency and pain degree of epigastric pain, inhibit the inflammatory reaction, and reduce the recurrence rate. Detailed implementation method

[0028] The present invention will be further described below in conjunction with specific embodiments. It should be understood that these embodiments are only used to illustrate the present invention and not to limit the scope of the present invention. In addition, it should be understood that after reading the content described in the present invention, those skilled in the art can make various changes or modifications to the present invention, and these equivalent forms also fall within the scope defined by the appended claims of the present application.

[0029] Example 1 An external traditional Chinese medicine composition for treating epigastric pain of liver-stomach disharmony type (I)

[0030] Evodia rutaecarpa 20 parts, Cinnamon 9 parts, Ginger 9 parts, Clove 9 parts, Chuanxiong rhizome 12 parts, Corydalis yanhusuo 15 parts, Fructus citri sarcodactylis 15 parts.

[0031] Example 2 An external traditional Chinese medicine composition for treating epigastric pain of liver-stomach disharmony type (II)

[0032] Evodia rutaecarpa 20 parts, Cinnamon 7 parts, Ginger 11 parts, Clove 8 parts, Chuanxiong rhizome 13 parts, Corydalis yanhusuo 15 parts, Fructus citri sarcodactylis 13 parts.

[0033] Example 3 An external traditional Chinese medicine composition for treating epigastric pain of liver-stomach disharmony type (III)

[0034] Evodia rutaecarpa 18 parts, Cinnamon 11 parts, Ginger 8 parts, Clove 10 parts, Chuanxiong rhizome 12 parts, Corydalis yanhusuo 13 parts, Fructus citri sarcodactylis 17 parts.

[0035] Example 4 An external traditional Chinese medicine composition for treating epigastric pain of liver-stomach disharmony type (IV)

[0036] Evodia rutaecarpa 22 parts, Cinnamon 8 parts, Ginger 10 parts, Clove 9 parts, Chuanxiong rhizome 10 parts, Corydalis yanhusuo 17 parts, Fructus citri sarcodactylis 14 parts.

[0037] Example 5 An external traditional Chinese medicine composition for treating epigastric pain of liver-stomach disharmony type (V)

[0038] Evodia rutaecarpa 19 parts, Cinnamon 10 parts, Ginger 9 parts, Clove 7 parts, Chuanxiong rhizome 14 parts, Corydalis yanhusuo 14 parts, Fructus citri sarcodactylis 16 parts.

[0039] Example 6 An external traditional Chinese medicine composition for treating epigastric pain of liver-stomach disharmony type (VI)

[0040] Evodia rutaecarpa 21 parts, Cinnamon 9 parts, Ginger 7 parts, Clove 11 parts, Chuanxiong rhizome 11 parts, Corydalis yanhusuo 16 parts, Fructus citri sarcodactylis 15 parts.

[0041] Example 7 An external traditional Chinese medicine composition for treating epigastric pain of liver-stomach disharmony type (VII)

[0042] Evodia rutaecarpa 20 parts, Cinnamon 11 parts, Ginger 8 parts, Clove 10 parts, Chuanxiong rhizome 12 parts, Corydalis yanhusuo 13 parts, Fructus citri sarcodactylis 17 parts.

[0043] Example 8. An external-use traditional Chinese medicine composition for treating epigastric pain of disharmony between the liver and stomach (VIII)

[0044] Evodia rutaecarpa: 18 parts, Cinnamon: 8 parts, Ginger: 10 parts, Clove: 9 parts, Chuanxiong Rhizome: 10 parts, Corydalis Rhizome: 17 parts, Fructus Citri Sarcodactylis: 14 parts.

[0045] Example 9. An external-use traditional Chinese medicine composition for treating epigastric pain of disharmony between the liver and stomach (IX)

[0046] Evodia rutaecarpa: 22 parts, Cinnamon: 10 parts, Ginger: 9 parts, Clove: 7 parts, Chuanxiong Rhizome: 14 parts, Corydalis Rhizome: 14 parts, Fructus Citri Sarcodactylis: 16 parts.

[0047] Example 10. An external-use traditional Chinese medicine composition for treating epigastric pain of disharmony between the liver and stomach (X)

[0048] Evodia rutaecarpa: 19 parts, Cinnamon: 9 parts, Ginger: 7 parts, Clove: 11 parts, Chuanxiong Rhizome: 11 parts, Corydalis Rhizome: 16 parts, Fructus Citri Sarcodactylis: 15 parts.

[0049] Example 11. An external-use traditional Chinese medicine composition for treating epigastric pain of disharmony between the liver and stomach (XI)

[0050] Evodia rutaecarpa: 21 parts, Cinnamon: 7 parts, Ginger: 11 parts, Clove: 8 parts, Chuanxiong Rhizome: 13 parts, Corydalis Rhizome: 15 parts, Fructus Citri Sarcodactylis: 13 parts.

[0051] Example 12. Clinical experiment

[0052] Experimental method

[0053] (1) General information

[0054] Sixty-one patients with chronic non-atrophic gastritis admitted to Jing'an District Traditional Chinese Medicine Hospital from August 2023 to August 2024 were selected and divided into two groups according to the random number table method. Treatment group: 31 cases, with an average age of (64.87 ± 5.41) years; 11 males and 22 females; Control group: 30 cases, with an average age of (65.14 ± 5.47) years; 8 males and 22 females. There was no significant difference in gender and age between the two groups (p > 0.05), and they were comparable.

[0055] (2) Diagnostic criteria

[0056] The Western medicine diagnosis conforms to the "Consensus on Chronic Gastritis in China 2017 (Shanghai)" [1] Diagnostic criteria. 1) Clinical symptoms such as upper abdominal pain, discomfort, burning sensation, early satiety, belching, acid reflux, nausea, etc.; 2) Gastroscopy shows patchy erythema, roughness, or diffuse congestion and edema of the gastric mucosa, and some have erosion and bleeding; 3) Pathological biopsy mainly shows plasma cell and lymphocyte infiltration.

[0057] The TCM diagnosis is in accordance with the "Consensus on the Diagnosis and Treatment of Chronic Non-atrophic Gastritis with Integrated Traditional Chinese and Western Medicine (2017)" [2] The syndrome is the liver-stomach disharmony syndrome. Main symptoms: epigastric pain, abdominal distension, chest tightness, belching, aggravated or recurring when emotional frustration. Secondary symptoms: irritability, sighing, distension in the flanks, poor appetite and nausea. Tongue diagnosis: red or light red tongue with thin white fur. Pulse diagnosis: stringy pulse. If the main symptoms, tongue coating and pulse are met, two of the secondary symptoms can be diagnosed. Inclusion criteria: Meet the above Western medical diagnostic criteria, and the syndrome is the liver-stomach disharmony syndrome according to TCM differentiation; age 18 ～ 80 years old; no standardized treatment in the past month; voluntarily signed the informed consent form and met the conditions for follow-up.

[0058] Exclusion criteria: patients with other clearly diagnosed digestive system diseases such as gastric cancer and Crohn's disease; patients with serious medical diseases such as cardiovascular, cerebrovascular, lung, and liver diseases; patients with mental illness; pregnant or lactating women; patients taking other drugs that affect digestive function during the same period.

[0059] (3) Treatment methods

[0060] Control group: conventional western medicine treatment. Omeprazole enteric-coated capsules (Hainan Hailing Chemical Pharmaceutical Co., Ltd., approval number: National Medicine Standard H10920092, specification: 20 mg / tablet) 1 tablet / time, 2 times / day, orally; Mosapride citrate tablets (Chengdu Kanghong Pharmaceutical Group Co., Ltd., approval number: National Medicine Standard H19990313, specification: 5 mg / tablet) 1 tablet / time, 3 times / day, orally. Treatment group: acupoint patch treatment was added on the basis of the control group. The composition of Chinese medicine for acupoint patch: 20g of Evodia rutaecarpa, 9g of cinnamon, 9g of ginger, 9g of cloves, 12g of Chuanxiong, 15g of Corydalis, and 15g of Citron. The above Chinese medicines are uniformly powdered, and sesame oil, honey and ginger juice are added to make a paste. The prepared paste is evenly applied to the center of the blank non-woven fabric patch with a diameter of 3cm and a thickness of 0.3 ～ 0.5cm. Acupoints: Zhongwan, bilateral Tianshu, bilateral Zusanli. Clean the skin around the acupoints and apply the medicine on each acupoint for 4 hours each time, once a day. The treatment cycle is 4 weeks.

[0061] (4) Observation indicators

[0062] 1) TCM syndrome score.

[0063] 2) The number of epigastric pain attacks per week; visual analogue scale (VAS).

[0064] 3) Inflammatory indicators: C-reactive protein (CRP), interleukin-6

[0065] (Interleukin-6, IL-6), Tumor necrosis factor-α (TNF-α) expression levels.

[0066] α, TNF-α) expression levels.

[0067] 4) Long-term follow-up.

[0068] 5) Safety observation: Observe and record the occurrence of adverse reactions during the treatment of the two groups of patients.

[0069] Traditional Chinese medicine syndrome score: Refer to the "Guiding Principles for Clinical Research of New Chinese Medicines". [3] , according to the traditional Chinese medicine syndrome scoring form, the clinical efficacy is divided into 4 levels: clinical control, marked effect, effective, and ineffective. The symptom grading and scoring are as follows: severe is 3 points, moderate is 2 points; mild is 1 point; asymptomatic is 0 point. The total effective rate is calculated as clinical control + marked effect + effective. (1) Clinical control: Clinical symptoms and signs disappear or basically disappear, and the syndrome score is reduced by ≥95%; (2) Marked effect: Clinical symptoms and signs are significantly improved, and the syndrome score is reduced by ≥70%; (3) Effective: Clinical symptoms and signs are both improved, and the syndrome score is reduced by ≥30%; (4) Ineffective: Clinical symptoms and signs are not significantly improved, or even worsened, and the syndrome score is reduced by less than 30%. Note: Calculation formula: (Pre-treatment score - Post-treatment score) / Pre-treatment score × 100%.

[0070] The visual analogue scale is used to evaluate the pain degree of patients during the attack of epigastric pain. Guide the patients to select a number from 1 ～ to 10 to represent their own pain degree. The higher the score, the more severe the pain.

[0071] Inflammatory indicators: 5 ml of venous blood is drawn from the patients in the fasting state in the early morning before and after treatment, centrifuged at a speed of 3000 r / min for 10 min to obtain the supernatant, and the expression levels of interleukin-6, C-reactive protein, and tumor necrosis factor-α are measured by enzyme-linked immunosorbent assay.

[0072] Long-term follow-up: All patients are followed up for 6 months. The recurrence situation of the two groups of patients 6 months after treatment is recorded through telephone and outpatient reexamination. The recurrence is mainly based on clinical comprehensive diagnosis.

[0073] (5) Statistical methods

[0074] SPSS 26.0 statistical software was used for statistical analysis. Measurement data were described by mean ± standard deviation (x±s). For comparison between two groups, if the data conformed to normal distribution and homogeneity of variance, independent sample t-test was used; if the data conformed to normal distribution but had inhomogeneous variance, corrected t-test (t’ test) was used; if the data did not conform to normal distribution, median M and quartile Q were used. For comparison within the group before and after treatment, if the data conformed to normal distribution, paired t-test was used; if the data did not conform to normal distribution, median M and quartile Q were used; for ranked data, rank sum test was used.

[0075] Experimental results

[0076] (1) Comparison of the curative effect of traditional Chinese medicine syndrome scores After 4 weeks of treatment, for the evaluation of the curative effect of traditional Chinese medicine syndrome, the effective rate of the treatment group was 83.87%, and the effective rate of the control group was 53.33%. The treatment group was significantly better than the control group (p < 0.01). See Table 1.

[0077] Table 1 Comparison of the curative effect of traditional Chinese medicine syndrome between two groups

[0078]

[0079] Note: For comparison between two groups, p < 0.01.

[0080] (2) Comparison of the attack frequency and pain degree of epigastric pain Before treatment, there were no significant differences in the attack frequency of epigastric pain and VAS scores between the two groups (p > 0.05). After treatment, the attack frequency of epigastric pain and VAS scores in the treatment group were lower than those in the control group (p < 0.05). When comparing within the group, the attack frequency of epigastric pain and VAS in both the treatment group and the control group decreased significantly (p < 0.05). See Table 2.

[0081] Table 2 Comparison of the attack frequency and pain degree of epigastric pain between two groups before and after treatment

[0082]

[0083] Note: Δ Compared with before treatment, p < 0.05; # Compared with the control group, p < 0.05.

[0084] (3) Comparison of inflammatory indicators Before treatment, there were no significant differences in CRP, IL-6, and TNF-α between the two groups (p > 0.05). After treatment, the levels of CRP, IL-6, and TNF-α in the treatment group were lower than those in the control group (p < 0.05). When comparing within the group, the levels of CRP, IL-6, and TNF-α in both the treatment group and the control group decreased significantly (p < 0.05).

[0085] Table 3 Comparison of inflammatory indicators between two groups before and after treatment

[0086]

[0087] Note: Compared with before treatment, Δ, p < 0.05; compared with the control group, #, p < 0.05.

[0088] (4) Comparison of long-term follow-up results All patients were followed up for 6 months. There were no lost-to-follow-up cases in both groups. The recurrence rate in the treatment group was 9.68%, and the recurrence rate in the control group was 33.33%. The treatment group was significantly lower than the control group (p < 0.05). See Table 4.

[0089] Table 4 Comparison of long-term follow-up results between the two groups

[0090]

[0091] (5) Safety observation: No obvious adverse reactions occurred in both groups during the treatment process.

[0092] In summary, acupoint application can improve the TCM syndromes of patients with chronic non-atrophic gastritis, reduce the frequency and degree of epigastric pain attacks, inhibit the inflammatory response, and reduce the recurrence rate.

[0093] References:

[0094] [1] Fang Jingyuan, Du Yiqi, Liu Wenzhong, et al. Chinese Consensus on Chronic Gastritis (Shanghai, 2017) [J]. Chinese Journal of Gastroenterology, 2017, 22(11): 670-687.

[0095] [2] Li Junxiang, Chen Jing, Hu Ling, et al. Chinese and Western Medicine Integrated Diagnosis and Treatment Consensus on Chronic Non-atrophic Gastritis (2017) [J]. Chinese Journal of Integrated Traditional and Western Medicine on Digestion, 2018, 26(01): 1-8.

[0096] [3] Zheng Xiaoyu. Guidelines for Clinical Research of New Chinese Medicines [M]. Beijing: China Medical Science and Technology Press, 2002, 89.

[0097] The above are only the preferred embodiments of the present invention. It should be noted that for those of ordinary skill in the art, without departing from the method of the present invention, several improvements and supplements can be made, and these improvements and supplements should also be regarded as the protection scope of the present invention.

Claims

1. An external-use traditional Chinese medicine composition for treating epigastric pain of liver-stomach disharmony type, characterized in that, The traditional Chinese medicine composition is prepared from the following raw materials by weight: 18-22 parts of Evodia rutaecarpa, 7-11 parts of Cinnamomum cassia, 7-11 parts of Zingiber officinale, 7-11 parts of Eugenia caryophyllata, 10-14 parts of Ligusticum wallichii, 13-17 parts of Corydalis yanhusuo, 13-17 parts of Citrus medica var. sarcodactylis.

2. The traditional Chinese medicine composition according to claim 1, wherein The traditional Chinese medicine composition is prepared from the following raw materials by weight: 19-21 parts of Evodia rutaecarpa, 8-10 parts of Cinnamomum cassia, 8-10 parts of Zingiber officinale, 8-10 parts of Eugenia caryophyllata, 11-13 parts of Ligusticum wallichii, 14-16 parts of Corydalis yanhusuo, 14-16 parts of Citrus medica var. sarcodactylis.

3. The traditional Chinese medicine composition according to claim 1, wherein The traditional Chinese medicine composition is prepared from the following raw materials by weight: 20 parts of Evodia rutaecarpa, 9 parts of Cinnamomum cassia, 9 parts of Zingiber officinale, 9 parts of Eugenia caryophyllata, 12 parts of Ligusticum wallichii, 15 parts of Corydalis yanhusuo, 15 parts of Citrus medica var. sarcodactylis.

4. The traditional Chinese medicine composition according to any one of claims 1-3, characterized in that, The traditional Chinese medicine composition is an ointment.

5. A preparation method of an external-use traditional Chinese medicine composition for treating epigastric pain of the disharmony between the liver and stomach type, characterized in that, Take the traditional Chinese medicine composition described in any one of claims 1-3, powder it uniformly, and add sesame oil, honey and ginger juice to adjust it to an ointment state.

6. Use of the traditional Chinese medicine composition described in any one of claims 1-3 in the preparation of a drug for treating epigastric pain of liver-stomach disharmony type.

7. A pharmaceutical composition for treating epigastric pain of liver-stomach disharmony type, characterized in that, The pharmaceutical composition is composed of the traditional Chinese medicine composition described in any one of claims 1-3, omeprazole enteric-coated capsules and mosapride citrate tablets.

8. The pharmaceutical composition according to claim 7, wherein The mass ratio of the omeprazole enteric-coated capsules to the mosapride citrate tablets is 40:15.

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