Traditional Chinese medicine composition for treating gastroesophageal reflux disease related chest pain

Abstract

The invention relates to the field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for treating gastroesophageal reflux disease related chest pain, which is prepared from the following raw material medicines in parts by weight: 15 to 30 parts of fructus trichosanthis, 10 to 15 parts of radix clematidis, 10 to 15 parts of radix curcumae, 10 to 15 parts of folium eriobotryae, 5 to 10 parts of zizanzibarane, 5 to 10 parts of dalbergia odorifera, 1 to 5 parts of piper cubeba, 15 to 30 parts of calcined oyster shell and 15 to 20 parts of caulis spatholobi. The Guanglingzhu leaf formula has the effects of freeing arthralgia, reducing phlegm, regulating qi, harmonizing stomach, calming adverse-rising energy and relieving pain, is safe and effective in treatment of gastroesophageal reflux disease related chest pain, and is worthy of clinical popularization and application.

Description

Technical Field

[0001] The invention relates to the field of traditional Chinese medicine, and in particular to a traditional Chinese medicine composition for treating gastroesophageal reflux disease-related chest pain. Background Art

[0002] Gastroesophageal reflux disease-associated chest pain (GERD associated with NCCP) refers to reflux-related ischemic chest pain symptoms caused by gastric contents reflux into the esophagus, oral cavity (including throat) or lungs, with or without typical heartburn and reflux symptoms. It is the most important atypical esophageal symptom of GERD, accounting for 60% of non-cardiac chest pain. The pathological mechanism of GERD-associated chest pain is relatively complex. Currently, it is mainly considered to be the result of the synergistic effect of multiple factors such as acid reflux injury, abnormal esophageal-cardiac reflex pathway, decreased esophageal clearance, and esophageal hypersensitivity.

[0003] Modern medicine mainly treats chest pain associated with gastroesophageal reflux disease with acid suppression. However, due to the complexity of reflux types, there are acid reflux, weak acid reflux, weak base reflux, gas reflux, and mixed reflux. Therefore, the clinical effect of simply using acid suppression, antacids, or combined with prokinetic drugs is not ideal. In addition, long-term use of acid suppression therapy may have many adverse reactions, such as: vitamin B12 deficiency, iron deficiency, hypomagnesemia, osteoporosis and fractures, acute and chronic kidney disease, infection, fundic gland polyps, gastrointestinal tumors, etc.

[0004] GERD-related chest pain is classified as "heartache after eating" and "chest pain" in traditional Chinese medicine. The disease is located in the esophagus, and the key is the stomach. The main pathogenesis is the stomach's failure to harmonize and descend, and the phlegm and qi are blocked. The upper-jiao chest yang is weak, and the qi movement is abnormal, resulting in the stomach's failure to harmonize and descend. Phlegm, blood stasis and other yin evils rush upward and stay in the heart and chest. Depending on the degree of obstruction (unsmooth, unfavorable, blocked), it can manifest as fullness, stuffiness or pain in the heart. If the stomach is affected by evil, there may be discomfort such as loss of appetite, nausea and vomiting, acid reflux and heartburn. Summary of the invention

[0005] The object of the present invention is to provide a Chinese medicine composition (hereinafter referred to as Gualing Yuye prescription) for treating chest pain associated with gastroesophageal reflux disease and its application. The Gualing Yuye prescription of the present invention has the effects of dispelling numbness and resolving phlegm, regulating qi and harmonizing the stomach, and relieving adverse reactions and pain, and is a practical and effective prescription for treating chest pain associated with gastroesophageal reflux disease.

[0006] The first aspect of the present invention provides a traditional Chinese medicine composition for treating gastroesophageal reflux disease-related chest pain, which is composed of the following raw materials in parts by weight:

[0007] 15-30 parts of whole Trichosanthes kirilowii, 10-15 parts of clematis, 10-15 parts of curcuma aromatica, 10-15 parts of loquat leaves, 5-10 parts of green amaranth, 5-10 parts of purple dalbergia, 1-5 parts of cubeb, 15-30 parts of calcined oyster shells, and 15-20 parts of Millettia reticulata.

[0008] Furthermore, the Chinese medicine composition for treating gastroesophageal reflux disease-related chest pain is composed of the following raw materials in parts by weight:

[0009] 20-30 parts of whole Trichosanthes kirilowii, 12-15 parts of clematis, 12-15 parts of curcuma aromatica, 12-15 parts of loquat leaves, 6-10 parts of green amaranth, 9-10 parts of purple dalbergia, 3-5 parts of cubeb, 20-30 parts of calcined oyster shells, and 15-18 parts of Millettia reticulata.

[0010] Furthermore, the Chinese medicine composition for treating gastroesophageal reflux disease-related chest pain is composed of the following raw materials in parts by weight:

[0011] 30 parts of whole Trichosanthes kirilowii, 12 parts of radix clematis, 12 parts of curcuma aromatica, 12 parts of loquat leaves, 6 parts of green atractylodes, 9 parts of dalbergia odorifera, 3 parts of piperita, 30 parts of calcined oyster shells, and 15 parts of millettia reticulata.

[0012] The second aspect of the present invention provides a Chinese medicine preparation having the Chinese medicine composition for treating gastroesophageal reflux disease-related chest pain as described above as an active ingredient, wherein the Chinese medicine preparation is prepared into a commonly used dosage form in pharmacy using conventional preparation methods in the art.

[0013] Furthermore, the dosage form of the Chinese medicine preparation is decoction, tablet, capsule, granule, pill, mixture, oral liquid or syrup.

[0014] Furthermore, the Chinese medicine preparation also includes pharmaceutically acceptable excipients.

[0015] The third aspect of the present invention provides a use of the above-mentioned traditional Chinese medicine composition in the preparation of a medicament for treating gastroesophageal reflux disease-related chest pain.

[0016] A fourth aspect of the present invention provides a use of the above-mentioned traditional Chinese medicine preparation in the preparation of a drug for treating gastroesophageal reflux disease-related chest pain.

[0017] The present invention has the advantages that:

[0018] 1. The Gualingyuye prescription of the present invention is one of the series of prescriptions of the "tong", "hua", "xuan" and "ping" diagnosis and treatment system of spleen and stomach diseases in the Chen Cunren academic thought research base of the Ding's Internal Medicine School of Shanghai School of Traditional Chinese Medicine. It embodies the "pingzheng light and smart" and "pure and gentle" medication method of Menghe, and is used for gastroesophageal reflux disease-related chest pain with remarkable efficacy. In the prescription, the whole Gualingyuye prescription is used to promote yang and relieve numbness, reduce adverse effects and resolve phlegm, cleanse the phlegm evil in the chest, and restore the function of chest and stomach descent. It is the main medicine, which is taken from the meaning of Zhishi Xiebai Guizhi Decoction in Zhang Zhongjing's "Golden Chamber Synopsis". Clematis chinensis and Curcuma aromatica, one cold and one hot, one promoting and one descending, promote the flow of qi and relieve pain, the two drugs are matched, the effect of promoting the flow of qi and relieving pain is greatly increased; loquat leaves can reduce adverse effects and resolve phlegm, harmonize the stomach and lower qi, to treat the cause of stomach qi rising; green plum can soothe the liver and harmonize the middle, regulate qi and resolve phlegm, the four drugs are used together, promote qi and relieve pain, soothe the liver and harmonize the stomach, and reduce qi and resolve phlegm, and they are all minister drugs. Purple yam is used to promote qi and relieve pain, promote blood circulation and reduce adverse effects; Piper serrata can dispel cold and relieve pain, promote qi and warm the middle; calcined oyster can reduce acid and relieve pain, and calm down and reduce adverse effects. Millettia spatholobi can replenish blood, promote blood circulation, dredge the meridians and relieve pain, which can prevent the warm, dry, bitter and cold nature of other drugs, and can moisten the esophagus, help stomach qi to promote esophageal peristalsis. All the medicines are used together to achieve the effects of relieving numbness and resolving phlegm, regulating qi and harmonizing the stomach, relieving adverse effects and relieving pain, so that the stagnation and depression are dispersed, the deficiency is replenished and the pain is stopped, the stomach qi is unblocked and descended, the qi flow is smooth, and all symptoms are eliminated.

[0019] 2. The Gualingyuye prescription of the present invention has the effects of relieving numbness and resolving phlegm, regulating qi and harmonizing the stomach, and relieving pain. It is safe and effective in treating chest pain associated with gastroesophageal reflux disease, especially for patients with weak base reflux, gas reflux, mixed reflux, etc. who are poorly treated with PPIs. It has remarkable efficacy and is worthy of clinical promotion and application. DETAILED DESCRIPTION

[0020] The specific implementation methods provided by the present invention are described in detail below in conjunction with examples.

[0021] Embodiment 1: Chinese medicine composition of the present invention

[0022] 30 parts of whole Trichosanthes kirilowii, 12 parts of radix clematis, 12 parts of curcuma aromatica, 12 parts of loquat leaves, 6 parts of green atractylodes, 9 parts of dalbergia odorifera, 3 parts of piperita, 30 parts of calcined oyster shells, and 15 parts of millettia reticulata.

[0023] Embodiment 2: Chinese medicine composition of the present invention

[0024] 25 parts of whole Fructus Trichosanthis, 15 parts of Radix Clematis, 15 parts of Radix Curcumae, 15 parts of Folium Eriobotryae, 10 parts of Rhizoma Cibotii, 10 parts of Dalbergia Odorifera, 5 parts of Solanum Cubeba, 25 parts of Concha Ostreae, and 20 parts of Caulis Spatholobi.

[0025] Embodiment 3: Chinese medicine composition of the present invention

[0026] 20 parts of whole Trichosanthes kirilowii, 14 parts of radix clematis, 14 parts of curcuma aromatica, 14 parts of loquat leaves, 8 parts of green plum, 8 parts of purple dalbergia, 2 parts of cubeb, 20 parts of calcined oyster shells, and 18 parts of millettia reticulata.

[0027] Embodiment 4: Chinese medicine composition of the present invention

[0028] 15 parts of whole Fructus Trichosanthis, 10 parts of Radix Clematis, 10 parts of Radix Curcumae, 10 parts of Folium Eriobotryae, 5 parts of Rhizoma Cibotii, 5 parts of Dalbergia Odorifera, 1 part of Solanum Cubeba, 15 parts of Concha Ostreae, and 16 parts of Caulis Spatholobi.

[0029] Example 5: Preparation of the Chinese medicine composition decoction of the present invention

[0030] The conventional preparation method of Chinese herbal medicine decoction is adopted, that is, each Chinese herbal medicine raw material is weighed according to the weight ratio, and water is added to boil it into a decoction.

[0031] Example 6: Preparation of Chinese medicine composition tablets / capsules of the present invention

[0032] Weigh each Chinese medicine raw material according to weight proportion, grind it into powder, decoct it, and concentrate it under reduced pressure to obtain an extract, dry and crush the extract into granules, add pharmaceutical excipients, and press it into tablets or fill it into capsules.

[0033] Example 7: Preparation of the Chinese medicine composition granules of the present invention

[0034] Weigh each Chinese medicine raw material according to weight proportion, grind it into powder, decoct it, and concentrate it under reduced pressure to obtain an extract, which is then dried and crushed to prepare granules.

[0035] Example 8: Preparation of Chinese medicine composition pills of the present invention

[0036] Weigh each Chinese medicinal raw material according to weight proportion, grind it into powder, decoct it, take the supernatant, and concentrate it into a thick extract; add appropriate pharmaceutical excipients (such as sugar, honey, benzopropionic acid or ethylparaben) to make pills.

[0037] Example 9: Clinical trial of the Chinese medicine composition of the present invention

[0038] 1. Experimental methods:

[0039] Data were collected from 36 patients with gastroesophageal reflux disease-related chest pain treated in our hospital from August 2022 to August 2023. They were randomly divided into a treatment group and a control group with 18 cases in each group. The treatment group was treated with Gualingyuyefang decoction, and the control group was treated with conventional Western medicine Rabeprazole Sodium Enteric-coated Capsules (Jinuo). Both groups took the medicine for 4 consecutive weeks. The changes in clinical efficacy before and after treatment were observed in the two groups.

[0040] 2. Experimental results:

[0041] ①The total effective rate of the treatment group was 88.89%, significantly higher than 55.56% of the control group (P<0.05); ②The symptom scores of both groups were reduced compared with those before treatment, and the scores of the treatment group were lower than those of the control group (P<0.05); ③The effective rate of VAS score in the treatment group was 88.89%, significantly higher than 50.00% of the control group (P<0.05). The specific analysis is as follows:

[0042] (1) Comparison of efficacy between the two groups before and after treatment

[0043] After treatment, the total effective rate of the treatment group was 88.89%, which was significantly higher than that of the control group (55.56%), and the difference was statistically significant (P < 0.05), as shown in Table 1.

[0044] Table 1 Comparison of the efficacy of the two groups before and after treatment Note: * Compared with the experimental group, P < 0.05.

[0045] (2) Comparison of symptom scores between the two groups before and after treatment

[0046] After treatment, the symptom scores of the two groups of patients were improved compared with those before treatment (P<0.001), and the scores of the treatment group were lower than those of the control group, and the difference was statistically significant (P<0.05), as shown in Table 2.

[0047] Table 2 Comparison of symptom scores between the two groups ( point)

[0048]

[0049]

[0050] Note: *** indicates that compared with before treatment, P < 0.001; # Compared with the experimental group, P < 0.05.

[0051] (3) Comparison of VAS scores between the two groups before and after treatment

[0052] After treatment, the VAS score effective rate of the treatment group was 88.89%, which was significantly higher than that of the control group (50.00%), and the difference was statistically significant (P < 0.05), as shown in Table 3.

[0053] Table 3 Comparison of VAS score effectiveness between the two groups

[0054]

[0055] Note: * Compared with the experimental group, P < 0.05.

[0056] 3. Experimental conclusion:

[0057] The Gualingyuye prescription of the present invention has the effects of relieving numbness and resolving phlegm, regulating qi and harmonizing the stomach, and relieving adverse reactions and relieving pain. It is safe and effective in treating chest pain associated with gastroesophageal reflux disease, and is worthy of clinical promotion and application.

[0058] The preferred embodiments of the present invention have been specifically described above, but the present invention is not limited to the embodiments. Those skilled in the art may make various equivalent modifications or substitutions without violating the spirit of the present invention. These equivalent modifications or substitutions are all included in the scope defined by the claims of this application.

Claims

1. A Chinese medicine composition for treating gastroesophageal reflux disease-related chest pain, It is characterized in that The invention is composed of the following raw materials in parts by weight: 15-30 parts of whole Trichosanthes kirilowii, 10-15 parts of Clematis chinensis, 10-15 parts of Curcuma aromatica, 10-15 parts of loquat leaves, 5-10 parts of Rhizoma Cibotii, 5-10 parts of Dalbergia odorifera, 1-5 parts of Solanum tuberosum, 15-30 parts of calcined Ostreae Conchae and 15-20 parts of Millettia reticulata.

2. The Chinese medicine composition for treating gastroesophageal reflux disease-related chest pain according to claim 1, It is characterized in that The invention is composed of the following raw materials in parts by weight: 20-30 parts of whole Trichosanthes kirilowii, 12-15 parts of Clematis chinensis, 12-15 parts of Curcuma aromatica, 12-15 parts of loquat leaves, 6-10 parts of Rhizoma Cibotii, 9-10 parts of Dalbergia odorifera, 3-5 parts of Solanum tuberosum, 20-30 parts of calcined Ostreae Concha and 15-18 parts of Millettia reticulata.

3. The Chinese medicine composition for treating gastroesophageal reflux disease-related chest pain according to claim 1, It is characterized in that The medicine is composed of the following raw materials in parts by weight: 30 parts of whole Trichosanthes kirilowii, 12 parts of Clematidis, 12 parts of Curcuma aromatica, 12 parts of Eriobotrya japonica, 6 parts of Rhizoma Cibotii, 9 parts of Dalbergia odorifera, 3 parts of Solanum tuberosum, 30 parts of calcined Oyster shell, and 15 parts of Millettia reticulata.

4. A Chinese medicine preparation comprising the Chinese medicine composition for treating gastroesophageal reflux disease-related chest pain according to any one of claims 1 to 3 as an active ingredient, It is characterized in that The Chinese medicine preparation is prepared into a common dosage form in pharmacy by conventional preparation methods in the art.

5. The Chinese medicine preparation according to claim 4, It is characterized in that The dosage form of the Chinese medicine preparation is decoction, tablet, capsule, granule, pill, mixture, oral liquid or syrup.

6. The Chinese medicine preparation according to claim 4, It is characterized in that The traditional Chinese medicine preparation also includes pharmaceutically acceptable auxiliary materials.

7. Use of the Chinese medicine composition according to any one of claims 1 to 3 in the preparation of a medicament for treating gastroesophageal reflux disease-related chest pain.

8. Use of the traditional Chinese medicine preparation according to any one of claims 4 to 6 in the preparation of a medicament for treating gastroesophageal reflux disease-related chest pain.

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