Golden bamboo scorch-promoting traditional Chinese medicine composition for treating digestive system diseases

Abstract

The invention discloses a golden bamboo scorch-promoting traditional Chinese medicine composition for treating digestive system diseases, which mainly comprises the following raw materials: 14-16 parts of inula herb, 14-16 parts of ginger bamboo shavings, 27-33 parts of dandelion, 8-10 parts of pericarpium citri reticulatae, 8-10 parts of fried fructus aurantii, 8-10 parts of bamboo juice pinellia ternate, 14-16 parts of poria cocos, 6-9 parts of fried coptis chinensis, 2-3 parts of fructus evodiae and 5-7 parts of raw liquorice. The traditional Chinese medicine composition is used for treating the irritable bowel syndrome (diarrhea type), especially damp-heat stagnation, triple-jiao qi movement disorder and liver-spleen disharmony type irritable bowel syndrome (diarrhea type), is small in side effect, common in raw materials, economical and practical, and has excellent clinical popularization value.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines, and in particular relates to a Jinzhulijiao traditional Chinese medicine composition for treating digestive system diseases. Background Art

[0002] Irritable bowel syndrome (IBS) is a functional intestinal disorder characterized by abnormal stool characteristics, recurrent abdominal pain, and changes in bowel habits. It is clinically divided into diarrhea type (IBS-D), constipation type, mixed type, and indeterminate type. Among them, diarrhea type accounts for about 40.83%, which is the main subtype. Modern medicine believes that its onset is closely related to visceral hypersensitivity, gastrointestinal motility abnormalities, brain-gut axis dysfunction, intestinal flora imbalance, and psychological factors, but the specific mechanism has not been fully elucidated. Clinical treatment is mainly symptomatic, and there are problems such as easy recurrence after discontinuation of medication and insufficient improvement of psychological symptoms. As an important subtype of functional gastrointestinal disease, diarrhea type irritable bowel syndrome (IBS-D) has always been a research hotspot in the field of digestion for its pathogenesis and diagnosis and treatment strategies.

[0003] Modern medicine treats IBS-D mainly by regulating intestinal flora, stopping diarrhea, and relieving spasms. Although it can relieve symptoms in the short term, the symptoms are prone to recurrence. Traditional Chinese medicine shows unique advantages through multi-target regulation (such as anti-inflammatory, regulating flora, and improving brain-gut interaction). Although there is no record of the disease name "IBS-D" in traditional Chinese medicine, it can be classified into the categories of "diarrhea", "abdominal pain", "intestinal habit" and so on according to its main symptoms such as abdominal pain, diarrhea, and urgent defecation. The "Expert Consensus on Diagnosis and Treatment of Irritable Bowel Syndrome in Traditional Chinese Medicine (2017)" points out that IBS is located in the intestines and is related to the liver and spleen. Spleen and stomach damp-heat syndrome is one of the common syndromes. Damp-heat is internally contained, the triple-burner qi is unfavorable, the ascending and descending functions are impaired, the spleen and stomach are in disharmony, and the clear and turbid are not distinguished, resulting in diarrhea.

[0004] Epidemiological data show that the global prevalence of IBS-D is 4.1%-5.2%, and is showing a trend of younger patients, seriously affecting the quality of life of patients. At present, there is still an unmet demand for effective, low-side-effect, and economical Chinese medicine compositions for the treatment of diarrhea-predominant irritable bowel syndrome. Summary of the invention

[0005] In view of the defects of the prior art, the present invention provides a Jinzhu Lijiao Chinese medicine composition based on the pathogenesis of diarrhea-type irritable bowel syndrome of "damp-heat stagnation, unfavorable triple-burner qi movement, and liver-spleen disharmony", in order to achieve the purpose of effectively treating diarrhea-type irritable bowel syndrome.

[0006] In one aspect, the present invention provides a Jinzhulijiao Chinese medicinal composition for treating digestive system diseases. The Jinzhulijiao Chinese medicinal composition comprises the following raw materials, by weight: 14-16 parts of Jinfeicao, 14-16 parts of Jiangzhuru, 27-33 parts of Taraxacum, 8-10 parts of dried tangerine peel, 8-10 parts of stir-fried Citrus aurantium, 8-10 parts of Bamboo Sap and Pinellia, 14-16 parts of Poria, 6-9 parts of stir-fried Coptis chinensis, 2-3 parts of Evodia rutaecarpa, and 5-7 parts of raw licorice.

[0007] Preferably, the digestive system disease is selected from one or more of pharyngeal paresthesia, gastroesophageal reflux disease, reflux esophagitis, chronic gastritis, chronic cholecystitis and irritable bowel syndrome.

[0008] More preferably, the digestive system disease is irritable bowel syndrome. Further preferably, the digestive system disease is diarrhea-type irritable bowel syndrome.

[0009] More preferably, the digestive system disease manifests one or more symptoms selected from the group consisting of damp-heat stagnation, unfavorable triple-burner qi movement, liver-spleen disharmony, foreign body sensation in the throat, phlegm stagnation in the throat, dry cough, belching, heartburn, nausea, bitter taste in the mouth, discomfort behind the sternum, discomfort in the stomach, distension in the back, discomfort in the flanks, irregular bowel movements, anxiety, palpitations, panic, insomnia, red tongue, thin and greasy fur, and stringy and slippery pulse.

[0010] In one or more embodiments, the weight ratio of stir-fried coptis root to evodia rutaecarpa is 3:1.

[0011] Preferably, the Jinzhulijiao Chinese medicine composition comprises the following raw materials, by weight: 15 parts of Jinfeicao, 15 parts of Jiangzhuru, 30 parts of Dandelion, 9 parts of Tangerine Peel, 9 parts of Stir-fried Citrus Aurantium, 9 parts of Bamboo Sap and Pinellia, 15 parts of Poria, 6 parts of Stir-fried Coptis chinensis, 2 parts of Evodia rutaecarpa, and 6 parts of Raw Licorice.

[0012] Preferably, the Jinzhulijiao Chinese medicine composition comprises the following raw materials, by weight: 15 parts of Jinfeicao, 15 parts of Jiangzhuru, 30 parts of Dandelion, 9 parts of Tangerine Peel, 9 parts of Stir-fried Citrus Aurantium, 9 parts of Bamboo Sap and Pinellia, 15 parts of Poria, 9 parts of Stir-fried Coptis chinensis, 3 parts of Evodia rutaecarpa, and 6 parts of raw licorice.

[0013] In another aspect, the present invention provides use of the Jinzhulijiao Chinese medicine composition as described in any embodiment herein in the preparation of a medicament for treating digestive system diseases.

[0014] In another aspect, the present invention provides a Jinzhulijiao Chinese medicine composition as described in any embodiment herein, wherein the dosage form of the Jinzhulijiao Chinese medicine composition is a conventional dosage form made of Chinese medicine and a pharmaceutically acceptable carrier or excipient.

[0015] In one or more embodiments, the dosage form of the Jinzhulijiao Chinese medicine composition is an oral dosage form.

[0016] In one or more embodiments, the dosage form of the Jinzhulijiao Chinese medicine composition is tablets, capsules, powders or granules.

[0017] Compared with the prior art, the Jinzhulijiao Chinese medicine composition of the present invention can effectively treat digestive system diseases, especially diarrhea-type irritable bowel syndrome, has few side effects, uses common and economical raw materials, and has excellent clinical promotion value. DETAILED DESCRIPTION

[0018] The preferred method for taking the Jinzhulijiao Chinese medicine composition of the present invention is: add 400 mL of water to each dose for decoction, take it warm in the morning and evening, take it twice a day, and take it continuously for 8 weeks.

[0019] The therapeutic principle of the Jinzhu Lijiao Chinese medicine composition of the present invention is: to promote the function of the triple-jiao qi, to clear away dampness and heat in the spleen and stomach, to calm the gallbladder and the heart, and to eliminate phlegm.

[0020] Among them, Jinfeicao and Jiangzhuru can clear the qi of the three burners and eliminate phlegm and dampness; Huanglian and Wuzhuyu are the drug pair, which are pungent and bitter, harmonize the liver and spleen, and clear the dampness and heat in the middle burner; Dandelion clears heat and detoxifies, dredges the liver and gallbladder, and prevents dampness and heat from turning into fire; Tangerine peel, Citrus aurantium, and Pinellia regulate qi and eliminate phlegm, and restore the ascending and descending functions of the spleen and stomach; Poria strengthens the spleen and eliminates dampness, and Licorice harmonizes all the drugs. The whole formula has the effect of clearing qi and removing dampness, and restoring the spleen to normal.

[0021] In addition, if there is an obvious foreign body sensation in the throat, which cannot be coughed out or swallowed, and the chest and diaphragm are full and stuffy, add Magnolia officinalis and Perilla frutescens; if there is obvious chest and abdominal fullness, pain when pressed, and yellow and thick sputum, add Trichosanthes peel; if there is obvious heartburn, noisy feeling like hunger, and pain in the stomach, add Cuttlefish bone and Fritillaria thunbergii; if there is dull pain and discomfort in the abdomen and ribs, add Paeonia lactiflora; if there is poor sleep and greasy tongue coating, add Northern Sorghum rice; if there is urgent diarrhea and burning sensation in the anus, add Plantago seed and Coix seed to enhance the effect of removing dampness and clearing heat; if the abdominal pain is severe, add Costus root and Corydalis yanhusuo to promote qi and relieve pain; if there is also damage to the yin, add Dendrobium candidum and Ophiopogon japonicus to nourish yin and protect body fluid.

[0022] Example 1

[0023] The Jinzhulijiao Chinese medicine composition for treating digestive system diseases comprises the following raw materials by weight:

[0024] 16 parts of Jinfeicao, 16 parts of Zingiberis Rhizoma, 31 parts of Taraxaci, 8 parts of Tangerine Peel, 10 parts of stir-fried Fructus Aurantii Immaturus, 10 parts of Bamboo Sap and Pinellia, 16 parts of Poria, 6 parts of stir-fried Coptis chinensis, 2 parts of Evodia rutaecarpa, and 5 parts of Raw Licorice.

[0025] Example 2

[0026] The Jinzhulijiao Chinese medicine composition for treating digestive system diseases comprises the following raw materials by weight:

[0027] 14 parts of Jinfeicao, 16 parts of Zingiberis japonicae, 28 parts of Taraxacum mongolicum, 6 parts of stir-fried Coptis chinensis, 9 parts of Rhizoma Pinelliae Rhizoma, 10 parts of Citrus reticulatae, 15 parts of Poria, 6 parts of Raw Licorice, 2 parts of Evodia rutaecarpa, 9 parts of stir-fried Fructus Aurantii Immaturus, 33 parts of Northern Sorghum, 22 parts of stir-fried White Peony Root, 10 parts of Magnolia officinalis, and 8 parts of Sophora flavescens.

[0028] Example 3

[0029] The Jinzhulijiao Chinese medicine composition for treating digestive system diseases comprises the following raw materials by weight:

[0030] 15 parts of Jinfeicao, 14 parts of Zingiberis japonicae, 30 parts of Taraxacum mongolicum, 6 parts of stir-fried Coptis chinensis, 8 parts of Rhizoma Pinelliae Rhizoma, 10 parts of Citrus reticulatae, 14 parts of Poria, 6 parts of Raw Licorice, 2 parts of Evodia rutaecarpa, 8 parts of stir-fried Fructus Aurantii Immaturus, 27 parts of Northern Sorghum, 26 parts of stir-fried White Peony Root, 8 parts of Magnolia officinalis, and 10 parts of Sophora flavescens.

[0031] Example 4

[0032] The Jinzhulijiao Chinese medicine composition for treating digestive system diseases comprises the following raw materials by weight:

[0033] 15 parts of Herba Chrysanthemi Indici, 14 parts of Rhizoma Zingiberis, 29 parts of Herba Taraxaci, 9 parts of Rhizoma Coptidis Rhizoma, 8 parts of Rhizoma Pinelliae Rhizoma, 8 parts of Pericarpium Citri Reticulatae, 15 parts of Poria, 6 parts of Radix Glycyrrhizae, 3 parts of Fructus Evodiae, 10 parts of Rhizoma Citrus Aurantii Immaturus, 27 parts of Rhizoma Sorghume, 8 parts of Flos Magnoliae Officinalis, 5 parts of Radix Polygalae, 33 parts of Red Dates, and 10 parts of Stem of Sophora Japonicae.

[0034] Example 5

[0035] The Jinzhulijiao Chinese medicine composition for treating digestive system diseases comprises the following raw materials by weight:

[0036] 14 parts of Jinfeicao, 15 parts of Zingiberis japonicae, 31 parts of Taraxacum mongolicum, 9 parts of stir-fried Coptis chinensis, 8 parts of Rhizoma Pinelliae Rhizoma, 10 parts of Citrus reticulatae, 14 parts of Poria, 6 parts of Radix Glycyrrhizae, 3 parts of Evodia rutaecarpa, 10 parts of stir-fried Fructus Aurantii Immaturus, 27 parts of Rhizoma Sorghume, 10 parts of Flos Magnoliae Officinalis, 7 parts of Polygala tenuifolia, 27 parts of Red Dates, and 10 parts of Stem of Sophora japonicae.

[0037] Example 6

[0038] The Jinzhulijiao Chinese medicine composition for treating digestive system diseases comprises the following raw materials by weight:

[0039] 15 parts of Herba Chrysanthemi Indici, 15 parts of Rhizoma Zingiberis, 31 parts of Herba Taraxaci, 9 parts of Pericarpium Citri Reticulatae, 9 parts of Stir-fried Fructus Aurantii Immaturus, 10 parts of Rhizoma Pinelliae, 15 parts of Poria, 6 parts of Stir-fried Rhizoma Coptidis, 2 parts of Fructus Evodiae, 6 parts of Radix Glycyrrhizae, 10 parts of Bark of Magnolia Bark, 8 parts of Perilla.

[0040] Example 7

[0041] The Jinzhulijiao Chinese medicine composition for treating digestive system diseases comprises the following raw materials by weight:

[0042] 15 parts of Herba Chrysanthemi Indici, 15 parts of Rhizoma Zingiberis, 27 parts of Herba Taraxaci, 10 parts of Pericarpium Citri Reticulatae, 10 parts of Stir-fried Fructus Aurantii Immaturus, 10 parts of Rhizoma Pinelliae, 16 parts of Poria, 6 parts of Stir-fried Rhizoma Coptidis, 2 parts of Fructus Evodiae, 5 parts of Radix Glycyrrhizae, 8 parts of Bark of Magnolia Bark, 10 parts of Perilla.

[0043] Example 8

[0044] The Jinzhulijiao Chinese medicine composition for treating digestive system diseases comprises the following raw materials by weight:

[0045] 15 parts of Jinfeicao, 15 parts of Zingiberis japonicae, 29 parts of Taraxacum mongolicum, 9 parts of Tangerine peel, 8 parts of stir-fried Fructus Aurantii Immaturus, 9 parts of Rhizoma Pinelliae Rhizoma, 14 parts of Poria, 9 parts of stir-fried Coptis chinensis, 3 parts of Evodia rutaecarpa, 7 parts of Raw Licorice, 14 parts of Fructus Trichosanthis.

[0046] Example 9

[0047] The Jinzhulijiao Chinese medicine composition for treating digestive system diseases comprises the following raw materials by weight:

[0048] 15 parts of Herba Chrysanthemi Indici, 14 parts of Rhizoma Zingiberis, 32 parts of Herba Taraxaci, 10 parts of Pericarpium Citri Reticulatae, 9 parts of Stir-fried Fructus Aurantii Immaturus, 10 parts of Rhizoma Pinelliae Rhizoma, 14 parts of Poria, 9 parts of Stir-fried Rhizoma Coptidis, 3 parts of Fructus Evodiae, 5 parts of Radix Glycyrrhizae, 33 parts of Ostreae Sepiae, 8 parts of Bulbus Fritillariae Thunbergii.

[0049] Example 10

[0050] The Jinzhulijiao Chinese medicine composition for treating digestive system diseases comprises the following raw materials by weight:

[0051] 14 parts of Herba Chrysanthemi Indici, 14 parts of Rhizoma Zingiberis, 30 parts of Herba Taraxaci, 8 parts of Pericarpium Citri Reticulatae, 8 parts of Stir-fried Fructus Aurantii Immaturus, 8 parts of Rhizoma Pinelliae Rhizoma, 15 parts of Poria, 9 parts of Stir-fried Rhizoma Coptidis, 3 parts of Fructus Evodiae, 7 parts of Radix Glycyrrhizae, 27 parts of Ostreae Sepiae, 10 parts of Bulbus Fritillariae Thunbergii.

[0052] Embodiment 11

[0053] The Jinzhulijiao Chinese medicine composition for treating digestive system diseases comprises the following raw materials by weight:

[0054] 15 parts of Jinfeicao, 14 parts of Zingiberis Rhizoma, 31 parts of Taraxaci, 9 parts of Tangerine Peel, 10 parts of stir-fried Fructus Aurantii Immaturus, 9 parts of Bamboo Sap and Pinellia, 14 parts of Poria, 6 parts of stir-fried Coptis chinensis, 2 parts of Evodia rutaecarpa, 5 parts of Raw Licorice, and 14 parts of Peony Root.

[0055] Example 12

[0056] The Jinzhulijiao Chinese medicine composition for treating digestive system diseases comprises the following raw materials by weight:

[0057] 14 parts of Jinfeicao, 14 parts of Zingiberis japonicae, 32 parts of Taraxacum mongolicum, 10 parts of dried tangerine peel, 10 parts of stir-fried Fructus Aurantii Immaturus, 10 parts of Rhizoma Pinelliae Rhizoma, 14 parts of Poria, 9 parts of stir-fried Coptis chinensis, 3 parts of Evodia rutaecarpa, 7 parts of raw liquorice, and 16 parts of Radix Paeoniae Rubra.

[0058] Example 13

[0059] The Jinzhulijiao Chinese medicine composition for treating digestive system diseases comprises the following raw materials by weight:

[0060] 16 parts of Jinfeicao, 14 parts of Zingiberis Rhizoma, 28 parts of Taraxaci, 9 parts of Tangerine Peel, 10 parts of stir-fried Fructus Aurantii Immaturus, 8 parts of Bamboo Sap and Pinellia, 14 parts of Poria, 6 parts of stir-fried Coptis chinensis, 2 parts of Evodia rutaecarpa, 5 parts of Raw Licorice, and 33 parts of Northern Sorghum Rice.

[0061] Embodiment 14

[0062] The Jinzhulijiao Chinese medicine composition for treating digestive system diseases comprises the following raw materials by weight:

[0063] 15 parts of Jinfeicao, 16 parts of Zingiberis japonicae, 30 parts of Taraxacum mongolicum, 10 parts of dried tangerine peel, 9 parts of stir-fried Fructus Aurantii Immaturus, 9 parts of Rhizoma Pinelliae Rhizoma, 15 parts of Poria, 9 parts of stir-fried Coptis chinensis, 3 parts of Evodia rutaecarpa, 7 parts of raw liquorice, and 27 parts of northern sorghum rice.

[0064] Embodiment 15

[0065] The Jinzhulijiao Chinese medicine composition for treating digestive system diseases comprises the following raw materials by weight:

[0066] 15 parts of Herba Chrysanthemi Indici, 15 parts of Rhizoma Zingiberis, 30 parts of Herba Taraxaci, 9 parts of Pericarpium Citri Reticulatae, 9 parts of Stir-fried Fructus Aurantii Immaturus, 9 parts of Rhizoma Pinelliae, 15 parts of Poria, 6 parts of Stir-fried Rhizoma Coptidis, 2 parts of Fructus Evodiae, 6 parts of Radix Glycyrrhizae, 16 parts of Semen Plantaginis, 33 parts of Semen Coix.

[0067] Example 16

[0068] The Jinzhulijiao Chinese medicine composition for treating digestive system diseases comprises the following raw materials by weight:

[0069] 14 parts of Herba Chrysanthemi Indici, 15 parts of Rhizoma Zingiberis, 30 parts of Herba Taraxaci, 9 parts of Pericarpium Citri Reticulatae, 9 parts of Stir-fried Fructus Aurantii Immaturus, 8 parts of Rhizoma Pinelliae, 16 parts of Poria, 9 parts of Stir-fried Rhizoma Coptidis, 3 parts of Fructus Evodiae, 7 parts of Radix Glycyrrhizae, 14 parts of Semen Plantaginis, 27 parts of Semen Coix.

[0070] Embodiment 17

[0071] The Jinzhulijiao Chinese medicine composition for treating digestive system diseases comprises the following raw materials by weight:

[0072] 15 parts of Jinfeicao, 15 parts of Zingiberis Rhizoma, 30 parts of Taraxaci, 9 parts of Tangerine Peel, 9 parts of Stir-fried Fructus Aurantii Immaturus, 9 parts of Bamboo Sap and Pinellia, 15 parts of Poria, 6 parts of Stir-fried Coptis chinensis, 2 parts of Evodia rutaecarpa, 6 parts of Raw Licorice, 10 parts of Aucklandiae Radix and 10 parts of Corydalis yanhusuo.

[0073] Embodiment 18

[0074] The Jinzhulijiao Chinese medicine composition for treating digestive system diseases comprises the following raw materials by weight:

[0075] 14 parts of Herba Chrysanthemi Indici, 15 parts of Rhizoma Zingiberis, 29 parts of Herba Taraxaci, 10 parts of Pericarpium Citri Reticulatae, 8 parts of Stir-fried Fructus Aurantii Immaturus, 10 parts of Rhizoma Pinelliae, 16 parts of Poria, 9 parts of Stir-fried Rhizoma Coptidis, 3 parts of Fructus Evodiae, 7 parts of Radix Glycyrrhizae, 8 parts of Radix Aucklandiae, and 8 parts of Rhizoma Corydalis.

[0076] Embodiment 19

[0077] The Jinzhulijiao Chinese medicine composition for treating digestive system diseases comprises the following raw materials by weight:

[0078] 15 parts of Jinfeicao, 15 parts of Zingiberis Rhizoma, 30 parts of Taraxaci, 9 parts of Tangerine Peel, 9 parts of Stir-fried Fructus Aurantii Immaturus, 9 parts of Bamboo Sap and Pinellia, 15 parts of Poria, 6 parts of Stir-fried Coptis chinensis, 2 parts of Evodia rutaecarpa, 6 parts of Raw Licorice, 10 parts of Dendrobium, and 14 parts of Ophiopogon japonicus.

[0079] Embodiment 20

[0080] The Jinzhulijiao Chinese medicine composition for treating digestive system diseases comprises the following raw materials by weight:

[0081] 16 parts of Jinfeicao, 14 parts of Zingiberis Rhizoma, 29 parts of Taraxaci, 9 parts of Tangerine Peel, 8 parts of Stir-fried Fructus Aurantii Immaturus, 8 parts of Bamboo Sap and Pinellia, 15 parts of Poria, 9 parts of Stir-fried Coptis chinensis, 3 parts of Evodia rutaecarpa, 7 parts of Raw Licorice, 8 parts of Dendrobium, and 16 parts of Ophiopogon japonicus.

[0082] Example 21: Clinical Trial

[0083] 1 Materials and methods

[0084] 1.1 General Information

[0085] A total of 70 patients with IBS-D with spleen and stomach damp-heat syndrome who were admitted to the outpatient department and hospitalized in the Department of Gastroenterology of our hospital from February 2024 to February 2025 were included and randomly divided into an experimental group and a control group with 35 cases in each group. There were 17 male patients (51.43%) and 18 female patients (48.57%) in the experimental group; there were 19 male patients (54.29%) and 16 female patients (45.71%) in the control group. 2 The test showed that there was no significant difference in gender distribution between the two groups (P>0.05). The average age of the patients in the experimental group was 50.2±5.22 years old, with a maximum age of 65 years old and a minimum age of 33 years old; the average age of the patients in the control group was 47.66±4.62 years old, with a maximum age of 64 years old and a minimum age of 35 years old. The t-test showed that there was no significant difference in age (P>0.05). The longest course of the patients in the experimental group was 70 months, the shortest was 6 months, and the average course of the disease was 34.4±15.64 years; the longest course of the patients in the control group was 68 months, the shortest was 9 months, and the average course of the disease was 31.23±14.22 years. The t-test showed that there was no significant difference in the course of the disease (P>0.05). There was no significant difference in the baseline data (gender, age, and course of disease) between the two groups (P>0.05), and they were comparable.

[0086] 1.2 Diagnostic criteria

[0087] It was formulated with reference to the "Rome IV Standards" revised internationally in 2016 and the "2020 Chinese Expert Consensus on Irritable Bowel Syndrome".

[0088] 1.2.1 Western medicine diagnostic criteria

[0089] ① Related to defecation; ② Accompanied by changes in defecation frequency; ③ More than 25% of bowel movements are Bristol stool trait type 6 or 7, and less than 25% of bowel movements are Bristol stool trait type 1 or type 1; Recurrent abdominal pain, with an average of at least 1 day per week in the past 3 months, accompanied by 2 or more of the above items, the Bristol stool trait scale is used to diagnose IBS subtypes.

[0090] 1.2.2 Standards for TCM Syndrome Differentiation

[0091] Refer to the 2017 edition of "Expert Consensus on Diagnosis and Treatment of Irritable Bowel Syndrome in Traditional Chinese Medicine" diagnostic criteria for spleen and stomach damp-heat syndrome: Main symptoms: abdominal pain and diarrhea; urgent or uncomfortable diarrhea. Secondary symptoms: abdominal discomfort; thirst without desire to drink; dry and sticky mouth; burning sensation in the anus; tongue and pulse: dark red or light red tongue; yellow and greasy tongue coating; slippery and rapid pulse. The syndrome is differentiated as damp-heat stagnation, unfavorable triple-burner qi movement, and liver-spleen disharmony. The syndrome is determined: the main symptoms are necessary, and 2 secondary symptoms are present. The tongue and pulse can be used to confirm the diagnosis.

[0092] 1.3 Inclusion criteria

[0093] Patients voluntarily participated in the study and signed informed consent; met the Rome IV criteria and were clearly diagnosed with IBS-D; met the TCM syndrome diagnostic criteria for IBS-D and were patients with spleen-stomach damp-heat syndrome; the age range was determined to be 18-65 years old (inclusive), regardless of gender.

[0094] 1.4 Exclusion criteria

[0095] Patients infected with Helicobacter pylori; patients with severe digestive tract diseases, such as digestive tract perforation, bleeding and other critically ill patients; patients with acute and critical diseases of important organs such as heart, liver, lungs, etc.; subjects participating in other clinical trials; patients who cannot tolerate gastroscopy; patients who are allergic to drugs related to the treatment of digestive system diseases; women who are preparing for pregnancy, pregnant or breastfeeding. Organic lesions found in colonoscopy; allergic to and intolerant of related therapeutic drugs in both groups; tumors, severe cardiovascular and cerebrovascular diseases; alcohol abuse or mental illness; recent use of other drugs that affect the efficacy of this study.

[0096] 2 Treatment methods

[0097] The treatment method of the experimental group is as follows: the Chinese medicine composition of Jinzhu Lijiao is used for syndrome differentiation treatment. The treatment principle is to dredge the qi of the three burners and clear the dampness and heat of the spleen and stomach. The formula is as follows: 15 grams of Jinfeicao (package), 15 grams of Jiangzhuru, 30 grams of dandelion, 9 grams of dried tangerine peel, 9 grams of stir-fried Citrus aurantium, 9 grams of Zhuli Pinellia, 15 grams of Poria, 6 grams of stir-fried Coptis chinensis, 2 grams of Evodia rutaecarpa, and 6 grams of raw licorice. The medicine is decocted uniformly by the hospital's decoction room, and each dose is decocted with 400 ml of water, taken warm in the morning and evening, twice a day, and taken continuously for 8 weeks.

[0098] The control group used compound Lactobacillus acidophilus tablets (specification: 0.5 g / tablet, 6 tablets / plate × 4 plates / box, Tonghua Jinma Pharmaceutical Group Co., Ltd., national medicine standard number: H10940114), with a dosage of 2 tablets / time, 3 times / day, taken with warm water for 8 consecutive weeks.

[0099] 3. Efficacy observation indicators and judgment criteria

[0100] 3.1 Observation of efficacy

[0101] The IBS-D TCM syndrome score quantitative table was developed with reference to the "Guidelines for Clinical Research of New Chinese Medicines (2002 Edition)" and combined with the specific clinical conditions. According to the clinical symptoms involved in the syndrome score scale, four levels are divided from mild to severe. The following is the specific scoring range: the main symptoms are divided into none (0 points), mild (2 points), moderate (4 points) and severe (6 points); the secondary symptoms are divided into none (0 points), mild (1 point), moderate (2 points) and severe (3 points). In the subsequent statistical analysis, the TCM syndrome scores before treatment, at the end of 8 weeks of treatment and 2 months after drug withdrawal were filled in and included in the analysis and comparison, and the total score and each secondary symptom score were calculated. The intra-group and inter-group comparisons were performed separately, and the changes in the scores of abdominal pain, urgent diarrhea, abdominal discomfort, thirst without drinking, dry mouth and sticky mouth, and anal burning before and after treatment were compared and tested.

[0102] 3.2 Overall symptom efficacy evaluation

[0103] With reference to the Guiding Principles for Clinical Research of New Chinese Medicines (2002 edition), the scores of the two groups before and after treatment were compared, and the overall efficacy was evaluated into four categories. According to the symptoms and signs, the specific efficacy index was evaluated: cured: the symptoms basically disappeared, and the symptom score decreased by ≥95%; markedly effective: the symptoms were significantly improved, and the symptom score decreased by ≥70% and <95%; effective: the symptoms were alleviated, and the symptom score decreased by ≥30% and <70%; ineffective: the symptoms were not improved or aggravated, and the symptom score decreased by <30%.

[0104] Total effective rate = [(number of cured cases + markedly effective cases + effective cases) / total number of cases] × 100%.

[0105] 3.3 IBS Symptom Severity Scale

[0106] The IBS Symptom Severity Scale (IBS-SSS) is divided into three levels: mild (76-175 points), moderate (176-300 points), and severe (≥300 points), covering five aspects: the degree and frequency of abdominal pain and bloating, satisfaction with bowel movements, and impact on quality of life.

[0107] 3.4 Statistical methods

[0108] This study used SPSS 27.0 statistical software to conduct statistical analysis on the data. The data sets for statistical analysis included the full analysis set and the per-protocol set. For measurement data, t-test, paired t-test, rank sum test, or paired rank sum test were used; for count data, chi-square test, Fisher's exact test, etc. were used; for ranked data, Wilcoxon rank sum test was used for analysis. The statistical significance level was set at α = 0.05.

[0109] 4 Results

[0110] 4.1 Comparison of TCM Syndrome Efficacy

[0111] According to the method in 3.2 of this embodiment, the total effective rate of TCM syndromes in the two groups was compared. The results are shown in Table 1. The total effective rate of the experimental group was significantly higher than that of the control group. The statistical results are: 2 =4.928, P = 0.026, P < 0.05, the difference is statistically significant.

[0112] Table 1 Comparison of the overall efficacy of TCM syndromes between the two groups after treatment

[0113]

[0114] Note: Compared with the control group, *P<0.05

[0115] 4.2 Comparison of total scores of TCM syndromes

[0116] According to the method in 3.1 of this embodiment, the total scores of TCM syndromes in the two groups were compared. The results are shown in Table 2. The total score of the experimental group after treatment was significantly lower than that of the control group. The statistical result was: t=12.105, P<0.05, and the difference was statistically significant.

[0117] Table 2 Comparison of total TCM syndrome scores between the two groups

[0118]

[0119] Note: Compared with before treatment, △Ρ<0.05; compared with the control group, *Ρ<0.05

[0120] 4.3 IBS-SSS comparison

[0121] According to the method of 3.3 of this embodiment, the two groups of IBS-SSS were compared. The results are shown in Table 3. The severity of the experimental group was significantly lower than that of the control group. The statistical results were: t=-7.202, P<0.05, and the difference was statistically significant, as shown in Table 3.

[0122] Table 3 Comparison of IBS-SSS between the two groups

[0123]

[0124] Note: Compared with before treatment, △Ρ<0.05; compared with the control group, *Ρ<0.05

[0125] The above clinical trial results show that the Jinzhulijiao Chinese medicine composition has significant therapeutic effect on the treatment of digestive system diseases including diarrhea-type irritable bowel syndrome.

Claims

1. A Jinzhulijiao Chinese medicine composition for treating digestive system diseases, characterized in that: The Jinzhulijiao Chinese medicine composition comprises the following raw materials by weight: 14-16 parts of Jinfeicao, 14-16 parts of Jiangzhuru, 27-33 parts of Dandelion, 8-10 parts of Tangerine Peel, 8-10 parts of Stir-fried Citrus Aurantium, 8-10 parts of Bamboo Sap and Pinellia, 14-16 parts of Poria, 6-9 parts of Stir-fried Coptis chinensis, 2-3 parts of Evodia rutaecarpa, and 5-7 parts of Raw Licorice.

2. The Jinzhulijiao Chinese medicine composition according to claim 1, characterized in that: The weight ratio of stir-fried Coptis chinensis and Evodia rutaecarpa is 3:

1.

3. Use of the Jinzhulijiao Chinese medicine composition as claimed in claim 1 or 2 in the preparation of medicines for treating digestive system diseases.

4. The Jinzhulijiao Chinese medicine composition according to claim 3, characterized in that: The dosage form of the Jinzhulijiao Chinese medicine composition is an oral dosage form.

5. The Jinzhulijiao Chinese medicine composition according to claim 4, characterized in that: The dosage form of the Jinzhulijiao Chinese medicine composition is tablets, capsules, powders or granules.

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