Traditional Chinese medicine composition for treating constipation-type irritable bowel syndrome and application thereof

Abstract

The invention discloses a traditional Chinese medicine composition for treating constipation type irritable bowel syndrome. The traditional Chinese medicine composition is prepared from the following components in parts by weight: 6-15 parts of radix bupleuri, 6-15 parts of parched white paeony root, 6-15 parts of parched fructus aurantii, 3-12 parts of pericarpium citri reticulatae, 6-15 parts of rhizoma cyperi, 6-15 parts of ligusticum wallichii, 3-12 parts of liquorice, 10-45 parts of pericarpium arecae, 10-45 parts of roasted malt, 6-15 parts of mangnolia officinalis, 6-15 parts of parched fructus aurantii immaturus, 5-30 parts of polygonum cuspidatum and 5-30 parts of fructus cannabis. The traditional Chinese medicine composition provided by the invention can obviously improve clinical symptoms of the constipation-type irritable bowel syndrome with liver depression and qi stagnation, and has the characteristics of high effective rate and low recurrence rate.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine preparation, and specifically relates to a traditional Chinese medicine composition for treating constipation-predominant irritable bowel syndrome and its application. Background Art

[0002] Irritable bowel syndrome (IBS) is a common disease caused by abnormal brain-gut axis interaction, most commonly seen in women and young patients, with a prevalence among adults globally ranging from 4.1% (according to the Rome IV criteria) to 10.1% (according to the Rome III criteria) [Oka P, Parr H, Barberio B, Black CJ, et al. Global prevalence of irritable bowel syndrome according to Rome III or IV criteria: a systematic review and meta-analysis[J]. Lancet Gastroenterol Hepatol, 2020;5(10):908-917. Palsson OS, Whitehead W, Törnblom H, et al. Prevalence of Rome IV Functional Bowel Disorders Among Adults in the United States, Canada, and the United Kingdom[J]. Gastroenterology, 2020;158(5):1262-1273.e3. Sperber AD, Bangdiwala SI, Drossman DA, et al. Worldwide Prevalence and Burden of Functional Gastrointestinal Disorders, Results of Rome Foundation Global Study[J]. Gastroenterology, 2021;160(1):99-114.e3.]. The Rome IV criteria define IBS as a disease associated with defecation or accompanied by changes in stool frequency or stool form for more than 6 months, and with abdominal pain.According to stool characteristics, it is divided into four subtypes: constipation-predominant (IBS-C), diarrhea-predominant (IBS-D), mixed (IBS-M), and unclassified (IBS-U) [Vasant DH, Paine PA, Black CJ, et al. British Society of Gastroenterology guidelines on the management of irritable bowel syndrome[J]. Gut, 2021;70(7):1214-1240.]. Irritable bowel syndrome with predominant constipation (IBS-C) accounts for more than one-third of all IBS cases, and abdominal pain or discomfort, prolonged bowel movement intervals, and hard stools are the most typical clinical symptoms.

[0003] Currently, it is considered that the pathogenesis of IBS-C is the result of abnormal gut-brain interaction caused by the combined action of multiple factors [Chinese Society of Gastroenterology, Collaborative Group on Gastrointestinal Functional Disorders, Chinese Society of Gastroenterology, Group on Gastrointestinal Motility. Expert consensus on irritable bowel syndrome in China, 2020 [J]. Chinese Journal of Digestion, 2020, 40(12): 803-818.]. The incidence of visceral hypersensitivity in IBS is 33% - 90% [Gwee KA, Lu CL, Ghoshal UC. Epidemiology of irritable bowel syndrome in Asia: something old, something new, something borrowed [J]. J Gastroenterol Hepatol, 2009;24(10):1601-1607.], which is the main cause of abdominal pain and discomfort in patients with IBS. Abnormal gastrointestinal motility is mainly manifested in the colon. Some studies have found that the colonic transit time in patients with IBS-C is longer than that in patients with IBS-D and IBS-M [DuPont AW, Jiang ZD, Harold SA, et al. Motility abnormalities in irritable bowel syndrome [J]. Digestion, 2014;89(2):119-123.], and the rhythmic reduction of the recto-reflex contraction caused by colonic distension [Kanazawa M, Palsson OS, van Tilburg MA, et al. Motility response to colonic distention is increased in postinfectious irritable bowel syndrome (PI-IBS) [J]. Neurogastroenterol Motil, 2014;26(5):696-704.].Psychological factors are an important factor for patients with moderate to severe IBS to seek medical treatment. Among them, depressive or anxiety disorders are significant risk factors for IBS-C, with an incidence of 40% - 60% in IBS patients. Moreover, mental symptoms are positively correlated with both the severity and frequency of intestinal symptoms [Pinto-Sanchez MI, Ford AC, Avila CA, et al. Anxiety and Depression Increase in a Stepwise Manner in Parallel With Multiple FGIDs and Symptom Severity and Frequency[J]. Am J Gastroenterol, 2015;110(7):1038 - 1048.]. Intestinal microecological imbalance also plays an important role in the pathogenesis of IBS, including changes in the composition ratio of intestinal flora and the activity of metabolites [Li Yannan, Yang Lixuan, Zhao Zhonghui, et al. Interpretation of the 2020 Chinese Expert Consensus on Irritable Bowel Syndrome[J]. Chinese Journal of Clinicians, 2021, 49(10):1151 - 1155.].

[0004] In the "AGA Clinical Practice Guideline on the Pharmacological Management of Irritable Bowel Syndrome With Constipation" [Chang L, Sultan S, Lembo A, et al. AGA Clinical Practice Guideline on the Pharmacological Management of Irritable Bowel Syndrome With Constipation[J]. Gastroenterology, 2022;163(1):118 - 136.], the expert panel reached a consensus on 9 medication recommendations for treating patients with IBS-C: Linaclotide is strongly recommended, and Tenapanor, Plecanatide, Tegaserod, Lubiprostone, polyethylene glycol laxatives, tricyclic antidepressants, and antispasmodics are conditionally recommended, while the use of selective serotonin reuptake inhibitors is opposed. The "2017 Chinese and Western Medicine Integrated Diagnosis and Treatment Consensus on Irritable Bowel Syndrome" developed by the Chinese Society of Integrated Traditional and Western Medicine [Li Junxiang, Chen Jing, Tang Xudong, et al. Chinese and Western Medicine Integrated Diagnosis and Treatment Consensus on Irritable Bowel Syndrome (2017)[J]. Chinese Journal of Integrated Traditional and Western Medicine on Digestion, 2018, 26(03):227 - 232.] recommends the application of gastrointestinal motility drugs to treat IBS-C, mainly to improve abdominal distension and constipation symptoms.

[0005] Modern traditional Chinese medicine classifies IBS-C into "constipation", "abdominal pain", etc. according to different symptoms. Its onset is mostly due to liver qi stagnation, which invades the spleen, and then the spleen loses its transportation and transformation function. The stagnant liver qi runs through the whole disease process. Ye Tianshi [Ma Xiaobing, Liu Li, Fan Zhen, et al. Cluster study on the law of using drugs for treating dampness by Ye Tianshi [J]. Guiding Journal of Traditional Chinese Medicine and Pharmacy, 2017, 23(08): 62-64.] said: "Liver diseases will surely affect the earth element, which is to bully the element it restrains. When it restrains the spleen, there will be abdominal distension, and the stools may be loose or unsmooth." As the key pathogenesis of this disease, liver qi stagnation plays a guiding role in treatment and medication.

[0006] Chaihu Shugan Powder comes from "Complete Works of Jingyue". Its main effects are to soothe the liver and relieve depression, regulate qi and relieve pain, and treat pain in both hypochondriac regions, chest tightness with frequent sighing, irritability and anger, acid regurgitation and belching, abdominal distension and fullness caused by liver qi stagnation. It is widely used in the treatment of various common digestive system diseases. Multiple Meta-analyses based on clinical RCT trials [Su Kaiqi, Shen Yanting, Lin Liubing, et al. Meta-analysis of randomized controlled clinical trials on the treatment of irritable bowel syndrome with modified Chaihu Shugan Powder [J]. Tianjin Journal of Traditional Chinese Medicine, 2017, 34(12): 802-805. Liu Lei, Gan Chun, Deng Lingnan. Systematic evaluation of the efficacy of Chaihu Shugan Powder in the treatment of irritable bowel syndrome [J]. Jiangxi Journal of Traditional Chinese Medicine, 2019, 50(04): 53-56. Chen Ruiyi, Cao Hui, Wei Fangmin, et al. Meta-analysis and sequential analysis of Chaihu Shugan Powder in the treatment of irritable bowel syndrome [J]. Clinical Journal of Chinese Medicine, 2022, 14(04): 145-148.] jointly show that Chaihu Shugan Powder has positive significance for the total effective rate of treating IBS, clinical symptom scores (abdominal pain, abdominal distension, stool characteristics, frequency of defecation, depression scale), etc., is superior to conventional western medicine treatment, and no obvious adverse reactions occur. Summary of the Invention

[0007] The purpose of the present invention is to provide a traditional Chinese medicine composition for treating constipation-predominant irritable bowel syndrome.

[0008] Another purpose of the present invention is to provide an application of the above-mentioned traditional Chinese medicine composition in the preparation of a drug for treating constipation-predominant irritable bowel syndrome.

[0009] In order to achieve the above purposes, the technical scheme adopted by the present invention is as follows:

[0010] In the first aspect of the present invention, there is provided a traditional Chinese medicine composition for treating constipation-predominant irritable bowel syndrome, which is made from the following components in parts by weight:

[0011] Bupleurum chinense DC. 6-15 parts, stir-fried Paeonia lactiflora Pall. 6-15 parts, stir-fried Fructus Aurantii 6-15 parts, Pericarpium Citri Reticulatae 3-12 parts, Cyperus rotundus L. 6-15 parts, Rhizoma Chuanxiong 6-15 parts, Glycyrrhiza uralensis Fisch. 3-12 parts, Areca peel 10-45 parts, stir-fried Fructus Hordei Germinatus 10-45 parts, Magnolia officinalis Rehd. et Wils. 6-15 parts, stir-fried Fructus Aurantii Immaturus 6-15 parts, Polygonum cuspidatum Sieb. et Zucc. 5-30 parts, Cannabis seed 5-30 parts.

[0012] The traditional Chinese medicine composition is made from the following components in parts by weight:

[0013] 9 parts of Bupleuri Radix, 12 parts of Paeoniae Radix Alba Praeparata, 12 parts of Aurantii Fructus Immaturus Praeparatus, 6 parts of Citri Reticulatae Pericarpium, 12 parts of Cyperi Rhizoma, 9 parts of Chuanxiong Rhizoma, 6 parts of Glycyrrhizae Radix, 30 parts of Arecae Pericarpium, 30 parts of Hordei Fructus Germinatus Praeparatus, 12 parts of Magnoliae Officinalis Cortex, 12 parts of Aurantii Fructus Immaturus Praeparatus, 15 parts of Polygoni Cuspidati Rhizoma et Radix, 15 parts of Cannabis Semen.

[0014] The traditional Chinese medicine composition is made from the following components in parts by weight:

[0015] 6 parts of Bupleuri Radix, 8 parts of Paeoniae Radix Alba Praeparata, 8 parts of Aurantii Fructus Immaturus Praeparatus, 3 parts of Citri Reticulatae Pericarpium, 6 parts of Cyperi Rhizoma, 6 parts of Chuanxiong Rhizoma, 3 parts of Glycyrrhizae Radix, 20 parts of Arecae Pericarpium, 20 parts of Hordei Fructus Germinatus Praeparatus, 8 parts of Magnoliae Officinalis Cortex, 8 parts of Aurantii Fructus Immaturus Praeparatus, 10 parts of Polygoni Cuspidati Rhizoma et Radix, 10 parts of Cannabis Semen.

[0016] The traditional Chinese medicine composition is made from the following components in parts by weight:

[0017] 15 parts of Bupleuri Radix, 15 parts of Paeoniae Radix Alba Praeparata, 15 parts of Aurantii Fructus Immaturus Praeparatus, 12 parts of Citri Reticulatae Pericarpium, 15 parts of Cyperi Rhizoma, 15 parts of Chuanxiong Rhizoma, 9 parts of Glycyrrhizae Radix, 40 parts of Arecae Pericarpium, 40 parts of Hordei Fructus Germinatus Praeparatus, 15 parts of Magnoliae Officinalis Cortex, 15 parts of Aurantii Fructus Immaturus Praeparatus, 20 parts of Polygoni Cuspidati Rhizoma et Radix, 20 parts of Cannabis Semen.

[0018] The traditional Chinese medicine composition is made from the following components in parts by weight:

[0019] 10 parts of Bupleuri Radix, 10 parts of Paeoniae Radix Alba Praeparata, 10 parts of Aurantii Fructus Immaturus Praeparatus, 9 parts of Citri Reticulatae Pericarpium, 10 parts of Cyperi Rhizoma, 10 parts of Chuanxiong Rhizoma, 6 parts of Glycyrrhizae Radix, 30 parts of Arecae Pericarpium, 15 parts of Hordei Fructus Germinatus Praeparatus, 12 parts of Magnoliae Officinalis Cortex, 12 parts of Aurantii Fructus Immaturus Praeparatus, 20 parts of Polygoni Cuspidati Rhizoma et Radix, 20 parts of Cannabis Semen.

[0020] The traditional Chinese medicine composition is made from the following components in parts by weight:

[0021] 12 parts of Bupleuri Radix, 15 parts of Paeoniae Radix Alba Praeparata, 15 parts of Aurantii Fructus Immaturus Praeparatus, 12 parts of Citri Reticulatae Pericarpium, 15 parts of Cyperi Rhizoma, 15 parts of Chuanxiong Rhizoma, 9 parts of Glycyrrhizae Radix, 15 parts of Arecae Pericarpium, 15 parts of Hordei Fructus Germinatus Praeparatus, 9 parts of Magnoliae Officinalis Cortex, 9 parts of Aurantii Fructus Immaturus Praeparatus, 15 parts of Polygoni Cuspidati Rhizoma et Radix, 15 parts of Cannabis Semen.

[0022] The traditional Chinese medicine composition of the present invention is used to treat the following disease: constipation-predominant irritable bowel syndrome with liver qi stagnation syndrome.

[0023] In the second aspect of the present invention, there is provided an application of the traditional Chinese medicine composition in the preparation of a medicament for treating constipation-predominant irritable bowel syndrome.

[0024] In the third aspect of the present invention, there is provided a pharmaceutical preparation which is made from the traditional Chinese medicine composition and pharmaceutically acceptable excipients.

[0025] The dosage form of the pharmaceutical preparation is selected from the group consisting of decoction, tablets, mixture, oral liquid, granules, pills, capsules, umbilical patches, suppositories, and syrup.

[0026] The pharmaceutically acceptable excipients are selected from at least one of fillers, disintegrants, binders, lubricants, and flavoring agents.

[0027] In the fourth aspect of the present invention, there is provided an application of a pharmaceutical preparation in the preparation of a medicament for treating constipation-predominant irritable bowel syndrome.

[0028] In the formula, Bupleuri Radix and Cyperi Rhizoma are used together, which are good at soothing the liver and relieving depression, regulating qi and relieving distension, and promoting digestion and evacuation, and they are the monarch drugs in total. Chuanxiong Rhizoma enters the jueyin liver meridian, can relieve the depression of wind-wood, disperse stagnant qi and break stasis, and cooperate with Bupleuri Radix to promote the recovery of the normal dispersing and discharging function of the liver, and regulate qi without damaging healthy qi. Chuanxiong Rhizoma, known as "the qi drug in blood", and Cyperi Rhizoma, known as "the blood drug in qi", are combined together to regulate both qi and blood, disperse stagnation and relieve pain, and assist Bupleuri Radix to soothe liver qi and relieve liver depression. Fructus Aurantii Immaturus, Fructus Aurantii, and Pericarpium Arecae are all qi-regulating drugs, which are of descending nature and act downward. Bupleuri Radix is of ascending nature. When used together, the ascending and descending of the liver and spleen qi mechanisms are coordinated, the liver qi is smooth, and the spleen can function in transportation, with the functions of regulating qi and promoting digestion, removing mass and relieving accumulation. Cortex Magnoliae Officinalis Praeparata enters the large intestine meridian, can regulate the gastrointestinal motility function, promote the ascending and descending of qi movement, prevent dampness pathogen from blocking, assist the spleen in healthy transportation, can not only remove the formless dampness and fullness, but also eliminate the tangible excess fullness, and is the key drug for relieving distension and fullness. The above five drugs are the ministerial drugs in total. Germinated Fructus Hordei Vulgaris can arouse the spleen to regulate qi, promote digestion and harmonize the stomach. When combined with multiple qi-regulating and mass-removing drugs, it is used in combination with one being urgent and the other being slow, one for purging and the other for tonifying, purging and tonifying simultaneously, so that the ascending and descending of the spleen and stomach qi mechanisms are orderly, the middle energizer can function in transportation, and healthy qi is not damaged. The liver stores blood, is yin in nature and yang in function. Paeoniae Radix Alba is sour and bitter, can relieve spasm and pain, nourish blood and soothe the liver, and is in the position of assistant drug together with germinated Fructus Hordei Vulgaris. In patients with IBS-C, the dryness of stools is obvious, and the course of disease is longer than 6 months. Only regulating qi and removing mass often has the drawback of insufficient efficacy. Therefore, Polygoni Cuspidati Rhizoma is added appropriately to clear heat and purge the bowels, and cooperate with Fructus Aurantii Immaturus to regulate qi and promote defecation through the bowel; Semen Cannabis can directly reach the affected area and moisten the intestines and relieve constipation. These four drugs are in the position of assistant drug together. Pericarpium Citri Reticulatae regulates qi, and Glycyrrhizae Radix et Rhizoma harmonizes all the drugs, playing the role of assistant and guiding drugs. Thus, all the drugs are used together to achieve the effects of soothing the liver and regulating qi, relieving depression and removing mass.

[0029] The nature, flavor, meridian tropism, functions and indications of the traditional Chinese medicine raw materials in the present invention are as follows:

[0030] Bupleurum: Bupleurum has a slightly cold nature, a pungent and bitter taste, and belongs to the liver, gallbladder, and lung meridians. Under the guidance of the state-target theory, the symptom targets of Bupleurum are fever, anxiety and depression, bitter taste in the mouth, amenorrhea, delayed menstruation, and discomfort in the chest and hypochondrium [Wang Rui, Shen Mengfei, Wu Hui, et al. Reconstructing Materia Medica - Bupleurum [J]. Journal of Changchun University of Chinese Medicine, 2024, 40(04): 367-370.]. Bupleurum saponin A, D, and total saponins of Bupleurum are the key active ingredients in the antidepressant effect of Bupleurum. It can play a role through channels such as inhibiting the apoptosis of nerve cells, regulating mood-related monoamine neurotransmitters, promoting brain-derived neurotrophic factor, improving the intestinal flora, and regulating protein expression [Wang Haiqiang, Zhou Qianyao, Li Bingqi, et al. Research progress on the chemical constituents and pharmacological effects of Bupleurum [J]. Jilin Journal of Chinese Medicine, 2024, 44(01): 96-100. Zhang Mingyuan, Xu Erping, Chen Yiheng, et al. Research status of the pharmacological effects of Bupleurum in the treatment of depression [J]. Chinese Archives of Traditional Chinese Medicine, 2023, 41(10): 102-108.].

[0031] White Peony Root: White Peony Root has a bitter, sour, and slightly cold nature and belongs to the liver and spleen meridians, with the effects of nourishing blood and regulating menstruation, soothing the liver and relieving pain, etc. White Peony Root and its extract total glucosides of paeony (TGP) have a wide range of pharmacological activities. Research shows that it has the effects of regulating prostaglandins and receptor analgesia, inhibiting cholinergic-like effects, calcium antagonism, antihistamine, and parasympathetic nerve excitation to relieve spasm [Dai Qianqian, Xia Huan, Xia Guiyang, et al. Research progress on the analgesic efficacy and mechanism of white peony root prescriptions and total glucosides of paeony [J]. World Science and Technology - Modernization of Traditional Chinese Medicine, 2020, 22(01): 39-46.]. In addition, TGP also has the effects of alleviating acute liver injury, anti-thrombosis, laxative, and regulating immunity [Zhao Jingyi, Ma Kele, Zhang Wei, et al. Reconstructing Materia Medica - White Peony Root [J]. Journal of Changchun University of Chinese Medicine, 2024, 40(01): 16-19.].

[0032] Fructus Aurantii Immaturus: Fructus Aurantii Immaturus is bitter, pungent, sour, and slightly cold in nature. It acts on the spleen and stomach meridians, and can regulate qi, soothe the middle, promote qi movement, and relieve distension. It is used for syndromes such as chest and hypochondrium fullness and discomfort, indigestion of food accumulation, and internal retention of phlegm-fluid. Fructus Aurantii Immaturus is often used clinically in compound forms and has curative effects on IBS, gastroesophageal reflux disease, FD, etc. [Xun Jing, Miao Deguang, Lu Yucheng, et al. Mechanism study on the compatibility of Bupleuri Radix and Fructus Aurantii Immaturus in the treatment of functional dyspepsia based on network pharmacology [J]. Chinese Medicine Modern Distance Education of China, 2024, 22(09): 82-85.]. The extract of Fructus Aurantii Immaturus and its active components such as flavonoids, volatile oils, alkaloids, and coumarins achieve the bidirectional regulation of gastrointestinal motility and treat diseases related to gastrointestinal motility disorders by regulating the secretion and activation of MTL, gastrin (GAS), cholecystokinin (CCK), and ghrelin, regulating neural pathways, and affecting interstitial cells of Cajal [Zhong Minyong, Tuo Fulin, Qiao Rifa, et al. Validation of the effectiveness of quality markers for regulating qi in Fructus Aurantii Immaturus [J]. Traditional Chinese Drug Research and Clinical Pharmacology, 2022, 33(03): 281-286. Yu Junbao, Zhu Jiayuan, Mei Wenya, et al. Research progress on the mechanism of Fructus Aurantii Immaturus and its active components in regulating gastrointestinal motility [J]. Chinese Journal of Experimental Traditional Medical Formulae, 2024, 30(10): 290-298.].

[0033] Pericarpium Citri Reticulatae: Pericarpium Citri Reticulatae is pungent and bitter in taste and warm in nature. It acts on the spleen, stomach, and lung meridians. It is good at regulating qi and soothing the middle, drying dampness and resolving phlegm, and promoting diuresis and defecation. Huang Yuanyu's "Explanation of Drugs in Treatise on Febrile Diseases" states that "Pericarpium Citri Reticulatae can descend turbid yin to stop vomiting and retching, and promote qi movement to relieve stagnation and fullness". Research shows that Pericarpium Citri Reticulatae can promote gastrointestinal motility, and its main mechanism is to enhance the activity of pepsin, increase the secretion of gastric acid, the content of MTL, GAS, and β-endorphin in plasma, down-regulate the leptin level in the hypothalamus, and up-regulate the NPY level [Guan Xutao, Yang Henian, Zhang Jincheng, et al. Research progress on the chemical constituents and pharmacological effects of Pericarpium Citri Reticulatae [J]. Chinese Archives of Traditional Chinese Medicine, 2024, 42(06): 41-49. Zhang Xu, Ji Zhongqi, Zhao Changmin, et al. Effects of Pericarpium Citri Reticulatae extract on gastric emptying, intestinal propulsion in mice and isolated ileum smooth muscle of rabbits [J]. Journal of Henan University (Medical Science), 2012, 31(01): 12-14. Yuan Li, Yu Jinrong, Li Jun, et al. Improvement effect and mechanism study of Pericarpium Citri Reticulatae on anorexia in young rats [J]. Shaanxi Journal of Traditional Chinese Medicine, 2020, 41(05): 585-588.].

[0034] Cyperus rotundus: Cyperus rotundus is pungent, slightly bitter, slightly sweet, and has a neutral nature. It belongs to the liver, spleen, and triple energizer meridians, and has the effects of soothing the liver and relieving depression, regulating qi and widening the middle, and regulating menstruation and relieving pain [Wang FX, Qian Q, Li BL, et al. Research progress on chemical constituents and pharmacological effects of Cyperus rotundus and prediction analysis of quality markers (Q-Markers) [J]. Chinese Traditional and Herbal Drugs, 2022, 53(16): 5225-5234.]. The research group of Meng XS [Zheng Y, Liu SC, Luo X, et al. Structure-activity relationship of anti-inflammatory and analgesic effects of Cyperus rotundus in Qizhi Weitong Granule [J]. Chinese Journal of Experimental Traditional Medical Formulae, 2024, 30(21): 153-160.] speculated from the perspective of structure-activity relationship that the structure of flavonoid components of Cyperus rotundus acts on the targets TP53 and PTGS2, inhibits the overexpression of cyclooxygenase-2, the gene expression product of PTGS2, during inflammatory stimulation, and thus participates in the protection of intestinal cells, regulation of vascular relaxation of vascular smooth muscle, and vasoconstriction of platelets [Maleki SJ, Crespo JF, Cabanillas B. Anti-inflammatory effects of flavonoids [J]. Food Chem, 2019; 299: 125124.], playing a good anti-inflammatory and analgesic role, and reflecting the effects of Cyperus rotundus in promoting blood circulation to remove blood stasis and regulating qi to relieve pain.

[0035] Ligusticum chuanxiong: Ligusticum chuanxiong has a warm nature, is pungent and slightly sweet, and belongs to the liver, gallbladder, and pericardium meridians. It is recorded in "Chinese Herbal Medicine" that it has the effects of promoting qi circulation and relieving depression, expelling wind and drying dampness, and promoting blood circulation and relieving pain. The research on the pharmacological effects of phthalide components in Ligusticum chuanxiong mainly focuses on cardiovascular and cerebrovascular diseases, nervous system diseases, anti-inflammatory, antioxidant, antibacterial and anti-insect, and anti-tumor aspects [Li YQ, Liu RQ, Liu XJ, et al. Research progress on pharmacological effects and pharmacokinetics of phthalide components in Ligusticum chuanxiong [J]. Chinese Traditional Patent Medicine, 2024, 46(01): 193-198.]. It is found that ferulic acid, the main absorbed component of Ligusticum chuanxiong, can increase the level of Ghrelin hormone in rats after administration, regulate hippocampal synaptic plasticity, and improve the depressive state [Gao Z, Sun B, Cai YW, et al. Multidisease study of Salvia miltiorrhiza-Ligusticum chuanxiong-Carthamus tinctorius on depression-cardiac injury in rats after craniocerebral injury [J]. Tianjin Journal of Traditional Chinese Medicine, 2024, 41(02): 199-206. Huang HJ, Chen XR, Han QQ, et al. The protective effects of Ghrelin / GHSR on hippocampal neurogenesis in CUMS mice [J]. Neuropharmacology, 2019; 155: 31-43.].

[0036] Licorice: Licorice has a sweet and neutral taste and belongs to the heart, lung, spleen, and stomach meridians. It has the effects of relieving spasm and pain, resolving phlegm and relieving cough, detoxifying and clearing heat, tonifying qi and strengthening the middle, and harmonizing various medicinal herbs. Relevant research shows that liquiritin has a good antidepressant effect [Wang Xiuyun, Li Yun, Zhu Hanxiao, et al. Effects of liquiritin on the expression of brain-derived neurotrophic factor, Bax, and Bcl-2 proteins in the prefrontal cortex of rats with post-stroke depression [J]. Chinese Journal of Geriatric Heart, Brain and Vessel Diseases, 2021, 23(06): 647-650.]. Licorice polysaccharide can achieve the purpose of protecting the liver by neutralizing free radicals in the liver, repairing damaged liver cell membranes, and increasing the activity of liver tissue, which is in line with the effects of licorice in detoxifying and harmonizing various medicinal herbs [Zhang Yuqian, Jiang Wenjun, Lv Hao, et al. Glycyrrhizic acid inhibits cochlear inflammation in C57BL / 6J mice and reduces cisplatin-induced ototoxicity [J]. Chinese Journal of Pathophysiology, 2024, 40(02): 291-300. Chen Dongxue, Chen Liang. Protective effect and mechanism of licorice polysaccharide on CCl4-induced acute liver injury model mice [J]. China Pharmacy, 2016, 27(10): 1322-1325.].

[0037] Areca Peel: "Compendium of Materia Medica Collection" records that it is "a fast-acting medicine for regulating qi and relieving distension in the middle energizer". It is slightly warm in nature, pungent in taste, and belongs to the spleen, stomach, large intestine, and small intestine meridians, with the effects of promoting qi circulation and relieving distension in the middle energizer, promoting diuresis and reducing edema. Its main active ingredients include alkaloids, phenols, oils, flavonoids, tannins, terpenoids, and steroids, etc. [Jing Yongshuai, Zhang Yuwei, Zhang Danshen, et al. Research progress on the textual research, chemical composition, and pharmacological effects of areca peel [J]. China Pharmacy, 2021, 32(14): 1784-1788. Tang Lijuan. Research on the quality standard of areca peel and the processing technology of its decoction pieces [D]. Nanjing University of Chinese Medicine, 2019.]. Research shows that the main mechanism of areca peel in treating gastrointestinal dysfunction caused by qi stagnation in the stomach and intestines is to increase the distribution of cholinergic nerves in the myenteric plexus of the gastrointestinal tract, promote the release of acetylcholine, regulate the secretion of gastrointestinal peptide hormones, and increase the excitability of the vagus nerve, etc. [Yuan Yuan, Liu Yangyang, Gong Xiao, et al. Comparison of antioxidant properties and component analysis of areca peel processed by different roasting methods [J]. Lishizhen Medicine and Materia Medica Research, 2020, 31(08): 1870-1873.].

[0038] Stir-fried Fructus Hordei Germinatus: Fructus Hordei Germinatus is neutral in nature, sweet in taste, and belongs to the spleen, stomach, and liver meridians. "Medicinal Properties" records that Fructus Hordei Germinatus can "digest accumulated food, disperse cold qi, and relieve fullness in the heart and abdomen" [Lin Chen, Ma Yizhong, Wang Yujie, et al. Experience of Wang Jianyi in treating stomach fullness with Liuwei Xiaopi Decoction [J]. Shanghai Journal of Traditional Chinese Medicine, 2023, 57(10): 39-43.]. Research shows that stir-fried Fructus Hordei Germinatus contains various amylases, which can promote the secretion of pepsin, increase the production of gastric acid, and then accelerate the decomposition, digestion, and absorption of food; it can not only promote intestinal peristalsis, increase the tension and contraction frequency of the digestive tract smooth muscle, but also increase the expression of intestinal AQP2 and AQP3 proteins, promote the transportation and transformation of water and dampness, and thus regulate gastrointestinal motility [Wu Lu, Lai Yan, Wang Ying, et al. Discussion on the mechanism of "stir-frying to fragrance and waking the spleen" of Fructus Hordei Germinatus from the perspective of digestive function based on the Maillard reaction [J]. Chinese Archives of Traditional Chinese Medicine, 2019, 37(12): 2905-2910. Hu Yunyao, Tan Peng, Yang Ting, et al. Research on the quality bioactivity determination method of 4 kinds of Chinese herbs for promoting digestion: selection of digestive enzyme types and determination of activity titer [J]. Chinese Traditional and Herbal Drugs, 2023, 54(07): 2106-2113.].

[0039] Magnolia officinalis: Processed Magnolia officinalis is warm in nature, bitter and pungent in taste, and belongs to the spleen, stomach, lung, and large intestine meridians. It has the effects of resolving phlegm, drying dampness, and lowering qi to relieve fullness. Clinically, it is commonly used for epigastric fullness, vomiting and diarrhea, dampness stagnating the middle-jiao, food accumulation and qi stagnation, abdominal distension and constipation, etc. [Qian Jinxiu, Meng Wuwei, Liu Huihui, et al. Textual research on Magnolia officinalis in classical famous formulas [J]. Chinese Journal of Experimental Traditional Medical Formulae, 2022, 28(10): 306-317.]. Modern research shows that the active ingredients contained in Magnolia officinalis, such as magnolol, honokiol, alkaloids, volatile oils, and polysaccharides, have the effects of anti-inflammatory, antibacterial, anti-tumor, antidepressant, and promoting gastrointestinal digestion [Wang Jing, Lai Yongquan. Analysis of the medication rules of traditional Chinese medicine formulae related to Magnolia officinalis in the Chinese Pharmacopoeia based on data mining [J]. Pharmacy Today, 2024, 34(05): 352-359. Zhang Mingfa, Shen Yaqin. Research progress on the pharmacological effects of traditional Chinese medicine Magnolia officinalis and its components magnolol and honokiol against various cocci in vitro [J]. Anti-Infection Pharmacy, 2021, 18(09): 1241-1244.].

[0040] Immature Bitter Orange: Immature Bitter Orange was first recorded in "Shennong's Classic of Materia Medica". It is bitter, sour, and pungent in taste, warm in nature, and belongs to the spleen, stomach, and large intestine meridians. It has the effects of breaking qi to eliminate accumulation and resolving phlegm to relieve fullness. Lin Yili et al. [Lin Yili, HU Ze-yuan, Tan Renqian, et al. Effects of Immature Bitter Orange on IL-6, SCF, and MTL in rats with functional dyspepsia [J]. Shanxi Journal of Traditional Chinese Medicine, 2020, 36(01): 52-53.] used drug gavage and HE staining method to observe the pathological changes of the gastric antrum tissue in rats with functional dyspepsia. The results showed that Immature Bitter Orange could improve gastrointestinal motility disorders by reducing the serum interleukin-6 level and increasing the levels of stem cell factor and motilin (MTL) in rats.

[0041] Polygonum cuspidatum: Polygonum cuspidatum tastes slightly bitter and is slightly cold in nature. It belongs to the liver, gallbladder, and lung meridians and has the functions of promoting diuresis to reduce jaundice, clearing heat and detoxifying, dissipating stasis and relieving pain, and relieving cough and resolving phlegm. Polygonum cuspidatum, also known as "soil rhubarb", can purge the heat of the stomach and intestines and has the effect of purging heat and promoting defecation. It can be used for constipation due to heat accumulation and bleeding from hemorrhoids [Hou Qiyun, Zhang Linlin, Hao Yanqi, et al. Research progress on Polygonum cuspidatum and prediction of quality markers [J]. Modern Chinese Medicine, 2024, 26(05): 912-926. Yan Hong. Observation on the curative effect of acidic polysaccharide from Polygonum cuspidatum on ulcerative colitis in mice [D]. Sichuan Agricultural University, 2023.]. Yan Hong [Bai Yuxin, Tong Rongsheng, Li Jinqi. Overview of the effects of different doses and compatibilities on the efficacy of Polygonum cuspidatum [J]. China Pharmacy, 2016, 27(01): 105-107.] proposed through experiments that acidic polysaccharide from Polygonum cuspidatum is one of the main active components of Polygonum cuspidatum, which can improve the intestinal flora structure of mice, upregulate beneficial intestinal bacteria, thereby reducing inflammatory factors, improving intestinal mucosal inflammation, and restoring intestinal barrier function.

[0042] Fructus Cannabis: Fructus Cannabis is a traditional crop with both medicinal and edible uses. It tastes sweet and is neutral in nature. It belongs to the spleen, stomach, and large intestine meridians and has the effects of moistening the intestines and promoting defecation, tonifying the middle-jiao and replenishing qi, etc. It is an important medicine for constipation, especially suitable for the elderly patients with constipation due to deficiency of blood and body fluid and dryness of the intestines. Its active substances are chemical components such as lignanamides, alkaloids, and flavonoids, which show significant curative effects in relieving constipation through multiple mechanisms such as regulating the intestinal microenvironment, affecting the expression of AQP proteins, and regulating neurotransmitters [Quan Qiyuan, Li Shuo, Yang Xiujuan, et al. Research progress on the chemical constituents of Fructus Cannabis and its mechanism of treating constipation [J]. Chinese Traditional Patent Medicine, 2023, 45(09): 2986-2996.].

[0043] Due to the adoption of the above technical solutions, the present invention has the following advantages and beneficial effects:

[0044] The traditional Chinese medicine composition of the present invention has the effects of soothing the liver, promoting qi flow, relieving pain, eliminating stagnation, and promoting defecation for the pathogenesis of constipation-predominant irritable bowel syndrome with liver qi stagnation syndrome, that is, "liver qi stagnation, abnormal conduction of the large intestine, obstruction of the intestinal lumen, and difficult defecation of constipation".

[0045] The traditional Chinese medicine composition of the present invention can significantly improve the clinical symptoms of constipation-predominant irritable bowel syndrome with liver qi stagnation syndrome, and has the characteristics of high efficiency and low recurrence rate.

[0046] The traditional Chinese medicine composition of the present invention has no toxic and side effects and can be made into capsules, granules, tablets, oral liquid mixtures or syrups, which are easy to be accepted by patients. Description of the Drawings

[0047] Figure 1 It is a schematic diagram of the comparison results of the total scores of two groups of traditional Chinese medicine symptoms.

[0048] Figure 2It is a schematic diagram showing the changing trends of the TCM symptom scores of two groups.

[0049] Figure 3 It is a schematic diagram showing the comparison results of the effective rates of two groups of patients. Specific implementation manners

[0050] To illustrate the present invention more clearly, the present invention will be further described below in conjunction with preferred embodiments. Those skilled in the art should understand that the content specifically described below is illustrative rather than restrictive, and should not be used to limit the protection scope of the present invention.

[0051] Example 1

[0052] A preparation method of a traditional Chinese medicine composition granule comprises the following steps:

[0053] Mix 9 g of Bupleuri Radix, 12 g of Paeoniae Radix Alba Praeparata, 12 g of Aurantii Fructus Immaturus Praeparata, 6 g of Citri Reticulatae Pericarpium, 12 g of Cyperi Rhizoma, 9 g of Chuanxiong Rhizoma, 6 g of Glycyrrhizae Radix, 30 g of Arecae Pericarpium, 30 g of Hordei Fructus Germinatus Praeparata, 12 g of Magnoliae Officinalis Cortex, 12 g of Aurantii Fructus Immaturus Praeparata, 15 g of Polygoni Cuspidati Rhizoma, and 15 g of Cannabis Semen; extract with water by reflux for 3 times (1000 ml, 1 hour; 1000 ml, 1 hour; 1000 ml, 1 hour), combine the extracts, concentrate, dry, pulverize to obtain the granule.

[0054] Example 2

[0055] A traditional Chinese medicine composition preparation is made from the following components in parts by weight:

[0056] Mix 6 g of Bupleuri Radix, 8 g of Paeoniae Radix Alba Praeparata, 8 g of Aurantii Fructus Immaturus Praeparata, 3 g of Citri Reticulatae Pericarpium, 6 g of Cyperi Rhizoma, 6 g of Chuanxiong Rhizoma, 3 g of Glycyrrhizae Radix, 20 g of Arecae Pericarpium, 20 g of Hordei Fructus Germinatus Praeparata, 8 g of Magnoliae Officinalis Cortex, 8 g of Aurantii Fructus Immaturus Praeparata, 10 g of Polygoni Cuspidati Rhizoma, and 10 g of Cannabis Semen and grind them finely; extract with water by reflux for 3 times (1000 ml, 1 hour; 1000 ml, 1 hour; 1000 ml, 1 hour), combine the extracts, concentrate to obtain an extract; add appropriate pharmaceutical excipients (such as white sugar, honey, benzoic acid or ethylparaben, etc.) to make pills, mixtures, oral liquids or syrups.

[0057] Example 3

[0058] A traditional Chinese medicine composition preparation is made from the following components in parts by weight:

[0059] Mix 15 g of Bupleuri Radix, 15 g of Paeoniae Radix Alba Praeparata, 15 g of Aurantii Fructus Immaturus Praeparata, 12 g of Citri Reticulatae Pericarpium, 15 g of Cyperi Rhizoma, 15 g of Chuanxiong Rhizoma, 9 g of Glycyrrhizae Radix, 40 g of Arecae Pericarpium, 40 g of Hordei Fructus Germinatus Praeparata, 15 g of Magnoliae Officinalis Cortex, 15 g of Aurantii Fructus Immaturus Praeparata, 20 g of Polygoni Cuspidati Rhizoma et Radix, and 20 g of Cannabis Semen; perform reflux extraction with water 3 times (1000 ml, 1 hour; 1000 ml, 1 hour; 1000 ml, 1 hour), combine the extraction solutions, concentrate to obtain an extract, and dry and pulverize the extract to prepare granules.

[0060] Example 4

[0061] A traditional Chinese medicine composition preparation is made from the following components in parts by weight:

[0062] Mix 10 g of Bupleuri Radix, 10 g of Paeoniae Radix Alba Praeparata, 10 g of Aurantii Fructus Immaturus Praeparata, 9 g of Citri Reticulatae Pericarpium, 10 g of Cyperi Rhizoma, 10 g of Chuanxiong Rhizoma, 6 g of Glycyrrhizae Radix, 30 g of Arecae Pericarpium, 15 g of Hordei Fructus Germinatus Praeparata, 12 g of Magnoliae Officinalis Cortex, 12 g of Aurantii Fructus Immaturus Praeparata, 20 g of Polygoni Cuspidati Rhizoma et Radix, and 20 g of Cannabis Semen; perform reflux extraction with water 3 times (1000 ml, 1 hour; 1000 ml, 1 hour; 1000 ml, 1 hour), combine the extraction solutions, concentrate to obtain an extract, dry and pulverize the extract to prepare granules, add pharmaceutical excipients, and press into tablets or fill into capsules.

[0063] Example 5

[0064] A traditional Chinese medicine composition preparation is made from the following components in parts by weight:

[0065] Mix 12 g of Bupleuri Radix, 15 g of Paeoniae Radix Alba Praeparata, 15 g of Aurantii Fructus Immaturus Praeparata, 12 g of Citri Reticulatae Pericarpium, 15 g of Cyperi Rhizoma, 15 g of Chuanxiong Rhizoma, 9 g of Glycyrrhizae Radix, 15 g of Arecae Pericarpium, 15 g of Hordei Fructus Germinatus Praeparata, 9 g of Magnoliae Officinalis Cortex, 9 g of Aurantii Fructus Immaturus Praeparata, 15 g of Polygoni Cuspidati Rhizoma et Radix, and 15 g of Cannabis Semen; perform reflux extraction with water 3 times (1000 ml, 1 hour; 1000 ml, 1 hour; 1000 ml, 1 hour), combine the extraction solutions, and concentrate into a decoction.

[0066] Example 6

[0067] 1 Research Data

[0068] 1.1 Case Source

[0069] All cases were from IBS-C patients who visited the general outpatient clinic, expert outpatient clinic, special needs outpatient clinic, and the digestive medicine ward of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine from March 2023 to January 2024.

[0070] 1.2 Sample Size Calculation

[0071] This experimental protocol is a randomized controlled clinical study. The main outcome measure is the clinical effective rate. According to the literature, the effective rate of using mosapride citrate tablets to treat IBS-C patients for 4 weeks is 71.70% (Cheng Yanhong, Jiang Baoling, Zhang Wenjuan. Efficacy observation of combined use of bifidobacterium lactobacillus triple viable tablets and mosapride in patients with constipation-predominant irritable bowel syndrome [J]. Guizhou Medical Journal, 2022, 46(01): 77-78.); According to relevant experiments and clinical experience, the effective rate of treating IBS-C with modified Chaihu Shugan Powder is 95.83% (Chu Lin, Tang Haijun. Efficacy observation of modified Chaihu Shugan Powder in the treatment of constipation-predominant irritable bowel syndrome [J]. Journal of Practical Traditional Chinese Internal Medicine, 2019, 33(11): 24-26.). Taking α = 0.05 and β = 0.10, using a two-sided test, the traditional Chinese medicine group and the western medicine group are allocated in a 1:1 ratio. The sample size of each group is estimated to be 36 by PASS 15.0. Considering a 10% dropout rate, a total of 80 patients are needed to enter this study.

[0072] 2 Diagnostic and case selection criteria

[0073] 2.1 Western medicine diagnostic criteria

[0074] Formulated with reference to the "Expert Consensus on Irritable Bowel Syndrome in China 2020" standard:

[0075] (1) Clinical manifestations: Recurrent abdominal pain, abdominal distension, abdominal discomfort, with any 2 or more of the following (related to defecation; accompanied by changes in defecation frequency; accompanied by changes in fecal characteristics or appearance);

[0076] (2) Course of disease: Symptoms have occurred for at least 6 months before diagnosis, and meet the above diagnostic criteria in the past 3 months;

[0077] (3) Typing characteristics: In defecation (calculated by days), >1 / 4 is type 1 or 2 in the Bristol Stool Form Scale, and <1 / 4 of the defecation is type 6 or 7.

[0078] 2.2 Traditional Chinese medicine diagnostic criteria

[0079] The liver qi stagnation syndrome of IBS-C is formulated with reference to the "Expert Consensus on Traditional Chinese Medicine Diagnosis and Treatment of Irritable Bowel Syndrome" (2017):

[0080] (1) Main symptoms: Difficult defecation; Abdominal pain or distension;

[0081] (2) Secondary symptoms: Chest tightness and discomfort; Frequent belching; Pain and distension in both flanks;

[0082] (3) Tongue and pulse: Dark red tongue; String-like pulse;

[0083] With 2 main symptoms plus 2 secondary symptoms, referring to the tongue and pulse, the diagnosis can be made.

[0084] 2.3 Inclusion Criteria

[0085] (1) Aged ≥ 18 and ≤ 70 years old, regardless of gender;

[0086] (2) Meeting the Western medicine diagnostic criteria for IBS-C;

[0087] (3) Meeting the traditional Chinese medicine syndrome diagnostic criteria for liver qi stagnation syndrome in IBS-C;

[0088] (4) Understanding and consenting to participate in this study and signing the informed consent form.

[0089] 2.4 Exclusion Criteria

[0090] (1) Having various organic diseases that can cause abdominal pain and constipation;

[0091] (2) Patients with severe primary diseases of important systems such as the heart, brain, liver, lungs, kidneys, blood, and endocrine, as well as severe psychiatric patients;

[0092] (3) Those who are in the process of preparing for pregnancy, pregnant, or lactating and cannot take medicine, those who are allergic to the drugs used in this study; or those who cannot cooperate with taking medicine and completing relevant records due to various reasons;

[0093] (4) Taking antispasmodics or other drugs that affect digestive system function within 2 weeks before enrollment;

[0094] (5) Those who participated in or are participating in other clinical trials within 2 weeks before enrollment.

[0095] 2.5 Exclusion Criteria

[0096] For the enrolled cases, if they meet any of the following criteria, they should be excluded:

[0097] (1) Using the prohibited treatment methods specified in the protocol;

[0098] (2) Cases that have not been treated regularly after inclusion need to be excluded;

[0099] (3) Incomplete medical record data, affecting the determination of curative effect;

[0100] The reasons for the excluded cases should be explained, and their CRF forms should be retained for future reference. The patient data will not be used for curative effect statistical analysis. However, those who have received one treatment and have at least one safety record can participate in the adverse reaction analysis.

[0101] 2.6 Withdrawal Criteria

[0102] The enrolled cases that do not complete the clinical protocol due to the following reasons should be regarded as withdrawals (dropouts):

[0103] (1) Unable to tolerate the test drug or experiencing serious adverse events / adverse reactions related to the treatment plan;

[0104] (2) The patient withdrew on their own (poor efficacy, adverse reactions, special physiological changes, etc.);

[0105] (3) The researcher asked them to withdraw (poor compliance; comorbidities, etc.);

[0106] (4) Patients who naturally dropped out or were lost to follow-up during the treatment process;

[0107] For the cases that dropped out, the reasons should be recorded in detail, and the last main efficacy test result should be transferred as the final result for statistical analysis.

[0108] 3 Treatment plan

[0109] In this study, according to the principles of randomization and control, 80 patients were randomly divided into a traditional Chinese medicine group and a western medicine group, with 40 patients in each group, using SPSS 26.0.

[0110] 3.1 Traditional Chinese medicine composition:

[0111] The prescription consists of 9 g of Bupleuri Radix, 12 g of Paeoniae Radix Alba Praeparata, 12 g of Aurantii Fructus Immaturus Praeparata, 6 g of Citri Reticulatae Pericarpium, 12 g of Cyperi Rhizoma, 9 g of Chuanxiong Rhizoma, 6 g of Glycyrrhizae Radix, 30 g of Arecae Pericarpium, 30 g of Hordei Fructus Germinatus Praeparata, 12 g of Magnoliae Officinalis Cortex, 12 g of Aurantii Fructus Immaturus Praeparata, 15 g of Polygoni Cuspidati Rhizoma, and 15 g of Cannabis Semen.

[0112] Mix the above drugs and extract them by water reflux for 3 times (1000 ml, 1 hour; 1000 ml, 1 hour; 1000 ml, 1 hour), combine the extraction solutions, and concentrate them into a decoction.

[0113] The above drugs are provided by the traditional Chinese medicine pharmacy of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine for decocting and delivering. Instruct the patients to store them below 20 °C, two packages per day, and take them warm 1 hour after breakfast and dinner, for a 4-week course of treatment.

[0114] 3.2 Western medicine group: Mosapride Citrate Dispersible Tablets

[0115] Mosapride Citrate Tablets (produced by Chengdu Kanghong Pharmaceutical Group Co., Ltd., national drug approval number H19990313, specification 5 mg / tablet).

[0116] During the period when the patients participated in the study, the drugs were from the western pharmacy of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine. Instruct the patients to take 1 tablet three times a day, before breakfast, lunch, and dinner, for a 4-week course of treatment.

[0117] 4 Observation indicators

[0118] 4.1 General information of patients

[0119] Before treatment, information such as the patient's gender, age, height, weight, body mass index (BMI), and past medical history was collected.

[0120] 4.2 Traditional Chinese Medicine Symptom Score Scale

[0121] Before the start of treatment, at 2 weeks, 4 weeks of treatment, and during the 4-week follow-up after the end of treatment, the patients were respectively evaluated for the scores of Traditional Chinese Medicine symptoms. The Traditional Chinese Medicine symptom score table was formulated according to the primary and secondary symptoms in the diagnostic criteria of "Consensus on the Integrated Traditional Chinese and Western Medicine Diagnosis and Treatment of Irritable Bowel Syndrome (2017)" and "Expert Consensus on the Traditional Chinese Medicine Diagnosis and Treatment of Irritable Bowel Syndrome (2017)" (Zhang Shengsheng, Wei Wei, Yang Jianqin. Expert Consensus on the Traditional Chinese Medicine Diagnosis and Treatment of Irritable Bowel Syndrome (2017)[J]. Journal of Traditional Chinese Medicine, 2017, 58(18): 1614-1620.

[12] Li Junxiang, Chen Jing, Tang Xudong, etc. Consensus on the Integrated Traditional Chinese and Western Medicine Diagnosis and Treatment of Irritable Bowel Syndrome (2017)[J]. Chinese Journal of Integrated Traditional and Western Medicine on Digestion, 2018, 26(03): 227-232.), and the severity of symptoms proposed in "Guiding Principles for Clinical Research of New Chinese Medicines" (Zheng Xiaoyu. Guiding Principles for Clinical Research of New Chinese Medicines (Trial)[S]. Beijing: China Medical Science and Technology Press, 2002: 366-368.) was used for grading.

[0122] According to the presence and severity of the patients' clinical symptoms, they were divided into four grades: asymptomatic, mild, moderate, and severe; for the four main symptoms (abdominal pain or discomfort, bowel movement condition, stool consistency, emotional depression and irritability), they were scored 0, 2, 4, and 6 respectively; for the secondary symptoms (fullness and distension in the chest and hypochondrium, borborygmus and flatulence, belching, poor appetite), the four grades of asymptomatic, mild, moderate, and severe were scored 0, 1, 2, and 3 respectively.

[0123] 5 Efficacy Evaluation Criteria

[0124] 5.1 Clinical Efficacy Evaluation

[0125] It was formulated with reference to the relevant standards of "Guiding Principles for Clinical Research of New Chinese Medicines", and the calculation formula of the Nimodipine method was used: Efficacy index = [(pre-treatment score - post-treatment score) / pre-treatment score] × 100%. The clinical efficacy was evaluated by the change in the total score of Traditional Chinese Medicine symptoms, and the effective rate was calculated.

[0126] Cured: Clinical symptoms and signs disappeared or basically disappeared, and the symptom score value after treatment decreased by ≥ 95% compared with that before treatment;

[0127] Markedly effective: Clinical symptoms and signs were significantly improved, and the symptom score value after treatment decreased by ≥ 70% compared with that before treatment;

[0128] Effective: Clinical symptoms and signs improved, and the symptom score value after treatment decreased by ≥ 30% compared with that before treatment;

[0129] Ineffective: Clinical symptoms and signs did not improve, and the symptom score value after treatment decreased by < 30% compared with that before treatment;

[0130] Total effective rate = (number of cured cases + number of markedly effective cases + number of effective cases) / total number of cases × 100%.

[0131] 6 Safety evaluation indicators

[0132] Record the changes in safety indicators before and after medication and the adverse events occurred during the clinical research process.

[0133] (1) Patients' vital signs: pulse, respiration, blood pressure, electrocardiogram;

[0134] (2) Routine laboratory tests: routine blood, urine, and feces tests, liver function (alanine aminotransferase, aspartate aminotransferase, total bilirubin, conjugated bilirubin, γ-glutamyltransferase), renal function (creatinine, urea, uric acid).

[0135] 7 Statistical analysis

[0136] In this study, the data were analyzed using the statistical software SPSS 26.0. The statistical description of measurement data was expressed as or M(P25, P75), and the t-test or Mann-Whitney U test was used for comparison between groups; the rate (%) and constituent ratio (%) were used for statistical description of count data, and the test or Fisher's exact probability method was used for comparison between groups; the Mann-Whitney U test was used for comparison of ranked data; the repeated measures analysis of variance was used for measurement data with repeated measurements, and P < 0.05 was considered statistically significant.

[0137] 8 Research results:

[0138] 8.1 Comparison of TCM symptom scores

[0139] 8.1.1 Comparison of total TCM symptom scores

[0140] By analysis of variance, compared with before treatment, the total TCM symptom scores of the two groups were significantly decreased at 2 weeks, 4 weeks of treatment, and 4-week follow-up after treatment (P < 0.001), indicating that the treatment with traditional Chinese medicine and western medicine had the effect of improving clinical symptoms. There was no statistical difference between the two groups before treatment at 0 week (t = 0.214, P = 0.831), and the groups were comparable. There was a statistical difference between the two groups at 2 weeks of treatment (t = -3.260, P = 0.002), and the improvement of symptoms in the traditional Chinese medicine group was better than that in the western medicine group. There was a statistical difference between the two groups at 4 weeks (t = -3.158, P = 0.002), and the improvement of symptoms in the traditional Chinese medicine group was better than that in the western medicine group. At follow-up, the difference between the two groups was highly significant (t = -4.365, P < 0.001), suggesting that the degree of symptom improvement and long-term efficacy of the traditional Chinese medicine group were better than those of the western medicine group. The results are shown in Table 1 and Figure 1 as shown Figure 1It is a schematic diagram of the comparison results of the total scores of two groups of traditional Chinese medicine symptoms.

[0141] Table 1 Comparison of the total scores of traditional Chinese medicine symptoms between two groups ( points)

[0142] Note: * indicates P < 0.001 compared with before treatment; # indicates P < 0.05 compared with the western medicine group, and ## indicates P < 0.001 compared with the western medicine group.

[0143] By repeated measures analysis of variance, the main effect of time existed (F = 136.944, P < 0.001), and there were statistically significant differences in the scores of traditional Chinese medicine symptoms measured at different time points. There was an interaction between time and drug (F = 3.357, P = 0.026), and the effect of the drug on the scores of traditional Chinese medicine symptoms changed with different time points, as shown in Table 2.

[0144] Comparing the means of the two groups, at 2 weeks, 4 weeks of treatment and during follow-up, the scores of traditional Chinese medicine symptoms in the traditional Chinese medicine group were lower than those in the western medicine group, and the efficiency of traditional Chinese medicine treatment for clinical symptoms was better than that of western medicine treatment. See Figure 2 as shown Figure 2 It is a schematic diagram of the change trend results of the scores of traditional Chinese medicine symptoms between two groups.

[0145] Table 2 Repeated measures analysis of variance of the scores of traditional Chinese medicine symptoms at different time points

[0146] 8.1.2 Comparison of the single scores of traditional Chinese medicine symptoms

[0147] The Mann-Whitney U test was used for the data of the traditional Chinese medicine group and the western medicine group. Before treatment, there were no statistically significant differences in each score (P > 0.05), and the groups were comparable. After 2 weeks of medication, there were statistically significant differences between the two groups in improving the stool characteristics (P = 0.011), and there were no statistically significant differences in the scores of the remaining main symptoms (P > 0.05). At the 4-week treatment course, there were statistically significant differences between the traditional Chinese medicine group and the western medicine group in improving defecation frequency, stool characteristics, and emotional depression (P < 0.05), and the difference in the improvement of defecation frequency between the groups was highly significant (P < 0.001). During follow-up, there were statistically significant differences between the traditional Chinese medicine group and the western medicine group in improving defecation frequency and stool characteristics (P < 0.05). Combining the above results, it can be seen that the overall efficacy and prognosis of the traditional Chinese medicine group in increasing the number of defecations, improving stool characteristics, and relieving depressive and irritable emotions are better than those of the western medicine group, as shown in Figure 3.

[0148] Table 3 Comparison of the single scores of the main symptoms of the two groups [M (P25, P75), points]

[0149] Note: # indicates P < 0.05 compared with the western medicine group, and ## indicates P < 0.001 compared with the western medicine group.

[0150] At the 4th week of treatment, there was a statistically significant difference in improving belching between the traditional Chinese medicine group and the western medicine group (P = 0.024). There was no statistically significant difference between the two groups in improving other secondary symptoms such as fullness and distension in the chest and hypochondrium, borborygmus with flatulence, and poor appetite (P > 0.05). This indicates that traditional Chinese medicine treatment is superior to the western medicine group in improving belching, and the curative effects of the traditional Chinese medicine group and the western medicine group are comparable for the remaining secondary symptoms, as shown in Table 4.

[0151] Table 4 Comparison of single-item clinical symptom scores of secondary symptoms between the two groups [M (P25, P75), points]

[0152] Note: # indicates P < 0.05 compared with the western medicine group.

[0153] 8.2 Clinical efficacy evaluation

[0154] At the 2nd week of treatment, the effective rate of the traditional Chinese medicine group was 74.36%, and that of the western medicine group was 57.89%. Among them, there were 29 effective cases and 10 ineffective cases in the traditional Chinese medicine group, 22 effective cases and 16 ineffective cases in the western medicine group. At the 4th week of treatment, the effective rate of the traditional Chinese medicine group was 87.18%, and that of the western medicine group was 68.42%. Among them, there were 34 effective cases and 5 ineffective cases in the traditional Chinese medicine group, 26 effective cases and 12 ineffective cases in the western medicine group. During the follow-up, the effective rate of the traditional Chinese medicine group was 71.79%, and that of the western medicine group was 47.37%. Among them, there were 28 effective cases and 11 ineffective cases in the traditional Chinese medicine group, 18 effective cases and 20 ineffective cases in the western medicine group.

[0155] A chi-square test was performed on the clinical effective rates of the traditional Chinese medicine group and the western medicine group. When comparing the two groups in the 2-week treatment course, there was no statistically significant difference ( = 2.333, P = 0.127). At the 4-week treatment course, there was a statistically significant difference in the effective rate between the traditional Chinese medicine group and the western medicine group ( = 3.937, P = 0.047). By comparing the efficiency values of the two groups, it can be seen that the curative effect of the traditional Chinese medicine group was superior to that of the western medicine group at the 4th week of treatment. There was also a statistically significant difference in the effective rates between the two groups during the follow-up ( = 4.775, P = 0.029), indicating that traditional Chinese medicine showed significant clinical efficacy, with a rapid onset, continuous and stable symptom improvement, and a significantly better long-term curative effect than the western medicine group. See Table 5 and Figure 3 as shown, Figure 3 is a schematic diagram of the comparison results of the effective rates of the two groups of patients.

[0156] Table 5 Comparison of the effective rates of the two groups of patients (cases, %)

[0157] Note: # indicates P < 0.05 compared with the western medicine group.

[0158] The clinical efficacy of the traditional Chinese medicine composition of the present invention in the treatment of IBS-C with liver qi stagnation syndrome is superior to mosapride citrate tablets, effectively improving the clinical symptoms, emotional state and quality of life of patients. The long-term efficacy is persistent and stable, and at the same time, it has reliable safety and can be further promoted clinically.

[0159] Example 7

[0160] Patient Zhang XX, female, 38 years old, company employee, visited on October 10, 2023. Chief complaint: constipation accompanied by abdominal distension and pain for 3 years, aggravated for 1 month. Three years ago, due to high work pressure and obvious mood swings, the patient gradually developed difficulty in defecation, with dry stools like sheep dung, once every 3 - 4 days, accompanied by abdominal distension and pain, and the symptoms were slightly relieved after defecation. In the past month, the symptoms have worsened, the defecation interval has extended to 5 - 6 days, the stool is hard and indurated, defecation is laborious, accompanied by obvious abdominal pain, irritability, poor sleep at night, and easy to wake up after dreaming. The patient has taken laxatives (such as lactulose, mosapride citrate tablets) by himself, which was effective initially, but the symptoms recurred after stopping the medicine. The patient has no chronic medical history such as hypertension and diabetes, no surgical history and trauma history. Personal history: likes to eat spicy food and drinks less water; is busy at work, often stays up late, and has poor sleep quality; has an impatient and irritable personality, and has obvious mood swings due to high work pressure recently. Physical examination: the tongue is red, the coating is thin and yellow; the pulse is stringy and thin; the abdomen is slightly distended, the percussion sound is tympanic, the bowel sounds are weakened, and there is mild tenderness in the left lower abdomen. Auxiliary examination: colonoscopy showed no obvious organic lesions, routine fecal examination was normal, and blood routine, liver and kidney function were all normal. Traditional Chinese medicine diagnosis: constipation (liver qi stagnation type), syndrome type is liver qi stagnation and bowel qi obstruction. Western medicine diagnosis: constipation-predominant irritable bowel syndrome (IBS-C). Syndrome differentiation and analysis: Due to long-term emotional discomfort, liver qi stagnation, qi movement disorder, resulting in the disorder of the large intestine conduction and bowel qi obstruction, so constipation, abdominal distension and pain are seen; liver qi transforming into fire disturbing the mind, so irritability, insomnia and dreaminess are seen; the red tongue, thin and yellow coating, stringy and thin pulse are all manifestations of liver qi stagnation. Treatment principle: soothe the liver and regulate qi, promote bowel movement and relieve stagnation.

[0161] Treatment plan: Mix 9 g of Bupleuri Radix, 12 g of Paeoniae Radix Alba Praeparata, 12 g of Aurantii Fructus Immaturus Praeparata, 6 g of Citri Reticulatae Pericarpium, 12 g of Cyperi Rhizoma, 9 g of Chuanxiong Rhizoma, 6 g of Glycyrrhizae Radix, 30 g of Arecae Pericarpium, 30 g of Hordei Fructus Germinatus Praeparatus, 12 g of Magnoliae Officinalis Cortex, 12 g of Aurantii Fructus Immaturus Praeparata, 15 g of Polygoni Cuspidati Rhizoma, 15 g of Cannabis Semen; extract by water reflux for 3 times (1000 ml, 1 hour; 1000 ml, 1 hour; 1000 ml, 1 hour), combine the extracts, concentrate, dry, pulverize to obtain granules. Take once in the morning and once in the evening, one pack each time, and take for 2 weeks.

[0162] Follow-up record: At the follow-up visit in the second week, the patient's bowel movement interval shortened to 2 - 3 days, the stool quality became softer than before, abdominal distension and pain were relieved, the mood was more stable than before, sleep improved, the tongue was pale red, the coating was thin and white, the pulse was string-like, and the original prescription was continued for treatment; At the follow-up visit in the fourth week, the patient's bowel movement basically returned to normal, once a day, the stool was soft, abdominal distension and pain disappeared, the mood was stable, sleep was good, the tongue was pale red, the coating was thin and white, the pulse was slow, and the patient was instructed to continue to regulate diet and emotions to consolidate the curative effect.

[0163] Example 8

[0164] Patient Li Moumou, male, 52 years old, an enterprise senior executive, visited the doctor on October 15, 2023. The main complaint was constipation accompanied by abdominal distension and pain for 5 years, which had worsened in the past 2 months. 5 years ago, due to high work pressure and emotional tension, the patient gradually developed difficulty in defecation, with dry and hard stools like sheep dung, once every 4 - 5 days, accompanied by abdominal distension and pain, and the symptoms were slightly relieved after defecation. In the past 2 months, the symptoms have worsened, the bowel movement interval has extended to 6 - 7 days, the stool is hard and indurated, defecation is laborious, accompanied by obvious abdominal pain, the mood is irritable and angry, and the sleep at night is poor, with many dreams and easy to wake up. The patient has no previous chronic medical history such as hypertension and diabetes, no surgical history or trauma history. The personal history shows that he likes to eat greasy food, drinks less water, is busy at work, often stays up late, has poor sleep quality, has an impatient and irritable personality, and has been under great work pressure and obvious mood swings recently. Physical examination showed a red tongue, a thin and yellow coating, a string-like and thready pulse, slightly distended abdomen, tympanic percussion sound, weakened bowel sounds, and mild tenderness in the left lower abdomen. Auxiliary examinations showed no obvious organic lesions in colonoscopy, and no abnormalities were found in fecal routine, blood routine, liver and kidney functions. The traditional Chinese medicine diagnosis was constipation (liver qi stagnation type), and the western medicine diagnosis was constipation-predominant irritable bowel syndrome (IBS-C). The treatment principle was to soothe the liver and regulate qi, and promote defecation and relieve stagnation.

[0165] Treatment plan: Mix 6 g of Bupleuri Radix, 8 g of Paeoniae Radix Alba Praeparata, 8 g of Aurantii Fructus Immaturus Praeparata, 3 g of Citri Reticulatae Pericarpium, 6 g of Cyperi Rhizoma, 6 g of Chuanxiong Rhizoma, 3 g of Glycyrrhizae Radix, 20 g of Arecae Pericarpium, 20 g of Hordei Fructus Germinatus Praeparata, 8 g of Magnoliae Officinalis Cortex, 8 g of Aurantii Fructus Immaturus Praeparata, 10 g of Polygoni Cuspidati Rhizoma, and 10 g of Cannabis Semen and grind them finely; Extract with water by reflux for 3 times (1000 ml, 1 hour; 1000 ml, 1 hour; 1000 ml, 1 hour), combine the extracts, and concentrate to obtain an extract; Add appropriate pharmaceutical excipients (such as white sugar, honey, benzoic acid or ethylparaben, etc.) to make pills, mixtures, oral liquids or syrups. Take once in the morning and once in the evening, one packet each time, and take for 2 weeks.

[0166] Follow-up record: At the follow-up visit in the second week, the patient's bowel movement interval shortened to 2 - 3 days, the stool quality became softer than before, abdominal distension and pain were relieved, the mood was more stable than before, sleep improved, the tongue was pale red, the coating was thin and white, the pulse was string-like, and the original prescription was continued for treatment. At the follow-up visit in the fourth week, the patient's bowel movement basically returned to normal, once a day, the stool was soft, abdominal distension and pain disappeared, the mood was stable, sleep was good, the tongue was pale red, the coating was thin and white, the pulse was slow, and the patient was instructed to continue to regulate diet and emotions to consolidate the curative effect.

[0167] Example 9

[0168] Patient Zhang XX, female, 35 years old, a company employee, was initially diagnosed on March 10, 2024 due to repeated constipation, abdominal distension, and abdominal pain for 3 years, with the condition aggravated for 1 week. Three years ago, due to high work pressure and emotional stress, the patient began to have constipation, with dry and hard stools that were difficult to excrete. She usually had a bowel movement once every 3 - 4 days, accompanied by abdominal distension and abdominal pain, which were more severe when her emotions fluctuated. She had visited local hospitals many times and was diagnosed with constipation-predominant irritable bowel syndrome (IBS-C), and was given laxative drugs for treatment, but the symptoms were sometimes mild and sometimes severe. In the past week, due to busy work and increased pressure, the constipation has worsened. The stools are as dry as sheep feces, the abdominal distension is obvious, and the abdominal pain has increased. The pain location is not fixed, mainly distending pain, with flatulence from time to time. After flatulence, the abdominal distension is slightly relieved, but the constipation has not improved, so she came to our hospital for treatment. The patient has a healthy past history, no other chronic disease history, no history of surgical trauma, and no drug allergy history. Physical examination showed stable vital signs, clear consciousness and fluent speech, poor spirit, flat abdomen, no gastrointestinal pattern or peristaltic wave seen, soft abdomen, no tenderness or rebound tenderness, the liver and spleen were not palpable under the ribs, no mass was palpable, and the bowel sounds were normal. The tongue was pale red, the coating was thin and white, and the pulse was stringy and thready. According to traditional Chinese medicine syndrome differentiation and analysis, the patient has been in a state of emotional tension for a long time, with liver qi stagnation and qi mechanism disharmony, resulting in the obstruction of the qi movement of the fu organs. Therefore, constipation, abdominal distension, and abdominal pain are seen. Qi stagnation leads to distending pain, the pain has no fixed location, and the distending pain is slightly relieved after flatulence. The tongue and pulse are both manifestations of liver qi stagnation. The traditional Chinese medicine diagnosis is constipation (syndrome of liver qi stagnation). The treatment principle is to soothe the liver and relieve depression, and regulate qi and unblock the fu organs.

[0169] Treatment plan: Mix 15 g of Bupleuri Radix, 15 g of Paeoniae Radix Alba Praeparata, 15 g of Aurantii Fructus Immaturus Praeparata, 12 g of Citri Reticulatae Pericarpium, 15 g of Cyperi Rhizoma, 15 g of Chuanxiong Rhizoma, 9 g of Glycyrrhizae Radix, 40 g of Arecae Pericarpium, 40 g of Hordei Fructus Germinatus Praeparata, 15 g of Magnoliae Officinalis Cortex, 15 g of Aurantii Fructus Immaturus Praeparata, 20 g of Polygoni Cuspidati Rhizoma, and 20 g of Cannabis Semen; extract by water reflux for 3 times (1000 ml, 1 hour; 1000 ml, 1 hour; 1000 ml, 1 hour), combine the extracts, concentrate to obtain an extract, and dry and crush the extract to make granules. Take one pack once, twice a day, for 2 weeks.

[0170] Follow-up record: At the second follow-up two weeks later, the patient had smooth bowel movements after taking the medicine, had a bowel movement once every 2 - 3 days, the dryness of the stools improved compared to before, the abdominal distension and abdominal pain were significantly relieved, the mood was more stable than before, the tongue was pale red, the coating was thin and white, and the pulse was stringy and thready. The treatment method was the same as before, and continue to take the medicine for 2 weeks.

[0171] At the third follow-up, the patient had normal bowel movements, had a bowel movement once every 1 - 2 days, the abdominal distension and abdominal pain disappeared, the mood was stable, the tongue was pale red, the coating was thin and white, and the pulse was stringy and thready. The condition improved, and the patient was advised to pay attention to regulating emotions and avoid emotional tension.

[0172] The above are only the preferred embodiments of the present invention, and do not impose any form of limitation on the present invention. Although the present invention has been disclosed above with the preferred embodiments, it is not intended to limit the present invention. Any person skilled in the art of this patent, without departing from the scope of the technical solution of the present invention, may make some changes or modifications using the technical content prompted above to form equivalent embodiments of equivalent changes. However, as long as it does not depart from the content of the technical solution of the present invention, any simple modification, equivalent change and modification made to the above embodiments based on the technical essence of the present invention still fall within the scope of the present invention's solution.

Claims

1. A Chinese medicine composition for treating constipation-type irritable bowel syndrome, characterized in that: It is made of the following components in parts by weight: 6-15 parts of bupleurum, 6-15 parts of stir-fried white peony root, 6-15 parts of stir-fried fructus aurantii, 3-12 parts of dried orange peel, 6-15 parts of cyperus rotundus, 6-15 parts of ligusticum chuanxiong, 3-12 parts of liquorice, 10-45 parts of dried tangerine peel, 10-45 parts of stir-fried malt, 6-15 parts of magnolia bark, 6-15 parts of stir-fried immature aurantium, 5-30 parts of polygonum cuspidatum, and 5-30 parts of hemp seed.

2. The Chinese medicine composition for treating constipation-type irritable bowel syndrome according to claim 1, characterized in that: The Chinese medicine composition is made of the following components in parts by weight: 9 parts of bupleurum, 12 parts of stir-fried white peony root, 12 parts of stir-fried fructus aurantii, 6 parts of dried orange peel, 12 parts of cyperus rotundus, 9 parts of ligusticum, 6 parts of liquorice, 30 parts of tangerine peel, 30 parts of stir-fried malt, 12 parts of magnolia bark, 12 parts of stir-fried immature bitter orange, 15 parts of polygonum cuspidatum, and 15 parts of seed of hemp.

3. The Chinese medicine composition for treating constipation-type irritable bowel syndrome according to claim 1, characterized in that: The Chinese medicine composition is made of the following components in parts by weight: 6 parts of bupleurum, 8 parts of stir-fried white peony root, 8 parts of stir-fried fructus aurantii, 3 parts of dried orange peel, 6 parts of cyperus rotundus, 6 parts of ligusticum chuanxiong, 3 parts of liquorice, 20 parts of tangerine peel, 20 parts of stir-fried malt, 8 parts of magnolia bark, 8 parts of stir-fried immature bitter orange, 10 parts of polygonum cuspidatum, and 10 parts of canna seed.

4. The Chinese medicine composition for treating constipation-type irritable bowel syndrome according to claim 1, characterized in that: The Chinese medicine composition is made of the following components in parts by weight: 15 parts of bupleurum, 15 parts of stir-fried white peony root, 15 parts of stir-fried fructus aurantii, 12 parts of dried orange peel, 15 parts of cyperus rotundus, 15 parts of ligusticum chuanxiong, 9 parts of liquorice, 40 parts of tangerine peel, 40 parts of stir-fried malt, 15 parts of magnolia bark, 15 parts of stir-fried immature aurantium, 20 parts of polygonum cuspidatum, and 20 parts of seed of hemp.

5. The Chinese medicine composition for treating constipation-type irritable bowel syndrome according to claim 1, characterized in that: The Chinese medicine composition is made of the following components in parts by weight: 10 parts of bupleurum, 10 parts of stir-fried white peony root, 10 parts of stir-fried fructus aurantii, 9 parts of dried orange peel, 10 parts of cyperus rotundus, 10 parts of ligusticum chuanxiong, 6 parts of liquorice, 30 parts of tangerine peel, 15 parts of stir-fried malt, 12 parts of magnolia bark, 12 parts of stir-fried immature aurantium, 20 parts of polygonum cuspidatum, and 20 parts of canna seed.

6. The Chinese medicine composition for treating constipation-type irritable bowel syndrome according to claim 1, characterized in that: The Chinese medicine composition is made of the following components in parts by weight: 12 parts of bupleurum, 15 parts of stir-fried white peony root, 15 parts of stir-fried fructus aurantii, 12 parts of dried orange peel, 15 parts of cyperus rotundus, 15 parts of ligusticum, 9 parts of liquorice, 15 parts of tangerine peel, 15 parts of stir-fried malt, 9 parts of magnolia bark, 9 parts of stir-fried immature bitter orange, 15 parts of polygonum cuspidatum, and 15 parts of canna seed.

7. Use of the Chinese medicine composition according to any one of claims 1 to 6 in the preparation of a medicament for treating constipation-type irritable bowel syndrome.

8. A pharmaceutical preparation, characterized in that The invention is prepared from the Chinese medicine composition according to any one of claims 1 to 6 and pharmaceutically acceptable excipients.

9. The pharmaceutical preparation according to claim 8, characterized in that The dosage form of the pharmaceutical preparation is selected from decoction, tablet, mixture, oral liquid, granule, pill, capsule, navel patch, suppository and syrup.

10. Use of the pharmaceutical preparation according to claim 8 or 9 in the preparation of a drug for treating constipation-type irritable bowel syndrome.

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