Traditional Chinese medicine composition for regulating qi and removing stagnation as well as preparation method and use method of traditional Chinese medicine composition

Abstract

The invention provides a traditional Chinese medicine composition for regulating qi and removing stagnation as well as a preparation method and a use method thereof, and relates to the technical field of traditional Chinese medicine compositions. The traditional Chinese medicine composition is prepared from the following components in parts by mass: 5 to 15 parts of rhizoma cyperi, 5 to 15 parts of radix linderae, 5 to 15 parts of rhizoma curcumae, 5 to 15 parts of fructus trichosanthis, 5 to 15 parts of semen armeniacae amarae, 5 to 15 parts of fructus cannabis, 5 to 15 parts of flos rosae rugosae and 5 to 15 parts of herba menthae. The technical problems that when western medicines are used for treating the constipation-type irritable bowel syndrome, the medicine use frequency is high, the variety is limited, the medical cost is high, the side effects are many, and the long-term curative effect is poor are solved. The traditional Chinese medicine composition has the advantages of few side effects, good curative effect, low recurrence rate, low price and good patient compliance.

Description

Technical Field

[0001] The present invention relates to the technical field of Chinese medicine compositions, and in particular to a Chinese medicine composition for regulating qi and relieving stagnation, and a preparation method and a use method thereof. Background Art

[0002] Irritable bowel syndrome with constipation (IBS-C) is a subtype of irritable bowel syndrome (IBS), accounting for about 48.72% of the distribution of IBS subtypes. At present, Western medicine treatment of IBS-C is mainly symptomatic treatment, and clinically it is mainly symptomatic treatment with drugs such as bulking agents, osmotic laxatives, prokinetics, intestinal fluid secretion drugs, antispasmodics, and antidepressants. Although clinical medical treatment methods have made great progress in recent years, there are still problems such as long treatment cycles, high recurrence rates, and complex medication. Studies have shown that polyethylene glycol increases the number of bowel movements in patients with IBS-C, but abdominal pain does not improve. In a meta-analysis of 26 trials, antispasmodics are more effective than placebo in treating abdominal pain, but the incidence of adverse events is significantly increased in patients taking antispasmodics. Linaclotide, a new secretagogue, can significantly relieve abdominal pain and discomfort in IBS-C patients after 12 weeks of treatment. The relevant symptom relief rate is 31.7%, which is significantly better than the 15.4% of the placebo group. However, diarrhea is prone to cause drug discontinuation (the incidence rate is about 5.7%), and there is a disadvantage of relatively high cost. In summary, Western medicine treatment of IBS-C faces difficulties such as high frequency of drug use, limited types, high medical costs, many side effects, and weak long-term efficacy. Therefore, a Chinese medicine composition is urgently needed to solve the above problems. Summary of the invention

[0003] One of the purposes of the present invention is to provide a Chinese medicine composition to solve the technical problems of high frequency of use, limited types, high medical costs, multiple side effects and poor long-term efficacy of Western medicine in treating constipation-type irritable bowel syndrome.

[0004] The traditional Chinese medicine composition provided by the invention comprises the following components by weight: 5-15 parts of cyperus rotundus, 5-15 parts of lindera striata, 5-15 parts of zedoaria, 5-15 parts of trichosanthes, 5-15 parts of apricot kernel, 5-15 parts of hemp seed, 5-15 parts of rose and 5-15 parts of mint.

[0005] Furthermore, the Chinese medicine composition includes the following components by mass: 8-12 parts of Cyperus rotundus, 8-12 parts of Linderae scutellariae, 8-12 parts of Curcuma zedoariae, 8-12 parts of Trichosanthes kirilowii, 8-12 parts of Apricot kernel, 8-12 parts of Cannabis sativa seed, 8-12 parts of Rose and 8-12 parts of Mint.

[0006] Furthermore, the Chinese medicine composition includes the following components by mass: 10 parts of Cyperus rotundus, 10 parts of Linderae scutellariae, 10 parts of Curcuma zedoariae, 10 parts of Trichosanthes kirilowii, 10 parts of Apricot kernel, 10 parts of Cannabis sativa seed, 10 parts of Rose and 10 parts of Mint.

[0007] Furthermore, the Chinese medicine composition is used to treat constipation-type irritable bowel syndrome, which is liver depression and qi stagnation syndrome in traditional Chinese medicine.

[0008] The main pathogenesis of constipation-type irritable bowel syndrome is "liver qi is against the spleen, spleen and stomach conduction is disordered", and the main treatment principle should be "soothing the liver and relieving depression, promoting qi and removing stagnation". In the prescription, Cyperus rotundus is bitter, fragrant and dry, and enters the Jueyin liver meridian. It is good at regulating qi and removing stagnation, benefiting the three burners, and relieving six depressions. Li Dongyuan said that it "treats all qi". Linderae odoratus has a masculine and warm nature, and enters the Taiyin spleen meridian. It is good at promoting qi and dispersing stagnant qi, and soothing the reverse qi of the spleen meridian. The two herbs complement each other, soothing the liver and relieving depression, helping the spleen to function properly, and unblocking the qi of the lower burner, so that the dregs can be conducted. Curcuma is pungent, bitter and warm in nature and flavor. It enters the liver and spleen meridians, promotes qi and eliminates stagnation. When used with Linderae odoratum, it increases its ability to promote qi and relieve pain. When used with Cyperus rotundus, it increases its effect of regulating meridians and has the function of digesting food and eliminating stagnation. It is combined with Trichosanthes to promote qi and relieve chest tightness, and Apricot kernel to moisten the lungs and lower qi, so that the qi can flow smoothly and promote the downward movement of body fluids. When combined with Cannabis sativa seed, it nourishes the dry intestines and facilitates the conduction of the large intestine. The four are used together as ministerial drugs. Rose and mint are clear and light, rising and dispersing products. They not only enter the liver meridian to relieve liver and depression, but also can clear the head and eyes, promote qi and regulate the mind, and assist the disadvantages of the monarch and minister drugs to lead the qi downward too harshly, and are all assistants. This prescription starts from soothing the liver and relieving depression, unblocking the spleen and stomach qi, regulating the triple burner qi, and distributing water and fluid to the large intestine, increasing its ability to conduct dregs.

[0009] The second object of the present invention is to provide a method for preparing a Chinese medicine composition, comprising the following steps:

[0010] Cyperus rotundus, Linderae strychnos, Curcuma zedoaria, Trichosanthes kirilowii, Apricot kernel, Fructus hemp, Rose and mint are decocted twice with water according to a certain proportion, and the decoction is filtered and the filtrate is combined to obtain a Chinese medicine composition liquid.

[0011] Furthermore, the volume of the medicinal solution is 400-500 mL.

[0012] The third object of the present invention is to provide a method for using the Chinese medicine composition, that is, the medicinal liquid is evenly divided into three portions, and one portion each is taken orally half an hour after a meal in the morning, afternoon and evening.

[0013] A fourth object of the present invention is to provide a Chinese medicine preparation comprising the Chinese medicine composition of the present invention, wherein the dosage form of the Chinese medicine preparation includes granules, granules, pills, capsules or tablets.

[0014] The traditional Chinese medicine composition provided by the present invention has the advantages of good therapeutic effect, low recurrence and small side effects, while low treatment cost and good patient compliance.

[0015] The traditional Chinese medicine composition provided by the invention has a simple preparation method, is easy to prepare and has a wide range of applications.

[0016] The method for using the traditional Chinese medicine composition provided by the invention is simple, easy to understand and convenient to operate. DETAILED DESCRIPTION

[0017] The embodiments of the present invention will be described in detail below in conjunction with the examples, but it will be appreciated by those skilled in the art that the following examples are only used to illustrate the present invention and should not be construed as limiting the scope of the present invention. If specific conditions are not specified in the examples, they are carried out according to conventional conditions or conditions recommended by the manufacturer. If the manufacturer is not specified for the reagents or instruments used, they are all conventional products that can be purchased commercially.

[0018] According to one aspect of the present invention, the present invention provides a traditional Chinese medicine composition, comprising the following components by mass: 5-15 parts of Cyperus rotundus, 5-15 parts of Linderae scutellariae, 5-15 parts of Curcuma zedoariae, 5-15 parts of Trichosanthes kirilowii, 5-15 parts of Apricot kernel, 5-15 parts of Cannabis sativa seed, 5-15 parts of Rose and 5-15 parts of Mint.

[0019] In a typical but non-limiting embodiment of the present invention, the mass fraction of Cyperus rotundus is 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 or 15 parts.

[0020] In a typical but non-limiting embodiment of the present invention, the mass fraction of Linderae obesa is 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 or 15 parts.

[0021] In a typical but non-limiting embodiment of the present invention, the mass fraction of Curcuma is 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 or 15 parts.

[0022] In a typical but non-limiting embodiment of the present invention, the mass fraction of Trichosanthes kirilowii is 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 or 15 parts.

[0023] In a typical but non-limiting embodiment of the present invention, the mass portions of almonds are 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 or 15 portions.

[0024] In a typical but non-limiting embodiment of the present invention, the mass fraction of hemp seed is 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 or 15 parts.

[0025] In a typical but non-limiting embodiment of the present invention, the mass fraction of rose is 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 or 15 parts.

[0026] In a typical but non-limiting embodiment of the present invention, the mass fraction of mint is 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 or 15 parts.

[0027] In a preferred embodiment of the present invention, the Chinese medicine composition provided by the present invention is used to treat constipation-type irritable bowel syndrome, which is liver depression and qi stagnation syndrome in traditional Chinese medicine.

[0028] According to a second aspect of the present invention, the present invention provides a method for preparing a Chinese medicine composition, comprising the following steps:

[0029] Cyperus rotundus, Linderae strychnos, Curcuma zedoaria, Trichosanthes kirilowii, Apricot kernel, Fructus hemp, Rose and mint are decocted twice with water according to a certain proportion, and the decoction is filtered and the filtrate is combined to obtain a Chinese medicine composition liquid.

[0030] The preparation method of the traditional Chinese medicine composition provided by the invention has simple process, is easy to prepare and has a wide range of applications.

[0031] In a preferred embodiment of the present invention, the volume of the filtrate is 400-500 mL.

[0032] In typical but non-limiting embodiments of the invention, the volume of the filtrate is, for example, 400, 410, 420, 430, 440, 450, 460, 470, 480, 490 or 500 mL.

[0033] According to the third aspect of the present invention, the present invention provides a method for using the Chinese medicine composition, that is, the medicinal liquid is evenly divided into three portions, and one portion each is taken orally half an hour after a meal in the morning, afternoon and evening.

[0034] According to the third aspect of the present invention, the present invention provides a Chinese medicine preparation comprising the Chinese medicine composition of the present invention, and the dosage form of the Chinese medicine preparation includes granules, granules, pills, capsules or tablets.

[0035] The method for using the traditional Chinese medicine composition provided by the invention is simple, easy to understand and convenient to operate.

[0036] The technical solution provided by the present invention is further described below in conjunction with embodiments and comparative examples.

[0037] Embodiment 1:

[0038] This embodiment provides a traditional Chinese medicine composition, comprising the following raw materials in parts by mass: 10 parts of Cyperus rotundus, 10 parts of Linderae scutellariae, 10 parts of Curcuma zedoariae, 10 parts of Trichosanthes kirilowii, 10 parts of Apricot kernel, 10 parts of Cannabis sativa seed, 10 parts of Rose flower and 10 parts of Mint.

[0039] Preparation method: Weigh 10 grams of Cyperus rotundus, 10 grams of Linderae scutellariae, 10 grams of Curcuma zedoaria, 10 grams of Trichosanthes kirilowii, 10 grams of Apricot kernel, 10 grams of Cannabis sativa seed, 10 grams of Rose and 10 grams of Mint according to their mass parts, add water and boil twice, filter the decoction and combine the filtrate to obtain 450 ml of the Chinese medicine composition liquid.

[0040] Embodiment 2:

[0041] This embodiment provides a traditional Chinese medicine composition, comprising the following raw materials in parts by mass: 5 parts of Cyperus rotundus, 5 parts of Linderae scutellariae, 5 parts of Curcuma zedoariae, 5 parts of Trichosanthes kirilowii, 15 parts of Apricot kernel, 15 parts of Cannabis sativa seed, 15 parts of Rose flower and 15 parts of Mint.

[0042] Preparation method: Weigh 5 grams of Cyperus rotundus, 5 grams of Linderae scutellariae, 5 grams of Curcuma zedoariae, 5 grams of Trichosanthes kirilowii, 15 grams of Apricot kernel, 15 grams of Cannabis sativa seed, 15 grams of Rose and 15 grams of Mint according to their mass parts, add water and boil twice, filter the decoction and combine the filtrate to obtain 450 ml of the Chinese medicine composition liquid.

[0043] Embodiment 3:

[0044] This embodiment provides a traditional Chinese medicine composition, comprising the following raw materials in parts by mass: 15 parts of Cyperus rotundus, 15 parts of Linderae scutellariae, 15 parts of Curcuma zedoariae, 15 parts of Trichosanthes kirilowii, 5 parts of Apricot kernel, 5 parts of Cannabis sativa seed, 5 parts of Rose flower and 5 parts of Mint.

[0045] Preparation method: Weigh 15 grams of Cyperus rotundus, 15 grams of Linderae scutellariae, 15 grams of Curcuma zedoariae, 15 grams of Trichosanthes kirilowii, 5 grams of Apricot kernel, 5 grams of Cannabis sativa seed, 5 grams of Rose and 5 grams of Mint according to their mass parts, add water and boil twice, filter the decoction and combine the filtrate to obtain 450 ml of the Chinese medicine composition liquid.

[0046] Embodiment 4:

[0047] This embodiment provides a traditional Chinese medicine composition, comprising the following raw materials in parts by mass: 8 parts of Cyperus rotundus, 8 parts of Linderae scutellariae, 8 parts of Curcuma zedoariae, 8 parts of Trichosanthes kirilowii, 12 parts of Apricot kernel, 12 parts of Cannabis sativa seed, 12 parts of Rose flower and 12 parts of Mint.

[0048] Preparation method: Weigh 8 grams of Cyperus rotundus, 8 grams of Linderae scutellariae, 8 grams of Curcuma zedoaria, 8 grams of Trichosanthes kirilowii, 12 grams of Apricot kernel, 12 grams of Cannabis sativa seed, 12 grams of Rose and 12 grams of mint according to their mass parts, add water and boil twice, filter the decoction and combine the filtrate to obtain 450 ml of the Chinese medicine composition liquid.

[0049] Embodiment 5:

[0050] This embodiment provides a traditional Chinese medicine composition, comprising the following raw materials in parts by mass: 12 parts of Cyperus rotundus, 12 parts of Linderae scutellariae, 12 parts of Curcuma zedoariae, 12 parts of Trichosanthes kirilowii, 8 parts of Apricot kernel, 8 parts of Cannabis sativa seed, 8 parts of Rose flower and 8 parts of Mint.

[0051] Preparation method: Weigh 12 grams of Cyperus rotundus, 12 grams of Linderae scutellariae, 12 grams of Curcuma zedoaria, 12 grams of Trichosanthes kirilowii, 8 grams of Apricot kernel, 8 grams of Cannabis sativa seed, 8 grams of Rose and 8 grams of Mint according to their mass parts, add water and boil twice, filter the decoction and combine the filtrate to obtain 450 ml of the Chinese medicine composition liquid.

[0052] Test Example 1

[0053] Zhu, female, 28 years old, visited the outpatient department of the Department of Gastroenterology of Chongqing Traditional Chinese Medicine Hospital on June 10, 2024, with the main complaint: repeated dry stools and difficulty in defecation for 10 years. Current medical history: The patient repeatedly had dry stools, shaped like sheep dung, difficulty in defecation, once every 3-5 days, and a small amount of stool each time. The difficulty in defecation worsened when she was in a bad mood, accompanied by abdominal distension, frequent belching, upper abdominal pain, dry mouth, normal diet, sleep, and normal urination. Past history: no history of hypertension, diabetes, coronary heart disease, etc. Personal history: regular menstrual cycle, once every 23-28 days, 3-5 days each time, last menstrual period: 2024-06-02. Family history: unknown. Physical examination: soft abdomen, mild tenderness in the upper abdomen, no rebound pain. Pale red tongue, thin white fur, and stringy pulse. Auxiliary examination: Colonoscopy performed in an external hospital 2 days ago indicated that there was no obvious abnormality in the colorectum.

[0054] TCM diagnosis: constipation (liver depression and qi stagnation syndrome)

[0055] Treatment: Orally take the Chinese medicine composition decoction provided in Example 1, a total of 7 doses, 1 dose per day, taken in 3 times.

[0056] First follow-up visit: June 25, 2024

[0057] After taking the medicine, the patient's stool was less dry and hard than before, and defecation was once every 1-2 days. It was a little more laborious, and the abdominal distension and belching had basically disappeared. The upper abdominal pain and dry mouth were significantly relieved. The appetite and sleep were good. The tongue was pale red, the coating was thin and white, and the pulse was stringy.

[0058] Treatment: Continue to take the previous 7 doses.

[0059] Second follow-up visit: July 16, 2024

[0060] The patient's constipation was further alleviated, and bowel movements were effortless and once a day. He had no discomfort such as abdominal distension, belching, abdominal pain, dry mouth, etc., and his diet and sleep were normal.

[0061] Treatment: Continue to take 7 doses of the previous medicine to consolidate the therapeutic effect.

[0062] During a telephone follow-up on August 25, 2024, the patient had normal bowel movements, well-formed stools that were not dry or hard, and had no discomfort such as abdominal distension, abdominal pain, belching, hiccups, or other discomfort. His diet and sleep were normal.

[0063] Test Example 2

[0064] Wang, female, 42 years old, visited the outpatient department of the Department of Gastroenterology of Chongqing Traditional Chinese Medicine Hospital on April 8, 2024. The main complaint was that the patient had difficulty defecating for more than 10 years. Current medical history: 10+ years ago, the patient had difficulty defecating without obvious causes. The stool was dry and hard like sheep dung, once every 3-4 days, accompanied by distension and pain in the middle and lower abdomen, obvious pain before defecation, and abdominal pain that can be relieved after defecation. Accompanied by bitter mouth, dry mouth, belching, no acid reflux, heartburn, nausea and vomiting, black stool, blood in the stool, etc. The patient had taken "Senna Leaves and Ma Ren Pills" orally to relieve constipation. At present, the defecation has not improved significantly after taking the medicine. Appetite is good, sleep is normal, and urination is normal. Past history: Denial of hypertension, diabetes, coronary heart disease, etc., self-reported that no abnormalities were found in the colonoscopy completed in an external hospital 3 months ago (no report). Personal history: previous regular menstruation, last menstruation: March 10, 2024, no history of drug or food allergies. Family history: denies family history of tumors and family history of genetic diseases. Physical examination: no abnormalities were found in the heart, lungs and abdomen. The tongue is pale red, the coating is thin and white, and the pulse is stringy.

[0065] Traditional Chinese medicine diagnosis: constipation (liver depression and qi stagnation syndrome) Western medicine diagnosis: constipation-type irritable bowel syndrome.

[0066] Treatment: 1. 2 boxes of Linaclotide capsules (290ug*7s / box). Usage: 290ug orally, twice a day.

[0067] 2. Orally take the Chinese medicine composition decoction provided in Example 1, a total of 7 doses, decocted in water, 1 dose per day, decocted over high heat and then simmered over low heat for about 20 minutes, and the Chinese medicine decoction was taken orally in 3 times.

[0068] Follow-up visit on April 15, 2024

[0069] At present, the patient's defecation difficulty has improved compared to before, and he can defecate 1-2 times a day. The stool is formed and not dry and hard. The abdominal pain is alleviated compared to before, and the dryness, bitterness in the mouth and belching have been relieved. The sleep is normal, the diet is normal, the urination is normal, and there is no other discomfort.

[0070] Physical examination: pale red tongue, thin white fur, and wiry pulse.

[0071] Treatment: 1. 2 boxes of Linaclotide Capsules (290ug*7s / box). Usage: 290ug orally once a day.

[0072] 2. Chinese herbal decoctions are the same as before.

[0073] Follow-up visit on April 23, 2024

[0074] The patient's bowel movements were basically normal, the stools were not dry and hard, and he had to defecate once a day. His sleep was improved compared to before, and he had no other discomfort.

[0075] Treatment: Take 7 doses of oral Chinese herbal decoction to consolidate the therapeutic effect, with the same prescription as before.

[0076] During a follow-up call on June 13, 2024, the patient had normal bowel movements and no special discomfort.

[0077] Test Example 3

[0078] 1. Materials and Methods

[0079] 1. Purpose

[0080] To observe the clinical efficacy and safety of Tiaoqi Daozhi Decoction in the treatment of constipation-type irritable bowel syndrome (liver depression and qi stagnation syndrome).

[0081] 2. Source of cases

[0082] Patients with constipation-predominant irritable bowel syndrome (IBS-C) who met the inclusion criteria and visited the outpatient department of gastroenterology at Chongqing Hospital of Traditional Chinese Medicine from June 2022 to June 2023.

[0083] 3. Diagnostic criteria

[0084] 3.1 TCM diagnostic criteria

[0085] The diagnostic criteria of TCM syndrome refer to the 2017 "Expert Consensus on TCM Diagnosis and Treatment of Irritable Bowel Syndrome" issued by the Spleen and Stomach Disease Branch of the Chinese Association of Traditional Chinese Medicine. The diagnostic criteria of liver depression and qi stagnation syndrome are summarized as follows:

[0086] Main symptoms: ① Difficult defecation; ② Abdominal pain

[0087] Secondary symptoms: ① chest tightness and discomfort; ② frequent belching; ③ swelling and pain in the flanks.

[0088] Tongue and pulse: dark red tongue, stringy pulse.

[0089] Diagnostic criteria: 2 main symptoms plus any 2 secondary symptoms, and the diagnosis can be made by referring to the tongue and pulse.

[0090] 3.2 Western medicine diagnostic criteria

[0091] The Western medicine diagnosis standard refers to the 2016 Rome IV standard. The Western medicine diagnosis of IBS-C should meet the following requirements:

[0092] (1) The patient has recurrent abdominal pain for at least 6 months, with an average of at least 1 episode per week in the past 3 months, and meets 2 or more of the following symptoms:

[0093] ① Related to defecation; ② The number of bowel movements per week is less than 3 times; ③ Accompanied by changes in stool characteristics, that is, at least 25% of the stool is lumpy or hard (Bristol type 1-2), and the proportion of watery or mushy (Bristol type 6-7) stool is less than 25%.

[0094] (2) Lack of biochemical abnormalities and morphological changes that could explain the symptoms.

[0095] 4 Inclusion criteria, exclusion criteria, dropout criteria, and termination criteria

[0096] 4.1 Inclusion criteria

[0097] (1) Meet the Western medical diagnostic criteria for IBS-C;

[0098] (2) meet the diagnostic criteria of TCM syndrome;

[0099] (3) Those who underwent colonoscopy within 1 year to exclude related organic diseases;

[0100] (4) Aged 18-65 years old, regardless of gender;

[0101] (5) Volunteer to participate in the study and sign the informed consent form.

[0102] 4.2 Exclusion criteria

[0103] (1) Patients with serious underlying diseases;

[0104] (2) Those with organic intestinal diseases confirmed by colonoscopy, or other diseases that may affect intestinal motility;

[0105] (3) Pregnant women;

[0106] (4) Those with severe allergies;

[0107] (5) Those who have participated in other clinical trials;

[0108] (6) Those who are currently taking other medications and cannot stop taking them for more than 2 weeks.

[0109] 4.3 Shedding Standard

[0110] (1) Those who do not follow the doctor's advice during the clinical research process;

[0111] (2) cases that were mistakenly included;

[0112] (3) Those with missing research data;

[0113] (4) Those who lost contact during the trial;

[0114] (5) Those who cannot return for follow-up consultation in time;

[0115] (6) Actively request to withdraw from this clinical observation.

[0116] 4.4 Termination criteria

[0117] (1) During the trial, the subject's condition cannot be controlled, continues to deteriorate, and threatens his life;

[0118] (2) Serious adverse drug reactions or other dangerous events occur during the trial;

[0119] (3) Those suffering from other diseases that threaten their life or health.

[0120] 5. Research Methods

[0121] 5.1 Study design

[0122] A single-center, completely randomized, open-label clinical study with positive drug control was used.

[0123] 5.2 Sample size estimation

[0124] PASS software was used to estimate the sample size of this study, which was 30 cases in the control group and 30 cases in the observation group.

[0125] 5.3 Case grouping

[0126] The 60 patients were numbered in sequence starting from 1 according to the chronological order of inclusion. Starting from any number in the random number table, 60 random numbers were selected from left to right, and the selected random numbers were matched one by one with the patient numbers. Then the random numbers were sequenced from small to large, and the patients corresponding to the random numbers from 1 to 30 were divided into the observation group, and the patients corresponding to the random numbers from 31 to 60 were divided into the control group.

[0127] 5.4 Treatment methods

[0128] Control group: Linaclotide capsules (Linaclotide) (290 μg / capsule, manufacturer: Almac Pharma Services Limited, national medicine standard H20190001), once a day, 1 capsule each time, 30 minutes before breakfast.

[0129] Observation group: on the basis of the control group, combined with oral administration of Tiaoqi Daozhi Decoction (the Chinese medicine composition decoction provided in Example 1), Tiaoqi Daozhi Decoction was uniformly decocted by the Chinese medicine pharmacy of Nanqiao Temple Department of Chongqing Traditional Chinese Medicine Hospital. Medication method: 1 dose per day, divided into 3 times after meals.

[0130] The treatment course for both the control group and the observation group was 4 weeks.

[0131] 5.5 Observation indicators

[0132] 5.5.1 Safety indicators

[0133] (1) Vital signs: body temperature, respiration, pulse, and blood pressure.

[0134] (2) Monitor and record adverse reactions that occur during the observation process, deal with them accordingly, analyze their causes, and evaluate their relevance to this study.

[0135] 5.5.2 Efficacy indicators

[0136] (1) Based on the guidance of the TCM Symptom Scale for Gastrointestinal Diseases, the 2017 TCM Expert Consensus on Diagnosis and Treatment of Irritable Bowel Syndrome, and the Bristol Stool Character Scale, a TCM Syndrome Scoring Scale was developed to better evaluate the TCM syndromes of gastrointestinal diseases and make the research results more reliable (see Appendix A).

[0137] (2) IBS Quality of Life Scale (IBS-QOL), see Appendix B.

[0138] (3) Hamilton Anxiety Rating Scale (HAMA) and Hamilton Depression Rating Scale (HAMD), see Appendices C and D.

[0139] (4) IBS Severity Scale (IBS-SSS), see Appendix E.

[0140] (5) Visceral Sensitivity Index (VSI), see Appendix F.

[0141] 5.6 Evaluation of efficacy

[0142] 5.6.1 Evaluation criteria for TCM syndrome efficacy

[0143] Referring to the nimodipine method: efficacy index = [(score before treatment - score after treatment) / score before treatment] × 100%, divided into 4 levels: cured, markedly effective, effective, and ineffective; total effective rate = (markedly effective + effective) / total number of cases × 100%.

[0144] (1) Recovery: The main symptoms and signs completely disappear, and the efficacy index reaches at least 95%;

[0145] (2) Significantly effective: major symptoms and signs are significantly alleviated, with an efficacy index between 70% and 94%;

[0146] (3) Effective: The main symptoms and signs were significantly improved, with the efficacy index ranging from 30% to 69%;

[0147] (4) Ineffective: The main symptoms and signs did not improve significantly, or even worsened, and the efficacy index was less than 30%.

[0148] 5.6.2 Quality of life assessment criteria

[0149] The IBS-QOL scale is divided into 8 dimensions, including anxiety, behavioral disorders, body thoughts, health worries, eating habits, social function, sexual behavior, and interpersonal relationships, with a total of 34 items, including 5 levels of asymptomatic, mild, moderate, severe, and severe, corresponding to 5 to 1 points respectively. Comparing the changes in the total score before and after treatment, the higher the score, the better the quality of life.

[0150] 5.6.3 Anxiety and Depression Assessment Criteria

[0151] The HAMA and HAMD scales can be used to assess the severity of anxiety and depression in patients, and can also be used to assess the effectiveness of various treatments and psychological interventions. The former has 14 items, while the latter has 17 items. Both use a 5-level scoring method of 0 to 4 points. Researchers evaluate the degree of improvement in patients' anxiety and depression by comparing the changes in scale scores before and after treatment.

[0152] 5.6.4 IBS severity assessment criteria

[0153] The IBS-SSS scale is a tool used to measure the severity of IBS, including five aspects: abdominal pain, bloating, frequency of abdominal pain, bowel satisfaction, and symptom life distress. Through this scale, researchers can accurately assess the condition of IBS patients and divide them into four levels: healthy, mild, moderate, and severe, corresponding to different score intervals such as 0-75 points, 76-175 points, 176-300 points, and >300 points. At the same time, the efficacy can be divided into three levels according to the decrease in the total score. The total effective rate = (significantly effective + effective) / total number of cases × 100%.

[0154] (1) Significantly effective: the score decreased by more than 2 levels after treatment;

[0155] (2) effective: the score decreased by 1 level after treatment;

[0156] (3) Ineffective: The score level does not change after treatment or is higher than the original level.

[0157] 5.6.5 Visceral Sensitivity Index Assessment Criteria

[0158] The visceral sensitivity index can be used to measure individual visceral sensitivity. The index consists of 15 items, each of which is further divided into 6 sub-items according to different degrees. Through the reverse scoring method, the score is positively correlated with the degree of visceral sensitivity.

[0159] 5.6.6 Safety assessment standards

[0160] Referring to the "Guidelines for Clinical Research of New Chinese Medicines", the safety evaluation standards are divided into the following four levels.

[0161] Level 1: safe, without any adverse reactions;

[0162] Level 2: relatively safe, there may be adverse reactions, but no special treatment is required and the patient can continue to take the medication;

[0163] Level 3: There are potential safety risks and moderate side effects. The patient can continue to take the medicine after appropriate treatment.

[0164] Grade 4: The trial was terminated due to adverse reactions.

[0165] 5.7 Data Processing

[0166] After Excel sorted and checked the data, SPSS25.0 was used for statistical analysis: ① The measurement data were calculated by adding or subtracting the standard deviation of the mean value. If the two groups of measurement data meet the normal distribution and variance homogeneity, the independent sample t test is used; if they do not meet the normal distribution, the two independent sample rank sum test is used to compare the median and interquartile range (M(P 25 , P 75 )) indicates; ② The difference before and after treatment (d) conforms to normal distribution, and paired sample t test is used; if it does not conform to normal distribution, paired sample rank sum test is used; ③ When the two groups of rank data are compared, when the total frequency of each group is <50, the rank sum test of rank data is used. The test level is set at α = 0.05, and P < 0.05 is considered to be statistically significant.

[0167] 2. Results and Analysis

[0168] 1. Case completion status

[0169] A total of 60 patients were included in this study, 30 in the control group and 30 in the observation group, and all patients in both groups completed follow-up.

[0170] 2. Comparison of baseline data between the two groups of patients

[0171] 2.1 Comparison of gender composition between the two groups of patients

[0172] The observation group had 7 males and 23 females, and the control group had 5 males and 25 females. The chi-square test showed that 2 =0.417, P=0.519>0.05, the difference was not statistically significant, and the gender distribution of the two groups was comparable, see Table 2-1.

[0173] Table 2-1 Gender distribution of patients in the two groups

[0174]

[0175] 2.2 Comparison of age distribution between the two groups

[0176] The age of the observation group was 46.50±11.65 years old, and the age of the control group was 46.13±8.56 years old. After test analysis, it was found that P=0.890, and the difference was not statistically significant, indicating that the two groups of patients were comparable in age distribution, see Table 2-2.

[0177] Table 2-2 Age distribution of patients in the two groups

[0178]

[0179] 2.3 Comparison of disease course between the two groups

[0180] The average course of the observation group was 22.17±12.10 months, and the average course of the control group was 20.10±11.53 months. After statistical analysis, P=0.486. There was no statistical difference in the distribution of the course of disease between the two groups, and they were comparable. See Table 2-3 for details.

[0181] Table 2-3 Disease course distribution of two groups of patients [M(P 25 , P 75 )]

[0182]

[0183] 2.4 Comparison of TCM syndrome scores between the two groups of patients before treatment

[0184] Before treatment, the scores of each single TCM syndrome in the two groups of patients did not meet the normality requirement. After the independent sample rank sum test, the P values ​​were all greater than 0.05, and the difference was not statistically significant, indicating that the scores of each single TCM syndrome in the two groups of patients before treatment were comparable, as shown in Table 2-4.

[0185] Table 2-4 Comparison of individual TCM syndrome scores between the two groups of patients before treatment [M(P 25 , P 75 )]

[0186]

[0187]

[0188] 2.5 Comparison of IBS-QOL scores between the two groups before treatment

[0189] After independent sample t test, t=-0.322, P=0.749, the difference was not statistically significant, indicating that the IBS-QOL scores of the two groups of patients before treatment were comparable, see Table 2-5 for details.

[0190] Table 2-5 Comparison of IBS-QOL scores between the two groups before treatment

[0191]

[0192] 2.6 Comparison of HAMA scores between the two groups before treatment

[0193] After independent sample rank sum test, Z=0.832, P=0.405>0.05, the difference was not statistically significant, indicating that the HAMA scores of the two groups of patients before treatment were comparable, see Table 2-6.

[0194] Table 2-6 Comparison of HAMA scores between the two groups before treatment [M(P 25 , P 75 )]

[0195]

[0196] 2.7 Comparison of HAMD scores between the two groups before treatment

[0197] After independent sample rank sum test, t=-0.967, P=0.338>0.05, the difference was not statistically significant, indicating that the HAMD scores of the two groups of patients before treatment were comparable, see Table 2-7.

[0198] Table 2-7 Comparison of HAMD scores between the two groups of patients before treatment

[0199]

[0200] 2.8 Comparison of IBS-SSS scores between the two groups before treatment

[0201] After independent sample rank sum test, Z=-1.668, P=0.095>0.05, the difference was not statistically significant, indicating that the IBS-SSS scores of the two groups of patients before treatment were comparable, see Table 2-8.

[0202] Table 2-8 Comparison of IBS-SSS scores between the two groups before treatment [M(P 25 , P 75 )]

[0203]

[0204] 2.9 Comparison of VSI scores between the two groups before treatment

[0205] After independent sample rank sum test, Z=-0.664, P=0.506>0.05, the difference was not statistically significant, indicating that the VSI scores of the two groups of patients before treatment were comparable, see Table 2-9.

[0206] Table 2-9 Comparison of VSI scores between the two groups before treatment [M(P 25 , P 75 )]

[0207]

[0208] 3 Comparison of efficacy

[0209] 3.1 Intra-group comparison

[0210] 3.1.1 Comparison of TCM syndrome scores

[0211] Comparison of each single TCM syndrome score between the two groups of patients: Intra-group comparison in the observation group showed that the P values ​​were all less than 0.05 after paired sample rank sum test, and the difference in each single TCM syndrome score between the observation group was statistically significant; Intra-group comparison in the control group showed that the P values ​​were less than 0.05 after paired sample rank sum test, and the difference in each single TCM syndrome score between the control group was statistically significant (P<0.05), indicating that each single TCM symptom in the observation group and the control group after treatment was alleviated compared with that before treatment, with statistical differences.

[0212] Table 3-1 Comparison of single TCM syndrome scores within the same group [M(P 25 , P 75 )]

[0213]

[0214]

[0215]

[0216] 3.1.2 Comparison of quality of life scores

[0217] The P values ​​of the two groups were less than 0.05, indicating that the quality of life of the patients in the observation group and the control group after treatment was higher than that before treatment, and the difference was statistically significant. See Table 3-2 for details.

[0218] Table 3-2 Comparison of quality of life scores between the two groups of patients

[0219]

[0220] 3.1.3 Comparison of anxiety and depression scores

[0221] The intra-group comparison of anxiety (HAMA) scores between the two groups of patients showed that the P values ​​were all less than 0.05, and the difference was statistically significant, as shown in Table 3-3. The intra-group comparison of depression (HAMD) scores between the two groups of patients showed that the P values ​​were all less than 0.05, and the difference was statistically significant, as shown in Table 3-4.

[0222] Table 3-3 Comparison of anxiety (HAMA) scores between the two groups of patients

[0223]

[0224] Table 3-4 Comparison of depression (HAMD) scores between the two groups of patients

[0225]

[0226] 3.1.4 Comparison of disease severity scores

[0227] Intra-group comparison of symptom severity between the two groups showed that the P values ​​of both groups were <0.05, and the difference was statistically significant, indicating that the severity of the disease in both groups was alleviated after treatment. See Table 3-5 for details.

[0228] Table 3-5 Comparison of disease severity scores within the group

[0229]

[0230] 3.1.5 Comparison of Visceral Sensitivity Index Scores

[0231] Intra-group comparison of the visceral sensitivity index scores of the two groups showed that the visceral sensitivity index scores of the two groups after treatment were lower than those before treatment, and the differences were statistically significant, as shown in Table 3-6 for details.

[0232] Table 3-6 Comparison of Visceral Sensitivity Index Scores between Two Groups

[0233]

[0234] 3.2 Comparison between groups

[0235] 3.2.1 Comparison of single TCM syndrome scores between the two groups after treatment

[0236] After treatment, the two groups were compared in terms of single TCM syndrome scores. The results are shown in Tables 5-15. The results showed that there was no statistical difference between the two groups in the improvement of dry stool, strained defecation, abnormal defecation frequency and poor appetite. The observation group was superior to the control group in improving abdominal pain and bloating, chest and flank pain, incomplete defecation, belching and hiccups, fatigue and insomnia in patients with IBS-C (liver depression and qi stagnation syndrome), and the difference was statistically significant.

[0237] Table 5-15 Comparison of single TCM syndrome scores between the two groups after treatment

[0238]

[0239]

[0240] Table 3-8 Comparison of TCM syndrome efficacy between two groups of patients

[0241]

[0242] 3.2.2 Comparison of IBS-QOL scores between the two groups after treatment

[0243] The comparison of the quality of life scores of the two groups of patients after treatment showed that the quality of life score of the observation group was higher than that of the control group. Statistical analysis showed that there was a statistically significant difference (P < 0.05), as shown in Table 3-9.

[0244] Table 3-9 Comparison of IBS-QOL scores between the two groups after treatment [M(P 25 , P 75 )]

[0245]

[0246] 3.2.3 Comparison of HAMA scores between the two groups after treatment

[0247] The HAMA scores of the two groups of patients were compared after treatment. The results showed that the HAMA score of the observation group was lower than that of the control group. After statistical analysis, it was statistically significant (P < 0.05), as shown in Table 3-10.

[0248] Table 3-10 Comparison of HAMA scores between the two groups after treatment [M(P 25 , P 75 )]

[0249]

[0250] 3.2.4 Comparison of HAMD scores between the two groups after treatment

[0251] The HAMD scores of the two groups of patients were compared after treatment. The results showed that the HAMD score of the observation group was lower than that of the control group. After statistical analysis, it was statistically significant (P < 0.05), as shown in Table 3-11.

[0252] Table 3-11 Comparison of HAMD scores between the two groups after treatment [M(P 25 , P 75 )]

[0253]

[0254] 3.2.5 Comparison of IBS-SSS scores between the two groups after treatment

[0255] The IBS-SSS scores of the two groups of patients after treatment were compared. The results showed that the IBS-SSS scores of the observation group were lower than those of the control group. After statistical analysis, it was statistically significant (P < 0.05), as shown in Table 3-12. The total effective rate of the observation group was 86.67%, and the total effective rate of the control group was 70.00%. After the rank sum test of graded data, P = 0.041 < 0.05, the difference was statistically significant, as shown in Table 3-13.

[0256] Table 3-12 Comparison of IBS-SSS scores between the two groups after treatment [M(P 25 , P 75 )]

[0257]

[0258] Table 3-13 Comparison of efficacy of symptom severity between the two groups of patients

[0259]

[0260] 3.2.6 Comparison of VSI scores between the two groups after treatment

[0261] After treatment, the VSI scores of the two groups were compared. After statistical analysis, P<0.05, and the difference was statistically significant. See Table 3-14 for details. The VSI score of the observation group was significantly lower than that of the control group, indicating that the effect of Tiaoqi Daozhi Decoction combined with linaclotide in reducing visceral sensitivity in patients with IBS-C is significantly better than that of linaclotide alone.

[0262] Table 3-14 Comparison of VSI scores between the two groups after treatment [M(P 25 , P 75 )]

[0263]

[0264] 4. Safety evaluation

[0265] No serious adverse reactions occurred during the clinical trials, and the safety evaluation of all patients was Grade 1 or 2, requiring no special treatment.

[0266] 3. Summary

[0267] Before treatment, there were no statistical differences in gender, age, course of disease, TCM syndrome score, IBS-QOL score, HAMA score, HAMD score, IBS-SSS score, and VSI score between the two groups, indicating that the two groups were comparable. After treatment, the observation group was better than the control group in improving the single TCM syndromes of IBS-C (liver depression and qi stagnation syndrome) such as abdominal pain and distension, chest and flank pain, incomplete defecation, belching and hiccups, fatigue and insomnia. The observation group was better than the control group in improving the quality of life score, anxiety score, depression score, IBS disease severity score, and visceral sensitivity index score. The total effective rate of TCM syndrome in the observation group was 100.00%, and the total effective rate of TCM syndrome in the control group was 70.00%, with statistically significant differences. The total effective rate of reducing the severity of symptoms in the observation group was 86.67%, which was significantly higher than 70.00% in the control group, with statistically significant differences.

[0268] appendix

[0269] Appendix A TCM Syndrome Score Table

[0270]

[0271] Appendix B IBS Quality of Life Scale (IBS-QOL)

[0272]

[0273]

[0274] Appendix C Hamilton Anxiety Rating Scale (HAMA)

[0275]

[0276]

[0277] Appendix D Hamilton Depression Rating Scale (HAMD)

[0278]

[0279]

[0280]

[0281] Appendix E IBS Symptom Severity Scale (IBS-SSS)

[0282]

[0283]

[0284] Note: IBS-SSS intestinal symptom severity grading: mild: 75-175; moderate: 175-300; severe: >300. Appendix F Visceral Sensitivity Index (VSI)

[0285]

[0286]

[0287] The embodiments described above are only descriptions of the preferred embodiments of the present invention, and are not intended to limit the scope of the present invention. Without departing from the design spirit of the present invention, various modifications and improvements made to the technical solutions of the present invention by ordinary technicians in this field should fall within the protection scope determined by the claims of the present invention.

Claims

1. A Chinese medicine composition for regulating qi and relieving stagnation, characterized in that: The invention comprises the following components by weight: 5-15 parts of Cyperus rotundus, 5-15 parts of Linderae strychnos, 5-15 parts of Curcuma zedoariae, 5-15 parts of Trichosanthes kirilowii, 5-15 parts of Apricot kernel, 5-15 parts of Cannabis sativa seeds, 5-15 parts of Rose flower and 5-15 parts of Mint.

2. The Chinese medicine composition according to claim 1, characterized in that: The invention comprises the following components by weight: 8-12 parts of cyperus rotundus, 8-12 parts of lindera striata, 8-12 parts of zedoaria, 8-12 parts of trichosanthes, 8-12 parts of apricot kernel, 8-12 parts of hemp seed, 8-12 parts of rose flower and 8-12 parts of mint.

3. The Chinese medicine composition according to claim 1, characterized in that The invention comprises the following components by weight: 10 parts of cyperus rotundus, 10 parts of lindera striata, 10 parts of zedoaria, 10 parts of trichosanthes, 10 parts of apricot kernel, 10 parts of hemp seed, 10 parts of rose flower and 10 parts of mint.

4. The Chinese medicine composition according to any one of claims 1 to 3, characterized in that: It is used to treat constipation-type irritable bowel syndrome, the TCM syndrome type of which is liver depression and qi stagnation.

5. The method for preparing the Chinese medicine composition according to any one of claims 1 to 3, characterized in that: The steps include: Cyperus rotundus, Linderae strychnos, Curcuma zedoaria, Trichosanthes kirilowii, Apricot kernel, Fructus hemp, Rose and mint are decocted twice with water according to a certain proportion, and the decoction is filtered and the filtrate is combined to obtain a Chinese medicine composition liquid.

6. The method for preparing the Chinese medicine composition according to claim 5, characterized in that: The volume of the medicinal solution is 100-150 mL.

7. The method for using the Chinese medicine composition according to any one of claims 1 to 3, characterized in that: Divide the medicine into three equal portions and take one portion each in the morning, afternoon and evening half an hour after meals.

8. A Chinese medicine preparation comprising the Chinese medicine composition according to any one of claims 1 to 3, characterized in that: The dosage form of the traditional Chinese medicine preparation includes granules, granules, pills, capsules or tablets.

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