A traditional Chinese medicine composition for treating constipation-predominant irritable bowel syndrome of spleen-kidney yang deficiency and application thereof

Abstract

The application discloses a traditional Chinese medicine composition for treating constipation type irritable bowel syndrome of spleen-kidney yang deficiency type and application. The traditional Chinese medicine composition is composed of the following raw materials in parts by weight: aconite 15-30g, cassia 15-25g, dried ginger 10-20g, evodia 8-12g, zanthoxylum 8-12g, magnolia officinalis 12-18g, cistanche 12-20g, and fried licorice 6-12g. The application is used in the preparation of the treatment of constipation type irritable bowel syndrome of spleen-kidney yang deficiency type. The traditional Chinese medicine composition has a precise compatibility and obvious effect on the patients with IBS-C of spleen-kidney yang deficiency type. The treatment group is obviously superior to the control group in the clinical curative effect experiment, and the difference has statistical significance (P<0.05). The total effective rate of the traditional Chinese medicine syndrome curative effect of the treatment group reaches 88.24%, which is obviously superior to 73.53% of the control group.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating constipation type irritable bowel syndrome of spleen-kidney yang deficiency and application. BACKGROUND

[0002] Irritable bowel syndrome (IBS) is mainly manifested in clinical symptoms of abdominal pain, abdominal distension or abdominal discomfort, accompanied by changes in defecation frequency and / or stool form, abnormal defecation can be manifested as constipation or diarrhea, or alternation of both, and no morphological changes and abnormal biochemical indicators are found in the clinical syndrome. According to the abnormal defecation habits of patients for more than 14 days, combined with Bristol stool classification, IBS is often divided into four subtypes in clinical practice, including diarrhea-predominant irritable bowel syndrome (IBS-D), constipation-predominant irritable bowel syndrome (IBS-C), mixed irritable bowel syndrome (IBS-M) and unstable irritable bowel syndrome (IBS-U). The main clinical manifestations of IBS-C are defecation difficulty and abdominal discomfort, so the syndrome differentiation and treatment of constipation disease are based on traditional Chinese medicine. Traditional Chinese medicine has rich experience in diagnosis and treatment of constipation disease, and has been repeatedly verified in clinical practice, and has the characteristics of good clinical efficacy, relatively few side effects on the human body, and relatively stable long-term efficacy.

[0003] The application aims to provide a traditional Chinese medicine composition for treating constipation type irritable bowel syndrome of spleen-kidney yang deficiency. SUMMARY

[0004] The first object of the application is to provide a traditional Chinese medicine composition for treating constipation type irritable bowel syndrome of spleen-kidney yang deficiency, and the second object of the application is to provide application of the traditional Chinese medicine composition.

[0005] The first object of the application is achieved by a traditional Chinese medicine composition for treating constipation type irritable bowel syndrome of spleen-kidney yang deficiency, which is composed of the following raw materials in parts by weight: aconite 15-30g, cassia 15-25g, dried ginger 10-20g, evodia 8-12g, zanthoxylum 8-12g, magnolia officinalis 12-18g, cistanche 12-20g, and fried licorice 6-12g.

[0006] The second object of the application is achieved by application of the traditional Chinese medicine composition in preparation of a medicine for treating constipation type irritable bowel syndrome of spleen-kidney yang deficiency.

[0007] In the present application, the monarch drugs are aconite and cassia, and aconite and cassia are used together to tonify the kidney and the fire of the conception vessel. When the fire of the conception vessel is strong, the kidney yang is warm and the kidney water is warm. Aconite and cassia are used together to enhance the efficacy and reduce toxicity. Cassia can also guide the fire back to the origin, so that the ginger and aconite are warm but not hot, so as to achieve rapid effect and safety. The minister drugs are dried ginger, evodia and zanthoxylum. Dried ginger is the main drug for warming the middle and dispelling cold, and aconite and dried ginger are used together to tonify the kidney and the fire of the conception vessel, and assist the spleen yang to transport, so that the kidney water is warm and the spleen earth is dry. Evodia is the main drug for liver cold and stagnation, and it can regulate the liver and warm the spleen to assist the liver wood to be smooth. Zanthoxylum has the functions of warming the liver, regulating qi and relieving pain. Evodia and zanthoxylum are used together to warm the liver and regulate qi. The auxiliary drugs are magnolia and cistanche. Magnolia is returned to the spleen, stomach, lung and large intestine, and it has the functions of promoting digestion and relieving fullness. It can also descend the lung, stomach and large intestine. Cistanche is returned to the kidney and large intestine, and it can strengthen the kidney, tonify qi and blood, and moisten the intestine. The ministerial drug is fried licorice, which has the functions of tonifying the spleen and qi, and regulating various drugs. The combination of all the drugs can warm water, dry earth and reach wood, so that the kidney water is warm, the spleen earth is dry, and the liver wood is smooth, and the three yin meridians ascend left, and the large intestine and stomach are unobstructed, so that constipation is cured.

[0008] The present application combines the theory of qi movement in traditional Chinese medicine, and for the first time, it systematically constructs the relationship between the deficiency of preheaven and postheaven yang qi (spleen and kidney yang deficiency) and the pathogenesis of three yin viscera cold (water cold, earth wet and wood stagnation) caused by the deficiency of preheaven and postheaven yang qi (spleen and kidney yang deficiency), which has a distinct theoretical innovation feature in the understanding of the pathogenesis of IBS-C (spleen and kidney yang deficiency type). The fire of the conception vessel in the kidney is weak, the promotion and warming of yang qi is insufficient, the large intestine transmission is weak, the spleen yang is deficient, the spleen earth is cold and wet, the spleen qi does not rise, the stomach qi does not descend, the intestine is not unobstructed, the liver wood is stagnant, the liver function is abnormal, which aggravates the abnormality of middle jiao qi and causes the lung qi not to descend, the lung and large intestine are interrelated, the large intestine metal is not unobstructed, and the stool is stagnant. The traditional Chinese medicine composition in the present application is well matched, and it has obvious effect on the treatment of IBS-C (spleen and kidney yang deficiency type). The treatment group is significantly better than the control group in the clinical curative effect experiment, which has statistical significance (P<0.05). The total effective rate of traditional Chinese medicine syndrome in the treatment group is 88.24%, which is significantly better than 73.53% in the control group. DETAILED DESCRIPTION

[0009] The present application is further described below in conjunction with examples, but it is not limited in any way. Any transformation or replacement based on the teaching of the present application belongs to the protection scope of the present application.

[0010] The application discloses a traditional Chinese medicine composition for treating constipation type irritable bowel syndrome of spleen-kidney yang deficiency type, which is prepared from the following raw materials in parts by weight: aconite 15-30g, cassia 15-25g, dried ginger 10-20g, evodia 8-12g, zanthoxylum 8-12g, magnolia officinalis 12-18g, cistanche 12-20g, and fried licorice 6-12g.

[0011] The traditional Chinese medicine composition is added with 12-18g of atractylodes and 12-18g of white atractylodes, and is suitable for treating spleen-kidney yang deficiency and combined with the syndrome of dampness accumulation due to deficiency of the middle.

[0012] The traditional Chinese medicine composition is added with 12-18g of Buddha's hand and 8-12g of cumin, and is suitable for treating spleen-kidney yang deficiency and combined with the syndrome of liver cold and stagnation of qi.

[0013] The traditional Chinese medicine composition is added with 12-18g of ephedra root and 3-6g of asarum, and is suitable for treating spleen-kidney yang deficiency and combined with the syndrome of cold dampness accumulation in lower jiao.

[0014] The traditional Chinese medicine composition is added with 20-30g of eucommia and 12-18g of dogwood, and is suitable for treating spleen-kidney yang deficiency and combined with the syndrome of deficiency of kidney yang.

[0015] The traditional Chinese medicine composition is added with 8-12g of polygala and 20-30g of platycladus seed, and is suitable for treating spleen-kidney yang deficiency and combined with the syndrome of restlessness of heart spirit.

[0016] The traditional Chinese medicine composition is added with 12-18g of clove and 12-18g of cassia seed, and is suitable for treating spleen-kidney yang deficiency and combined with the syndrome of stomach cold and adverse flow of qi.

[0017] The application further provides a preparation based on the traditional Chinese medicine composition for treating constipation type irritable bowel syndrome of spleen-kidney yang deficiency type, wherein medical acceptable auxiliary materials are added in the prescription of the traditional Chinese medicine composition to prepare any one of the following: a decoction, a granule, a pill, a tablet, a capsule, a plaster, a syrup, and a powder.

[0018] The granule is prepared by the following method:

[0019] 1) The prescription is powdered, aconite is first decocted with 8-12 times of water for 1.5-2 hours, then dried ginger, fried licorice, cassia, evodia, zanthoxylum, magnolia officinalis and cistanche are added and decocted for 1-1.5 hours, 8-10 times of water is added and decocted for 2 times, each time for 2-3 hours, the decocted liquid is combined, concentrated to a relative density of 1.20, 95% ethanol is added to a concentration of 75%, and after 24-40 hours, filtration is conducted, ethanol is distilled dry under reduced pressure, filtration is conducted, the filtrate is concentrated under reduced pressure to a density of 1.25 at a temperature of 80 DEG C, the extract is dried and powdered to obtain extract powder;

[0020] 2) The extract powder is mixed with starch as auxiliary material at a mass ratio of 1:2, wet granulation is conducted by adding appropriate amount of 50% ethanol, drying is conducted, sieving is conducted to obtain granules.

[0021] The application further provides application of the traditional Chinese medicine composition in preparation of a medicament for treating constipation type irritable bowel syndrome of spleen-kidney yang deficiency type.

[0022] The application will be further described below in combination with examples.

[0023] Example 1

[0024] Ingredients: Fuzi 30g, Rougui 15g, Ganjiang 20g, Wuzhuyu 10g, Huajiao 10g, Hupo 15g, Shiliunong 20g, Zhigancao 6g.

[0025] 1) The ingredients in the prescription are crushed. Fuzi is first decocted with 10 times water for 2 hours. Then Ganjiang, Zhigancao, Rougui, Wuzhuyu, Huajiao, Hupo and Shiliunong are added and decocted for 1.5 hours. Then 10 times water is added and decocted for 2 times, each for 3 hours. The decoction is combined and concentrated to a relative density of 1.20. Then 95% ethanol is added to a concentration of 75%. After 36 hours, filtration is performed. The ethanol is distilled dry under reduced pressure. Filtration is performed. The filtrate is concentrated under reduced pressure to an extract at a density of 1.25 at a temperature of 80°C. The extract is dried and crushed to obtain an extract powder.

[0026] 2) The extract powder and starch as an excipient are mixed at a mass ratio of 1:2. Wet granulation is performed with 50% ethanol. Drying is performed. Sieving is performed to obtain granules.

[0027] Example 2

[0028] Ingredients: Fuzi 20g, Rougui 15g, Ganjiang 10g, Wuzhuyu 8g, Huajiao 8g, Hupo 12g, Shiliunong 12g, Zhigancao 8g.

[0029] 1) The ingredients in the prescription are crushed. Fuzi is first decocted with 12 times water for 2 hours. Then Ganjiang, Zhigancao, Rougui, Wuzhuyu, Huajiao, Hupo and Shiliunong are added and decocted for 1.5 hours. Then 10 times water is added and decocted for 2 times, each for 2-3 hours. The decoction is combined and concentrated to a relative density of 1.20. Then 95% ethanol is added to a concentration of 75%. After 40 hours, filtration is performed. The ethanol is distilled dry under reduced pressure. Filtration is performed. The filtrate is concentrated under reduced pressure to an extract at a density of 1.25 at a temperature of 80°C. The extract is dried and crushed to obtain an extract powder.

[0030] 2) The extract powder and starch as an excipient are mixed at a mass ratio of 1:2. Wet granulation is performed with 50% ethanol. Drying is performed. Sieving is performed to obtain granules.

[0031] Example 3

[0032] Ingredients: Fuzi 30g, Rougui 25g, Ganjiang 20g, Wuzhuyu 12g, Huajiao 12g, Hupo 18g, Shiliunong 18g, Zhigancao 12g.

[0033] 1) The medicinal ingredients in the formula are ground. First, take Fuzi and add 8 times the amount of water and decoct for 1.5 hours. Then add Ganjiang, Zhigancao, Rougui, Wuzhuyu, Huajiao, Huhuo, Shijun and decoct for another 1 hour. Then add 8-10 times the amount of water and decoct for 2 hours. Combine the decoctions, concentrate to a relative density of 1.20, then add 95% ethanol to a concentration of 75%. After 24 hours, filter, distill the ethanol under reduced pressure, filter, and concentrate the filtrate under reduced pressure to an extract at a density of 1.25 at a temperature of 80°C. Dry the extract and grind to obtain an extract powder.

[0034] 2) Mix the extract powder with the excipient starch at a mass ratio of 1:2, add an appropriate amount of 50% ethanol, granulate by wet method, dry, sieve, and granulate to obtain granules.

[0035] Example 4

[0036] Formula: Fuzi 30g, Rougui 20g, Ganjiang 10g, Wuzhuyu 10g, Huajiao 12g, Huhuo 12g, Shijun 12g, Zhigancao 10g.

[0037] Example 5

[0038] Formula: Fuzi 20g, Rougui 20g, Ganjiang 15g, Wuzhuyu 8g, Huajiao 10g, Huhuo 15g, Shijun 18g, Zhigancao 10g.

[0039] Example 6

[0040] Formula: Fuzi 25g, Rougui 25g, Ganjiang 15g, Wuzhuyu 12g, Huajiao 8g, Huhuo 12g, Shijun 20g, Zhigancao 12g.

[0041] Example 7

[0042] Formula: Fuzi 15g, Rougui 15g, Ganjiang 10g, Wuzhuyu 10g, Huajiao 10g, Huhuo 12g, Shijun 12g, Zhigancao 8g.

[0043] Example 8

[0044] Formula: Fuzi 20g, Rougui 15g, Ganjiang 10g, Wuzhuyu 8g, Huajiao 10g, Huhuo 12g, Shijun 12g, Zhigancao 8g, Cangzhu 12g, Baizhu 12g.

[0045] Take the medicinal ingredients in the formula and weigh according to the formula. Add 800ml of water and soak for 20 minutes. Boil over low heat for 30 minutes. Take the first decoction of 300ml. Take the second decoction of 300ml. Mix the two decoctions to obtain a decoction. This formula is suitable for spleen and kidney yang deficiency with concurrent deficiency and dampness.

[0046] Example 9

[0047] Ingredients: Fuzi 30g, Rougui 15g, Ganjiang 20g, Wuzhuyu 10g, Huajiao 10g, Hupu 15g, Shuizhuyun 20g, Zhigancao 6g, Foshou 15g, Xiaohuixiang 15g.

[0048] Each medicine in the prescription is weighed according to the prescription, 800ml of water is added, soaked for 20 minutes, boiled for 30 minutes on low heat, the first decoction is taken 300ml, the second decoction is taken 300ml, and the two decoctions are mixed to get the decoction. This prescription is suitable for spleen and kidney yang deficiency, combined with liver cold and qi depression.

[0049] Example 10

[0050] Ingredients: Fuzi 30g, Rougui 25g, Ganjiang 15g, Wuzhuyu 10g, Huajiao 8g, Hupu 18g, Shuizhuyun 15g, Zhigancao 6g, Mahuanggen 15g, Xixin 5g.

[0051] Each medicine in the prescription is weighed according to the prescription, 800ml of water is added, soaked for 20 minutes, boiled for 30 minutes on low heat, the first decoction is taken 300ml, the second decoction is taken 300ml, and the two decoctions are mixed to get the decoction. This prescription is suitable for spleen and kidney yang deficiency, combined with lower cold and dampness.

[0052] Example 11

[0053] Ingredients: Fuzi 30g, Rougui 25g, Ganjiang 15g, Wuzhuyu 12g, Huajiao 10g, Hupu 18g, Shuizhuyun 15g, Zhigancao 10g, Duzhong 20g, Xuduan 15g.

[0054] Each medicine in the prescription is weighed according to the prescription, 800ml of water is added, soaked for 20 minutes, boiled for 30 minutes on low heat, the first decoction is taken 300ml, the second decoction is taken 300ml, and the two decoctions are mixed to get the decoction. This prescription is suitable for spleen and kidney yang deficiency, combined with kidney yang deficiency.

[0055] Example 12

[0056] Ingredients: Fuzi 30g, Rougui 15g, Ganjiang 20g, Wuzhuyu 10g, Huajiao 10g, Hupu 15g, Shuizhuyun 20g, Zhigancao 6g, Yuanzhi 10g, Baiziren 25g.

[0057] Each medicine in the prescription is weighed according to the prescription, 800ml of water is added, soaked for 20 minutes, boiled for 30 minutes on low heat, the first decoction is taken 300ml, the second decoction is taken 300ml, and the two decoctions are mixed to get the decoction. This prescription is suitable for spleen and kidney yang deficiency, combined with heart and spirit restlessness.

[0058] Example 13

[0059] Composition: Fuzi 30g, Cinnamon 20g, Dried ginger 18g, Evodia 12g, Zanthoxylum 10g, Magnolia officinalis 12g, Cistanche 15g, Fried licorice 12g, Clove 15g, Cinnamon 15g.

[0060] Each medicine in the composition is weighed according to the composition, 800ml of water is added, soaked for 20 minutes, boiled for 30 minutes on low heat, 300ml of juice is obtained by the first decoction, 300ml of juice is obtained by the second decoction, and the two decoctions are mixed to obtain the decoction. This prescription is suitable for spleen-kidney yang deficiency, combined with stomach cold and adverse syndrome.

[0061] The following introduces the clinical efficacy test of the composition of the present application

[0062] 1. Case source: The clinical research cases in this application are all from the IBS-C (spleen-kidney yang deficiency type) patients in the outpatient and inpatient department of the Department of Spleen, Stomach and Liver Diseases of the Third Affiliated Hospital of Yunnan University of Chinese Medicine from December 2021 to February 2023.

[0063] 2. Diagnostic criteria

[0064] Western medicine diagnostic criteria: Refer to the diagnostic criteria of IBS and IBS-C typing in "Rome IV standard"

[16] (2016): (1) Repeated abdominal pain, abdominal distension or abdominal discomfort, symptoms persist for ≥6 months before diagnosis, average onset at least 1 day per week in the last 3 months, accompanied by the following 2 or ≥2: ① associated with defecation; ② less than 3 times per week; ③ accompanied by stool shape (appearance) change. (2) The proportion of stool shape meeting Bristol classification type 1 and / or type 2 is >25%, and the proportion of Bristol classification type 6 and / or type 7 is <25%. (3) Physical examination only shows abdominal tenderness, lack of biochemical abnormalities and morphological changes that can explain the symptoms.

[0065] TCM diagnostic criteria: Refer to the diagnostic criteria of IBS-C (spleen-kidney yang deficiency syndrome) in "Expert Consensus on Diagnosis and Treatment of Irritable Bowel Syndrome in Traditional Chinese Medicine"

[17] . (1) Main symptoms: ① dry or not dry stool, difficult to discharge; ② abdominal cold pain, relieved by heat. (2) Secondary symptoms: ① clear urine; ② cold limbs; ③ pale face. Tongue and pulse: pale tongue with white fur; slow and deep pulse. Diagnosis of syndrome: 2 main symptoms, 2 secondary symptoms, and tongue and pulse manifestations of pale tongue with white fur and slow and deep pulse.

[0066] 3. Inclusion criteria

[0067] ① Meet the western medicine diagnostic criteria;

[0068] ② Meet the diagnostic criteria of IBS-C (spleen-kidney yang deficiency syndrome);

[0069] ③ Age ≥18 years old and ≤65 years old;

[0070] ④Exclusion of organic lesions by colonoscopy;

[0071] ⑤Duration of disease ≥ 6 months;

[0072] ⑥The subject is willing to join this clinical study and signs the informed consent form.

[0073] Seventy-two cases meeting the inclusion criteria were randomly divided into treatment group - "Chinese medicine composition of the invention" and control group - "Jichuan decoction", 36 cases in each group.

[0074] 4. Treatment method

[0075] (1) Basic treatment

[0076] Health education on related diseases was given to the enrolled IBS-C patients to relieve their nervous and anxious emotions caused by lack of understanding of the disease, adjust their life and living, and improve their daily diet structure and maintain moderate exercise.

[0077] (2) Group treatment

[0078] ① Treatment group: Give Fuxie Tongbian Decoction, the composition of which is as follows: Fuzi 15g, Rougui 20g, Ganjiang 20g, Wuzhuyu 10g, Huajiao 10g, Hupo 15g, Zhigancao 10g. (The drug dosage of Fuxie Tongbian Decoction is determined according to the actual drug dosage of Yunnan Wu's Fuyang academic school of clinical practice.)

[0079] ② Control group: Give Jichuan Decoction, the composition of which is as follows: Danggui 15g, Niuxi 6g, Zhigancao 9g, Zexie 4g, Shengma 3g, Zhisheng 3g. (The drug dosage of Jichuan Decoction is determined according to "Prescription Science", Li Ji, 3rd edition, P53-54.)

[0080] The drugs of the treatment group and the control group are all formula granules, which are provided by the Third Affiliated Hospital of Yunnan University of Chinese Medicine.

[0081] The patients in the two groups are required to take 1 dose of the drug per day, bid, po, and take it with 200ml of warm water 1 hour after meals. During the medication period, the patients in the two groups are strictly prohibited from eating sour and cold foods, fruits, mushrooms and wine, and drink more warm water.

[0082]

[0083] 5. Main observation index

[0084] ​The following observation indexes are mainly included: general information, safety index, TCM syndrome score, clinical efficacy evaluation, Bristol stool form scale, IBS quality of life scale, mental and psychological state, and long-term efficacy evaluation of TCM.

[0085] 6. Efficacy evaluation criteria

[0086] The following efficacy evaluation criteria are mainly included: TCM syndrome score determination criteria, Bristol stool form score evaluation criteria, IBS-QOL score evaluation criteria, mental and psychological state evaluation criteria, long-term efficacy evaluation criteria, and safety evaluation of clinical research.

[0087] 7. Statistical processing

[0088] The data collected in this clinical efficacy experiment are analyzed by SPSS 26.0.

[0089] 8. Result analysis

[0090] 8.1 Baseline data analysis

[0091] The final effective number of cases in this clinical efficacy experiment is 68, including 34 cases in the treatment group and 34 cases in the control group. In terms of gender distribution, the male to female ratio in the treatment group is 14:20, and the male to female ratio in the control group is 11:23,

[0092] The total male to female ratio in the two groups is 25:43. In terms of age distribution, the IBS-C incidence age is mainly in the 18-44 and 45-59 age

[0093] groups, and is mainly distributed in the young and middle-aged age groups. In terms of disease duration, the average disease duration of the treatment group and the control group is 7.79±8.22 years and 8.58±7.80 years, respectively. The baseline data shows that IBS-C is more common in women than in men, more common in young and middle-aged people, and the disease duration is relatively long, which is consistent with the current epidemiological characteristics of IBS-C.

[0094] 8.2 Comparative analysis of overall efficacy of TCM syndrome

[0095] From Table 1, the overall efficacy of TCM syndrome in the treatment group is significantly better than that in the control group, indicating that the clinical efficacy of the traditional Chinese medicine composition for treating IBS-C (spleen-kidney yang deficiency type) is better than that of Jichuan Decoction.

[0096] Table 1 Overall efficacy of TCM syndrome after 4 weeks of treatment

[0097]

[0098] 8.3 Comparative analysis of TCM syndrome total score before and after treatment

[0099] From table 2, after 4 weeks of treatment, the total score of the two groups after treatment and the total score before treatment were significantly decreased (P<0.05), and the treatment group was more obvious in reducing the total score of TCM syndrome (P<0.05). It shows that the traditional Chinese medicine composition and Jichuan decoction can improve the clinical symptoms of patients, and the traditional Chinese medicine composition is better than Jichuan decoction.

[0100] Table 2 Comparison of total TCM syndrome scores of two groups of patients

[0101]

[0102] 8.4 Comparison and analysis of single syndrome score of two groups before and after treatment

[0103] From table 3 and table 4, the single syndrome score, after 2 weeks of treatment, the treatment group was significantly improved in symptoms of constipation, defecation difficulty, abdominal pain, clear urine, limbs not warm, pale face (P<0.05), the control group was improved in symptoms of constipation, defecation difficulty, pale face (P<0.05), and had no obvious improvement in symptoms of abdominal pain, clear urine, limbs not warm (P>0.05). It shows that the traditional Chinese medicine composition can improve the main symptoms and secondary symptoms of IBS-C patients in a short time, and Jichuan decoction can improve part of the symptoms of patients in a short time. After 4 weeks of treatment, the two drugs can significantly relieve the clinical symptoms of IBS-C patients (P<0.05), and the curative effect of the two drugs in treating constipation is equivalent (P>0.05), but the curative effect of the treatment group in defecation difficulty, abdominal pain, clear urine, limbs not warm, pale face is better than that of the control group (P<0.05). It shows that the traditional Chinese medicine composition can better improve the clinical symptoms of IBS patients with spleen and kidney yang deficiency compared with Jichuan decoction.

[0104] Table 3 Comparison of single syndrome score after 2 weeks of treatment

[0105]

[0106] Table 4 Comparison of single syndrome score after 4 weeks of treatment

[0107]

[0108] 8.5 Bristol stool form score analysis

[0109] From table 5, the comparison of treatment group and control group before and after treatment, the stool character integral is obviously decreased (P<0.05), but the difference of two groups after treatment is not statistically significant (P>0.05). It shows that the traditional Chinese medicine composition and Jichuan decoction in the application can improve the stool character of patients, but there is no obvious difference between the two.

[0110] Table 5 Bristol stool score comparison

[0111]

[0112] 8.6 IBS-QOL scale score analysis

[0113] From table 6, the IBS-QOL score of two groups of patients after treatment is compared with that before treatment, and the integral is obviously increased (P<0.05), and after treatment, the treatment group is more significant in improving the IBS-QOL score than the control group (P<0.05. It shows that the traditional Chinese medicine composition and Jichuan decoction can improve the quality of life of IBS-C (spleen and kidney yang deficiency type) patients, and the traditional Chinese medicine composition in the application is more obvious in improving the quality of life of patients than Jichuan decoction.

[0114] Table 6 Comparison of IBS-QOL of two groups of patients before and after treatment

[0115]

[0116] 8.7 Analysis of mental and psychological curative effect results

[0117] From table 7, after treatment, the HAMA integral and HAMD integral of two groups show a downward trend (P<0.05), and the traditional Chinese medicine composition in the treatment group is obviously better than the control group in improving the adverse mental and psychological state of patients (P<0.05).

[0118] It shows that the traditional Chinese medicine composition and Jichuan decoction can improve the anxiety, depression and other negative mental and psychological state of patients, and the traditional Chinese medicine composition in the application is better than Jichuan decoction. The traditional Chinese medicine composition in the application warms and supplements the kidney and the gate of life, warms the kidney water, makes the yang qi hide in the kidney water, the water warms the dry soil, then the wood reaches, the liver wood reaches, and the emotion is relaxed, so it can improve the emotion of patients.

[0119] Table 7 Comparison of HAMA integral of two groups of patients before and after treatment

[0120]

[0121] 8.8 Comparison and analysis of long-term curative effect of two groups in follow-up period

[0122] From table 8, after 6 weeks of treatment, 30 patients in the treatment group were followed up, and among the 30 patients in the treatment group, the cure rate was 6.67%, the significant efficiency was 40.00%, the effective rate was 36.67, the ineffective rate was 16.67, and the total effective rate was 83.33%; among the 25 patients in the control group, the cure rate was 4%, the significant efficiency was 20.00%, the effective rate was 24.00%, the ineffective rate was 52.00%, and the total effective rate was 48.00%. The long-term overall effective rate of the treatment group is higher than that of the control group, which shows that the long-term effect of the traditional Chinese medicine composition in the application on IBS-C (spleen-kidney yang deficiency type) is better than that of Jichuan decoction.

[0123] Table 8: Overall efficacy of TCM syndrome after 6 weeks of treatment

[0124]

[0125] 9. Safety index evaluation and analysis

[0126] In this clinical efficacy experiment, the general vital signs, three routine examinations (blood, urine and stool routine examinations), liver and kidney biochemical function examinations, electrocardiogram examinations and the like of the patients in the two groups were normal, and no adverse reaction events occurred. It shows that the traditional Chinese medicine composition and Jichuan decoction in the application have good safety in treating IBS-C (spleen-kidney yang deficiency type).

[0127] Case 1

[0128] Ms. Yang, 54 years old, presented in January 2023 with a 20-year history of recurrent constipation, which had worsened over the past year. She reported experiencing hard, difficult bowel movements 20 years prior without any apparent cause, occurring every 3-6 days. The condition had worsened over the past year, with bowel movements occurring every 3-5 days. The stools were formed, difficult to pass, and sticky at the end. She did not experience hiccups, but had abdominal distension without abdominal pain, excessive yellow phlegm that was easily expectorated, bilateral upper limb edema, no acid reflux, heartburn, nausea, vomiting, dry mouth, or bitter taste. She was generally sensitive to cold and prone to getting overheated. Her appetite was good, but she had poor sleep, difficulty falling asleep, and vivid dreams. Her urination was normal, with 1-2 nighttime awakenings. Her tongue was pale red with a white, greasy coating, and the sublingual veins were full and tortuous. Her pulse was deep and wiry, with weak and thready pulses in both cun positions. Based on the four diagnostic methods, this disease falls under the category of "constipation" in Traditional Chinese Medicine (TCM), with the syndrome being "deficiency of spleen and kidney yang, and stagnation of liver qi due to cold." The TCM treatment principle is to tonify fire to generate earth, dispel cold to reach wood, and warm yang to promote bowel movement. The formula is based on Example 1 with added ingredients, as follows: 10g of Evodia rutaecarpa (processed with wine), 20g of dried ginger, 40g of Poria cocos, 30g of cinnamon twig, 15g of stir-fried Atractylodes macrocephala (processed with wheat bran), 20g of stir-fried Alisma plantago-aquatica (processed with wheat bran), 20g of Leonurus japonicus, 6g of licorice root, 30g of Aconitum carmichaelii (processed with wheat bran), 15g of cinnamon bark, 20g of Cistanche deserticola, 10g of stir-fried Sichuan pepper, 10g of Ligusticum chuanxiong, 15g of Citrus medica var. sarcodactylis, 15g of fennel, and 20g of amethyst. Prepare 5 doses of the following herbs: 10g of Phellodendron bark (processed with salt), 10g of Amomum villosum, 30g of Drynaria fortunei (processed with hot water), 10g of bitter almond, 15g of Magnolia officinalis (processed with ginger), 15g of Prunus mume, 15g of Ephedra sinica root, 6g of Asarum heterotropoides, 30g of Epimedium brevicornu, 20g of Dipsacus asper (processed with wine), and 20g of Eucommia ulmoides (processed with salt). Place all the herbs in a pot, add 800ml of water, soak for 20 minutes, then simmer over low heat for 30 minutes. Take 300ml of the first decoction and 300ml of the second decoction. Mix the two decoctions and divide into three warm doses. One dose per day, three times a day, taken warm half an hour after meals. Avoid sour and cold foods, fruits, and fungi.

[0129] On the second visit, the patient reported that after taking the previous prescription, bowel movements had improved, abdominal distension and upper limb edema had improved, and fatigue, aversion to cold, and cold extremities had improved. Appetite was good, but sleep was poor with many dreams. Tongue was pale red with a white, greasy coating, and pulse was deep, thready, and weak. The previous prescription was continued for five more doses, with the addition of 10 grams of Polygala tenuifolia and 15 grams of Poria cocos to calm the mind and soothe the nerves, and 15 grams of Prunus persica to moisten the intestines and promote bowel movements.

[0130] On the third visit, the patient reported a significant improvement in bowel movements, with defecation now largely effortless. The tongue was pale red with a thin white coating, the pulse was deep and wiry, and the pulse at both cun positions was weak and thready. The previous prescription was continued. After one month of continuous use, the patient reported no significant discomfort.

[0131] Note: The patient usually suffers from aversion to cold, cold extremities, fatigue, and weakness. His pulse is deep and thready. "In the case of Shaoyin disease, the pulse is weak and thready, and the patient is sleepy." Therefore, the patient exhibits signs of deficiency of Shaoyin Yang in the foot. Kidney Yang is the innate Yang, and Spleen Yang is the acquired Yang. If the innate Kidney Yang is insufficient, the acquired Spleen Yang is easily damaged. When Spleen Yang is insufficient, phlegm and dampness are generated internally. Liver wood is generated from Kidney water and grows from Spleen earth. If the water is cold and the earth is damp, the liver wood will be stagnant and unable to flow smoothly. When the liver is cold and the liver wood is stagnant, the flow of Qi is obstructed. The Kidney governs urination and defecation. When Shaoyin Yang is deficient, the Geng metal is cold and stagnant and cannot descend, hence the difficulty in defecation. Phlegm and turbidity obstruct the middle Jiao, and the body fluids cannot be transformed. When the phlegm and turbidity rise to the lungs, cough and phlegm are observed. The tongue is pale red with a white and greasy coating, and the pulse is deep and wiry. The weak and thready pulses in both cun positions are all signs of deficiency of Spleen and Kidney Yang and stagnation of Liver Qi due to cold. The formula uses Aconitum carmichaelii and dried ginger as the principal herbs, which are extremely pungent and hot, and can warm and tonify the true yang of the spleen and kidneys. Liver wood grows from kidney water and nourishes spleen earth, and its nature is to promote upward movement and smooth flow. Warmth promotes growth and smooth flow, while coldness easily leads to stagnation. Evodia rutaecarpa is pungent and warm, and is used to regulate the liver and warm the spleen, and help the wood and earth elements to flow smoothly. Amomum villosum is pungent and warm, and enters the spleen, stomach and kidney meridians. When used with Evodia rutaecarpa, it can enhance the effect of warming and tonifying the true yang of the gate of life, and together they are used as assistant herbs. Ligusticum chuanxiong, Citrus medica, and Foeniculum vulgare regulate qi and relieve depression, dry dampness and resolve phlegm, and promote the smooth movement of qi in the body. Prunus mume, apricot kernel, ginger and Magnolia officinalis are used together. Taking its essence from the principles of "metal descending and yang subduing," and "water warming and earth transporting," the formula includes Poria cocos, stir-fried Atractylodes macrocephala, Alisma plantago-aquatica, and Leonurus japonicus to dry the earth and drain dampness, thus regulating qi and blood. Cinnamomum cassia and Zanthoxylum bungeanum warm and raise the wood element, while amethyst heavily subdues and calms the yang. Cinnamomum cassia, Phellodendron chinense, Amomum villosum, and Drynaria fortunei warm the water and subdue the yang, allowing qi to return to the kidneys. Ephedra sinica root, Asarum sieboldii, and Epimedium brevicornu warm and unblock the yin and cold in the lower burner. Eucommia ulmoides and Dipsacus asper warm and tonify the kidney yang. Cistanche deserticola moistens the intestines and promotes bowel movement. Glycyrrhiza uralensis, which is warm in nature and sweet in taste, is used as a guiding herb because it can detoxify and harmonize the other herbs, while also tonifying fire and subduing earth to moderate the body's vital energy.

[0132] Case 2

[0133] Mr. Li, male, 44 years old, consulted in January 2023 due to "recurrent constipation for 3 months". The patient reported that 3 months prior, after eating raw or cold food, he developed hard and difficult bowel movements, passing stool every 3-4 days. The stool was hard and difficult to pass, accompanied by poor sleep with many dreams, easy awakening during sleep, no hiccups, no abdominal pain, no acid reflux, no heartburn, no nausea, no vomiting, no dry mouth or bitter taste. He was usually sensitive to cold. His appetite was good, his sleep was good, his urination was normal, and he got up 1-2 times at night. His tongue was pale red with a white and greasy coating, his pulse was deep and wiry, and his pulse at both cun positions was thin, weak, and feeble. Based on the four diagnostic methods, this disease falls under the category of "constipation" in Traditional Chinese Medicine (TCM), with the syndrome being "deficiency of spleen and kidney yang, and restlessness of mind." TCM treatment focuses on tonifying fire and generating earth, calming the mind and soothing the spirit, and warming yang to promote bowel movement. The prescription is based on the formula in Example 12 with added ingredients. The specific ingredients are as follows: 30g of Aconitum carmichaelii, 15g of Cinnamomum cassia, 20g of Zingiber officinale, 10g of Evodia rutaecarpa, 10g of Zanthoxylum bungeanum, 15g of Magnolia officinalis, 20g of Cistanche deserticola, 6g of Glycyrrhiza uralensis (processed), 10g of Polygala tenuifolia, and 25g of Platycladus orientalis seed. For 5 doses, weigh each ingredient according to the formula, add 800ml of water, soak for 20 minutes, simmer over low heat for 30 minutes, obtain 300ml of decoction from the first decoction, and 300ml of decoction from the second decoction. Mix the two decoctions to obtain the soup.

[0134] The second diagnosis, the patient complained of hard stool, basically no effort to defecate, sleep difference, basically ease, tongue pale red, white, pulse, double inch pulse weak, followed by the front. After 1 month of continuous service, the patient complained of no obvious discomfort.

[0135] The patient is generally cold, four ends lack of warmth, pulse, "Shao Yin disease, pulse thin, but sleep", so the foot Shao Yin Yang deficiency, liver cold and depressed, and the kidney governs the two, Shao Yin Yang decline, then the gold cold and stagnation and can not be reduced, so see hard stool; sleep difference, multiple dreams, tongue pale red, white, pulse, double inch pulse weak, are the signs of spleen and kidney Yang deficiency. In the recipe, with Aconite, Ginger as the monarch drug, Daxin Daxin hot, can warm and invigorate the true Yang of the spleen and kidney, liver wood grows in kidney water and long spleen soil, its nature is mainly lifting and smooth, warm and smooth, cold and easy to block and stagnation, because of the bitter and warm taste of Evodia, it has the effect of regulating the liver and warming the spleen, helping wood and soil to be smooth; pepper, warm and lift the wood, Cinnamon, warm water and hide Yang, gas into the kidney, Polygala, Platycladus Ning heart and mind, Cistanche moistens the intestines and relieves constipation, Magnolia bark, gas and fu, Zhigancao, gas, sweet, on the one hand, it can detoxify and harmonize various drugs, on the other hand, it can supplement the fire and hide the earth, and it can be used as a medicine.

[0136] Case 3, Zhang, male, 30 years old, February 2023, "repeated hard stool for 2 months, 1 week" for treatment, the patient complained of hard stool for 2 months without obvious cause, 3 days a line, hard stool, hard to solve, accompanied by belching, hiccup, no abdominal pain, no acid reflux, no dry mouth, cold and cold; food can, sleep can, urine, get up 1-2 times. Tongue pale red, white, pulse, double inch pulse weak. Four diagnoses, this disease belongs to the category of "constipation" in traditional Chinese medicine, and the syndrome belongs to "spleen and kidney Yang deficiency, stomach cold and adverse syndrome"; traditional Chinese medicine treatment with fire and soil, dispelling cold and descending adverse, warming Yang and relieving constipation, the recipe is to add flavor to the group in Example 12, the specific prescription is as follows: Aconite 30g, Cinnamon 20g, Ginger 18g, Evodia 12g, Pepper 10g, Magnolia Bark 12g, Cistanche 15g, Zhigancao 12g, Clove 15g, Cinnamon 15g 5 doses. The medicine in the group is weighed according to the group prescription, 800ml of water is added, soaked for 20 minutes, boiled for 30 minutes, the first decoction is 300ml, the second decoction is 300ml, and the two decoctions are mixed to get the decoction.

[0137] The second diagnosis, the patient complained of hard stool, basically no effort to defecate, belching, hiccup, basically ease, tongue pale red, white, pulse, double inch pulse weak, followed by the front. After 1 month of continuous service, the patient complained of no obvious discomfort.

[0138] The patient is usually cold and afraid of cold, four ends lack of warmth, pulse is fine, "Shao Yin disease, pulse is fine, but want to sleep", so the foot Shao Yin Yang deficiency, liver cold and stagnation, and kidney control two, Shao Yin Yang decline, then the gold is cold and stagnation and can not be down, so see the stool is difficult to solve; belching and reverse for stomach cold, tongue red, white and greasy, pulse is fine and thin, both pulse is weak and weak are the signs of spleen and kidney Yang deficiency. In the prescription, with Aconite, dried ginger as the monarch drug, big Xing big hot, can warm and invigorate the true Yang of the spleen and kidney, liver wood is born in kidney water and long spleen soil, its nature is mainly rising and developing, smooth and smooth, warm and easy to develop, cold and easy to block and stagnation, because of the bitter and warm of evodia, take its function of regulating liver and warming spleen, helping wood and soil to be smooth and smooth; pepper warm and rise the wood, cassia warm water and hide Yang, gas into the kidney, cistanche moistens the intestine and unblocks the stool, clove, cassia son dispels cold and reverses, magnolia officinalis moves qi and opens the fu, fried licorice, gas warm and sweet, on the one hand, take its ability to detoxify and harmonize various drugs, on the other hand, take its ability to supplement fire and hide soil, slow down the vital qi as the auxiliary drug.

Claims

1. A traditional Chinese medicine composition for treating irritable bowel syndrome with constipation due to spleen and kidney yang deficiency, characterized in that, It is composed of the following ingredients in parts by weight: 15-30g of Aconitum carmichaelii, 15-25g of Cinnamomum cassia, 10-20g of Zingiber officinale, 8-12g of Evodia rutaecarpa, 8-12g of Zanthoxylum bungeanum, 12-18g of Magnolia officinalis, 12-20g of Cistanche deserticola, and 6-12g of Glycyrrhiza uralensis (processed).

2. The traditional Chinese medicine composition for treating constipation-type irritable bowel syndrome according to claim 1, characterized in that, The traditional Chinese medicine composition, with the addition of 12-18 grams of Atractylodes lancea and 12-18 grams of Atractylodes macrocephala, is suitable for spleen and kidney yang deficiency, accompanied by symptoms of spleen deficiency and dampness.

3. The traditional Chinese medicine composition for treating constipation-type irritable bowel syndrome according to claim 1, characterized in that, The herbal composition containing 12-18 grams of Buddha's Hand and 8-12 grams of Fennel is suitable for spleen and kidney yang deficiency with concurrent liver cold and qi stagnation syndrome.

4. The traditional Chinese medicine composition for treating constipation-type irritable bowel syndrome according to claim 1, characterized in that, The aforementioned herbal composition, with the addition of 12-18 grams of Ephedra root and 3-6 grams of Asarum, is suitable for spleen and kidney yang deficiency, accompanied by symptoms of cold and dampness in the lower jiao.

5. The traditional Chinese medicine composition for treating constipation-type irritable bowel syndrome according to claim 1, characterized in that, The traditional Chinese medicine composition, with the addition of 20-30 grams of Eucommia ulmoides and 12-18 grams of Dipsacus asper, is suitable for spleen and kidney yang deficiency, with concurrent kidney yang insufficiency.

6. The traditional Chinese medicine composition for treating constipation-type irritable bowel syndrome according to claim 1, characterized in that, The herbal composition containing 8-12 grams of Polygala tenuifolia and 20-30 grams of Platycladus orientalis seed is suitable for spleen and kidney yang deficiency with symptoms of restlessness.

7. The traditional Chinese medicine composition for treating constipation-type irritable bowel syndrome according to claim 1, characterized in that, The herbal composition contains 12-18 grams of cloves and 12-18 grams of cinnamon, and is suitable for spleen and kidney yang deficiency with symptoms of stomach cold and qi stagnation.

8. A traditional Chinese medicine preparation for treating irritable bowel syndrome with constipation due to spleen and kidney yang deficiency, characterized in that, The traditional Chinese medicine composition according to claim 1 is prepared by adding medically acceptable excipients to form any one of the following: decoction, granules, pills, tablets, capsules, ointments, syrups, and powders.

9. The traditional Chinese medicine preparation for treating constipation-type irritable bowel syndrome according to claim 8, characterized in that, The granules are prepared according to the following method: 1) Crush each ingredient in the formula into powder. First, take Aconitum carmichaelii and decoct it with 8-12 times the amount of water for 1.5-2 hours. Then add dried ginger, prepared licorice root, cinnamon, Evodia rutaecarpa, Sichuan pepper, Magnolia officinalis, and Cistanche deserticola and decoct for another 1-1.5 hours. Then add 8-10 times the amount of water and decoct twice, each time for 2-3 hours. Combine the decoctions and concentrate them to a relative density of 1.

20. Then add 95% ethanol to a concentration of 75%. After 24-40 hours, filter the solution. Distill the ethanol under reduced pressure until dry. Filter the solution and concentrate the filtrate under reduced pressure to obtain an extract with a density of 1.25 at 80°C. Then dry the extract and crush it to obtain extract powder. 2) Mix the extract powder and the excipient starch at a mass ratio of 1:2, add an appropriate amount of 50% ethanol, wet granulate, dry, and sieve to obtain granules.

10. The use of the traditional Chinese medicine composition according to claim 1 in the preparation of a medicament for treating irritable bowel syndrome with constipation due to spleen and kidney yang deficiency.

Images