Traditional Chinese medicine composition for treating diarrhea-type irritable bowel syndrome and preparation method thereof

Abstract

The invention provides a traditional Chinese medicine composition for treating diarrhea-type irritable bowel syndrome and a preparation method thereof, the composition comprises raw materials such as ovateleaf holly bark, fried bighead atractylodes rhizome, white peony root, radix bupleuri and the like, auxiliary materials such as radix curcumae, fried malt and the like can be added as required, and the Li medicine ovateleaf holly bark and katsumadai seed are core components. During preparation, a step-by-step treatment process is adopted, specifically, fructus amomi, alpinia katsumadai and other volatile oil-containing raw materials are independently crushed, the rest of medicinal materials are decocted firstly, then volatile components are added for continuous decoction, clear paste is obtained through vacuum concentration, and the clear paste can be prepared into decoction, granules and other dosage forms. The composition aims at liver depression and spleen deficiency and damp-heat diarrhea type irritable bowel syndrome, the effects of tonifying the spleen, soothing the liver, clearing heat and eliminating dampness are achieved through cooperation of multiple components, active components can be effectively reserved through the preparation process, and the composition is suitable for preparation of related drugs and is definite in curative effect and good in safety.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine, in particular to a traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome and a preparation method thereof. BACKGROUND

[0002] Irritable bowel syndrome (IBS) is a psychosomatic disease of the digestive system closely related to psychological, social and environmental factors, with abdominal pain, abdominal distension and changes in bowel habits as the main characteristics. Diarrhea-predominant irritable bowel syndrome (IBS-D) is the most common type, with a global prevalence rate of 3.3%-31.6%, and a prevalence rate of 1.4%-11.5% in China. The incidence rate in women is significantly higher than that in men. IBS-D patients often have mental and psychological disorders such as anxiety and depression, which seriously affect the quality of life, and frequent visits to the doctor bring a heavy burden on public health.

[0003] Modern medicine believes that the pathogenesis of IBS-D is related to multiple factors such as family history, dietary factors, history of gastrointestinal infection, dysfunction of the brain-gut axis, visceral hypersensitivity and imbalance of intestinal flora. Current western medicine treatment mainly focuses on symptomatic intervention, including antispasmodic agents (such as pinaverium bromide), antidiarrheal agents (such as loperamide), and gastrointestinal microecological preparations (such as Bacillus licheniformis live bacteria capsules), but there are limitations such as high recurrence rate (recurrence rate after drug withdrawal can be more than 40%), obvious side effects, and limited improvement of mental and psychological symptoms, making it difficult to fundamentally solve the core pathological links such as liver stagnation and spleen deficiency, and internal accumulation of dampness and heat.

[0004] Traditional Chinese medicine classifies IBS-D as "diarrhea" and "abdominal pain", and believes that the pathogenesis is liver stagnation and spleen deficiency, with dampness-heat and qi stagnation as the secondary factors. In hot and humid climates such as Hainan, patients often have "liver stagnation and spleen deficiency with dampness-heat", and the disease is persistent and difficult to cure. Existing traditional Chinese medicine treatment mainly uses classical prescriptions such as Tongxie Yaofang and Sini San, but there are the following shortcomings: first, the targeting of dampness-heat type is not strong, and there is a lack of synergistic regulation of clearing heat and dampness and soothing the liver and strengthening the spleen; second, there is a lack of exploration of minority medicinal materials, such as Rhizoma Alpiniae Oxophyllae and Amomum kravanh, which have the effects of clearing heat and dampness and regulating qi and relieving pain, and their unique effects have not been fully integrated; third, the mechanism of the compound is not clear, and the clinical efficacy lacks systematic evidence-based support.

[0005] Therefore, in view of the pathological characteristics of IBS-D with liver stagnation and spleen deficiency combined with dampness-heat, combined with regional characteristic medicinal materials, it is an important requirement in the field of traditional Chinese medicine to develop a traditional Chinese medicine composition with definite efficacy, high safety, and consideration of symptom improvement and long-term prognosis. SUMMARY

[0006] In view of this, the present application provides a traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome and a preparation method thereof, which solves the above problems.

[0007] The technical solution of the present invention is as follows: A traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome, comprising the following active ingredients in parts by weight: 10-20 parts of Jiubiying, 10-20 parts of stir-fried Atractylodes macrocephala, 10-20 parts of Paeonia lactiflora, 5-15 parts of Bupleurum chinense, 10-20 parts of Citrus aurantium, 10-20 parts of Saposhnikovia divaricata, 5-15 parts of Citrus reticulata peel, 5-15 parts of Amomum villosum, 5-15 parts of Amomum cardamomum, 10-20 parts of Punica granatum peel, and 5-15 parts of prepared Glycyrrhiza uralensis.

[0008] Furthermore, a traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome also includes the following active ingredients in parts by weight: 12-18 parts of Perilla stem, 8-12 parts of Scutellaria baicalensis, 8-12 parts of Ligusticum chuanxiong, and 24-36 parts of Codonopsis pilosula.

[0009] Furthermore, it also includes any one or a combination of the following excipients by weight: 10-15 parts turmeric, 10-15 parts cyperus rhizome, 5-10 parts mimosa flower, 10-15 parts polygala root, 20-30 parts poria cocos, 10-15 parts longan pulp, 10-15 parts roasted malt, 20-30 parts radish seed, 10-15 parts medicated leaven, 10-15 parts cuttlebone, 10-15 parts fritillaria thunbergii. 15 parts, 10-15 parts of oyster shell, 10-15 parts of areca nut, 10-15 parts of Buddha's hand, 10-15 parts of magnolia bark, 10-15 parts of corydalis rhizome, 10-15 parts of ginger-processed pinellia, 10-15 parts of fresh ginger, 10-15 parts of agastache, 20-30 parts of stir-fried coix seed, 10-15 parts of poria cocos, 10-15 parts of yam, 10-15 parts of burnet root, 10-15 parts of bletilla rhizome.

[0010] Specifically, for those with severe emotional distress, add 15 parts Curcuma longa, 15 parts Cyperus rotundus, and 10 parts Albizia julibrissin; for those with insomnia, add 10 parts Polygala tenuifolia, 30 parts Poria cocos, and 10 parts Longan aril; for those with indigestion and poor appetite, add 15 parts roasted malt, 30 parts Radish seed, and 10 parts Medicated Leaven; for those with acid reflux and heartburn, add 15 parts Cuttlebone, 10 parts Fritillaria thunbergii, and 15 parts Oyster shell; for those with significant abdominal distension, add 10 parts Areca catechu, 15 parts Citrus medica, and 15 parts Magnolia officinalis; for those with severe pain, use 15 parts Corydalis yanhusuo and 15 parts Corydalis yanhusuo; for those with vomiting, add 15 parts Pinellia ternata, 15 parts fresh ginger, and 15 parts Pogostemon cablin; for those with very sticky stools, add 30 parts roasted Coix lacryma-jobi, 15 parts Poria cocos, and 15 parts Dioscorea opposita; for those with hematochezia, add 10 parts Sanguisorba officinalis and 10 parts Bletilla striata.

[0011] Furthermore, a method for preparing a traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome includes the following steps:

[0012] S1. Weigh each ingredient according to the weight proportions. Among them, cardamom, nutmeg, ginger, and patchouli are crushed separately into coarse powder with a particle size of 20-40 mesh. The remaining ingredients are mixed and crushed into coarse powder with a particle size of 20-40 mesh.

[0013] S2, the coarse powder of step S1 except for Amomum villosum, Elettaria cardamomum, Zingiber officinale and Agastache rugosa is added into 8-10 times of purified water, soaked for 30-60 minutes, then heated to 90-100 DEG C and decocted for 1.5-2 hours, during which the state of slight boiling is kept and stirred for 3-5 times, filtered while hot, and the first filtrate is obtained;

[0014] S3, 6-8 times of purified water is added into the residue of step S2, and the coarse powder of Amomum villosum, Elettaria cardamomum, Zingiber officinale and Agastache rugosa is added, heated to 80-90 DEG C and decocted for 40-60 minutes, the state of slight boiling is kept, and filtered while hot, and the second filtrate is obtained;

[0015] S4, the first filtrate and the second filtrate are combined, and concentrated under reduced pressure at a vacuum degree of 0.06-0.08 MPa and a temperature of 50-60 DEG C until the relative density of the clear paste is 1.10-1.20 (60 DEG C).

[0016] Further, the concentration in step S4 adopts reduced pressure concentration, the vacuum degree is 0.06-0.08 MPa, and the temperature is 50-60 DEG C.

[0017] Further, pharmaceutically acceptable adjuvant is added into the clear paste to prepare decoction, granules, capsules or tablets, and the mass ratio of the adjuvant to the clear paste is 1:1-3.

[0018] Further, the adjuvant is selected from sucrose, dextrin or magnesium stearate.

[0019] Further, the Chinese medicine composition is applied to the preparation of a medicine for treating diarrhea-predominant irritable bowel syndrome.

[0020] Further, the diarrhea-predominant irritable bowel syndrome is liver stagnation and spleen deficiency with damp-heat syndrome.

[0021] Compared with the prior art, the present application has the following beneficial effects:

[0022] In this traditional Chinese medicine combination, Ilex rotunda is bitter and cold, capable of clearing heat and promoting diuresis, regulating qi and relieving pain. Stir-fried Atractylodes macrocephala is bitter, sweet and warm, strengthening the spleen and drying dampness to cultivate the earth element, preventing Ilex rotunda from damaging the middle-jiao, and not hindering its clearing of damp-heat in the stomach and intestines. The qi-regulating function of Ilex rotunda helps Atractylodes macrocephala to tonify without stagnation. Using cold and warm herbs together, with both dredging and tonifying methods, they are the monarch drugs in common. Based on Ye Tianshi's theory that "heat emerges from dampness, and treating dampness should be the fundamental approach", it is advocated to decompose damp-heat, with emphasis on dispelling dampness, which is one of the concepts of using Ilex rotunda as the monarch drug. Paeonia lactiflora is sour and cold, capable of purging the liver. When the liver is balanced, the spleen will not be invaded by pathogenic factors. Its astringing yin and softening the liver to relieve spasm, when combined with Atractylodes macrocephala, can purge the liver in the earth element. Together with the ascending and dispersing Bupleurum chinense, it regulates the qi of the liver, soothes emotions, and combines dispersing and softening, reflecting the nature of the liver with yin-natured body and yang-natured function. Immature Citrus aurantium breaks knots and reduces qi reversal. When combined with Bupleurum chinense, one ascending and one descending, it restores the function of qi ascending and descending, making the clear and turbid rise and fall normally. Bupleurum chinense soothes the liver and relieves depression, leading the qi of the Shaoyang meridian to ascend. Saposhnikovia divaricata guides the herbs into the jueyin and taiyin meridians, enabling the qi of the liver to be soothed and the qi of the spleen to ascend. Its property of wind herbs has a significant effect on drying dampness. Combined with Paeonia lactiflora for soothing the liver and Atractylodes macrocephala for strengthening the spleen, it precisely targets the pathogenesis of "liver depression and spleen weakness, accompanied by damp-heat". With the addition of Citrus reticulata, Amomum villosum, and Alpinia katsumadai, the effect of strengthening the spleen, drying dampness, and regulating qi is even more prominent. Clinically, according to syndrome differentiation, Punica granatum peel is used to antibacterial and antidiarrheal, combining pathogen-dispelling and astringing without the drawback of "retaining pathogens" and showing an increased antidiarrheal effect. Prepared Glycyrrhiza glabra调和 the various herbs, benefiting the spleen and regulating the middle-jiao. All the herbs combined together achieve the effects of strengthening the spleen, soothing the liver, regulating qi, clearing heat, and resolving dampness for antidiarrheal. Detailed implementation manners

[0023] To better understand the technical content of the present invention, specific examples are provided below to further illustrate the present invention.

[0024] Unless otherwise specified, the experimental methods used in the embodiments of the present invention are all conventional methods.

[0025] Unless otherwise specified, the materials, reagents, etc. used in the embodiments of the present invention can all be obtained from commercial channels.

[0026] Example 1

[0027] Traditional Chinese medicine composition formula: Ilex rotunda 15g, stir-fried Atractylodes macrocephala 15g, Paeonia lactiflora 15g, Bupleurum chinense 10g, Immature Citrus aurantium 15g, Saposhnikovia divaricata 15g, Citrus reticulata 10g, Amomum villosum 10g (added later), Alpinia katsumadai 10g (added later), Punica granatum peel 15g, prepared Glycyrrhiza glabra 10g;

[0028] Preparation method:

[0029] S1. Weigh the above raw materials, separately crush Amomum villosum and Alpinia katsumadai into 30-mesh coarse powder, and mix the remaining raw materials and crush them into 30-mesh coarse powder;

[0030] S2. Add 9 times the amount of purified water to the coarse powder except for Amomum villosum and Alpinia katsumadai, soak for 45 minutes, heat to 95°C and decoct for 1.8 hours (in a slightly boiling state, stir 4 times), and filter while it is hot to obtain the first filtrate;

[0031] S3. Add 7 times the amount of purified water to the dregs, add coarse powder of Amomum villosum and Amomum cardamomum, heat to 85℃ and decoct for 50 minutes (at a gentle boil), filter while hot to obtain the second filtrate;

[0032] S4. Combine the filtrates and concentrate them under reduced pressure at a vacuum of 0.07 MPa and 55°C to obtain a clear extract with a relative density of 1.15 (60°C), thus obtaining the decoction.

[0033] Example 2

[0034] The formula of the Chinese herbal composition is as follows: 15g of Jiubiying, 15g of stir-fried Atractylodes macrocephala, 10g of Bupleurum chinense, 15g of Paeonia lactiflora, 15g of stir-fried Citrus aurantium, 10g of Citrus reticulata peel, 15g of Saposhnikovia divaricata, 10g of Amomum villosum (added later), 10g of prepared Glycyrrhiza uralensis, 15g of Perilla frutescens stem, 10g of Amomum villosum (added later), 10g of prepared Pinellia ternata, 15g of Magnolia officinalis, 10g of Scutellaria baicalensis, 10g of Ligusticum chuanxiong, 30g of Codonopsis pilosula, and 10g of prepared Polygala tenuifolia.

[0035] Preparation method: Same as in Example 1.

[0036] Example 3

[0037] The formula of the Chinese herbal composition is as follows: 10g of Jiubiying, 20g of stir-fried Atractylodes macrocephala, 10g of Paeonia lactiflora, 15g of Bupleurum chinense, 10g of Citrus aurantium, 20g of Saposhnikovia divaricata, 5g of Citrus reticulata peel, 15g of Amomum villosum (added later), 5g of Amomum cardamomum (added later), 20g of pomegranate peel, 5g of prepared Glycyrrhiza uralensis, plus the excipients Curcuma longa 15g and Cyperus rotundus 15g (for emotional distress);

[0038] Preparation method:

[0039] Similar to Example 1, in step S1, turmeric, cyperus and other raw materials are added and pulverized together. In step S4, after concentration, dextrin is added (excipient to extract mass ratio 1:2) to make granules (dried at 65℃, moisture 7%).

[0040] Example 4

[0041] Traditional Chinese medicine composition formula: 20g of Jiubiying, 10g of stir-fried Atractylodes macrocephala, 20g of Paeonia lactiflora, 5g of Bupleurum chinense, 20g of Citrus aurantium, 10g of Saposhnikovia divaricata, 15g of Citrus reticulata peel, 5g of Amomum villosum (added later), 15g of Amomum cardamomum (added later), 10g of Punica granatum peel, 15g of prepared Glycyrrhiza uralensis, plus excipients such as 15g of stir-fried malt, 30g of Raphanus sativus seed, and 10g of Medicated Leaven (for indigestion);

[0042] Preparation method:

[0043] Same as in Example 1, after concentration in step S4, magnesium stearate (excipient to extract mass ratio 1:3) is added to prepare capsules.

[0044] Clinical research

[0045] I. General Information

[0046] (I) Case source

[0047] The study cases were randomly selected from patients with diarrhea-predominant irritable bowel syndrome with liver stagnation and spleen deficiency combined with damp-heat syndrome who visited the outpatient and inpatient departments of Hainan Provincial Hospital of Traditional Chinese Medicine from March 2024 to January 2025.

[0048] (II) Diagnostic criteria

[0049] Western medicine diagnostic criteria

[0050] The diagnostic criteria were developed in reference to the 2020 Chinese Expert Consensus on Irritable Bowel Syndrome and the Rome IV criteria.

[0051] Diagnostic criteria for irritable bowel syndrome (IBS):

[0052] 1. Long-term recurrent episodes of abdominal pain, abdominal distension, and abdominal discomfort;

[0053] 2. Accompanied by 2 or more of the following symptoms: (1) associated with defecation; (2) change in defecation frequency; (3) change in stool form;

[0054] 3. The above symptoms have occurred for more than 6 months, and at least once a week in the past 3 months.

[0055] Diagnostic criteria for diarrhea-predominant irritable bowel syndrome (IBS-D): Based on the above IBS diagnostic criteria, in reference to the Bristol Stool Form Scale, more than 25% of the abnormal defecation days have stool form 6 or 7, and less than 25% have stool form 1 or 2.

[0056] Traditional Chinese medicine diagnostic criteria

[0057] In reference to the Tenth Edition of Internal Medicine of Traditional Chinese Medicine and the Expert Consensus on Diagnosis and Treatment of Irritable Bowel Syndrome in Traditional Chinese Medicine (2017), the Chinese medical name diagnosis of diarrhea-predominant irritable bowel syndrome is diarrhea disease.

[0058] According to the syndrome diagnostic criteria of diarrhea disease, the diagnostic criteria for diarrhea-predominant irritable bowel syndrome with liver stagnation and spleen deficiency combined with damp-heat syndrome were developed:

[0059] 1. Major symptoms: (1) abdominal pain with diarrhea, pain relieved after diarrhea; (2) onset related to emotional factors, irritability; (3) urgent or uncomfortable defecation;

[0060] 2. Secondary symptoms: (1) distended and fullness in both sides of the chest; (2) epigastric fullness and poor appetite; (3) fatigue and weakness; (4) sticky or foul-smelling stool; (5) dry mouth and no desire to drink, or bitter taste and bad breath; (6) anal burning;

[0061] 3. Tongue and pulse: pale or red tongue with teeth marks, thin white or greasy or thin yellow fur, and thin or slippery or slippery pulse.

[0062] Diagnosis criteria: 3 major symptoms + 1 minor symptom; or 2 major symptoms + 1 of (1) (2) (3) + 1 of (4) (5) (6); or 1 major symptom + 4 or more minor symptoms. Diagnosis can be made according to tongue and pulse conditions.

[0063] Exclusion criteria: organic intestinal diseases, severe systemic diseases, pregnant or lactating women, etc. (see document for details)

[0064] II. Intervention measures

[0065] Using random number table method, patients were randomly allocated to treatment group and control group according to their visit order, with 36 cases in each group, a total of 72 patients.

[0066] Treatment group: Example 1 formula, 1 dose per day, decocted with water 400 ml, taken in the morning and evening, 4 weeks of treatment.

[0067] Control group: Bacillus licheniformis live bacteria capsules (2 capsules each time, 3 times a day, the first time doubled), 4 weeks of treatment.

[0068] Both groups were given health education (regular diet, emotional regulation, etc.).

[0069] III. Observation indicators

[0070] Primary indicators: total score of TCM symptoms and single item score (abdominal pain, stool shape, etc.), IBS disease severity score (IBS-SSS), quality of life score (IBS-QOL).

[0071] Secondary indicators: anxiety / depression score (HAMA, HAMD), relapse rate 4 weeks after drug withdrawal, safety indicators (blood routine, liver and kidney function, etc.).

[0072] IV. Clinical trial results

[0073] Table 1 Comparison of total TCM symptom scores of patients in two groups before and after treatment (n = 71)

[0074]

[0075] As shown in Table 1, the total TCM symptom scores of patients in both groups before treatment obeyed normal distribution (Shapiro-Wilk = 0.978, 0.950, P = 0.678, 0.102 > 0.05); after variance homogeneity test, the variance was homogeneous (F = 0.288, P = 0.593 > 0.05). Independent sample t test was used for comparison. Compared with the control group, there was no significant difference in total TCM symptom score in the treatment group (t = -1.191, P = 0.238 > 0.05), and the difference was not statistically significant.

[0076] ​

[0077] The total scores of TCM symptoms of the two groups after treatment obeyed normal distribution (Shapiro-Wilk=0.957, 0.943, P=0.184, 0.065>0.05); the variance was not equal (F=8.700, P=0.004<0.05) by variance homogeneity test. Independent sample t test was used for comparison. Compared with the control group, the total scores of TCM symptoms of the treatment group had significant difference (t'=6.018, P=0.000<0.01), and the difference was statistically significant.

[0078] The mean difference of the total scores of TCM symptoms of the control group and the treatment group before and after treatment both obeyed normal distribution (Shapiro-Wilk=0.972, 0.973, P=0.493, 0.509>0.05). The mean difference of the total scores of TCM symptoms of the two groups before and after treatment had equal variance (F=1.350, P=0.249>0.05). Compared with the control group, the mean of the total scores of TCM symptoms of the treatment group had significant difference (t=6.638, P=0.000<0.01) by two independent sample t test. The treatment group was better than the control group in relieving TCM symptoms.

[0079] By paired t test, compared with before treatment, the mean of the total scores of TCM symptoms of the control group and the treatment group after treatment both had significant decrease (t=9.015, 15.794, P=0.000, 0.000<0.01).

[0080] Table 2-1 Comparison of the scores of abdominal pain degree of the two groups before and after treatment (f, n=71)

[0081]

[0082] Note: Compared with the control group, ##P<0.01; compared with before treatment, **P<0.01.

[0083] Table 2-1 shows that the degree of abdominal pain was classified (score: 0 = none, 2 = mild, 4 = moderate, 6 = severe) using non-parametric test Mann-Whitney U test. There was no significant difference in the degree of abdominal pain in the treatment group before treatment compared with the control group (Mann-Whitney U = 526.00, P = 0.185 > 0.05), which was comparable. There was a significant difference in the degree of abdominal pain in the treatment group after treatment (Mann-Whitney U = 303.00, P = 0.000 < 0.01). There was a significant difference in the difference before and after treatment in the two groups (Mann-Whitney U = 396.50, P = 0.003 < 0.01). According to the Wilcoxon Z test, there was a significant difference in the degree of abdominal pain in the control group and the treatment group after treatment compared with before treatment (Wilcoxon Z = -4.359, -4.824, P = 0.000, 0.000 < 0.01).

[0084] Table 2-2 shows that the stool character score (f, n = 71

[0085]

[0086] Note: Compared with the control group, ##P < 0.01; compared with before treatment, **P < 0.01.

[0087] As shown in Table 2-2, the stool character score (f,

[0088] Table 2-3 shows that the stool frequency score (f, n = 71

[0089]

[0090] As shown in Table 2-3, the stool frequency classification (score: 0 = none, 2 = mild, 4 = moderate, (6 = severe) was analyzed by non-parametric test Mann-Whitney U test. There was no significant difference in stool frequency before treatment between the two groups (Mann-Whitney (U = 489.00, (P = 0.076 > 0.05), which was comparable; compared with the control group, there was a significant difference in stool frequency classification after treatment in the treatment group (Mann-Whitney (U = 422.00, (P = 0.002 < 0.01). There was a significant difference in the difference before and after treatment between the two groups (Mann-Whitney (U = 339.00, (P = 0.000 < 0.01). According to Wilcoxon Z test, there was a significant difference in stool frequency after treatment compared with before treatment in the control group and the treatment group (Wilcoxon (Z = -3.138, -4.815, (P = 0.002, (0.000 < 0.01).

[0091] Table 2-4 Comparison of irritability and anger scores between the two groups before and after treatment (f, n = 71

[0092]

[0093] Note: Compared with the control group, ##P < 0.01; compared with before treatment, *P < 0.05, **P < 0.01.

[0094] Note: Compared with the control group, ##P < 0.01; compared with before treatment, *P < 0.05, **P < 0.01.

[0095] As shown in Table 2-4, the irritability and anger classification (score: (0 = none, 2 = mild, 4 = moderate, (6 = severe) was analyzed by non-parametric test Mann-Whitney U test. There was no significant difference in irritability and anger before treatment between the two groups (Mann-Whitney (U = 534.50, (P = 0.240 > 0.05), which was comparable; compared with the control group, there was a significant difference in irritability and anger classification after treatment in the treatment group (Mann-Whitney (U = 352.50, (P = 0.001 < 0.01). There was a significant difference in the difference before and after treatment between the two groups (Mann-Whitney (U = 229.50, (P = 0.000 < 0.01). According to Wilcoxon Z test, there was a significant difference in irritability and anger after treatment compared with before treatment in the control group and the treatment group (Wilcoxon (Z = -2.449, -4.686, (P = 0.014 < 0.05, (P = 0.000 < 0.01).

[0096] Table 2-5 Comparison of pain and diarrhea scores between the two groups before and after treatment (f, n = 71

[0097]

[0098] Note: Compared with the control group, ##P<0.01; compared with before treatment, **P<0.01.

[0099] As shown in Table 2-5, the pain and diarrhea grades (score: 0 = none, 2 = mild, 4 = moderate, 6 = severe) were analyzed by non-parametric test Mann-Whitney U test. There was no significant difference in pain and diarrhea before treatment between the two groups (Mann-Whitney U = 585.00, P = 0.575 > 0.05), which was comparable; compared with the control group, there was significant difference in pain and diarrhea grades after treatment in the treatment group (Mann-Whitney U = 406.00, P = 0.004 < 0.01). There was significant difference in the difference before and after treatment between the two groups (Mann-Whitney U = 378.50, P = 0.002 < 0.01). By Wilcoxon Z test, compared with before treatment, there was significant difference in pain and diarrhea after treatment in the control group and the treatment group (Wilcoxon Z = -4.290, -4.920, P = 0.000, 0.000 < 0.01).

[0100] Table 2-6 Comparison of defecation discomfort or urgent defecation scores (f, n = 71

[0101]

[0102] Note: Compared with before treatment, **P < 0.01.

[0103] As shown in Table 2-6, the defecation discomfort or urgent defecation grades (score: 0 = none, 2 = mild, 4 = moderate, 6 = severe) were analyzed by non-parametric test Mann-Whitney U test. There was no significant difference in defecation discomfort or urgent defecation before treatment between the two groups (Mann-Whitney U = 554.50, P = 0.333 > 0.05), which was comparable; compared with the control group, there was no significant difference in defecation discomfort or urgent defecation grades after treatment in the treatment group (Mann-Whitney U = 544.00, P = 0.254 > 0.05). There was no significant difference in the difference before and after treatment between the two groups (Mann-Whitney U = 481.50, P = 0.059 > 0.05). By Wilcoxon Z test, compared with before treatment, there was significant difference in defecation discomfort or urgent defecation after treatment in the control group and the treatment group (Wilcoxon Z = -3.130, -4.399, P = 0.002, 0.000 < 0.01).

[0104] Table 2-7 Comparison of defecation discomfort or urgent defecation scores (f, n = 71

[0105]

[0106] Note: Compared with the control group, ##P<0.01; compared with before treatment, **P<0.01.

[0107] As shown in Table 2-7, the two sides of the chest were full of grades (score: 0 = no, 1 = light, 2 = medium, 3 = heavy) using non-parametric test Mann-Whitney U test analysis of two groups before treatment two sides of the chest were full of no significant difference (Mann-Whitney U = 619.00, P = 0.888 > 0.05), with comparable; compared with the control group, the treatment group after treatment two sides of the chest were full of grades have significant difference (Mann-Whitney U = 171.50, P = 0.000 <0.01). The difference between the two groups before and after treatment was significant (Mann-Whitney U = 195.00, P = 0.000 <0.01). By Wilcoxon Z test, compared with before treatment, the control group after treatment two sides of the chest were full of no significant difference (Wilcoxon Z = -1.732, P = 0.083 > 0.05), the treatment group after treatment was significant (Wilcoxon Z = -4.668, P = 0.000 <0.01).

[0108] Table 2-8 Comparison of defecation or diarrhea urgency scores between the two groups before and after treatment (f, n = 71

[0109]

[0110] Note: Compared with the control group, ##P<0.01; compared with before treatment, **P<0.01.

[0111] As shown in Table 2-8, the epigastric fullness and stagnation grading (score: 0 = none, 1 = mild, 2 = moderate, 3 = severe) was analyzed by non-parametric test Mann-Whitney U test. There was no significant difference in the epigastric fullness and stagnation of the two groups before treatment (Mann-Whitney U = 597.50, P = 0.668 > 0.05), which was comparable. Compared with the control group, there was significant difference in the epigastric fullness and stagnation grading of the treatment group after treatment (Mann-Whitney U = 427.50, P = 0.007 < 0.01). There was significant difference in the difference before and after treatment of the two groups (Mann-Whitney U = 385.50, P = 0.002 < 0.01). By Wilcoxon Z test, compared with before treatment, there was no significant difference in the epigastric fullness and stagnation of the control group after treatment (Wilcoxon Z = -1.941, P = 0.052 > 0.05), and there was significant difference in the treatment group after treatment (Wilcoxon Z = -4.326, P = 0.000 < 0.01).

[0112] Table 2-9 Comparison of body fatigue scores of the two groups before and after treatment (f, n = 71)

[0113]

[0114] Note: Compared with the control group, #P < 0.05; compared with before treatment, **P < 0.01.

[0115] As shown in Table 2-9, the body fatigue grading (score: 0 = none, 1 = mild, 2 = moderate, 3 = severe) was analyzed by non-parametric test Mann-Whitney U test. There was no significant difference in the body fatigue of the two groups before treatment (Mann-Whitney U = 618.50, P = 0.878 > 0.05), which was comparable. Compared with the control group, there was no significant difference in the body fatigue grading of the treatment group after treatment (Mann-Whitney U = 488.50, P = 0.062 > 0.05). There was significant difference in the difference before and after treatment of the two groups (Mann-Whitney U = 448.00, P = 0.013 < 0.05). By Wilcoxon Z test, compared with before treatment, there was significant difference in the body fatigue of the control group and the treatment group after treatment (Wilcoxon Z = -2.646, -3.788, P = 0.008, 0.000 < 0.01).

[0116] Table 2-10 Comparison of sticky stool scores of the two groups before and after treatment (f, n = 71)

[0117]

[0118] Note: Compared with the control group, ##P<0.01; compared with before treatment, **P<0.01.

[0119] As shown in Table 2-10, the sticky stool classification (score: 0 = none, 1 = light, 2 = medium, 3 = heavy) was analyzed by non-parametric test Mann-Whitney U test. There was no significant difference in sticky stool between the two groups before treatment (Mann-Whitney U = 542.00, P = 0.278 > 0.05), which was comparable; compared with the control group, the sticky stool classification of the treatment group after treatment had significant difference (Mann-Whitney U = 315.00, P = 0.000 < 0.01). There was no significant difference in the difference before and after treatment between the two groups (Mann-Whitney U = 505.50, P = 0.128 > 0.05). By Wilcoxon Z test, compared with before treatment, the sticky stool of the control group and the treatment group after treatment had significant difference (Wilcoxon Z = -4.292, -4.383, P = 0.000, 0.000 < 0.01).

[0120] Table 2-11 Comparison of stool odor scores between the two groups before and after treatment (f, n = 71)

[0121]

[0122]

[0123] Note: Compared with the control group, ##P<0.01; compared with before treatment, **P<0.01.

[0124] As shown in Table 2-11, the stool odor classification (score: 0 = none, 1 = light, 2 = medium, 3 = heavy) was analyzed by non-parametric test Mann-Whitney U test. There was no significant difference in stool odor between the two groups before treatment (Mann-Whitney U = 487.00, P = 0.076 > 0.05), which was comparable; compared with the control group, the stool odor classification of the treatment group after treatment had significant difference (Mann-Whitney U = 387.00, P = 0.002 < 0.01). There was no significant difference in the difference before and after treatment between the two groups (Mann-Whitney U = 561.00, P = 0.377 > 0.05). By Wilcoxon Z test, compared with before treatment, the stool odor of the control group and the treatment group after treatment had significant difference (Wilcoxon Z = -3.962, -4.181, P = 0.000, 0.000 < 0.01).

[0125] Table 2-12 Comparison of dry mouth, or bitter mouth, or bad breath scores between the two groups before and after treatment (f, n = 71)

[0126]

[0127] Note: Compared with control group, #P<0.05, ##P<0.01; Compared with before treatment, *P<0.05, **P<0.01.

[0128] As shown in Table 2-12, the dry mouth and no desire to drink, or bitter taste, or bad breath classification (score: 0 = none, 1 = light, 2 = medium, 3 = heavy) was analyzed by non-parametric test Mann-Whitney U test. There was no significant difference in dry mouth and no desire to drink, or bitter taste, or bad breath before treatment between the two groups (Mann-Whitney U = 593.50, P = 0.654 > 0.05), which was comparable. There was significant difference in dry mouth and no desire to drink, or bitter taste, or bad breath classification after treatment between the treatment group and the control group (Mann-Whitney U = 405.00, P = 0.004 < 0.01). There was significant difference in the difference before and after treatment between the two groups (Mann-Whitney U = 442.50, P = 0.013 < 0.05). By Wilcoxon Z test, there was significant difference in dry mouth and no desire to drink, or bitter taste, or bad breath after treatment compared with before treatment in the control group and the treatment group (Wilcoxon Z = -2.530, -4.082, P = 0.011 < 0.05, P = 0.000 < 0.01).

[0129] Table 2-13 Comparison of anal burning scores between the two groups before and after treatment (f, n = 71)

[0130]

[0131] Note: Compared with control group, #P<0.05; Compared with before treatment, **P<0.01.

[0132] As shown in Table 2-13, the anal burning classification (score: 0 = none, 1 = light, 2 = medium, 3 = heavy) was analyzed by non-parametric test Mann-Whitney U test. There was no significant difference in anal burning before treatment between the two groups (Mann-Whitney U = 539.00, P = 0.235 > 0.05), which was comparable. There was no significant difference in anal burning classification after treatment between the treatment group and the control group (Mann-Whitney U = 548.00, P = 0.251 > 0.05). There was significant difference in the difference before and after treatment between the two groups (Mann-Whitney U = 447.00, P = 0.016 < 0.05). By Wilcoxon Z test, there was significant difference in anal burning after treatment compared with before treatment in the control group and the treatment group (Wilcoxon Z = -2.673, -4.690, P = 0.008, 0.000 < 0.01).

[0133] V. Clinical efficacy evaluation comparison

[0134] Table 3 Comparison of total effective rate of two groups of patients after treatment (f, P, n = 71)

[0135]

[0136] Note: Compared with the control group, #P<0.05, ##P<0.01.

[0137] After treatment, 0 cases were cured, 5 cases were markedly effective, 19 cases were effective, 11 cases were ineffective in the control group, 6 cases were cured, 16 cases were markedly effective, 10 cases were effective, and 4 cases were ineffective in the treatment group. By Mann-Whitney U test, there was a significant difference in the efficacy of the two groups (Mann-Whitney U = 303.00, P = 0.000 < 0.01); the total effective rate of the treatment group was 88.90%, which was better than that of the control group, and there was a significant difference (P = 0.045 < 0.05) by Fisher χ2test.

[0138] Table 4 Comparison of IBS-SSS scores of two groups of patients before and after treatment n = 71)

[0139]

[0140] Note: Compared with the control group, ##P<0.01; compared with before treatment, **P<0.01.

[0141] As shown in Table 4, the IBS-SSS scores of the two groups of patients before treatment were subject to normal distribution (Shapiro-Wilk = 0.961, 0.961, P = 0.238, 0.232 > 0.05); by variance homogeneity test, the variance was homogeneous (F = 2.411, P = 0.125 > 0.05). Independent sample t test was used for comparison, and there was no significant difference in IBS-SSS score between the treatment group and the control group (t = 1.081, P = 0.283 > 0.05), and the difference was not statistically significant.

[0142] The IBS-SSS scores of the two groups of patients after treatment were subject to normal distribution (Shapiro-Wilk = 0.952, 0.944, P = 0.135, 0.068 > 0.05); by variance homogeneity test, the variance was homogeneous (F = 0.001, P = 0.980 > 0.05). Independent sample t test was used for comparison, and there was a significant difference in IBS-SSS score between the treatment group and the control group (t = 5.896, P = 0.000 < 0.01), and the difference was statistically significant.

[0143] The mean difference of IBS-SSS scores of the control group and the treatment group before and after treatment was in normal distribution (Shapiro-Wilk=0.940, 0.950, P=0.055, 0.104>0.05). The variance of the mean difference of IBS-SSS scores of the two groups before and after treatment was not equal (F=6.326, P=0.014<0.05). The mean of IBS-SSS scores of the treatment group was significantly different from that of the control group (t'=-4.934, P=0.000<0.01) by two independent sample t' test. The IBS-SSS scores of the treatment group were better than those of the control group.

[0144] The mean of IBS-SSS scores of the control group and the treatment group after treatment was significantly lower than that before treatment (t=7.937, 11.889, P=0.000, 0.000<0.01) by paired t test.

[0145] Table 5 Comparison of IBS-QOL scores of the two groups before and after treatment n=71)

[0146]

[0147] Note: Compared with the control group, ##P<0.01; compared with before treatment, **P<0.01.

[0148] As shown in Table 5, the IBS-QOL scores of the two groups before treatment were in normal distribution (Shapiro-Wilk=0.980, 0.973, P=0.769, 0.523>0.05). The variance was equal (F=1.002, P=0.320>0.05) by variance homogeneity test. The IBS-QOL scores of the treatment group were not significantly different from those of the control group (t=1.641, P=0.105>0.05) by independent sample t test, and the difference was not statistically significant. The IBS-QOL scores of the two groups after treatment were in normal distribution (Shapiro-Wilk=0.943, 0.941, P=0.068, 0.054>0.05). The variance was not equal (F=29.878, P=0.000<0.05) by variance homogeneity test. The IBS-QOL scores of the treatment group were significantly different from those of the control group (t'=-4.964, P=0.000<0.01) by independent sample t' test, and the difference was statistically significant.

[0149] The mean difference of IBS-QOL scores of the control group and the treatment group before and after treatment was in normal distribution (Shapiro-Wilk=0.951, 0.980, P=0.120, 0.740>0.05), and the mean difference of IBS-QOL scores of the two groups before and after treatment was in homoscedasticity (F=0.160, P=0.691>0.05). The mean of IBS-QOL scores of the treatment group was significantly different from that of the control group (t=5.522, P=0.000<0.01) by two independent sample t test. The treatment group was superior to the control group in improving the quality of life of IBS-D patients.

[0150] The mean of IBS-QOL scores of the control group and the treatment group after treatment was significantly lower than that before treatment (t=-7.599, -13.924, P=0.000, 0.000<0.01) by paired t test.

[0151] Table 6 Comparison of HAMA scores of the two groups of patients before and after treatment n=71)

[0152]

[0153] Note: Compared with the control group, ##P<0.01; compared with before treatment, **P<0.01.

[0154] As shown in Table 6, the HAMA scores of the two groups of patients before treatment were in normal distribution (Shapiro-Wilk=0.958, 0.952, P=0.198, 0.121>0.05); and the variance was in homoscedasticity (F=1.484, P=0.227>0.05) by variance homogeneity test. The HAMA scores of the treatment group were not significantly different from those of the control group (t=-1.314, P=0.193>0.05) by independent sample t test, and the difference was not statistically significant.

[0155] The HAMA scores of the two groups of patients after treatment were in normal distribution (Shapiro-Wilk=0.946, 0.965, P=0.085, 0.297>0.05); and the variance was not in homoscedasticity (F=4.929, P=0.030<0.05) by variance homogeneity test. The HAMA scores of the treatment group were significantly different from those of the control group (t'=3.502, P=0.001<0.01) by independent sample t' test, and the difference was statistically significant.

[0156] The mean difference of HAMA score of the control group and the treatment group before and after treatment was in normal distribution (Shapiro-Wilk=0.939, 0.945, P=0.051, 0.072>0.05). The variance of the mean difference of HAMA score of the two groups before and after treatment was equal (F=1.220, P=0.273>0.05). The mean of HAMA score of the treatment group was significantly different from that of the control group (t=-6.328, P=0.000<0.01) by two independent sample t test. The treatment group was superior to the control group in relieving the anxiety of IBS-D patients.

[0157] The mean of HAMA score of the control group and the treatment group after treatment was significantly lower than that before treatment (t=8.021, 15.021, P=0.000, 0.000<0.01) by paired t test.

[0158] Table 7 Comparison of HAMD scores of the two groups before and after treatment n=71)

[0159]

[0160] Note: Compared with the control group, #P<0.05, ##P<0.01; compared with before treatment, **P<0.01.

[0161] As shown in Table 7, the HAMD scores of the two groups before treatment were in normal distribution (Shapiro-Wilk=0.949, 0.949, P=0.108, 0.095>0.05). The variances were equal (F=1.312, P=0.256>0.05) by homogeneity of variance test. The HAMD scores of the treatment group were not significantly different from those of the control group (t=-1.577, P=0.119>0.05) by independent sample t test, and the difference was not statistically significant.

[0162] The HAMD scores of the two groups after treatment were in normal distribution (Shapiro-Wilk=0.959, 0.947, P=0.221, 0.082>0.05). The variances were equal (F=1.009, P=0.319>0.05) by homogeneity of variance test. The HAMD scores of the treatment group were significantly different from those of the control group (t=2.072, P=0.042<0.05) by independent sample t test, and the difference was statistically significant.

[0163] The mean difference of HAMD score before and after treatment in the control group and the treatment group was in normal distribution (Shapiro-Wilk=0.943, 0.968, P=0.068, 0.375>0.05). The variance of the mean difference of HAMD score before and after treatment in the two groups was not uniform (F=6.442, P=0.013<0.05). The mean of HAMD score in the treatment group was significantly different from that in the control group (t'=-5.138, P=0.000<0.01) by two independent sample t' test. The improvement of depressive state in the treatment group was better than that in the control group.

[0164] The mean of HAMD score after treatment in the control group and the treatment group was significantly lower than that before treatment (t=8.841, 12.099, P=0.000, 0.000<0.01) by paired t test.

[0165] Table 8 Follow-up recurrence rate

[0166]

[0167] Note: Compared with the control group, #P<0.05

[0168] As shown in Table 8, the patients with effective treatment were followed up 4 weeks after drug withdrawal. In the control group, 24 cases (14 cases did not relapse, and 10 cases relapsed), and the recurrence rate was 41.70%. In the treatment group, 32 cases (27 cases did not relapse, and 5 cases relapsed), and the recurrence rate was 15.60%. The difference in recurrence rate between the two groups was statistically significant (P=0.037<0.05) by Fisher χ2 test. The recurrence rate in the treatment group was significantly lower than that in the control group, indicating that the long-term efficacy in the treatment group was better. 2

[0169] Typical case

[0170] Case 1

[0171] ​Zhou Moumou, male, 22 years old, on February 7, 2025, initial diagnosis. Complaint: repeated loose and foul-smelling stool for more than 10 years, aggravated for 2 days. Present illness: The patient has had loose and foul-smelling stool for more than 10 years without obvious provocation, 2-3 times / day. During the onset, he was treated in many hospitals, and the symptoms improved after oral medication, but the disease was recurrent. Two days ago, the symptoms recurred after improper diet, and he was diagnosed with gastroenteritis in the local hospital. After drug treatment, the symptoms did not improve. Therefore, he came to the hospital. He has a history of gastritis and gastric polyps after surgery. At this moment, the patient's appearance, spirit is slightly tired, the stool is slightly rotten, 2-3 times / day, abdominal pain after breakfast, abdominal pain, diarrhea, abdominal pain, abdominal distension, occasional acid regurgitation, general appetite, normal urine, red tongue with a few points, thin yellow and slightly greasy fur, and thin pulse. Western medical diagnosis: diarrhea-predominant irritable bowel syndrome, TCM diagnosis: diarrhea disease-liver stagnation and spleen deficiency with damp-heat syndrome. The formula of Jiebiyingchangyankangfang is used to invigorate the spleen, soothe the liver, regulate qi, clear heat and dampness, and stop diarrhea. Jiebiying 15g, fried Baizhu 15g, Baishao 15g, Chaihu 10g, Jujing 15g, Fangfeng 15g, Chenpi 10g, Sharen 10g (after taking), Caodoukou 10g (after taking), Shiliupi 15g, Zhan Gancao 10g. 7 doses, decocted with water, taken in the morning and evening.

[0172] February 14, 2025, second diagnosis: The patient complained that the symptoms were improved, the stool was slightly formed, 1-2 times / day, the abdominal pain and abdominal distension were relieved, the mouth was relieved, there was no obvious acid regurgitation, the appetite was normal, the sleep was general, the urine was normal, the tongue was red with a few points, the fur was thin and yellow, and the pulse was thin. The effective prescription is 7 doses.

[0173] Note: The patient came to the hospital because of the change in stool shape. Four diagnoses, when it belongs to diarrhea disease with liver stagnation and spleen deficiency with damp-heat syndrome. The patient has been weak in spleen and stomach since childhood, and has difficulty in transporting and transforming food and water. In addition, the liver qi fails to reach the spleen due to improper emotional regulation, and the liver and spleen are reversed. The spleen is weak in transportation and transformation, and the dampness is accumulated in the middle jiao. Over time, it turns into heat, so it can be seen that the mouth is bitter; the middle jiao is stagnant, so it can be seen that the abdomen is distended and painful; over time, the heat is stagnant, the stomach is not descending, and the acid regurgitation and belching are seen; combined with the tongue fur and pulse, it belongs to liver stagnation and spleen deficiency with damp-heat syndrome. The formula of Jiebiyingchangyankangfang is used to invigorate the spleen, soothe the liver, regulate qi, clear heat and dampness, and stop diarrhea. Jiebiyingqingrelichenshiqi, assisting Baizhu in supplementing without stagnation, Baizhu in drying dampness and supplementing the spleen, can prevent Jiebiying from damaging the middle, and also does not hinder its clearing of stomach and intestinal heat. The two complement each other and are the monarch herb. Baishao is cold and acid, which can be used in the soil to drain wood, combined with Chaihu to regulate liver qi; Jujing breaks down and down-regulates qi, and is combined with Chaihu to regulate the function of qi rising and falling; Fangfeng has the function of drying dampness, combined with Baishao to soothe the liver, Baizhu to invigorate the spleen, Chenpi, Sharen, and Caodoukou to make the effect of invigorating the spleen, drying dampness, and promoting qi circulation even longer; Shiliupi is used to astringe the intestines and stop diarrhea, and Zhan Gancao is used to regulate all herbs and benefit the spleen and harmonize the center. The combination of all herbs can invigorate the spleen, soothe the liver, regulate qi, clear heat, and dampness, and stop diarrhea. The patient is advised to avoid wind and cold, be careful of living, relax emotions, and regulate diet. The symptoms are improved at the second diagnosis, and he is advised to take 7 more doses of oral medication to consolidate the curative effect.

[0174] Case two

[0175] Wang, female, 69 years old, on November 22, 2024, initial diagnosis. Complaint: recurrent loose and runny stool for more than 2 years. Present history: The patient had loose and runny stool for more than 2 years without obvious inducement, accompanied by mucus 2-3 times / day. During the onset, the patient was treated in various hospitals multiple times. After oral administration of traditional Chinese medicine and acupuncture treatment, the symptoms improved, but the disease was recurrent. Past medical history: Hepatitis B virus carrier, coronary atherosclerotic heart disease, thyroid nodule, and breast nodule for many years. Allergic history: Allergic to amoxicillin, with symptoms of vomiting and skin itching. No family genetic diseases. Current symptoms: The patient's appearance, spirit, and stool are slightly tired, with loose and runny stool, sometimes accompanied by mucus, 2-3 times / day, abdominal pain, and diarrhea. After defecation, the pain decreased, acid reflux, belching, sometimes heartburn, occasional dizziness, foreign body sensation in the throat, sometimes chest tightness and palpitations, more obvious after exercise, slight abdominal distension, bitter taste in the mouth, more thinking, good appetite, poor sleep, more dreams, easy to wake up, normal urination, red tongue, thin yellow and slightly greasy fur, and slippery pulse. Auxiliary examination: (November 2024, our hospital) Blood routine, stool routine + occult blood, 13 carbon breath test showed no abnormalities. Gastroscopy showed reflux esophagitis and chronic non-atrophic gastritis. Colonoscopy showed no abnormalities in the whole large intestine mucosa. Western medical diagnosis: Diarrhea-predominant irritable bowel syndrome. Traditional Chinese medical diagnosis: Diarrhea-disease, liver stagnation and spleen deficiency, combined with dampness. Prescription: Jiebiyingongfengkang Decoction plus addition and subtraction to invigorate the spleen, soothe the liver, regulate qi, clear heat, and stop diarrhea. Jiebiying 15g, fried white atractylodes 15g, north bupleurum 10g, white peony root 15g, fried citron fruit 15g, dried tangerine or orange peel 10g, silvertop 15g, sandalwood 10g, baked licorice 10g, perilla stem 15g, cardamom 10g, half-fried pinellia 10g, thick-wooded ginger 15g, yellow kudzu vine 10g, Szechuan lovage 10g, prepared milkvetch root 30g, prepared rhizoma polygalae 10g. 3 doses, decocted in water, taken in the morning and evening.

[0176] November 25, 2024, second diagnosis: The patient complained that the symptoms were improved, dizziness and chest tightness were relieved, stool was slightly formed, 2-3 times / day, abdominal pain and abdominal distension were relieved, sometimes acid reflux, heartburn, belching, foreign body sensation in the throat, and lower extremity weakness, normal appetite, poor sleep, normal urination, red tongue, thin yellow fur, and slippery pulse. On the basis of the previous prescription, Szechuan lovage was removed, and milkvetch root 30g, Szechuan donkey's hoof 15g, kudzu vine 20g, and radix mori 10g were added. 10 doses, decocted in water, taken in the morning and evening.

[0177] Note: The patient presented with abnormal bowel movements. Based on the four diagnostic methods (inspection, auscultation and olfaction), the diagnosis is diarrhea with liver stagnation and spleen deficiency, accompanied by damp-heat syndrome. The patient is a hepatitis B virus carrier, and the external pathogenic factors inevitably suppress the smooth flow of liver qi. This indicates the patient's pre-existing emotional distress. Furthermore, due to the patient's advanced age, spleen qi is already deficient, leading to liver qi imbalance and stagnation in the spleen, resulting in liver-spleen syndrome. Impaired qi circulation causes dampness to accumulate and form phlegm, which congests the throat, causing a foreign body sensation. Obstruction of the middle jiao's qi flow causes abdominal distension and pain. Prolonged stagnation and heat disrupt the stomach's descending function, resulting in acid reflux, heartburn, and belching. The spleen's inability to ascend clear qi, coupled with a history of coronary heart disease, inevitably leads to blood stasis. Poor qi and blood circulation can cause dizziness. Based on the principles of individualized treatment according to location and patient condition, the patient has long resided in a southern region, indicating a constitution leaning towards damp-heat. The spleen is deficient with damp-heat accumulation, and the liver is stagnant with fire and heat. Combined with the tongue coating and pulse, the diagnosis is liver stagnation and spleen deficiency with damp-heat syndrome. The prescription was modified from the Jiubiying Enteritis Formula to strengthen the spleen, soothe the liver, regulate qi, clear heat, resolve dampness, and stop diarrhea. The Tongxie and Si Ni formulas aim to harmonize the liver and spleen. Based on the theory that "heat originates from dampness," the key to resolving damp-heat lies in eliminating dampness. Jiubiying clears heat, promotes diuresis, and regulates qi, while Baizhu (Atractylodes macrocephala) tonifies without causing stagnation. Baizhu dries dampness and tonifies the spleen, preventing Jiubiying from harming the middle jiao without hindering its ability to clear damp-heat from the stomach and intestines. Both are used as principal herbs, combining tonification and purgation. Dangshen (Codonopsis pilosula) tonifies the spleen without causing dryness and nourishes the stomach without causing dampness. Amomum villosum and Amomum cardamomum resolve dampness, regulate qi, and stop diarrhea. Scutellaria baicalensis is added to clear heat and dry dampness. For the patient's throat sensation, Pinellia ternata, Magnolia officinalis, and Perilla frutescens are used, following the principle of Banxia Houpu Decoction. Ligusticum chuanxiong invigorates blood, ascends to the head and eyes, and relieves stagnation in the middle jiao to alleviate dizziness. Polygala tenuifolia calms the mind and aids sleep. The patient was advised to avoid wind and cold, be careful with daily activities, maintain emotional well-being, and regulate diet. At the second consultation, all symptoms had improved, with bowel movements slightly better. Occasional dizziness and chest tightness remained, along with lower limb weakness. Given the patient's advanced age and long-term illness, the condition was considered to be a mixture of deficiency and excess. Astragalus was prescribed in combination with Codonopsis to tonify, and Achyranthes bidentata to promote bowel movement. Pueraria lobata and Polygonum multiflorum were added to further enhance the spleen-strengthening, diarrhea-stopping, and sleep-inducing effects. A follow-up phone call revealed that the symptoms had subsided, bowel movements were formed once a day, sometimes sticky, acid reflux and belching were less frequent, dizziness and chest tightness were absent, appetite was good, sleep was improving, and urination was normal. The patient was instructed to take another 7 doses orally to consolidate the therapeutic effect.

[0178] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome, characterized in that, The active ingredients include the following parts by weight: 10-20 parts of Jiubiying, 10-20 parts of stir-fried Atractylodes macrocephala, 10-20 parts of Paeonia lactiflora, 5-15 parts of Bupleurum chinense, 10-20 parts of Citrus aurantium, 10-20 parts of Saposhnikovia divaricata, 5-15 parts of Citrus reticulata peel, 5-15 parts of Amomum villosum, 5-15 parts of Amomum cardamomum, 10-20 parts of Punica granatum peel, and 5-15 parts of prepared Glycyrrhiza uralensis.

2. The traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome as described in claim 1, characterized in that, It also includes the following active ingredients in parts by weight: 12-18 parts of perilla stem, 8-12 parts of scutellaria, 8-12 parts of chuanxiong rhizome, and 24-36 parts of codonopsis root.

3. The traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome as described in claim 1, characterized in that, It also includes any one or a combination of the following excipients by weight: 10-15 parts Curcuma longa, 10-15 parts Cyperus rotundus, 5-10 parts Albizia julibrissin, 10-15 parts Polygala tenuifolia, 20-30 parts Poria cocos, 10-15 parts Longan aril, 10-15 parts roasted malt, 20-30 parts Radish seed, 10-15 parts Medicated leaven, 10-15 parts Cuttlebone, 10-15 parts Fritillaria thunbergii. 10-15 parts of oyster shell, 10-15 parts of areca nut, 10-15 parts of Buddha's hand, 10-15 parts of magnolia bark, 10-15 parts of corydalis rhizome, 10-15 parts of ginger-processed pinellia, 10-15 parts of fresh ginger, 10-15 parts of agastache, 20-30 parts of stir-fried coix seed, 10-15 parts of poria cocos, 10-15 parts of yam, 10-15 parts of burnet root, and 10-15 parts of bletilla rhizome.

4. A method for preparing a traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome as described in any one of claims 1-3, characterized in that, Includes the following steps: S1. Weigh each ingredient according to the weight proportions. Among them, cardamom, nutmeg, ginger, and patchouli are crushed separately into coarse powder with a particle size of 20-40 mesh. The remaining ingredients are mixed and crushed into coarse powder with a particle size of 20-40 mesh. S2. Add the coarse powder (excluding Amomum villosum, Amomum cardamomum, ginger, and patchouli) from step S1 to 8-10 times the amount of purified water, soak for 30-60 minutes, heat to 90-100℃ and decoct for 1.5-2 hours, keeping it at a gentle boil and stirring 3-5 times during the process. Filter while hot to obtain the first filtrate. S3. Add 6-8 times the amount of purified water to the dregs from step S2, and add Amomum villosum, Amomum cardamomum, ginger and coarsely ground patchouli. Heat to 80-90℃ and decoct for 40-60 minutes, keeping it at a gentle boil. Filter while hot to obtain the second filtrate. S4. Combine the first and second filtrates and concentrate them under reduced pressure at a vacuum of 0.06-0.08 MPa and a temperature of 50-60℃ to obtain a clear extract with a relative density of 1.10-1.20 (60℃).

5. The method for preparing a traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome as described in claim 4, characterized in that, In step S4, the concentration is carried out under reduced pressure, with a vacuum degree of 0.06-0.08 MPa and a temperature of 50-60℃.

6. The method for preparing a traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome as described in claim 4, characterized in that, It also includes adding pharmaceutically acceptable excipients to the extract to prepare a decoction, granules, capsules or tablets, wherein the mass ratio of the excipients to the extract is 1:1-3.

7. The method for preparing a traditional Chinese medicine composition for treating diarrhea-predominant irritable bowel syndrome as described in claim 6, characterized in that, The excipients are selected from sucrose, dextrin, or magnesium stearate.

8. The use of a traditional Chinese medicine composition as described in any one of claims 1-4 in the preparation of a drug for treating diarrhea-predominant irritable bowel syndrome.

9. According to claim 8, the diarrhea-predominant irritable bowel syndrome is a syndrome of liver stagnation and spleen deficiency with damp-heat.

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