Traditional Chinese medicine composition for irritable bowel syndrome

Abstract

The application provides a traditional Chinese medicine composition for irritable bowel syndrome, and relates to the technical field of traditional Chinese medicine pharmacy.The traditional Chinese medicine composition is composed of 14 traditional Chinese medicine materials, i.e., Fructus Aurantii, Semen Raphani, Fructus Cannabis, Fructus Pruni, Semen Liquidambaris, Cantharis, Semen Arecae, Radix Bupleuri, Citrus medica, Rhizoma Corydalis, Fructus Psoraleae, Myristicae, Rhizoma Alpiniae Officinarum, Rhizoma Alpiniae Officinarum, and Rhizoma Alpiniae Officinarum, and the traditional Chinese medicine materials are reasonably matched to achieve synergistic effect.Animal experiments show that the traditional Chinese medicine composition can significantly improve the intestinal function, inflammatory reaction and visceral hypersensitivity state of rats with irritable bowel syndrome.Clinical experiments show that the traditional Chinese medicine composition can build a three-dimensional intervention mechanism of 'anti-inflammation, mind regulation and intestinal motility promotion', significantly improve the total effective rate of clinical treatment of irritable bowel syndrome, reduce the IBS-SSS score and TCM syndrome score of patients, and reduce the levels of TNF-alpha, 5-HT and VIP in serum, thereby restoring the normal intestinal motility, reducing the low-grade inflammation of the intestinal tract, and providing an effective, clear-mechanism, safe and reliable treatment scheme for irritable bowel syndrome.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine pharmaceutical technology, specifically to a traditional Chinese medicine composition for irritable bowel syndrome. Background Technology

[0002] Irritable bowel syndrome (IBS) is a chronic functional bowel disorder characterized by recurrent episodes of abdominal pain, bloating, and discomfort, accompanied by changes in bowel frequency and stool consistency. The disease is characterized by its prolonged course and recurrent episodes, causing significant psychological and lifestyle stress for patients. Global epidemiological surveys show that the prevalence of IBS varies from 1.1% to 35.5% depending on diagnostic criteria and geographical, cultural, and demographic differences across regions. Epidemiological studies in China indicate that the overall prevalence of IBS in the Chinese population is 6.5%, with gender differences (significantly higher prevalence in women than men) and age-related distribution patterns (peak incidence in young and middle-aged adults).

[0003] Modern medicine primarily treats IBS with symptomatic relief, using medications such as antispasmodics, antidiarrheals, and prokinetic drugs to alleviate the main symptoms. However, existing treatments suffer from clinical limitations, including single-target effects, significant individual variability in efficacy, controversial safety profiles with long-term use, and high relapse rates, making it difficult to fully meet the treatment needs arising from the complex mechanisms of the disease.

[0004] Indigestive tract infections (IBS) fall under the categories of "diarrhea," "abdominal pain," and "constipation" in Traditional Chinese Medicine (TCM). TCM treatments for IBS encompass a variety of techniques, including herbal medicine, acupuncture, moxibustion, massage, and acupoint application. Based on the principles of "holistic view" and "syndrome differentiation and treatment," TCM intervenes in IBS through multiple targets, levels, and pathways, demonstrating significant advantages in improving clinical symptoms, reducing recurrence rates, and enhancing treatment safety. Existing literature reports numerous TCM compound formulas or single-herb remedies for IBS, showing certain clinical efficacy and safety advantages. However, TCM treatment of IBS still faces challenges such as unstable efficacy and a single mechanism of action. Therefore, there is an urgent need to develop a TCM composition with definite efficacy, a clear mechanism of action, and high safety to meet clinical treatment needs. Summary of the Invention

[0005] (a) Technical problems to be solved

[0006] In view of the shortcomings of the prior art, the present invention provides a traditional Chinese medicine composition for irritable bowel syndrome.

[0007] (II) Technical Solution

[0008] To achieve the above objectives, the present invention provides the following technical solution:

[0009] This invention provides a traditional Chinese medicine composition for irritable bowel syndrome, the composition being made from the following raw materials in parts by weight: 10-30 parts of Citrus aurantium, 10-30 parts of Raphanus sativus seed, 5-25 parts of Cannabis sativa seed, 5-25 parts of Prunus japonica seed, 3-22 parts of Melia toosendan fruit, 1-15 parts of Eupolyphaga sinensis, 1-20 parts of Areca catechu, 1-20 parts of Bupleurum chinense, 3-22 parts of Citronella foenum-graecum, 1-20 parts of Corydalis yanhusuo (processed with vinegar), 3-22 parts of Psoralea corylifolia, 1-20 parts of roasted Myristica fragrans, 3-22 parts of Alisma plantago-aquatica, and 1-20 parts of roasted Glycyrrhiza uralensis.

[0010] Specifically, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 15-25 parts of Citrus aurantium, 15-25 parts of Raphanus sativus, 10-20 parts of Cannabis sativa, 10-20 parts of Prunus japonica, 8-16 parts of Melia toosendan, 3-9 parts of Eupolyphaga sinensis, 5-15 parts of Areca catechu, 5-15 parts of Bupleurum chinense, 8-16 parts of Citronella foenum-graecum, 5-15 parts of Corydalis yanhusuo (processed with vinegar), 8-16 parts of Psoralea corylifolia, 5-15 parts of Myristica fragrans (processed with roasted), 8-16 parts of Alisma plantago-aquatica, and 5-15 parts of Glycyrrhiza uralensis (processed with roasted).

[0011] Specifically, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 20 parts of Citrus aurantium, 20 parts of Raphanus sativus, 15 parts of Cannabis sativa, 15 parts of Prunus japonica, 12 parts of Melia toosendan, 6 parts of Eupolyphaga sinensis, 10 parts of Areca catechu, 10 parts of Bupleurum chinense, 12 parts of Citronella foenum-graecum, 10 parts of Corydalis yanhusuo (processed with vinegar), 12 parts of Psoralea corylifolia, 9 parts of roasted Myristica fragrans, 12 parts of Alisma plantago-aquatica, and 10 parts of roasted Glycyrrhiza uralensis.

[0012] This invention provides a method for preparing a traditional Chinese medicine composition for irritable bowel syndrome. The medicine is prepared into an oral dosage form by using traditional Chinese medicine manufacturing methods and adding excipients. The oral dosage form includes pills, powders, granules, oral liquids, decoctions, and tablets.

[0013] Furthermore, the decoction of the traditional Chinese medicine composition for irritable bowel syndrome is prepared according to the following steps:

[0014] (1) Weigh each Chinese herbal raw material according to the above weight proportions, wash, dry and grind into coarse powder, put the coarse powder of the herbs into a clay pot, add water to cover the herbs and soak for 30 minutes.

[0015] (2) After soaking the medicinal materials, bring them to a boil over high heat and then simmer over low heat for 30 minutes. Filter the solution and take the filtrate. Add water to the residue and simmer for another 30 minutes. Filter the solution and combine the two filtrates. Concentrate the filtrate under reduced pressure to 400 mL to obtain the Chinese herbal decoction of the present invention.

[0016] This invention provides the use of the traditional Chinese medicine composition in the preparation of medicaments for the prevention and / or treatment of irritable bowel syndrome.

[0017] The pharmacological effects of each herbal component in the herbal composition of this invention are as follows:

[0018] Fructus Aurantii Immaturus: It tastes bitter, pungent, and sour, and is slightly cold in nature. It enters the spleen and stomach meridians. It has the effects of regulating qi, relieving chest tightness, and promoting digestion and relieving bloating. It is used for qi stagnation in the chest and ribs, fullness and pain, indigestion, phlegm retention, and organ prolapse.

[0019] Radish seed: It has a pungent and sweet taste, and is neutral in nature. It enters the lung, spleen, and stomach meridians. It has the effects of relieving indigestion and bloating, and reducing phlegm. It is used for food stagnation, abdominal distension and pain, constipation, diarrhea due to food stagnation, and cough with phlegm accumulation.

[0020] Hemp seeds: sweet in taste, neutral in nature, and enter the spleen, stomach, and large intestine meridians; they have the effect of moistening the intestines and relieving constipation; used for blood deficiency and fluid depletion, and constipation due to intestinal dryness.

[0021] Prunus japonica seed: It has a pungent, bitter and sweet taste, and is neutral in nature. It enters the spleen, large intestine and small intestine meridians. It has the effects of moistening the intestines and relieving constipation, lowering qi and promoting diuresis. It is used for dry intestines due to dryness of body fluids, food stagnation and qi stagnation, abdominal distension and constipation, edema, beriberi and difficulty in urination.

[0022] Sichuan Chinaberry: It tastes bitter and is cold in nature. It enters the liver, small intestine and bladder meridians. It has the effects of soothing the liver and relieving heat, promoting qi and relieving pain, and killing parasites. It is used for liver stagnation transforming into fire, chest and rib pain, abdominal distension and pain, hernia pain, and abdominal pain due to intestinal parasites.

[0023] Nine-fragrant insect: salty in taste, warm in nature, and enters the liver, spleen, and kidney meridians; it has the effects of regulating qi and relieving pain, warming the middle and assisting yang; it is used for stomach cold and bloating pain, liver and stomach qi pain, kidney deficiency and impotence, and soreness and pain in the waist and knees.

[0024] Areca nut: bitter and pungent in taste, warm in nature, and enters the stomach and large intestine meridians; it has the effects of killing parasites, eliminating food stagnation, promoting qi circulation, promoting diuresis, and treating malaria; it is used for tapeworm disease, ascariasis, fascioliasis, abdominal pain due to intestinal parasites, diarrhea due to food stagnation, tenesmus, edema, beriberi, and malaria.

[0025] Bupleurum: It has a pungent and bitter taste, is slightly cold in nature, and enters the liver, gallbladder, and lung meridians; it has the effects of dispersing and reducing fever, soothing the liver and relieving depression, and raising yang qi; it is used for colds with fever, alternating chills and fever, chest and rib pain, irregular menstruation, uterine prolapse, and rectal prolapse.

[0026] Citron: It has a pungent, bitter, and sour taste, and is warm in nature. It enters the liver, spleen, and lung meridians. It has the effects of soothing the liver and regulating qi, relieving chest congestion, and resolving phlegm. It is used for liver and stomach qi stagnation, chest and rib pain, abdominal distension, vomiting and belching, and cough with excessive phlegm.

[0027] Vinegar-processed Corydalis: It has a pungent and bitter taste, is warm in nature, and enters the liver and spleen meridians; it has the effects of promoting blood circulation, regulating qi, and relieving pain. The analgesic effect is enhanced after processing with vinegar; it is used for chest and rib pain, abdominal pain, chest pain, amenorrhea and dysmenorrhea, postpartum blood stasis, and swelling and pain from falls.

[0028] Psoralea corylifolia: It is pungent and bitter in taste, warm in nature, and enters the kidney and spleen meridians; it has the effects of warming the kidney and assisting yang, regulating qi and relieving asthma, and warming the spleen and stopping diarrhea; it is used for kidney yang deficiency, impotence and seminal emission, enuresis and frequent urination, cold pain in the waist and knees, asthma due to kidney deficiency, and diarrhea in the early morning.

[0029] Roasted Myristicae Semen: pungent in flavor, warm in nature, and acts on the spleen, stomach and large intestine meridians; it has the effects of warming the middle and regulating qi, as well as astringing the intestine to stop diarrhea. After roasting, its laxative effect is reduced, while the effect of astringing the intestine to stop diarrhea is enhanced; it is used for deficiency-cold in the spleen and stomach, protracted diarrhea, abdominal distension and pain, poor appetite and vomiting.

[0030] Alismatis Rhizoma: sweet and bland in flavor, cold in nature, and acts on the kidney and bladder meridians; it has the effects of promoting diuresis and excreting dampness, clearing heat, resolving turbidity and reducing lipid; it is used for dysuria, edema and fullness, diarrhea with oliguria, vertigo caused by phlegm-fluid retention, stranguria with heat and astringent pain, and hyperlipidemia.

[0031] Glycyrrhizae Radix et Rhizoma Praeparata cum Melle: sweet in flavor, neutral in nature, and acts on the heart, lung, spleen and stomach meridians; it has the effects of tonifying the spleen and harmonizing the stomach, replenishing qi and restoring the pulse; it is used for spleen-stomach deficiency, lassitude and debilitation, palpitation, and irregular intermittent pulse.

[0032] (3) Beneficial Effects

[0033] The present invention provides a traditional Chinese medicine composition for irritable bowel syndrome, and the traditional Chinese medicine composition consists of fourteen traditional Chinese medicines: Aurantii Fructus Immaturus, Raphani Semen, Cannabis Semen, Pruni Semen, Toosendan Fructus, Aspongopus, Arecae Semen, Bupleuri Radix, Citri Fructus, Corydalis Rhizoma (processed with vinegar), Psoraleae Fructus, Roasted Myristicae Semen, Alismatis Rhizoma, and Glycyrrhizae Radix et Rhizoma Praeparata cum Melle. Irritable bowel syndrome falls under the categories of "abdominal pain", "diarrhea", "constipation" and the like in traditional Chinese medicine, and its core pathogenesis mostly lies in liver depression and spleen deficiency, qi movement stagnation, and dysfunction of the intestinal fu-organ. This formula follows the principle of promoting the descent of qi movement, applying both attacking and tonifying methods, and combining cold and warm properties, so as to jointly exert the functions of soothing liver and regulating qi, invigorating spleen and harmonizing the middle, unblocking the fu-organ to remove stagnation, and regulating intestinal functions. In the formula, Aurantii Fructus Immaturus and Raphani Semen are taken as the monarch drugs. Aurantii Fructus Immaturus is pungent for dispersion and bitter for descent, and is good at broadening the middle and lowering qi, resolving masses and relieving fullness; Raphani Semen promotes digestion and relieves distension, lowers qi and resolves phlegm; the two drugs, one ascending and the other descending, regulate and smooth qi movement, directly targeting the core of qi stagnation and intestinal obstruction of IBS. Cannabis Semen, Pruni Semen, Toosendan Fructus, Aspongopus and Arecae Semen are used as the ministerial drugs. Cannabis Semen nourishes yin and moistens dryness, lubricates the intestine to relax bowels; Pruni Semen lubricates the intestine to relax bowels, promotes diuresis and reduces edema; the combination of the two nourishes intestinal dryness and lubricates the intestinal tract; Toosendan Fructus soothes liver and clears heat, moves qi to relieve pain, and kills parasites; Aspongopus regulates qi to relieve pain, warms kidney and assists yang; Arecae Semen kills parasites and eliminates retention, moves qi and promotes diuresis, and prevents malaria; the combined use of these three drugs not only assists the monarch drugs to break qi and remove stagnation, targeting the key pathogenesis of liver qi invading the spleen and tangled abdominal pain of IBS, but also prevents the monarch drugs from being pungent and dry to damage yin. Bupleuri Radix, Citri Fructus, Corydalis Rhizoma (processed with vinegar), Psoraleae Fructus, Roasted Myristicae Semen and Alismatis Rhizoma are used as adjuvant drugs. Bupleuri Radix soothes liver and relieves depression, and harmonizes shaoyang; Citri Fructus soothes liver and regulates qi, broadens the middle and resolves phlegm; Corydalis Rhizoma (processed with vinegar) activates blood and moves qi to relieve pain; Psoraleae Fructus tonifies kidney and assists yang, secures essence and reduces urination, warms spleen to stop diarrhea; Roasted Myristicae Semen warms the middle and moves qi, astringes the intestine to stop diarrhea; Alismatis Rhizoma promotes diuresis and excretes dampness, and clears heat; the compatibility of these six drugs not only assists the monarch and ministerial drugs to regulate qi movement, but also restricts the biased properties of all drugs, taking into account the complex pathogenesis of IBS characterized by root deficiency and excess manifestation, as well as intermingled cold and heat. Glycyrrhizae Radix et Rhizoma Praeparata cum Melle is used as the conductant drug, which harmonizes all the drugs, moderates urgency to relieve pain, consolidates and protects the spleen and stomach, so that the whole formula applies both attacking and tonifying methods without damaging healthy qi, and jointly forms a formula that regulates liver and fortifies spleen, unblocks the fu-organ and removes stagnation.

[0034] Animal experiments have shown that the herbal composition of this invention exhibits significant therapeutic effects on rats with irritable bowel syndrome (IBS) through a multi-target synergistic mechanism. It can effectively improve the rats' mental state, fur cleanliness, activity level, and perianal hygiene, reduce aggressive behavior and huddling, and significantly reduce the fecal Bristol score. Simultaneously, the herbal composition of this invention has a bidirectional regulatory effect on serum inflammatory factors, reducing TNF-α, IFN-γ, and IL-4 levels while increasing IL-10 levels, and exerting anti-inflammatory effects by inhibiting the NF-κB pathway. Furthermore, the herbal composition of this invention can significantly reduce the visceral sensitivity score of rats and alleviate abdominal pain symptoms.

[0035] Clinical trials have shown that the herbal composition of this invention forms a three-dimensional intervention mechanism of "anti-inflammatory-psychoregulation-promoting motility," which can significantly improve the overall effective rate of clinical treatment for irritable bowel syndrome (IBS), effectively improve patients' clinical symptoms, and reduce patients' IBS-SSS scores and TCM syndrome scores. At the same time, the herbal composition of this invention can effectively reduce the levels of TNF-α, 5-HT, and VIP in patients' serum, regulate brain-gut axis function, restore normal intestinal motility, and reduce low-grade intestinal inflammation. In addition, no significant adverse reactions were observed during the treatment, showing good safety and tolerability, providing an effective, well-mechanism-clear, safe and reliable treatment option for IBS. Attached Figure Description

[0036] Figure 1 Comparison of Bristol scores in feces of rats in each treatment group. Note: Compared with the control group, # P<0.05, ## P<0.01; compared with the model group, * P<0.05, ** P<0.01.

[0037] Figure 2 Comparison of visceral sensitivity scores among rats in each treatment group. Note: Compared with the control group, # P<0.05, ## P<0.01; compared with the model group, * P<0.05, ** P<0.01. Detailed Implementation

[0038] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below in conjunction with the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0039] Example 1

[0040] A traditional Chinese medicine composition for irritable bowel syndrome, comprising the following raw materials in parts by weight: 20 parts of Citrus aurantium, 20 parts of Raphanus sativus, 15 parts of Cannabis sativa seed, 15 parts of Prunus japonica seed, 12 parts of Melia toosendan, 6 parts of Eupolyphaga sinensis, 10 parts of Areca catechu, 10 parts of Bupleurum chinense, 12 parts of Citronella foenum-graecum, 10 parts of Corydalis yanhusuo (processed with vinegar), 12 parts of Psoralea corylifolia, 9 parts of roasted Myristica fragrans, 12 parts of Alisma plantago-aquatica, and 10 parts of roasted Glycyrrhiza uralensis.

[0041] Example 2

[0042] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 10 parts of Citrus aurantium, 10 parts of Raphanus sativus, 5 parts of Cannabis sativa, 5 parts of Prunus japonica, 3 parts of Melia toosendan, 1 part of Eupolyphaga sinensis, 1 part of Areca catechu, 1 part of Bupleurum chinense, 3 parts of Citronella foenum-graecum, 1 part of Corydalis yanhusuo (processed with vinegar), 3 parts of Psoralea corylifolia, 1 part of Myristica fragrans (processed with roasted), 3 parts of Alisma plantago-aquatica, and 1 part of Glycyrrhiza uralensis (processed with roasted).

[0043] Example 3

[0044] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 28 parts of Citrus aurantium, 28 parts of Raphanus sativus, 23 parts of Cannabis sativa, 23 parts of Prunus japonica, 20 parts of Melia toosendan, 13 parts of Eupolyphaga sinensis, 18 parts of Areca catechu, 18 parts of Bupleurum chinense, 20 parts of Citronella foenum-graecum, 18 parts of Corydalis yanhusuo (processed with vinegar), 20 parts of Psoralea corylifolia, 18 parts of Myristica fragrans (processed with roasted), 20 parts of Alisma plantago-aquatica, and 15 parts of Glycyrrhiza uralensis (processed with roasted).

[0045] Example 4

[0046] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 30 parts of Citrus aurantium, 30 parts of Raphanus sativus, 25 parts of Cannabis sativa, 25 parts of Prunus japonica, 22 parts of Melia toosendan, 15 parts of Eupolyphaga sinensis, 20 parts of Areca catechu, 20 parts of Bupleurum chinense, 22 parts of Citronella foenum-graecum, 20 parts of Corydalis yanhusuo (processed with vinegar), 22 parts of Psoralea corylifolia, 20 parts of Myristica fragrans (processed with roasted), 22 parts of Alisma plantago-aquatica, and 20 parts of Glycyrrhiza uralensis (processed with roasted).

[0047] Example 5

[0048] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine composition consists of the following raw materials in parts by weight: 15 parts of Citrus aurantium, 15 parts of Raphanus sativus, 9 parts of Cannabis sativa, 9 parts of Prunus japonica, 6 parts of Melia toosendan, 5 parts of Eupolyphaga sinensis, 5 parts of Areca catechu, 5 parts of Bupleurum chinense, 9 parts of Citronella foenum-graecum, 5 parts of Corydalis yanhusuo (processed with vinegar), 9 parts of Psoralea corylifolia, 5 parts of Myristica fragrans (processed with roasted), 9 parts of Alisma plantago-aquatica, and 5 parts of Glycyrrhiza uralensis (processed with roasted).

[0049] Example 6

[0050] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 12 parts of Citrus aurantium, 12 parts of Raphanus sativus, 7 parts of Cannabis sativa, 7 parts of Prunus japonica, 5 parts of Melia toosendan, 3 parts of Eupolyphaga sinensis, 3 parts of Areca catechu, 3 parts of Bupleurum chinense, 5 parts of Citronella foenum-graecum, 3 parts of Corydalis yanhusuo (processed with vinegar), 5 parts of Psoralea corylifolia, 3 parts of Myristica fragrans (processed with roasted), 5 parts of Alisma plantago-aquatica, and 3 parts of Glycyrrhiza uralensis (processed with roasted).

[0051] Example 7

[0052] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 22 parts of Citrus aurantium, 22 parts of Raphanus sativus, 18 parts of Cannabis sativa, 18 parts of Prunus japonica, 15 parts of Melia toosendan, 7 parts of Eupolyphaga sinensis, 5 parts of Areca catechu, 5 parts of Bupleurum chinense, 8 parts of Citronella foenum-graecum, 13 parts of Corydalis yanhusuo (processed with vinegar), 7 parts of Psoralea corylifolia, 5 parts of Myristica fragrans (processed with roasted), 6 parts of Alisma plantago-aquatica, and 12 parts of Glycyrrhiza uralensis (processed with roasted).

[0053] Example 8

[0054] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 25 parts of Citrus aurantium, 25 parts of Raphanus sativus, 20 parts of Cannabis sativa, 20 parts of Prunus japonica, 16 parts of Melia toosendan, 9 parts of Eupolyphaga sinensis, 15 parts of Areca catechu, 15 parts of Bupleurum chinense, 16 parts of Citronella foenum-graecum, 15 parts of Corydalis yanhusuo (processed with vinegar), 16 parts of Psoralea corylifolia, 12 parts of roasted Myristica fragrans, 15 parts of Alisma plantago-aquatica, and 14 parts of roasted Glycyrrhiza uralensis.

[0055] Experimental Example 1

[0056] 1. Materials and Methods

[0057] 1.1 Laboratory Animals

[0058] Thirty-five SPF-grade SD rats, half male and half female, weighing 170-200 g, were purchased from Liaoning Changsheng Biotechnology Co., Ltd.

[0059] 1.2 Test Drugs

[0060] Experimental Group 1: 20 parts of Citrus aurantium, 20 parts of Raphanus sativus, 15 parts of Cannabis sativa, 15 parts of Prunus japonica, 12 parts of Melia toosendan, 6 parts of Eupolyphaga sinensis, 10 parts of Areca catechu, 10 parts of Bupleurum chinense, 12 parts of Citronella foenum-graecum, 10 parts of Corydalis yanhusuo (processed with vinegar), 12 parts of Psoralea corylifolia, 9 parts of Myristica fragrans (processed with roasted), 12 parts of Alisma plantago-aquatica, and 10 parts of Glycyrrhiza uralensis (processed with roasted).

[0061] Experimental Group 2: Radish seed 20 parts, hemp seed 15 parts, Prunus japonica seed 15 parts, Melia toosendan 12 parts, worm 6 parts, areca nut 10 parts, vinegar-processed Corydalis yanhusuo 10 parts, Psoralea corylifolia 12 parts, roasted nutmeg 9 parts, Alisma plantago-aquatica 12 parts, and roasted licorice root 10 parts.

[0062] Experimental Group 3: 20 parts of Citrus aurantium, 15 parts of Cannabis sativa seed, 15 parts of Prunus japonica seed, 12 parts of Melia toosendan, 6 parts of Eupolyphaga sinensis, 10 parts of Areca catechu, 10 parts of Bupleurum chinense, 12 parts of Citronella cuspidatum, 9 parts of roasted Myristica fragrans, 12 parts of Alisma plantago-aquatica, and 10 parts of roasted Glycyrrhiza uralensis.

[0063] Experimental Group 4: 20 parts of Citrus aurantium, 20 parts of Raphanus sativus, 15 parts of Cannabis sativa, 15 parts of Prunus japonica, 10 parts of Areca catechu, 10 parts of Bupleurum chinense, 12 parts of Citronella cuspidatum, 10 parts of Corydalis yanhusuo (processed with vinegar), 12 parts of Psoralea corylifolia, and 10 parts of Glycyrrhiza uralensis (processed with honey).

[0064] Experimental Group 5: 20 parts of Citrus aurantium, 20 parts of Radish seed, 12 parts of Melia toosendan, 6 parts of Stinkbug, 10 parts of Bupleurum chinense, 12 parts of Citronella foenum-graecum, 10 parts of Corydalis yanhusuo (processed with vinegar), 12 parts of Psoralea corylifolia, 9 parts of Myristica fragrans (processed with malt), and 10 parts of Glycyrrhiza uralensis (processed with licorice).

[0065] Weigh each herb according to the above-mentioned weight proportions (each weight proportion is 1g), wash and dry them, then grind them into coarse powder. Place them in a clay pot, add water to cover the herbs, and soak for 30 minutes. After soaking, bring the herbs to a boil over high heat, then reduce to low heat and simmer for 30 minutes. Filter and collect the filtrate. Add water to the residue again and simmer for 30 minutes. Filter again and combine the two filtrates. Concentrate the filtrate under reduced pressure to a relative density of 1 g / mL to obtain the original Chinese medicine solutions for test groups 1-5.

[0066] 1.3 Animal modeling, grouping, and drug administration

[0067] After one week of acclimatization, an irritable bowel syndrome (IBS) model was established in rats using senna leaf gavage. Rats were randomly divided into a control group, a model group, and experimental groups 1-5, with five rats in each group. Except for the control group, all other groups were administered a 0.3 g / mL senna leaf decoction at a concentration of 10 mL / kg body weight via gavage to establish the IBS model, once daily for 14 consecutive days. The control group was administered an equal volume of physiological saline via gavage. The senna leaf decoction was prepared by soaking senna leaves in five times their volume of boiling water for 12 hours, filtering, and concentrating the filtrate to 0.3 g / mL. After successful model establishment, experimental groups 1-5 were administered the corresponding 200 mg / kg of the decoction via gavage, while the control and model groups were administered an equal volume of physiological saline via gavage, once daily for 14 consecutive days.

[0068] 1.4 Detection Indicators

[0069] 1.4.1 General condition of rats

[0070] During the treatment period, the mental state, hair color, diet, activity, and fecal Bristol score of rats in each group were observed.

[0071] Table 1. Bristol Score Scale for Feces

[0072]

[0073] 1.4.2 Serum marker detection

[0074] After administration, rats were anesthetized with 3% sodium pentobarbital (40 mg / kg) and blood was collected via the abdominal aorta. The blood was centrifuged at 4℃ and 3500 rpm for 15 min to separate the serum. The serum levels of TNF-α, IFN-γ, IL-4, and IL-10 were measured strictly according to the instructions of the ELISA kit.

[0075] 1.4.3 Visceral Sensitivity

[0076] The abdominal withdrawal reflex (AWR) score was used to assess the sensitivity of rats to colorectal dilation (CRD). After fasting for 12 hours with unlimited water, rats were anesthetized with a lubricated balloon catheter (approximately 2 mm in diameter and 2 cm in length) and inserted into the colon through the anus, with the distal end of the balloon approximately 8 cm from the anus. After the rats were awake and calm (approximately 30 min), warm water was injected into the balloon using a pressure pump, and varying dilation pressures were gradually applied, each lasting 20 seconds, with a 5-minute interval between dilations. The AWR scores of the rats were observed and recorded simultaneously (0: no behavioral response; 1: slight head movement, no abdominal contraction; 2: slight abdominal muscle contraction; 3: significant abdominal elevation; 4: arched back and elevation of the pelvic region).

[0077] 1.5 Statistical Methods

[0078] SPSS 26.0 was used for data analysis, and GraphPad Prism 8.0 software was used for statistical graphing. Quantitative data were expressed as mean ± standard deviation. When variances were homogeneous, one-way ANOVA was used for comparisons among multiple groups, and the LSD test was used for pairwise comparisons between groups. When variances were unequal, the Games-Howell test was used for pairwise comparisons between groups. Repeated measures ANOVA was used for comparisons of repeated measures data. A p-value < 0.05 was considered statistically significant.

[0079] 2 Results

[0080] 2.1 Effects of each drug on the general condition of rats

[0081] The control group rats were in normal mental condition, with shiny and clean fur, moved freely and agilely, had good endurance, showed no aggressive behavior, had a normal diet, and had smooth and shiny paws and tails, and rosy ears with no obvious abnormalities. The model group rats were in poor mental condition, easily irritated, with messy fur, liked to curl up and huddle together, were prone to fighting, had a poor diet, and reduced spontaneous activity. The rats in the drug-treated groups showed some recovery in mental state, with clean fur, normal diet, and were more active, and fighting among rats decreased.

[0082] Depend on Figure 1It was found that the feces of rats in the blank group were normal in shape and firm in texture, with a clean perianal area and no fecal residue, and the bedding was dry. The feces of rats in the model group were soft, unformed, or even loose or watery, with obvious fecal stains around the anus, limbs, nails, and hair, and the bedding was damp. Compared with the model group, the fecal shape of rats in each treatment group was improved, with no fecal stains around the anus, and the fecal Bristol score was significantly reduced (P<0.05, P<0.01). Among them, the fecal texture of experimental group 1 was close to that of the blank group, and the fecal Bristol score was significantly reduced (P<0.01). The fecal Bristol scores of experimental groups 2-5 were reduced, and some samples showed a mixed state of soft and formed stool. Only a few individuals showed mild stickiness, indicating that the traditional Chinese medicine composition of the present invention has a significant regulatory effect on intestinal function in rats with irritable bowel syndrome.

[0083] 2.2 Effects of various drugs on serum inflammatory factor levels in rats

[0084] As shown in Table 2, compared with the blank group, the serum levels of inflammatory factors TNF-α, IFN-γ, and IL-4 in the model group rats were significantly increased, while the IL-10 level was significantly decreased (P<0.01). Compared with the model group, the serum inflammatory factors in each treatment group rats showed a bidirectional regulatory effect. Among them, the levels of TNF-α, IFN-γ, and IL-4 in the experimental group showed the most significant decreasing trend, while the IL-10 level rose to 1.6 times that of the model group. This indicates that the traditional Chinese medicine composition of the present invention may inhibit the NF-κB signaling pathway to exert an anti-inflammatory effect, thereby alleviating the inflammatory response in rats with irritable bowel syndrome.

[0085] Table 2 Comparison of serum inflammatory factor levels in rats of different treatment groups (pg / mL)

[0086]

[0087] Note: Compared with the blank group, # P<0.05, ## P<0.01; compared with the model group, * P<0.05, ** P<0.01.

[0088] 2.3 Effects of various drugs on the visceral sensitivity of rats

[0089] Depend on Figure 2 It can be seen that, compared with the blank group, the visceral sensitivity score of rats in the model group was significantly increased (P<0.01), indicating that the irritable bowel syndrome model was successfully established; compared with the model group, the visceral sensitivity scores of rats in each treatment group were significantly decreased (P<0.01), among which the experimental group 1 showed the best analgesic effect, indicating that the traditional Chinese medicine composition of the present invention can exert the effect of relieving abdominal pain by regulating the hypersensitive state of the viscera.

[0090] 3. Conclusion

[0091] The herbal composition of this invention can significantly improve behavioral indicators in rats with irritable bowel syndrome (IBS), effectively restoring their mental state, fur cleanliness, activity level, and perianal hygiene, reducing aggressive behavior and huddling, and significantly lowering fecal Bristol scores. Simultaneously, the herbal composition exhibits a bidirectional regulatory effect on serum inflammatory factors, reducing TNF-α, IFN-γ, and IL-4 levels while increasing IL-10 levels, exerting anti-inflammatory effects by regulating Th1 / Th2 balance and inhibiting the NF-κB pathway. Furthermore, the herbal composition can significantly reduce visceral sensitivity scores in rats, regulating visceral hypersensitivity and alleviating abdominal pain symptoms. Intergroup comparisons showed that group 1 exhibited the best therapeutic effect across all observed indicators, while groups 2-5, lacking certain herbal ingredients, showed varying degrees of weakened overall therapeutic effects on IBS. The above experimental results show that the traditional Chinese medicine composition of the present invention can significantly improve intestinal function, inflammatory response and visceral hypersensitivity in rats with irritable bowel syndrome. Moreover, the various traditional Chinese medicine raw materials have synergistic effects and none of them can be omitted, which lays a solid experimental foundation for subsequent clinical application.

[0092] Experimental Example 2

[0093] 1. Clinical Data

[0094] 1.1 General Information

[0095] Eighty-four patients with IBS were randomly divided into a control group and an observation group, with 42 patients in each group. The control group consisted of 18 males and 24 females, with a mean age of (52.14±8.25) years and a mean disease duration of (15.33±4.69) months. The observation group consisted of 15 males and 27 females, with a mean age of (50.37±9.22) years and a mean disease duration of (17.45±6.34) months. There were no statistically significant differences in general characteristics between the two groups (P>0.05), indicating comparability.

[0096] 1.2 Diagnostic Criteria

[0097] 1.2.1 Western Medicine Diagnostic Criteria

[0098] Based on the standards set forth in the "2020 Chinese Expert Consensus on Irritable Bowel Syndrome": Symptoms have recurred for at least 6 months, with at least 1 day of recurrence per week for the past 3 months, and are accompanied by two or more of the following symptoms: abdominal pain or discomfort is relieved after defecation; changes in defecation frequency; changes in stool shape: at least 25% of stools are loose (pasty) or watery, and less than 25% are hard or dry; colonoscopy and other examinations show no organic lesions.

[0099] 1.2.2 Traditional Chinese Medicine Diagnostic Criteria

[0100] The following criteria were established based on the "Expert Consensus on the Diagnosis and Treatment of Irritable Bowel Syndrome in Traditional Chinese Medicine (2017)": Primary symptoms: Abdominal pain followed by diarrhea, with pain relieved after defecation; irritability and anger. Secondary symptoms: Distension in the hypochondriac region; poor appetite; fatigue and weakness. Tongue and pulse: Pale and swollen tongue, possibly with teeth marks, thin white coating; wiry and thready pulse. A diagnosis can be made if the primary symptoms and at least three secondary symptoms are present.

[0101] 1.3 Inclusion Criteria

[0102] Meet the above diagnostic criteria; be between 18 and 70 years old; understand and agree to participate in this study and sign the informed consent form.

[0103] 1.4 Exclusion Criteria

[0104] Individuals with organic gastrointestinal lesions or diseases; pregnant or lactating women; those with mental illness; those allergic to the drugs used in this study; those with severe heart, liver, kidney, or other functional disorders; and those with poor adherence to the treatment protocol of this study.

[0105] 2. Treatment methods

[0106] Control group: Mosapride citrate dispersible tablets were taken orally, one tablet (5 mg) three times a day for 4 weeks.

[0107] Observation group: In addition to the control group, the patients were given oral administration of the traditional Chinese medicine composition of this invention. The prescription is as follows: 20 parts of Citrus aurantium, 20 parts of Raphanus sativus, 15 parts of Cannabis sativa, 15 parts of Prunus japonica, 12 parts of Melia toosendan, 6 parts of Eupolyphaga sinensis, 10 parts of Areca catechu, 10 parts of Bupleurum chinense, 12 parts of Citronella foenum-graecum, 10 parts of Corydalis yanhusuo (processed with vinegar), 12 parts of Psoralea corylifolia, 9 parts of Myristica fragrans (processed with roasted), 12 parts of Alisma plantago-aquatica, and 10 parts of Glycyrrhiza uralensis (processed with roasted). Each ingredient was weighed according to the above weight proportions (each weight proportion is 1g), and decocted with 5 times its weight of water for more than 30 minutes until 400 mL of decoction remained. The decoction was taken twice a day, morning and evening, for 4 consecutive weeks.

[0108] 3. Observation of therapeutic effects

[0109] 3.1 Irritable Bowel Syndrome-Severity Score (IBS-SSS)

[0110] The IBS-SSS scale was used to assess the severity of abdominal pain, frequency of abdominal pain, degree of bloating, bowel movement satisfaction, and impact on quality of life. Each item had a maximum score of 100 points, for a total score of 500 points. The severity of the condition was directly proportional to the total score: 0-74 points indicated healthy; 75-174 points indicated mild; 175-299 points indicated moderate; and 300-500 points indicated severe.

[0111] 3.2 Traditional Chinese Medicine Syndrome Scoring

[0112] The TCM syndrome scores of the two groups of patients before and after treatment were evaluated according to the "Expert Consensus on the Diagnosis and Treatment of Irritable Bowel Syndrome with Traditional Chinese Medicine (2017)" and the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines (Trial Implementation)". The primary symptoms were: abdominal pain followed by diarrhea, with pain relief after defecation; irritability and anger. Secondary symptoms included: distension in the hypochondriac region; poor appetite; and fatigue. The primary symptoms were assigned scores of 0, 2, 4, and 6 points respectively (none, mild, moderate, severe); and secondary symptoms were assigned scores of 0, 1, 2, and 3 points respectively (none, mild, moderate, severe). The total score for all items was the TCM syndrome score; a higher score indicated a more severe condition.

[0113] 3.3 Serum markers

[0114] Venous blood was collected from patients before and after treatment in a fasting state. After standing for 30 minutes, the blood was centrifuged at 4℃ and 3000 rpm for 10 minutes to separate the serum. The levels of tumor necrosis factor-α (TNF-α), 5-hydroxytryptamine (5-HT), and vasoactive intestinal peptide (VIP) in the serum were detected according to the ELISA kit instructions.

[0115] 3.4 Clinical efficacy evaluation

[0116] Based on the relevant provisions of the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines", the efficacy index is calculated as follows: [(Pre-treatment score) - (Post-treatment score) / Pre-treatment score] × 100%. The clinical efficacy is evaluated through TCM syndrome scores, and the effective rate is calculated.

[0117] Cure: Clinical symptoms and signs disappear or basically disappear, and the symptom score after treatment decreases by ≥95% compared with that before treatment;

[0118] Significant effect: Clinical symptoms and signs are significantly improved, and the symptom score after treatment decreases by ≥70% compared with that before treatment;

[0119] Effective: Clinical symptoms and signs improve, and the symptom score decreases by ≥30% after treatment compared to before treatment;

[0120] Ineffective: No improvement was observed in clinical symptoms and signs, and the symptom score decreased by <30% after treatment compared to before treatment;

[0121] Overall effective rate = (number of cured cases + number of cases with significant improvement + number of cases with improvement) / total number of cases × 100%.

[0122] 3.5 Safety Evaluation Indicators

[0123] The study aimed to observe the adverse reactions that may occur in both groups of patients during treatment, including but not limited to symptoms such as allergies, gastrointestinal dysfunction (e.g., indigestion), and nervous system reactions (e.g., dizziness).

[0124] 4. Statistical Methods

[0125] Data analysis was performed using SPSS 21.0 statistical software. Quantitative data were expressed as mean ± standard deviation and analyzed using t-tests; categorical data were expressed as percentages (%) and analyzed using... Test. P < 0.05 indicates that the difference is statistically significant.

[0126] 5 Results

[0127] 5.1 Comparison of clinical efficacy between the two groups

[0128] As shown in Table 3, the total effective rate of clinical treatment in the control group was 73.81%, while the total effective rate of clinical treatment in the observation group was 92.86%, which was significantly higher than that in the control group.

[0129] Table 3 Comparison of clinical efficacy between the two groups of patients [n(%)]

[0130]

[0131] 5.2 Comparison of IBS-SSS and TCM syndrome scores between the two groups

[0132] As shown in Table 4, there were no significant differences in IBS-SSS scores and TCM syndrome scores between the control group and the observation group before treatment (P>0.05). After treatment, both IBS-SSS scores and TCM syndrome scores decreased significantly in both the control group and the observation group (P<0.05, P<0.01), and the IBS-SSS scores and TCM syndrome scores in the observation group were significantly lower than those in the control group. This indicates that the TCM composition of the present invention can significantly improve the discomfort symptoms such as abdominal pain, diarrhea, and bitter taste in patients with irritable bowel syndrome and effectively control the severity of the condition.

[0133] Table 4 Comparison of IBS-SSS and TCM syndrome scores between the two groups of patients

[0134]

[0135] Note: Compared with the pre-treatment group, * P<0.05, ** P<0.01; compared with the control group after treatment, # P<0.05, ## P<0.01.

[0136] 5.3 Comparison of serum markers between the two groups

[0137] As shown in Table 5, there were no significant differences in serum TNF-α, 5-HT, and VIP levels between the control group and the observation group before treatment (P>0.05). After treatment, serum TNF-α, 5-HT, and VIP levels in both the control group and the observation group were significantly reduced (P<0.05), and the serum indicators in the observation group were significantly lower than those in the control group (P<0.05). This indicates that the herbal composition of the present invention can effectively improve the clinical symptoms of patients with irritable bowel syndrome by inhibiting intestinal inflammatory response, regulating the "brain-gut axis" function, and correcting intestinal motility disorders, forming a three-dimensional intervention mechanism of "anti-inflammatory-psychological regulation-motility promotion".

[0138] Table 5 Comparison of serum indicators between the two groups of patients

[0139]

[0140] Note: Compared with the pre-treatment group, * P<0.05, ** P<0.01; compared with the control group after treatment, # P<0.05, ## P<0.01.

[0141] 5.4 Safety Evaluation

[0142] No abnormalities in blood routine tests or liver and kidney function were found in either group of patients, and no adverse reactions occurred, indicating that the traditional Chinese medicine composition of the present invention has good safety.

[0143] 6 Conclusions

[0144] The traditional Chinese medicine composition of this invention can significantly improve the overall effective rate of clinical treatment for irritable bowel syndrome (IBS), effectively improve the main clinical symptoms of patients, and reduce the IBS-SSS score and TCM syndrome score. Simultaneously, the composition can effectively reduce the levels of key inflammatory factors (TNF-α), neurotransmitters (5-HT), and gastrointestinal regulatory peptides (VIP) in the serum of patients, effectively regulate brain-gut axis function, restore normal intestinal motility, and alleviate low-grade intestinal inflammation, revealing its three-dimensional intervention mechanism of "anti-inflammatory-psychological-promoting". Furthermore, no adverse reactions related to the composition were observed during treatment, demonstrating good safety and tolerability. These experimental results indicate that the traditional Chinese medicine composition of this invention exhibits significant technical effects and clinical application value in the treatment of IBS, providing a treatment option for IBS that is effective, has a clear mechanism, and is safe and reliable.

[0145] The above embodiments are only used to illustrate the technical solutions of the present invention, and are not intended to limit it. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A traditional Chinese medicine composition for irritable bowel syndrome, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 15-25 parts of Citrus aurantium, 15-25 parts of Raphanus sativus, 10-20 parts of Cannabis sativa, 10-20 parts of Prunus japonica, 8-16 parts of Melia toosendan, 3-9 parts of Eupolyphaga sinensis, 5-15 parts of Areca catechu, 5-15 parts of Bupleurum chinense, 8-16 parts of Citronella foenum-graecum, 5-15 parts of Corydalis yanhusuo (processed with vinegar), 8-16 parts of Psoralea corylifolia, 5-15 parts of Myristica fragrans (processed with roasted), 8-16 parts of Alisma plantago-aquatica, and 5-15 parts of Glycyrrhiza uralensis (processed with roasted).

2. The traditional Chinese medicine composition for irritable bowel syndrome according to claim 1, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 20 parts of Citrus aurantium, 20 parts of Raphanus sativus, 15 parts of Cannabis sativa, 15 parts of Prunus japonica, 12 parts of Melia toosendan, 6 parts of Eupolyphaga sinensis, 10 parts of Areca catechu, 10 parts of Bupleurum chinense, 12 parts of Citronella foenum-graecum, 10 parts of Corydalis yanhusuo (processed with vinegar), 12 parts of Psoralea corylifolia, 9 parts of Myristica fragrans (processed with roasted), 12 parts of Alisma plantago-aquatica, and 10 parts of Glycyrrhiza uralensis (processed with roasted).

3. A method for preparing a traditional Chinese medicine composition for irritable bowel syndrome as described in any one of claims 1 to 2, characterized in that, The preparation method of the decoction of the traditional Chinese medicine composition includes the following steps: (1) Weigh each Chinese herbal raw material according to the above weight proportions, wash, dry and grind into coarse powder, put the coarse powder of the herbs into a clay pot, add water to cover the herbs and soak for 30 minutes. (2) After soaking the medicinal materials, bring them to a boil over high heat, then simmer over low heat for 30 minutes. Filter the liquid, take the filtrate, add water to the residue and simmer for 30 minutes, filter the liquid, combine the two filtrates, and concentrate the filtrate under reduced pressure to 400 mL.

4. The use of the traditional Chinese medicine composition according to any one of claims 1 to 2 in the preparation of a medicament for the prevention and / or treatment of irritable bowel syndrome.

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