A traditional Chinese medicine composition for treating or preventing diarrhea-predominant irritable bowel syndrome and a preparation method thereof

Abstract

The application provides a traditional Chinese medicine composition for preventing or treating diarrhea type irritable bowel syndrome, a preparation method and application thereof. In the composition, the monarch drug is radix codonopsis and atractylodes, the ministerial drug is poria cocos, myristica, and portulaca oleracea, the auxiliary drug is prunus mume, radix pulsatillae, radix salviae miltiorrhizae, and radix morindae officinalis, and the complementary drug is radix glycyrrhizae. The drugs are combined to treat the root and branch of the disease, make the spleen and liver healthy, regulate the qi movement, eliminate dampness and stop diarrhea, and relieve pain. The traditional Chinese medicine composition has a remarkable effect on treating diarrhea type irritable bowel syndrome, improves the symptoms of the patient, and reduces the recurrence.

Description

Technical Field

[0001] The present invention relates to the use of a traditional Chinese medicine composition in preparing a medicament for preventing and treating diarrhea-type irritable bowel syndrome, and belongs to the field of traditional Chinese medicines. Background Art

[0002] Irritable Bowel Syndrome is a common functional intestinal disease, which is characterized by long-term repeated attacks of abdominal pain and abdominal distension accompanied by changes in fecal properties and defecation habits in the absence of gastrointestinal structural and biochemical abnormalities.

[0003] Irritable bowel syndrome includes four types, among which irritable bowel syndrome with diarrhea is the most common. Diagnostic criteria for diarrhea-type irritable bowel syndrome: repeated abdominal pain, with an average attack of at least 1 day per week in the past 3 months, accompanied by 2 or more of the following items: associated with defecation; accompanied by changes in defecation frequency; more than 25% of defecations are Bristol stool type 6 or 7, and defecations of Bristol stool type 1 or 2 account for less than 25%. Symptoms appear at least 6 months before diagnosis, and the above diagnostic criteria are met in the past 3 months.

[0004] The 2017 edition of *Consensus Opinions of Experts on Traditional Chinese Medicine Diagnosis and Treatment of Irritable Bowel Syndrome* divides diarrhea-type irritable bowel syndrome into 5 types. For liver depression and spleen deficiency syndrome: the therapeutic method is to soothe the liver and strengthen the spleen, with the main prescription being Tongxie Yaofang. For spleen deficiency and excessive dampness syndrome: the therapeutic method is to invigorate spleen, replenish qi, resolve dampness and arrest diarrhea, with the main prescription being Shenling Baizhu Powder. For spleen-kidney yang deficiency syndrome: the therapeutic method is to warm and tonify spleen and kidney, with the main prescription being Aconite Zhongli Decoction combined with Sishen Pill. For spleen-stomach dampness-heat syndrome: the therapeutic method is to clear heat and promote diuresis, with the main prescription being Gegen Qinlian Decoction. For syndrome of intermingled cold and heat: the therapeutic method is to regulate cold and heat, replenish qi and warm middle warmer, with the main prescription being Wumei Pill.

[0005] Relevant studies show that in modern medicine, treatment methods for diarrhea-type irritable bowel syndrome include drug therapy such as antibiotics, antispasmodics, probiotics, etc., and non-drug therapy such as dietary intervention, fecal microbiota transplantation, lifestyle improvement, psychotherapy, etc. The short-term curative effect is acceptable, but it has the disadvantages of easy recurrence and poor long-term curative effect. Studies in recent years have shown that traditional Chinese medicine treatment of diarrhea-type irritable bowel syndrome has unique advantages in improving clinical symptoms, improving quality of life, and reducing recurrence rate. Summary of the Invention

[0006] The present invention discloses a traditional Chinese medicine composition for preventing or treating diarrhea-type irritable bowel syndrome, as well as a preparation method and use thereof. The traditional Chinese medicine composition of the present invention has a significant therapeutic effect on treating diarrhea-type irritable bowel syndrome, with simple preparation process, high safety and low recurrence rate.

[0007] Specifically, the technical object of the present invention is achieved through the following technical solutions:

[0008] This invention provides a traditional Chinese medicine composition for the prevention or treatment of diarrhea-predominant irritable bowel syndrome. The traditional Chinese medicine composition is made from Codonopsis pilosula, Atractylodes macrocephala, Poria cocos, Myristica fragrans, Portulaca oleracea, Prunus mume, Pulsatilla chinensis, Epimedium brevicornu, Morinda officinalis, and Glycyrrhiza uralensis.

[0009] Specifically, the traditional Chinese medicine composition comprises the following raw materials in parts by weight:

[0010] Codonopsis pilosula 10-20 parts, Atractylodes macrocephala 10-20 parts, Poria cocos 10-20 parts, Myristica fragrans 10-20 parts, Portulaca oleracea 10-20 parts, Prunus mume 10-20 parts, Pulsatilla chinensis 10-20 parts, Epimedium brevicornu 5-15 parts, Morinda officinalis 5-15 parts, Glycyrrhiza uralensis 2-8 parts.

[0011] In one embodiment, the traditional Chinese medicine composition comprises the following raw materials in parts by weight:

[0012] Codonopsis pilosula 15 parts, Atractylodes macrocephala 15 parts, Poria cocos 15 parts, Myristica fragrans 15 parts, Portulaca oleracea 15 parts, Prunus mume 15 parts, Pulsatilla chinensis 15 parts, Epimedium brevicornu 10 parts, Morinda officinalis 10 parts, Glycyrrhiza uralensis 6 parts.

[0013] The preparation method of the traditional Chinese medicine composition for the prevention or treatment of diarrhea-predominant irritable bowel syndrome of the present invention is as follows: weigh the raw materials, add purified water, soak, heat to boiling and maintain a slight boil, filter to obtain the first filtrate; add the residue to purified water, heat to boiling and maintain a slight boil, filter to obtain the second filtrate;

[0014] The first and second filtrates are combined, the filtrates are concentrated, spray-dried, and the dried fine powder is sieved to obtain the traditional Chinese medicine composition of the present invention.

[0015] Furthermore, the preparation method of the traditional Chinese medicine composition for preventing or treating diarrhea-predominant irritable bowel syndrome of the present invention is as follows: weigh the above raw materials according to the ratio, add 8-12 times the weight of purified water, soak for 1.5-2.5 hours, heat to boiling and maintain a gentle boil for 0.5-1.5 hours, filter to obtain the first filtrate; add 6-10 times the weight of purified water to the residue, heat to boiling and maintain a gentle boil for 2.5-3.5 hours, filter to obtain the second filtrate;

[0016] The first and second filtrates are combined, and the filtrates are concentrated to a relative density of 1.05-1.25. The mixture is then spray-dried, and the dried fine powder is passed through an 80-100 mesh sieve to obtain the traditional Chinese medicine composition of this invention.

[0017] Furthermore, the preparation method of the traditional Chinese medicine composition for preventing or treating diarrhea-predominant irritable bowel syndrome of the present invention is as follows: weigh the above raw materials according to the ratio, add 10 times the weight of purified water, soak for 2 hours, heat to boiling and maintain a gentle boil for 1 hour, filter to obtain the first filtrate; add 8 times the weight of purified water to the residue, heat to boiling and maintain a gentle boil for 3 hours, filter to obtain the second filtrate.

[0018] The first and second filtrates were combined, and the filtrates were concentrated to a relative density of 1.15. The mixture was then spray-dried, and the dried fine powder was passed through a 100-mesh sieve to obtain the traditional Chinese medicine composition of the present invention.

[0019] Furthermore, the dosage form of the traditional Chinese medicine composition is decoction, pill, gel, tablet, mixture, capsule, granule, powder or paste, more preferably granule.

[0020] This invention provides the use of the traditional Chinese medicine composition in the preparation of drugs for the prevention or treatment of diarrhea-predominant irritable bowel syndrome.

[0021] Furthermore, the diarrhea-predominant irritable bowel syndrome is a liver-stagnation and spleen-deficiency type of diarrhea-predominant irritable bowel syndrome.

[0022] The herbal composition of this invention has all the necessary ingredients, and the combination is appropriate. The principal ingredients are Codonopsis pilosula and Atractylodes macrocephala, the assistant ingredients are Poria cocos, Myristica fragrans, and Portulaca oleracea, which treat the root cause of the disease, pain and diarrhea. The adjuvant ingredients are Prunus mume, Pulsatilla chinensis, Epimedium brevicornu, and Morinda officinalis, which treat the symptoms. The guiding ingredient is Glycyrrhiza uralensis. The combination of these herbs treats both the root cause and the symptoms, strengthens the spleen and soothes the liver, regulates the flow of Qi, removes dampness and stops diarrhea, and regulates Qi and relieves pain.

[0023] The herbal composition of this invention significantly improves the symptoms of diarrhea-predominant irritable bowel syndrome (IBS), reduces fecal water content, decreases intestinal propulsion rate, reduces SP and SS content in colonic tissue, and improves intestinal motility, thereby alleviating or improving diarrhea symptoms and achieving the goal of treating IBS-predominant diarrhea. The herbal composition of this invention has significant therapeutic effects, improves patient symptoms, and reduces recurrence.

[0024] Compared with the prior art, the present invention has the following advantages:

[0025] (1) The traditional Chinese medicine composition of the present invention improves the symptoms of diarrhea-type irritable bowel syndrome, reduces fecal water content, reduces intestinal propulsion rate, reduces the content of SP and SS in colon tissue, and improves intestinal motility.

[0026] (2) The raw materials of the traditional Chinese medicine composition of the present invention are readily available and the preparation method is simple. The obtained traditional Chinese medicine composition has a definite curative effect on the prevention and treatment of diarrhea-type irritable bowel syndrome, with no toxic side effects and is not prone to recurrence. Attached Figure Description

[0027] Figure 1 Comparison of fecal water content in rats of different groups before drug administration

[0028] Compared with the blank control group, ** P < 0.01.

[0029] Figure 2 Comparison of fecal water content in rats of different groups after drug administration

[0030] Compared with the blank control group, ## P < 0.01; compared with the model control group, * P < 0.05 ** P < 0.01; compared with Example 2 group, & P < 0.05 && P < 0.01.

[0031] Figure 3 Comparison of intestinal propulsion rate among rats in different groups after drug administration

[0032] Compared with the blank control group, ## P < 0.01; compared with the model control group, * P < 0.05 ** P < 0.01; compared with Example 2 group, & P < 0.05 && P < 0.01.

[0033] Figure 4 Comparison of SP content in colon tissue of rats in different groups after drug administration

[0034] Compared with the blank control group, ## P < 0.01; compared with the model control group, * P < 0.05 ** P < 0.01; compared with Example 2 group, & P < 0.05.

[0035] Figure 5 Comparison of SS content in colon tissue of rats in different groups after drug administration

[0036] Compared with the blank control group, ## P < 0.01; compared with the model control group, * P < 0.05 ** P < 0.01; compared with Example 2 group, & P < 0.05. Detailed Implementation

[0037] The technical solution of the present invention will be clearly and completely described below. 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.

[0038] Example 1

[0039] A traditional Chinese medicine composition for the prevention or treatment of diarrhea-predominant irritable bowel syndrome, comprising the following ingredients by weight:

[0040] Codonopsis pilosula 20 parts, Atractylodes macrocephala 20 parts, Poria cocos 20 parts, Myristica fragrans 10 parts, Portulaca oleracea 10 parts, Prunus mume 10 parts, Pulsatilla chinensis 20 parts, Epimedium brevicornu 15 parts, Morinda officinalis 5 parts, Glycyrrhiza uralensis 8 parts.

[0041] The preparation method is as follows: Weigh the above raw materials according to the ratio, add 8 times the weight of purified water, soak for 2.5 hours, heat to boiling and maintain a gentle boil for 1.5 hours, filter to obtain the first filtrate; add 6 times the weight of purified water to the residue, heat to boiling and maintain a gentle boil for 2.5 hours, filter to obtain the second filtrate;

[0042] The first and second filtrates were combined, and the filtrates were concentrated to a relative density of 1.25. The mixture was then spray-dried, and the dried fine powder was passed through a 100-mesh sieve. Pharmaceutically acceptable excipients were added through conventional processes to prepare the capsules of the traditional Chinese medicine composition of this invention.

[0043] Example 2

[0044] A traditional Chinese medicine composition for the prevention or treatment of diarrhea-predominant irritable bowel syndrome, comprising the following ingredients by weight:

[0045] Codonopsis pilosula 15 parts, Atractylodes macrocephala 15 parts, Poria cocos 15 parts, Myristica fragrans 15 parts, Portulaca oleracea 15 parts, Prunus mume 15 parts, Pulsatilla chinensis 15 parts, Epimedium brevicornu 10 parts, Morinda officinalis 10 parts, Glycyrrhiza uralensis 6 parts.

[0046] The preparation method is as follows: Weigh the above raw materials according to the ratio, add 10 times the weight of purified water, soak for 2 hours, heat to boiling and keep simmering for 1 hour, filter to obtain the first filtrate; add 8 times the weight of purified water to the residue, heat to boiling and keep simmering for 3 hours, filter to obtain the second filtrate;

[0047] The first and second filtrates were combined, and the filtrates were concentrated to a relative density of 1.15. Then, the mixture was spray-dried, and the dried fine powder was passed through a 100-mesh sieve, granulated, and dried to obtain the granules of the traditional Chinese medicine composition of the present invention.

[0048] Example 3

[0049] A traditional Chinese medicine composition for the prevention or treatment of diarrhea-predominant irritable bowel syndrome, comprising the following ingredients by weight:

[0050] Codonopsis pilosula 10 parts, Atractylodes macrocephala 10 parts, Poria cocos 10 parts, Myristica fragrans 20 parts, Portulaca oleracea 20 parts, Prunus mume 10 parts, Pulsatilla chinensis 10 parts, Epimedium brevicornu 5 parts, Morinda officinalis 15 parts, Glycyrrhiza uralensis 2 parts.

[0051] The preparation method is as follows: Weigh the above raw materials according to the ratio, add 12 times the weight of purified water, soak for 1.5 hours, heat to boiling and maintain a gentle boil for 1.5 hours, filter to obtain the first filtrate; add 10 times the weight of purified water to the residue, heat to boiling and maintain a gentle boil for 2.5 hours, filter to obtain the second filtrate;

[0052] The first and second filtrates were combined, and the filtrates were concentrated to a relative density of 1.05. The mixture was then spray-dried, and the dried fine powder was passed through an 80-mesh sieve. Pharmaceutically acceptable excipients were added through conventional processes to prepare the tablets of the traditional Chinese medicine composition of this invention.

[0053] Example 4

[0054] A traditional Chinese medicine composition for the prevention or treatment of diarrhea-predominant irritable bowel syndrome, comprising the following ingredients by weight:

[0055] Codonopsis pilosula 15 parts, Atractylodes macrocephala 15 parts, Poria cocos 10 parts, Myristica fragrans 10 parts, Portulaca oleracea 20 parts, Prunus mume 20 parts, Pulsatilla chinensis 10 parts, Epimedium brevicornu 15 parts, Morinda officinalis 10 parts, Glycyrrhiza uralensis 6 parts.

[0056] The preparation method is as follows: Weigh the above raw materials according to the ratio, add 10 times the weight of purified water, soak for 1.5 hours, heat to boiling and maintain a gentle boil for 0.5 hours, filter to obtain the first filtrate; add 8 times the weight of purified water to the residue, heat to boiling and maintain a gentle boil for 2.5 hours, filter to obtain the second filtrate;

[0057] The first and second filtrates were combined, and the filtrates were concentrated to a relative density of 1.15. The mixture was then spray-dried, and the dried fine powder was passed through an 80-mesh sieve. Pharmaceutically acceptable excipients were added through conventional processes to prepare the pills of the traditional Chinese medicine composition of this invention.

[0058] Comparative Example 1

[0059] A traditional Chinese medicine composition for the prevention or treatment of diarrhea-predominant irritable bowel syndrome, comprising the following ingredients by weight:

[0060] Ginseng 15 parts, Astragalus 15 parts, Poria 15 parts, Nutmeg 15 parts, Purslane 15 parts, Mume 15 parts, Pulsatilla chinensis 15 parts, Epimedium 10 parts, Morinda officinalis 10 parts, Licorice 6 parts.

[0061] The preparation method is as follows: Weigh the above raw materials according to the ratio, add 10 times the weight of purified water, soak for 2 hours, heat to boiling and keep simmering for 1 hour, filter to obtain the first filtrate; add 8 times the weight of purified water to the residue, heat to boiling and keep simmering for 3 hours, filter to obtain the second filtrate;

[0062] The first and second filtrates were combined, and the filtrates were concentrated to a relative density of 1.15. Then, the mixture was spray-dried, and the dried fine powder was passed through a 100-mesh sieve, granulated, and dried to obtain the traditional Chinese medicine composition granules.

[0063] Comparative Example 2

[0064] A traditional Chinese medicine composition for the prevention or treatment of diarrhea-predominant irritable bowel syndrome, comprising the following ingredients by weight:

[0065] 15 parts Poria cocos, 15 parts Myristica fragrans, 15 parts Portulaca oleracea, 15 parts Prunus mume, 15 parts Pulsatilla chinensis, 10 parts Epimedium, 10 parts Morinda officinalis, and 6 parts Glycyrrhiza uralensis.

[0066] The preparation method is as follows: Weigh the above raw materials according to the ratio, add 10 times the weight of purified water, soak for 2 hours, heat to boiling and keep simmering for 1 hour, filter to obtain the first filtrate; add 8 times the weight of purified water to the residue, heat to boiling and keep simmering for 3 hours, filter to obtain the second filtrate;

[0067] The first and second filtrates were combined, and the filtrates were concentrated to a relative density of 1.15. Then, the mixture was spray-dried, and the dried fine powder was passed through a 100-mesh sieve, granulated, and dried to obtain the traditional Chinese medicine composition granules.

[0068] Comparative Example 3

[0069] A traditional Chinese medicine composition for the prevention or treatment of diarrhea-predominant irritable bowel syndrome, comprising the following ingredients by weight:

[0070] Codonopsis pilosula 15 parts, Atractylodes macrocephala 15 parts, Cinnamomum cassia 15 parts, Evodia rutaecarpa 15 parts, Forsythia suspensa 15 parts, Prunus mume 15 parts, Pulsatilla chinensis 15 parts, Epimedium brevicornu 10 parts, Morinda officinalis 10 parts, Glycyrrhiza uralensis 6 parts.

[0071] The preparation method is as follows: Weigh the above raw materials according to the ratio, add 10 times the weight of purified water, soak for 2 hours, heat to boiling and keep simmering for 1 hour, filter to obtain the first filtrate; add 8 times the weight of purified water to the residue, heat to boiling and keep simmering for 3 hours, filter to obtain the second filtrate;

[0072] The first and second filtrates were combined, and the filtrates were concentrated to a relative density of 1.15. Then, the mixture was spray-dried, and the dried fine powder was passed through a 100-mesh sieve, granulated, and dried to obtain the traditional Chinese medicine composition granules.

[0073] Comparative Example 4

[0074] A traditional Chinese medicine composition for the prevention or treatment of diarrhea-predominant irritable bowel syndrome, comprising the following ingredients by weight:

[0075] Codonopsis pilosula 15 parts, Atractylodes macrocephala 25 parts, Poria cocos 22 parts, Myristica fragrans 25 parts, Portulaca oleracea 15 parts, Prunus mume 15 parts, Pulsatilla chinensis 8 parts, Epimedium brevicornu 20 parts, Morinda officinalis 10 parts, Glycyrrhiza uralensis 10 parts.

[0076] The preparation method is as follows: Weigh the above raw materials according to the ratio, add 10 times the weight of purified water, soak for 2 hours, heat to boiling and keep simmering for 1 hour, filter to obtain the first filtrate; add 8 times the weight of purified water to the residue, heat to boiling and keep simmering for 3 hours, filter to obtain the second filtrate;

[0077] The first and second filtrates were combined, and the filtrates were concentrated to a relative density of 1.15. Then, the mixture was spray-dried, and the dried fine powder was passed through a 100-mesh sieve, granulated, and dried to obtain the traditional Chinese medicine composition granules.

[0078] Pharmacological Example 1: Study on the treatment of irritable bowel syndrome with liver stagnation and spleen deficiency type diarrhea by the traditional Chinese medicine composition of the present invention.

[0079] 1. Establishment of a rat model of diarrhea-predominant irritable bowel syndrome

[0080] Ninety SPF-grade SD rats, weighing 180-220g, were given free access to water and food. The room temperature was maintained at 25±1℃, and the light-dark cycle was 12 hours. After one week of acclimatization, they were randomly divided into 9 groups of 10 rats each, based on their body weight: blank control group, model control group, pinaverium bromide group, Example 1 group, Example 2 group, Comparative Example 1 group, Comparative Example 2 group, Comparative Example 3 group, and Comparative Example 4 group.

[0081] Except for the blank control group, rat models of diarrhea-predominant irritable bowel syndrome (IBS-D) were established using a combination of senna leaf gavage and restraint stimulation in the model control group, pinaverium bromide group, Example 1 group, Example 2 group, Comparative Example 1 group, Comparative Example 2 group, Comparative Example 3 group, and Comparative Example 4 group. The specific procedures were as follows: 20 mL / kg of senna leaf decoction was administered by gavage twice daily. One hour after administration, the rats' forelimbs were restrained with soft hair ties, and their chests and shoulders were wrapped with transparent tape to restrict scratching of their heads and faces with their forelimbs, but not to restrict their movement. This restraint was maintained for one hour, and the model was maintained for 14 consecutive days. The blank control group was administered only 20 mL / kg of physiological saline by gavage daily, without any restraint stimulation.

[0082] On day 15 of modeling, medication was administered. Except for the blank control group, all other groups continued to be administered 20 mL / kg of senna leaf decoction by gavage, followed by oral administration 1 hour later. The medication administration for each group was as follows:

[0083] The pinaverium bromide group was given 0.0125 g / kg pinaverium bromide by gavage daily.

[0084] In Example 1 group, 0.6 g / kg of the composition of Example 1 was administered by gavage daily.

[0085] In Example 2 group, 0.6 g / kg of the Composition of Example 2 was administered by gavage daily.

[0086] Comparative Example 1 group was given 0.6 g / kg of the Comparative Example 1 composition by gavage daily.

[0087] Comparative Example 2 group was given 0.6 g / kg of the Comparative Example 2 composition by gavage daily.

[0088] Comparative Example 3 groups were administered 0.6 g / kg of the Comparative Example 3 composition by gavage daily.

[0089] Comparative Example 4 groups were administered 0.6 g / kg of the Comparative Example 4 composition by gavage daily.

[0090] Rats in the blank control group and the model control group were administered an equal volume of physiological saline by gavage at a dose of 10 mL / kg.

[0091] One hour after administration, bind the affected area for one hour as described above, once daily. Continue administration for 14 days.

[0092] 2. Model Observation and Indicator Testing

[0093] 2.1 General State

[0094] Observe the mental state, activity, and defecation of rats after modeling and before and after drug administration.

[0095] 2.2 Fecal moisture content. Feces were collected from rats in each group before and 14 days after drug administration. The wet weight of the feces within 1 hour of defecation was measured as W1. The feces were then placed in a drying oven and dried until the weight of the feces no longer changed. The dry weight of the feces was measured as W2. Fecal moisture content = (W1 - W2) / W1 × 100%.

[0096] 2.3 Intestinal propulsion rate. One day before the end of drug administration, rats in each group were fasted for 24 hours but allowed free water. Drug administration was not stopped. The next day, 0.4 mL of 2% DB-2000 was administered by gavage as a gastrointestinal marker. After 20 minutes, the rats were euthanized by dislocation and the abdomen was immediately dissected. The distances from the pylorus to the anterior end of the pigmented area and from the pylorus to the end of the rectum were measured. The percentage of the ratio of the two distances was the intestinal propulsion rate (%).

[0097] 2.4 Content of SP and SS in colonic tissue. After blood collection, 1 cm of colonic tissue was taken from 5 cm away from the rat's anus. The tissue was blotted with moistened filter paper, weighed, and placed in a tissue homogenizer. 1 mL of 1 mol / L glacial acetic acid was added, and the mixture was boiled for 5 min, homogenized, and then neutralized with 1 mL of 1 mol / L NaOH. The mixture was centrifuged at 3000 r / min for 10 min and stored at -70℃ until analysis. Enzyme-linked immunosorbent assay (ELISA) was used for detection.

[0098] 3. Statistical Methods

[0099] Data processing was performed using SPSS 22.0 software, and the obtained data are expressed as mean ± standard deviation. This indicates that normality and homogeneity of variance tests were performed on each group of data, and one-way ANOVA was used for comparisons between groups. A p-value < 0.05 was considered statistically significant.

[0100] 4. Experimental Results

[0101] 4.1 General State

[0102] Before modeling, the rats in all groups were in good spirits, active, with smooth and glossy fur, and soft, granular stools. After modeling, the rats exhibited lethargy, irritability, aggression, rough and disheveled fur, loss of luster, reduced food intake, and loose stools around the anus. After drug administration, the rats' spirits improved, their mood stabilized, their activity increased, their fur became smoother, their weight increased, their stools became formed, and their anal area was cleaner than the control group.

[0103] 4.2 Comparison of fecal moisture content

[0104] Compared with the blank control group, the fecal water content of rats in the model control group was significantly increased before drug administration. After drug administration, the fecal water content of the pinaverium bromide group, as well as groups 1 and 2 of Example 1, was significantly decreased compared with the model control group. Compared with group 2 of Example 1, comparative group 2, comparative group 3, and comparative group 4 had higher fecal water content. See Figure 1 , Figure 2 .

[0105] 4.3 Comparison of intestinal propulsion rates

[0106] Compared with the blank control group, the intestinal propulsion rate of rats in the model control group was significantly increased before drug administration. After drug administration, compared with the model control group, the intestinal propulsion rate of the pinaverium bromide group, as well as groups 1 and 2 of Example, was significantly decreased. Compared with group 2 of Example, groups 1, 2, 3, and 4 of Comparative Example had higher intestinal propulsion rates. See Figure 3 .

[0107] 4.4 Comparison of SP and SS content in colon tissue

[0108] Compared with the blank control group, the SP content in the colonic tissue of rats in the model control group was significantly increased before drug administration. After drug administration, compared with the model control group, the SP content in the colonic tissue of the pinaverium bromide group, as well as the groups in Example 1 and Example 2, was significantly decreased. Compared with the Example 2 group, the SP content in the colonic tissue of Comparative Example 1, Comparative Example 2, Comparative Example 3, and Comparative Example 4 groups was higher. See Figure 4 .

[0109] Compared with the blank control group, the SS content in the colonic tissue of rats in the model control group was significantly increased before drug administration. After drug administration, compared with the model control group, the SS content in the colonic tissue of the pinaverium bromide group, as well as the groups in Example 1 and Example 2, was significantly decreased. Compared with the Example 2 group, the SS content in the colonic tissue of Comparative Example 1, Comparative Example 2, Comparative Example 3, and Comparative Example 4 groups was higher. See Figure 5 .

[0110] The herbal composition of this invention significantly improves the general condition of rats with diarrhea-predominant irritable bowel syndrome, reduces fecal water content, reduces intestinal propulsion rate, reduces SP and SS content in colon tissue, improves intestinal motility, and alleviates or improves diarrhea symptoms, thereby achieving the purpose of treating diarrhea-predominant irritable bowel syndrome.

[0111] Clinical observation of the efficacy of the herbal composition of this invention on diarrhea-predominant irritable bowel syndrome.

[0112] I. Materials and Methods

[0113] 1. Clinical Data

[0114] Eighty patients with diarrhea-predominant irritable bowel syndrome (IBS) who visited the outpatient clinic were randomly divided into two groups: the herbal composition group of this invention and the control group, with 40 patients in each group. In the herbal composition group, there were 17 males and 23 females, with an average age of 45.0 ± 10.8 years and a disease duration of 3.1 ± 1.1 years. In the control group, there were 18 males and 22 females, with an average age of 42.0 ± 9.4 years and a disease duration of 2.6 ± 0.91 years. There were no statistically significant differences in gender, age, or disease duration between the two groups.

[0115] 2. Traditional Chinese Medicine Symptom Standards

[0116] Based on the diarrhea classification in the 2018 Consensus Opinion on the Diagnosis and Treatment of Irritable Bowel Syndrome with Integrated Traditional Chinese and Western Medicine and the symptom criteria for diarrhea in the 2002 Guidelines for Clinical Research of New Traditional Chinese Medicines, the syndrome is diagnosed as Liver-Spleen Disharmony.

[0117] Main symptoms: ① Loose stools, abdominal pain, relieved after defecation; ② Triggered by emotional changes or eating; ③ Abdominal distension and borborygmus. Secondary symptoms: ① Poor appetite and fatigue; ② Chest and rib distension; ③ Frequent sighing; ④ Depression or irritability; ⑤ Wiry and thready pulse or wiry pulse.

[0118] Requirements: Must have 1 primary symptom plus 3 secondary symptoms, or 2 primary symptoms plus 2 secondary symptoms.

[0119] 3. Inclusion criteria

[0120] Patients must meet the diagnostic criteria for diarrhea-predominant irritable bowel syndrome in Western medicine and be classified as having liver-spleen disharmony syndrome according to the above-mentioned TCM syndrome differentiation; be aged 21-60 years; have a disease duration of ≥6 months; and have provided informed consent and signed their consent.

[0121] 4. Exclusion Criteria

[0122] Individuals with inflammatory bowel disease, intestinal tuberculosis, or intestinal tumors; those with other clearly identifiable causes of diarrhea, including radiation-induced, infectious, or drug-induced diarrhea; those with severe organic diseases, systemic diseases, or who are breastfeeding; those with mental illnesses; those allergic to drugs, with local skin damage, or who cannot accept the experimental methods; and those with poor compliance.

[0123] 5. Treatment methods

[0124] The herbal composition of this invention is administered orally at a dose of 100 mg / kg, as described in Example 3, once daily.

[0125] The control group received 100 mg / kg of the herbal composition from Comparative Example 4 orally, once a day.

[0126] 6. Indicator Observation

[0127] Record the patient's main symptoms (diarrhea, abdominal pain, abdominal distension, borborygmus). Refer to the grading and quantification standards for diarrhea in the 2002 "Guiding Principles for Clinical Research of New Traditional Chinese Medicines". The main symptoms are scored as 0, 2, 4, and 6 points respectively according to their presence and severity, and the secondary symptoms are scored as 0, 1, 2, and 3 points respectively.

[0128] The efficacy index was calculated using the nimodipine method: (Total score before treatment - Total score after treatment) / Total score before treatment × 100%. Clinical cure: Patients had no abdominal pain, diarrhea, or other symptoms, with an efficacy index ≥ 95%; Marked improvement: Patients' abdominal pain, diarrhea, or other symptoms significantly improved, with an efficacy index between 70% and < 95%; Effective: Patients' abdominal pain, diarrhea, or other symptoms improved to some extent, with an efficacy index between 30% and < 70%; Ineffective: Patients' abdominal pain, diarrhea, or other symptoms showed no significant improvement, or even worsened, with an efficacy index < 30%. The marked improvement rate was calculated based on the total number of clinically cured and markedly effective cases, and the total effective rate was calculated based on the total number of clinically cured, markedly effective, and effective cases.

[0129] Blood, urine, and stool routine tests, as well as liver and kidney function tests, were performed on patients before enrollment and again after treatment. All adverse reactions occurring in both groups during the treatment process were observed and recorded.

[0130] Patients who achieved clinical cure and significant improvement after treatment in both groups were followed up for six months to observe and record recurrence.

[0131] 7. Statistical Methods

[0132] Data processing was performed using SPSS 22.0 software, and the obtained data are expressed as mean ± standard deviation. This indicates that normality and homogeneity of variance tests were performed on each group of data, and one-way ANOVA was used for comparisons between groups. A p-value < 0.05 was considered statistically significant.

[0133] II. Results

[0134] 1. Comparison of clinical efficacy

[0135] The efficacy and total efficacy of the herbal composition of this invention are superior to those of the control group, as shown in Table 1.

[0136] Table 1 Comparison of clinical efficacy between the two groups

[0137]

[0138] 2. Comparison of recurrence rates

[0139] Table 2 Comparison of recurrence rates between the two groups

[0140]

[0141] As shown in Table 2, the recurrence rate of the herbal composition group of the present invention was lower than that of the control group.

[0142] 3. Adverse Reactions

[0143] No abnormalities in blood routine tests or liver and kidney function were found in either group of patients, and no adverse reactions occurred.

[0144] The above embodiments are merely illustrative examples for clear explanation and are not intended to limit the implementation. Those skilled in the art will recognize that other variations or modifications can be made based on the above description, and any obvious variations or modifications derived therefrom are still within the scope of protection of this invention.

Claims

1. A traditional Chinese medicine composition for preventing or treating diarrhea-predominant irritable bowel syndrome, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: Codonopsis pilosula 10-20 parts, Atractylodes macrocephala 10-20 parts, Poria cocos 10-20 parts, Myristica fragrans 10-20 parts, Portulaca oleracea 10-20 parts, Prunus mume 10-20 parts, Pulsatilla chinensis 10-20 parts, Epimedium brevicornu 5-15 parts, Morinda officinalis 5-15 parts, and Glycyrrhiza uralensis 2-8 parts.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 15 parts Codonopsis pilosula, 15 parts Atractylodes macrocephala, 15 parts Poria cocos, 15 parts Myristica fragrans, 15 parts Portulaca oleracea, 15 parts Prunus mume, 15 parts Pulsatilla chinensis, 10 parts Epimedium, 10 parts Morinda officinalis, and 6 parts Glycyrrhiza uralensis.

3. The traditional Chinese medicine composition according to any one of claims 1 or 2, characterized in that, The preparation method of the traditional Chinese medicine composition is as follows: weigh the raw materials, add purified water, soak, heat to boiling and maintain a slight boil, filter to obtain the first filtrate; add the residue to purified water, heat to boiling and maintain a slight boil, filter to obtain the second filtrate; combine the first filtrate and the second filtrate, concentrate the filtrate, spray dry, and sieve the dried fine powder to obtain the traditional Chinese medicine composition of the present invention.

4. The traditional Chinese medicine composition according to any one of claims 1 or 2, characterized in that, The preparation method of the traditional Chinese medicine composition is as follows: Weigh the above raw materials according to the ratio, add 8-12 times the weight of purified water, soak for 1.5-2.5 hours, heat to boiling and maintain a gentle boil for 0.5-1.5 hours, filter to obtain the first filtrate; add 6-10 times the weight of purified water to the residue, heat to boiling and maintain a gentle boil for 2.5-3.5 hours, filter to obtain the second filtrate; combine the first and second filtrates, concentrate the filtrate to a relative density of 1.05-1.25, spray dry, and pass the dried fine powder through an 80-100 mesh sieve to obtain the traditional Chinese medicine composition.

5. The traditional Chinese medicine composition of any one of claims 1 or 2, characterized in that, The preparation method of the traditional Chinese medicine composition is as follows: Weigh the above raw materials according to the ratio, add 10 times the weight of purified water, soak for 2 hours, heat to boiling and maintain a gentle boil for 1 hour, filter to obtain the first filtrate; add 8 times the weight of purified water to the residue, heat to boiling and maintain a gentle boil for 3 hours, filter to obtain the second filtrate; combine the first filtrate and the second filtrate, concentrate the filtrate to a relative density of 1.15, spray dry, and pass the dried fine powder through a 100-mesh sieve to obtain the traditional Chinese medicine composition.

6. The traditional Chinese medicine composition of any one of claims 1 or 2, characterized in that, The dosage form of the traditional Chinese medicine composition is decoction, pill, gel, tablet, mixture, capsule, granule, powder or paste.

7. The traditional Chinese medicine composition according to claim 6, characterized in that, The dosage form of the traditional Chinese medicine composition is granules.

8. Use of the traditional Chinese medicine composition according to any one of claims 1 or 2 in the preparation of a medicament for the prevention or treatment of diarrhea-predominant irritable bowel syndrome.

9. Use according to claim 8, characterized in that, The diarrhea-predominant irritable bowel syndrome is a type of diarrhea-predominant irritable bowel syndrome characterized by liver stagnation and spleen deficiency.

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