Compound traditional Chinese medicine preparation for treating inflammatory bowel disease as well as preparation method and application of compound traditional Chinese medicine preparation

Abstract

The invention provides a compound traditional Chinese medicine preparation for treating inflammatory bowel disease as well as a preparation method and application thereof. The compound traditional Chinese medicine preparation consists of the following traditional Chinese medicine raw materials in parts by weight: 15-25 parts of American ginseng, 10-20 parts of fenugreek, 5-15 parts of schisandra chinensis, 5-15 parts of dandelion, 5-15 parts of white paeony root, 5-10 parts of ginkgo, 5-10 parts of liquorice and 5-10 parts of aloe. In-vivo and in-vitro tests show that the compound traditional Chinese medicine preparation provided by the invention is scientific and reasonable in proportioning and relatively low in toxicity, has the effects of warming and clearing, tonifying qi and nourishing yin, repairing intestinal mucosa, improving intestinal immunity and the like, can regulate and control key inflammatory immune targets, and is expected to treat inflammatory bowel diseases in a form of treating both symptoms and root causes.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of traditional Chinese medicine, and particularly relates to a compound traditional Chinese medicine preparation for treating inflammatory bowel disease and a preparation method and application thereof. BACKGROUND

[0002] The cases of inflammatory bowel disease (IBD) are increasing year by year worldwide, and the main symptoms are hematochezia, chronic diarrhea, abdominal pain, weight loss, etc. Patients are mostly children and young adults, and severe cases can cause disability or death. Inflammatory bowel disease refers to various intestinal inflammatory diseases, mainly including ulcerative colitis and Crohn's disease, etc. The pathogenesis of inflammatory bowel disease is not clear, and it is usually considered to be an inflammatory immune system disease of the intestinal tract. Amino salicylic acid preparations such as 5-aminosalicylic acid (5-ASA) can be used for the treatment of inflammatory bowel disease, but such drugs only have certain effect on mild and moderate patients, and often have no effect on severe patients and are prone to drug resistance. In addition, immunosuppressants are also selected in clinic to inhibit the immune response to the body. Unfortunately, these treatment programs often have limited effect on the relief of inflammatory bowel disease, and can produce obvious toxic and side effects, including liver toxicity and bone marrow suppression toxicity, etc. Therefore, it is of great significance to find safer and more effective drugs for inflammatory bowel disease.

[0003] The pathological mechanism of inflammatory bowel disease involves intestinal immune imbalance and persistent inflammation of the mucosa caused by the interaction of multiple factors, and the core mechanism of the disease involves abnormal elevation of intestinal pro-inflammatory factors and overactivation of the JAK / STAT3 inflammatory immune signaling pathway. Studies have shown that the activation of the JAK / STAT3 inflammatory immune signaling pathway (elevation of JAK2 phosphorylation level) can drive Th17 cell differentiation and promote IL-17 release, leading to intestinal epithelial barrier damage and persistent inflammation.

[0004] Traditional Chinese medicine has shown unique advantages in the treatment of inflammatory bowel disease, especially when the western medicine has insufficient effect or obvious side effects, it can provide complementary or alternative solutions. The core advantage mainly lies in the overall regulation of multiple targets of patients, which can achieve overall conditioning of patients, treating both symptoms and root causes, and has low side effects, can effectively reduce recurrence and stabilize the disease. Especially for patients with poor response to western medicine, hormone dependence or postoperative recovery, traditional Chinese medicine can provide a better solution.

[0005] Although there are some compound traditional Chinese medicine prescriptions for preventing or treating inflammatory bowel disease in the clinic at present, most of these prescriptions are determined by traditional Chinese medicine doctors according to experience, without the support of contemporary biology mechanism and the test of pharmacodynamic model, and thus often result in poor curative effect and other problems. In addition, the compound traditional Chinese medicine prescriptions designed by experience often have large side effects, such as stimulation to the gastrointestinal tract, and in addition, the medication compliance of patients is poor, so that patients are difficult to adhere to long-term use.

[0006] The present inventors found a compound traditional Chinese medicine preparation in the research of inflammatory bowel disease in combination with contemporary biology and knowledge graph technology, which has small dosage and scientific and reasonable proportion, and can effectively treat inflammatory bowel disease. In addition, the compound traditional Chinese medicine preparation can regulate the intestinal inflammatory immune function of patients and enhance the intestinal barrier. In addition, the compound traditional Chinese medicine preparation has very low side effects and good compliance, and is expected to provide an efficient and low-toxicity treatment method for the clinical treatment of patients with inflammatory bowel disease. SUMMARY

[0007] The purpose of the present application is to solve the problems of the prior art, and to provide a compound traditional Chinese medicine preparation for treating inflammatory bowel disease, and to provide a preparation method of the compound traditional Chinese medicine preparation and the application of the compound traditional Chinese medicine preparation in the preparation of a medicine for treating inflammatory bowel disease.

[0008] Specifically, the present application is realized through the following technical solutions: In a first aspect, the present application provides a compound traditional Chinese medicine preparation for treating inflammatory bowel disease, wherein the effective components of the compound traditional Chinese medicine preparation are made of extracts of traditional Chinese medicine raw materials in the following weight proportions: American ginseng 15-30 parts, fenugreek 10-20 parts, Schisandra 5-15 parts, dandelion 5-15 parts, white peony root 5-15 parts, white ginkgo 5-10 parts, licorice 5-10 parts, and aloe 5-10 parts.

[0009] As an optional mode, in the compound traditional Chinese medicine preparation for treating inflammatory bowel disease, the effective components of the compound traditional Chinese medicine preparation are made of extracts of traditional Chinese medicine raw materials in the following weight proportions: American ginseng 20-25 parts, fenugreek 12-18 parts, Schisandra 8-12 parts, dandelion 8-12 parts, white peony root 8-12 parts, white ginkgo 6-9 parts, licorice 6-9 parts, and aloe 6-9 parts.

[0010] As an optional mode, in the compound traditional Chinese medicine preparation for treating inflammatory bowel disease, the effective components of the compound traditional Chinese medicine preparation are made of extracts of traditional Chinese medicine raw materials in the following weight proportions: American ginseng 25 parts, fenugreek 15 parts, Schisandra 10 parts, dandelion 10 parts, white peony root 10 parts, white ginkgo 8 parts, licorice 8 parts, and aloe 8 parts.

[0011] As an optional mode, in the compound traditional Chinese medicine preparation for treating inflammatory bowel disease, the compound traditional Chinese medicine preparation further comprises a pharmaceutically acceptable carrier and / or excipient.

[0012] As an optional mode, in the compound traditional Chinese medicine preparation for treating inflammatory bowel disease, the pharmaceutically acceptable carrier and / or excipient is selected from one or more of liposome, microcrystalline cellulose, sodium carboxymethyl starch, sodium carboxymethyl cellulose, polyethylene glycol, polyvinyl alcohol, acrylate polymer, glycerol, propylene glycol, sorbitol, beta-cyclodextrin, Tween-80, lactose, starch, Eudragit S-100, Eudragit L-100, sodium alginate, pectin, dextrin.

[0013] As an optional mode, in the compound traditional Chinese medicine preparation for treating inflammatory bowel disease, the dosage form of the compound traditional Chinese medicine preparation is granules, capsules, oral liquid, tablets, pills, ointments, decoction, injection or microcapsules.

[0014] In the second aspect, the application further provides a preparation method of the compound traditional Chinese medicine preparation for treating inflammatory bowel disease in the first aspect, and the preparation method comprises the following steps: A: the prescription traditional Chinese medicine is decocted with 5-10 times of water, filtered, and the filtrate is concentrated to obtain a first filtrate; B: the residue is added with 5-10 times of water for secondary decoction, filtered to obtain a second filtrate; C: the first filtrate and the second filtrate are combined, filtered naturally by using a stainless steel mesh, then eluted by using a macroporous adsorption resin column, and then concentrated under reduced pressure to obtain a concentrated solution, which is the extract of the traditional Chinese medicine raw material.

[0015] As an optional mode, in the preparation method, a D1300 type macroporous resin column is used for elution, and 70% ethanol solution is used as an eluent for elution.

[0016] In the third aspect, the application provides an application of the compound traditional Chinese medicine preparation in the first aspect or prepared by the preparation method in the second aspect in preparing a medicine for treating inflammatory bowel disease.

[0017] As an optional mode, in the application, the inflammatory bowel disease is ulcerative colitis or Crohn's disease.

[0018] In the compound traditional Chinese medicine preparation for treating inflammatory bowel disease provided by the application: American ginseng is sweet and bitter and cold, and returns to heart, lung and kidney channels. It has the effects of tonifying qi and nourishing yin and repairing immunity, can consolidate the foundation and nourish qi, and has the effect of reducing intestinal mucosa damage.

[0019] Fenugreek, bitter and warm in nature, enters the kidney meridian. It has the effect of warming the kidney and moistening the intestines, relieving intestinal stress symptoms, and enhancing intestinal barrier function.

[0020] Schisandra chinensis is warm in nature, sour and sweet in taste, and enters the lung, kidney, and heart meridians. It has the effects of astringing and consolidating, replenishing qi and promoting body fluid production, and regulating intestinal immunity.

[0021] Dandelion is bitter and cold in nature, slightly sweet in taste, and enters the liver and stomach meridians. It has the effect of clearing heat and detoxifying. It can inhibit the progression of ulcers and relieve rectal bleeding.

[0022] White peony root is slightly cold in nature, bitter and sour in taste, and enters the liver and spleen meridians. It has the effects of nourishing blood and astringing yin, and repairing the intestinal epithelial barrier.

[0023] Ginkgo nuts are astringent and neutral in nature, sweet and bitter in taste, and enter the lung and kidney meridians. They have the effects of astringing and stopping diarrhea, and repairing the intestinal mucosa.

[0024] Licorice is neutral in nature and sweet in taste, and it enters the heart, lung, spleen, and stomach meridians. It has the effects of tonifying the spleen and replenishing qi, clearing heat and detoxifying, harmonizing various medicines, and restoring immune homeostasis.

[0025] Aloe vera is bitter and cold in nature, sweet and pungent in taste, and enters the liver and intestines meridians. It has the effects of clearing heat and relieving constipation, and promoting the excretion of toxins.

[0026] The above-mentioned herbs are combined according to the "principal, assistant, adjuvant, and guide" theory of traditional Chinese medicine, rationally configured and mutually compatible. American ginseng and fenugreek replenish qi and nourish yin, repair immunity, and enhance the intestinal barrier, serving as the principal herbs; dandelion and schisandra clear damp-heat, inhibit ulcers, and regulate intestinal immunity, serving as the assistant herbs; white peony root, ginkgo, and aloe vera nourish blood, astringe yin, and repair the intestinal mucosa, serving as the adjuvant herbs; licorice clears heat and detoxifies, harmonizing the other herbs, serving as the guide herb. The eight herbs work together to achieve a synergistic effect of warming and clearing, replenishing qi and nourishing yin, repairing the intestinal barrier, and enhancing intestinal immunity.

[0027] The compound traditional Chinese medicine preparation for treating inflammatory bowel disease provided by this invention has the following advantages compared with the prior art: 1. Based on traditional Chinese medicine theory and combined with the latest research results on inflammatory bowel disease, this invention adopts the principle of dialectical treatment and systemic regulation, and uses knowledge graph technology to screen Chinese medicine prescriptions. The compound Chinese medicine preparation provided can regulate intestinal inflammation and immune function, and has a good therapeutic effect on inflammatory bowel disease.

[0028] 2. Experimental results show that the compound traditional Chinese medicine preparation for treating inflammatory bowel disease provided by this invention has the effects of both warming and clearing, replenishing qi and nourishing yin, repairing intestinal mucosa, and enhancing intestinal immunity. Simultaneously, it can downregulate phosphorylated JAK2 protein, thereby regulating the patient's inflammatory immune system, exerting a multi-target systemic therapeutic effect on inflammatory bowel disease, and reducing patient suffering. The compound traditional Chinese medicine preparation for treating inflammatory bowel disease provided by this invention has high safety and very low toxicity and side effects.

[0029] 3. The compound traditional Chinese medicine preparation for treating inflammatory bowel disease provided by this invention can be prepared into various dosage forms using pharmaceutical carriers / excipients, making it convenient for patients to take. Furthermore, the compound traditional Chinese medicine preparation for treating inflammatory bowel disease provided by this invention has a scientifically sound drug combination ratio, requires a small dosage, can exert its efficacy quickly, and has a stable preparation process, making it suitable for large-scale industrial production. Attached Figure Description

[0030] Figure 1 These are photographs taken of the anal (fecal) bleeding state of the experimental animals in Example 1 of this invention.

[0031] Figure 2 These are statistical data on the fecal length of the experimental animals in Example 1 of this invention.

[0032] Figure 3 This is statistical data on the DAI score (Disease Activity Index) of the animal in Example 1 of the present invention.

[0033] Figure 4 These are the H&E section data of the colonic villi of the animal in Example 1 of this invention. Detailed Implementation

[0034] Example 1 A compound traditional Chinese medicine preparation for treating inflammatory bowel disease. The effective components of the compound traditional Chinese medicine preparation are made from extracts of the following traditional Chinese medicine raw materials: 25g American ginseng, 15g fenugreek, 10g schisandra, 10g dandelion, 10g white peony root, 8g ginkgo, 8g licorice, and 8g aloe.

[0035] The preparation method of the compound traditional Chinese medicine preparation includes the following steps: American ginseng, fenugreek, schisandra, dandelion, white peony root, ginkgo, licorice, and aloe vera are ground into fine powder and decocted in 470 mL of distilled water. After the first decoction for 2 hours, the mixture is filtered to obtain a primary filtrate. The residue is then decocted in 470 mL of distilled water for 1.5 hours and filtered again to obtain a secondary filtrate. The primary and secondary filtrates are combined and naturally filtered through a 120-mesh stainless steel mesh. Subsequently, the mixture is eluted using a D1300 macroporous adsorption resin column with 70% ethanol solution as the eluent, and then concentrated under reduced pressure to obtain 100 mL of concentrated solution.

[0036] Example 2 A compound traditional Chinese medicine preparation for treating inflammatory bowel disease. The active ingredients of the compound traditional Chinese medicine preparation are made from extracts of the following traditional Chinese medicine raw materials: American ginseng 10g, fenugreek 10g, schisandra chinensis 10g, dandelion 10g, white peony root 10g, ginkgo 10g, licorice root 10g, and aloe vera 10g.

[0037] The preparation method of the compound traditional Chinese medicine preparation is the same as in Example 1.

[0038] Example 3 A compound traditional Chinese medicine preparation for treating inflammatory bowel disease. The effective components of the compound traditional Chinese medicine preparation are made from extracts of the following traditional Chinese medicine raw materials: 20g American ginseng, 20g fenugreek, 20g Schisandra chinensis, 20g dandelion, 20g white peony root, 20g ginkgo, 20g licorice, and 20g aloe vera.

[0039] The preparation method of the compound traditional Chinese medicine composition is the same as in Example 1.

[0040] Comparative Example 1 A compound traditional Chinese medicine preparation. The effective components of the compound traditional Chinese medicine preparation are made from extracts of the following traditional Chinese medicine raw materials: 25g Ganoderma lucidum, 15g Astragalus membranaceus, 10g Pueraria lobata, 10g Taraxacum mongolicum, 10g Paeonia lactiflora, 8g Ginkgo biloba, 8g Glycyrrhiza uralensis, and 8g Aloe vera.

[0041] The preparation method of the compound traditional Chinese medicine preparation includes the following steps: Ganoderma lucidum, Astragalus membranaceus, Pueraria lobata, Taraxacum mongolicum, Paeonia lactiflora, Ginkgo biloba, Glycyrrhiza uralensis, and Aloe vera are ground into fine powder and decocted in 470 mL of distilled water. After the first decoction for 2 hours, the mixture is filtered to obtain a primary filtrate. The residue is then decocted in 470 mL of distilled water for 1.5 hours and filtered again to obtain a secondary filtrate. The primary and secondary filtrates are combined and naturally filtered through a 120-mesh stainless steel mesh. Subsequently, the mixture is eluted using a D1300 macroporous adsorption resin column with 70% ethanol solution as the eluent, and then concentrated under reduced pressure to obtain 100 mL of concentrated solution.

[0042] Comparative Example 2 A compound traditional Chinese medicine preparation. The effective components of the compound traditional Chinese medicine preparation are made from extracts of the following traditional Chinese medicine raw materials: 25g of American ginseng, 15g of fenugreek, 10g of schisandra, 10g of ophiopogon japonicus, 10g of red peony root, 8g of mulberry, 8g of licorice, and 8g of aloe vera.

[0043] The preparation method of the compound traditional Chinese medicine preparation includes the following steps: American ginseng, fenugreek, schisandra, ophiopogon japonicus, red peony root, mulberry, licorice, and aloe vera are ground into fine powder and decocted in 470 mL of distilled water. After the first decoction for 2 hours, the mixture is filtered to obtain a primary filtrate. The residue is then decocted in 470 mL of distilled water for 1.5 hours and filtered again to obtain a secondary filtrate. The primary and secondary filtrates are combined and naturally filtered through a 120-mesh stainless steel mesh. Subsequently, the mixture is eluted using a D1300 macroporous adsorption resin column with 70% ethanol solution as the eluent, and then concentrated under reduced pressure to obtain 100 mL of concentrated solution.

[0044] Comparative Example 3 A compound traditional Chinese medicine preparation. The effective components of the compound traditional Chinese medicine preparation are made from extracts of the following traditional Chinese medicine raw materials: 25g fenugreek, 15g schisandra, 10g dandelion, 10g white peony root, 8g ginkgo, 8g licorice, and 8g aloe.

[0045] The preparation method of the compound traditional Chinese medicine preparation includes the following steps: Fenugreek, Schisandra chinensis, Taraxacum mongolicum, Paeonia lactiflora, Ginkgo biloba, Glycyrrhiza uralensis, and Aloe vera are ground into fine powder and decocted in 470 mL of distilled water. After the first decoction for 2 hours, the mixture is filtered to obtain a primary filtrate. The residue is then decocted in 470 mL of distilled water for 1.5 hours and filtered again to obtain a secondary filtrate. The primary and secondary filtrates are combined and naturally filtered through a 120-mesh stainless steel mesh. Subsequently, the mixture is eluted using a D1300 macroporous adsorption resin column with 70% ethanol solution as the eluent, and then concentrated under reduced pressure to obtain 100 mL of concentrated solution.

[0046] Comparative Example 4 A compound traditional Chinese medicine preparation. The effective components of the compound traditional Chinese medicine preparation are made from extracts of the following traditional Chinese medicine raw materials: American ginseng 35g, fenugreek 23g, schisandra chinensis 18g, and dandelion 18g.

[0047] The preparation method of the compound traditional Chinese medicine preparation includes the following steps: American ginseng, fenugreek, schisandra, dandelion, white peony root, ginkgo, licorice, and aloe vera are ground into fine powder and decocted in 470 mL of distilled water. After the first decoction for 2 hours, the mixture is filtered to obtain a primary filtrate. The residue is then decocted in 470 mL of distilled water for 1.5 hours and filtered again to obtain a secondary filtrate. The primary and secondary filtrates are combined and naturally filtered through a 120-mesh stainless steel mesh. Subsequently, the mixture is eluted using a D1300 macroporous adsorption resin column with 70% ethanol solution as the eluent, and then concentrated under reduced pressure to obtain 100 mL of concentrated solution.

[0048] Comparative Example 5 A compound traditional Chinese medicine preparation. The effective components of the compound traditional Chinese medicine preparation are made from extracts of the following traditional Chinese medicine raw materials: 35 grams of American ginseng, 25 grams of fenugreek, 18 grams of licorice, and 16 grams of aloe vera.

[0049] The preparation method of the compound traditional Chinese medicine preparation includes the following steps: American ginseng, fenugreek, licorice, and aloe vera are pulverized into fine powder, and 470 mL of distilled water is added for decoction. After the first decoction for 2 hours, the mixture is filtered to obtain a first filtrate. The residue is then added to 470 mL of distilled water and decocted for 1.5 hours, followed by filtration to obtain a second filtrate. The first and second filtrates are combined and naturally filtered through a 120-mesh stainless steel mesh. Subsequently, the mixture is eluted using a D1300 macroporous adsorption resin column with 70% ethanol solution as the eluent, and then concentrated under reduced pressure to obtain 100 mL of concentrated solution.

[0050] Comparative Example 6 A compound traditional Chinese medicine preparation. The effective components of the compound traditional Chinese medicine preparation are made from extracts of the following traditional Chinese medicine raw materials: 35 grams of American ginseng, 25 grams of fenugreek, and 34 grams of dandelion.

[0051] The preparation method of the compound traditional Chinese medicine preparation includes the following steps: American ginseng, fenugreek, and dandelion are ground into fine powder and decocted in 470 mL of distilled water. After the first decoction for 2 hours, the mixture is filtered to obtain a first filtrate. The residue is then added to 470 mL of distilled water and decocted for 1.5 hours, followed by filtration to obtain a second filtrate. The first and second filtrates are combined and naturally filtered through a 120-mesh stainless steel mesh. Subsequently, the mixture is eluted using a D1300 macroporous adsorption resin column with 70% ethanol solution as the eluent, and then concentrated under reduced pressure to obtain 100 mL of concentrated solution.

[0052] Example 1 This study evaluated the regulatory effects of various traditional Chinese medicine preparations prepared according to the embodiments and comparative proportions of the present invention on the JAK2 / STAT3 signaling pathway and the function of the inflammatory immune system using an in vitro inflammatory cell model induced by lipopolysaccharide (LPS). JAK2 / STAT3 is a pathway related to the human autoimmune system, and abnormalities in this signaling pathway are closely related to the occurrence and development of autoimmune diseases and the function of the human immune system. Mouse macrophages Raw264.7 were cultured in vitro, and an in vitro inflammatory cell model was established by stimulating Raw264.7 cells with lipopolysaccharide at a concentration of 1 μg / mL. The induced cells were digested with trypsin, counted, and prepared to a concentration of 6... 10 4 Add 100 μL of cell suspension per well to each well of a 96-well plate (6 cells / mL). 10 3 Cells were cultured for 24 hours. The compound traditional Chinese medicine preparations from the above examples and comparative examples were prepared into 50 mg / mL aqueous solutions. AG-490 is a classic small molecule inhibitor of the JAK2 / STAT3 pathway. AG-490 was prepared into a 50 mg / mL solution using DMSO. After thorough mixing, 2 μL of these drug solutions were added to 96-well white microplates. JAK2 antibody and phosphorylated JAK2 antibody (p-JAK2) were purchased from Abcam. The p-JAK2 / JAK2 ratio after drug treatment was quantitatively calculated using Western spectroscopy and software such as ImageJ. If this ratio decreased after treatment, it indicated that the drug effectively downregulated the JAK2 / STAT3 signaling pathway and related targets, thereby regulating inflammatory and immune functions. The cells were divided into three groups: a buffer solution (9% physiological saline), an AG-490 control drug group, and a treatment group containing the traditional Chinese medicine preparations obtained in the examples and comparative examples.

[0053] Table 1. Evaluation of the regulatory effect on intestinal inflammation and immune system function This experiment shows (see Table 1) that the compound traditional Chinese medicine preparation of Example 1 has a stronger regulatory effect on the JAK2 / STAT3 signaling pathway than other examples and the comparative treatment group, proving that the formulation of Example 1 is superior. Furthermore, the regulatory effect of Example 1 on the JAK2 / STAT3 signaling pathway after treatment is comparable to that of the control drug AG-490, demonstrating that Example 1 has a good regulatory effect on inflammatory and immune functions.

[0054] Example 2 Male C57 mice aged 6-8 weeks were acclimatized for 3-7 days and then divided into four groups (n=10 per group, totaling 40 mice): a blank control group, a model group, a positive control group treated with 5-aminosalicylic acid (5-ASA), and a group treated as described in Example 1 (n=10 per group, totaling 40 mice). Animals in the model group and the drug treatment groups were allowed free access to 2.5% DSS solution (sodium dextran sulfate, 5 mL / day) for model initiation, while the blank control group had free access to sterile water. In the drug treatment groups, each group was administered the respective drug daily by gavage starting the day before model initiation. The dose of the positive control group treated with 5-ASA was 10 mg / kg, and the dose in the Example 1 treatment group was 6 g / kg. After 2 weeks of treatment, the animals were sacrificed and dissected. The colon was removed and fixed in 4% formalin solution for 30 minutes. The colon was longitudinally cut from the mesenteric side, photographed, and its length measured. Based on experimental observation and measurement, the following were assessed: 1. Anal (fecal) bleeding status; 2. Stool length; 3. Colon length and colonic ulcer status; 4. Disease Activity Index (DAI) score. The DAI score was calculated by averaging the scores of weight loss, stool characteristics, and degree of rectal bleeding.

[0055] This experiment shows (see...) Figure 1 Compared with the blank control group, the anal (fecal) bleeding condition in the model group was severe, and the positive drug administration group had a certain alleviating effect on the anal (fecal) bleeding condition. The drug administration group in Example 1 had a better therapeutic effect on the anal (fecal) bleeding condition.

[0056] Stool length is a key pathological indicator for assessing inflammatory bowel disease. This experiment shows (see...) Figure 2 The fecal length was shortest in the DSS model group, while the fecal length recovered to a certain extent in the positive drug 5-ASA administration group. The fecal length was longest in the administration group of Example 1, indicating that the treatment effect was better than that of the positive drug.

[0057] The Disease Activity Index (DAI) is a key pathological indicator for assessing inflammatory bowel disease. This study shows (see...) Figure 3The disease activity index score of the model group was the highest, the disease activity index of the positive drug administration group was significantly reduced, and the disease activity index of the Example 1 administration group was also significantly reduced and better than that of the positive drug administration group, indicating that Example 1 has a better therapeutic effect on inflammatory bowel disease and the therapeutic effect is better than that of the positive drug.

[0058] Microscopic H&E section data of colonic villi are an important indicator for assessing inflammatory bowel disease. This experiment shows (see...) Figure 4 Compared with the blank group, the colonic villi in the model group were significantly damaged, while the positive drug group recovered a certain degree of colonic villi state. The drug administration group in Example 1 also showed good recovery effects on colonic villi state and intestinal barrier.

[0059] Example 3 The acute toxicity safety of the compound traditional Chinese medicine preparation prepared according to the embodiments of the present invention was tested in animals via oral administration. Specifically, 6-week-old male SD rats were administered the solution of the traditional Chinese medicine preparation prepared according to the embodiments of the present invention by gavage for 24 consecutive hours (n=10 rats per group) to conduct acute drug toxicity tests. The experimental results showed that no abnormalities were observed in the animals in the experimental group in terms of general condition, weight change, food consumption, or histopathology.

[0060] Based on the experimental results (see Table 2), the non-toxic dosage of the compound traditional Chinese medicine preparations obtained in Examples 1-3 of this invention is above 15 g / kg / day. The experimental results indicate that the compound traditional Chinese medicine preparations prepared in the examples of this invention are non-toxic or low-toxic, and have a very high degree of biosafety.

[0061] Table 2. Acute toxicity assessment Obviously, the above embodiments are merely examples for clearly illustrating the present invention, and are not intended to limit the implementation of the present invention. Those skilled in the art can make various modifications and variations to the present invention without departing from the spirit and scope of the invention. Therefore, if these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention also intends to include these modifications and variations.

Claims

1. A compound traditional Chinese medicine preparation for treating inflammatory bowel disease, characterized in that, The effective components of the compound traditional Chinese medicine preparation are made from extracts of the following traditional Chinese medicine raw materials in the following weight ratios: American ginseng 15-30 parts, fenugreek 10-20 parts, schisandra chinensis 5-15 parts, dandelion 5-15 parts, white peony root 5-15 parts, ginkgo 5-10 parts, licorice root 5-10 parts, and aloe vera 5-10 parts.

2. The compound traditional Chinese medicine preparation for treating inflammatory bowel disease according to claim 1, characterized in that, The effective components of the compound traditional Chinese medicine preparation are made from extracts of the following traditional Chinese medicine raw materials in the following weight ratios: American ginseng 20-25 parts, fenugreek 12-18 parts, schisandra chinensis 8-12 parts, dandelion 8-12 parts, white peony root 8-12 parts, ginkgo 6-9 parts, licorice 6-9 parts, and aloe vera 6-9 parts.

3. The compound traditional Chinese medicine preparation for treating inflammatory bowel disease according to claim 2, characterized in that, The effective components of the compound traditional Chinese medicine preparation are made from extracts of the following traditional Chinese medicine raw materials in the following weight ratios: 25 parts American ginseng, 15 parts fenugreek, 10 parts Schisandra chinensis, 10 parts dandelion, 10 parts white peony root, 8 parts ginkgo, 8 parts licorice, and 8 parts aloe vera.

4. The compound traditional Chinese medicine preparation for treating inflammatory bowel disease according to any one of claims 1 to 3, characterized in that, The compound traditional Chinese medicine preparation also contains pharmaceutically acceptable carriers and / or excipients.

5. The compound traditional Chinese medicine preparation for treating inflammatory bowel disease according to claim 4, characterized in that, The pharmaceutically acceptable carrier and / or excipient is selected from one or more of liposomes, microcrystalline cellulose, sodium carboxymethyl starch, sodium carboxymethyl cellulose, polyethylene glycol, polyvinyl alcohol, acrylate polymers, glycerol, propylene glycol, sorbitol, β-cyclodextrin, Tween-80, lactose, starch, Urogene S-100, Urogene L-100, sodium alginate, pectin, and dextrin.

6. The compound traditional Chinese medicine preparation for treating inflammatory bowel disease according to any one of claims 1 to 3, characterized in that, The dosage forms of the compound traditional Chinese medicine preparations are granules, capsules, oral liquids, tablets, pills, ointments, decoctions, injections, or microcapsules.

7. The method for preparing a compound traditional Chinese medicine preparation for treating inflammatory bowel disease according to any one of claims 1-6, characterized in that, The preparation method includes the following steps: A: Add 5-10 times the amount of water to the prescription herbs and decoct together. Filter the decoction and concentrate the filtrate to obtain a primary filtrate. B: Add 5-10 times the amount of water to the filter residue and boil it again. Filter it to obtain the secondary filtrate. C: Combine the primary and secondary filtrates, filter naturally using a stainless steel mesh, then elute with a macroporous adsorption resin column, and finally concentrate under reduced pressure to obtain a concentrate, which is the extract of the Chinese herbal raw material.

8. The use of the compound traditional Chinese medicine preparation according to any one of claims 1-6 or the compound traditional Chinese medicine preparation prepared by the preparation method according to claim 7 in the preparation of a drug for treating inflammatory bowel disease.

9. The application according to claim 8, characterized in that, The inflammatory bowel disease mentioned is either ulcerative colitis or Crohn's disease.

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