A traditional Chinese medicine enema liquid for treating active ulcerative colitis

Abstract

This invention discloses a traditional Chinese medicine enema solution for treating the active phase of ulcerative colitis. The enema solution is made from the following raw materials in parts by weight: 8-15 parts Coptis chinensis, 10-20 parts charred Scutellaria baicalensis, 8-15 parts charred Toona sinensis root bark, 8-15 parts donkey-hide gelatin beads, 5-8 parts Indigo naturalis, 8-15 parts Ampelopsis japonica, 10-20 parts raw Astragalus membranaceus, 8-15 parts Halloysite, and 2-5 parts Panax notoginseng powder. When using this enema solution, a rectal drip enema is performed using an enema bag, 100 mL each time. The bowels should be emptied before the enema. The temperature of the enema solution should be (39±0.5)℃. The patient should lie on their side while the enema is administered in a rectal drip (slowly dripping over 5-10 minutes), allowing the enema solution to remain in the body for at least 1 hour. This should be done once every night. The herbal enema formula of this invention allows the medicine to directly reach the affected area, thereby enabling better absorption, promoting intestinal mucosal repair, reducing inflammatory response, and promoting the healing of sores. At the same time, it avoids the first-pass effect of oral medication, reduces gastric irritation, and lowers the risk of toxic side effects caused by long-term oral medication.

Description

Technical Field

[0001] This invention relates to a traditional Chinese medicine enema solution for treating the active phase of ulcerative colitis, belonging to the field of traditional Chinese medicine technology. Background Technology

[0002] Ulcerative colitis (UC) is a chronic, nonspecific inflammatory bowel disease characterized by abdominal pain, diarrhea, bloody mucus in stool, and tenesmus. The etiology and pathogenesis of this disease are not yet fully understood. Commonly used Western medicine treatments include aminosalicylic acids, glucocorticoids, immunosuppressants, and biologics. However, their efficacy in rapidly inducing remission, promoting deep mucosal healing, and preventing recurrence is far from satisfactory. Furthermore, long-term maintenance medication consumes significant medical resources and has numerous adverse reactions.

[0003] Traditional Chinese medicine (TCM) classifies ulcerative colitis (UC) as falling under the categories of "relapsing dysentery," "chronic dysentery," and "dysentery." Spleen deficiency is considered the root cause, while damp-heat accumulation in the intestines and qi stagnation are the most important pathogenic mechanisms during the active phase of UC, and key factors leading to recurrent and persistent symptoms. UC typically follows a reverse-flow pattern, with the rectum and left colon being most susceptible and exhibiting more severe lesions. Enemas with Chinese medicine are a commonly used external treatment method in TCM, widely applied for UC treatment due to their simplicity, convenience, effectiveness, and affordability. Enemas allow medication to directly contact the ulcerated intestinal surface, improving absorption and repairing the intestinal mucosa, reducing inflammation, and promoting ulcer healing. However, the market currently lacks locally applied TCM enema solutions and other formulations with proven efficacy. Therefore, developing innovative TCM enema drugs for treating ulcerative colitis based on clinical efficacy is essential. Summary of the Invention

[0004] The purpose of this invention is to provide a traditional Chinese medicine enema solution for treating active ulcerative colitis, which can significantly treat mild to moderate active ulcerative colitis, effectively reduce the disease activity index score, restore colon length, repair intestinal mucosal damage, and reduce inflammatory cell infiltration.

[0005] The traditional Chinese medicine enema solution for treating active ulcerative colitis provided by this invention is made from the following raw materials in parts by weight:

[0006] Coptis chinensis 8-15 parts, Scutellaria baicalensis charcoal 10-20 parts, Toona sinensis root bark charcoal 8-15 parts, donkey-hide gelatin beads 8-15 parts, Indigo naturalis 5-8 parts, Ampelopsis japonica 8-15 parts, Astragalus membranaceus raw 10-20 parts, Halloysite 8-15 parts, Panax notoginseng powder 2-5 parts.

[0007] Preferably, the herbal enema solution is made from the following raw materials in parts by weight:

[0008] Coptis chinensis 10-15 parts, Scutellaria baicalensis charcoal 15-20 parts, Toona sinensis root bark charcoal 10-15 parts, donkey-hide gelatin beads 10-15 parts, Indigo naturalis 6-8 parts, Ampelopsis japonica 10-15 parts, Astragalus membranaceus raw 15-20 parts, Halloysite 10-15 parts, Panax notoginseng powder 3-5 parts.

[0009] More preferably, the herbal enema solution is made from the following raw materials in parts by weight:

[0010] Coptis chinensis 10 parts, Scutellaria baicalensis charcoal 15 parts, Toona sinensis root bark charcoal 10 parts, donkey-hide gelatin beads 10 parts, Indigo naturalis 6 parts, Ampelopsis japonica 10 parts, Astragalus membranaceus 15 parts, Halloysite 10 parts, Panax notoginseng powder 3 parts.

[0011] The herbal enema solution of this invention is preferably a decoction.

[0012] When using the herbal enema solution of this invention, use an enema bag for rectal drip enema, 100mL each time. Empty your bowels before enema. The temperature of the enema solution should be (39±0.5)℃. Administer the enema in a lateral position with rectal drip (slowly dripping in over 5-10 minutes) so that the enema solution remains in the body for more than 1 hour. Do this once every night.

[0013] The formulation of this herbal enema solution is based on the following: The active phase of ulcerative colitis is characterized by internal damp-heat in the intestines, qi stagnation and blood stasis, and blood putrefaction and tissue decay. Spleen and stomach weakness is the root cause, leading to the production of pathological products such as dampness, blood stasis, and heat toxins. Blood stasis persists throughout the entire course of the disease. Treatment should combine tonifying the body's resistance with eliminating pathogenic factors, clearing heat and detoxifying, strengthening the spleen and resolving dampness, and removing blood stasis and stopping diarrhea. Ulcerative colitis often originates in the rectum and can progress retrogradely to the proximal colon and the entire colon. Herbal enemas are a traditional Chinese medicine method of drug administration, allowing the medication to directly reach the affected area and exert its therapeutic effect. Considering the tendency of ulcerative colitis to recur frequently and the limitations of existing drugs (ineffectiveness and high cost), this invention provides a herbal enema formula for treating the active phase of ulcerative colitis, developed through extensive clinical observation and integration with traditional Chinese medicine experience.

[0014] Analysis of the formulation of the herbal enema solution of this invention: The herbal enema composition of this invention for treating active ulcerative colitis uses Coptis chinensis and Scutellaria baicalensis charcoal as the principal ingredients. Coptis chinensis and Scutellaria baicalensis are bitter and cold in nature, and have the effects of clearing heat and drying dampness, purging fire and detoxifying. Charcoalized Scutellaria baicalensis can enhance the hemostatic effect. Ampelopsis japonica is bitter and slightly cold, and can clear heat and detoxify, eliminate carbuncles and dissipate nodules, and promote tissue regeneration. Indigo naturalis is salty and cold, and can enhance the blood-cooling and hemostatic effect of the principal ingredients. Charcoalized Toona sinensis root bark is bitter and slightly cold, and can enhance the hemostatic and anti-dysentery effects. Red ochre is sweet, sour, astringent and warm, and can astringe the intestines and stop diarrhea, promote tissue regeneration. These four are the assistant ingredients. Panax notoginseng powder is sweet and warm, and can resolve blood stasis and stop bleeding, and promote blood circulation and relieve pain. Colla corii asini is sweet and neutral in nature, and can nourish blood and stop bleeding. These two are the adjuvant ingredients. Astragalus membranaceus promotes detoxification and pus drainage, promotes tissue regeneration, and also has the effects of tonifying qi and raising yang, and nourishing blood. It is the guiding ingredient. When used together, these herbs work synergistically to clear heat and detoxify, strengthen the spleen and resolve dampness, remove blood stasis and stop dysentery.

[0015] The present invention also provides a method for preparing the traditional Chinese medicine enema solution, comprising the following steps:

[0016] S1. Mix all the raw materials except Panax notoginseng powder, add water to soak; then heat to a boil and simmer over low heat, filter to obtain the first extract and dregs;

[0017] S2. Add water to the dregs, heat and boil, then simmer over low heat, and filter to obtain the second extract.

[0018] S3. Combine the first extract and the second extract, heat and concentrate, let stand, filter to remove precipitate to obtain drug solution;

[0019] S4. Add Panax notoginseng powder to the medicinal liquid and mix well to obtain the traditional Chinese medicine enema liquid.

[0020] In step S1, the soaking time is 30-60 minutes;

[0021] The simmering time is 15-20 minutes.

[0022] In step S2, the simmering time is 15-20 minutes.

[0023] The present invention has the following beneficial technical effects:

[0024] 1. The main pathogenesis of active ulcerative colitis is the accumulation of damp-heat in the intestines, qi stagnation and blood stasis, and blood putrefaction and tissue decay. Spleen and stomach weakness is the root cause, leading to the production of pathological products such as dampness, blood stasis, and heat toxins. Blood stasis persists throughout the entire course of the disease. Treatment should combine tonifying the body's resistance with eliminating pathogenic factors, addressing both the root cause and the symptoms. The herbal enema formula of this invention has the effects of clearing heat and detoxifying, strengthening the spleen and resolving dampness, and removing blood stasis and stopping diarrhea. Using this as a treatment principle is more in line with the clinical diagnosis and treatment patterns of UC.

[0025] 2. Ulcerative colitis most commonly affects the rectum and left colon, where the lesions are more severe. Traditional Chinese medicine enemas are a commonly used external treatment method, offering rapid therapeutic effects for UC patients, especially those with proximal colitis. This invention's herbal enema formula allows the medication to directly reach the affected area, resulting in better absorption, promoting intestinal mucosal repair, reducing inflammation, and accelerating ulcer healing. It also avoids the first-pass effect of oral medication, reducing gastric irritation and lowering the risk of adverse reactions from long-term oral administration. Furthermore, enemas have a wider range of applications, particularly suitable for patients unable to swallow medication. Compared to traditional oral methods, intestinal administration results in faster and more stable absorption, and a longer duration of effect. Detailed Implementation

[0026] Unless otherwise specified, the experimental methods used in the following examples are conventional methods.

[0027] Unless otherwise specified, all materials and reagents used in the following examples are commercially available.

[0028] Example 1: Preparation of a traditional Chinese medicine enema formula for treating active ulcerative colitis.

[0029] The amounts of each raw material are as follows:

[0030] Coptis chinensis 10g, Scutellaria baicalensis charcoal 15g, Toona sinensis root bark charcoal 10g, donkey-hide gelatin beads 10g, Indigo naturalis 6g, Ampelopsis japonica 10g, Astragalus membranaceus 15g, Halloysite 10g, Panax notoginseng powder 3g.

[0031] Prepared according to the following method:

[0032] Weigh out each raw material according to the formula, mix all raw materials except Panax notoginseng powder and add them to a clay pot, add water to cover the surface of the herbs, soak for 50 minutes, then heat to a boil and simmer for 20 minutes, filter to obtain the first extract and the dregs.

[0033] After boiling the dregs in water again, simmer over low heat for 20 minutes, then filter to obtain the second extract.

[0034] Mix the first and second extracts, heat and concentrate to 120 ml, let stand and filter out the precipitate.

[0035] Take 100mL of the medicinal liquid, add Panax notoginseng powder and mix well to obtain a traditional Chinese medicine enema formula for treating the active phase of ulcerative colitis.

[0036] Example 2: Application of Traditional Chinese Medicine Enema Formula for Treating Active Ulcerative Colitis

[0037] Use an enema bag for rectal drip enema, 100mL each time. Empty your bowels before enema. The temperature of the enema solution should be (39±0.5)℃. Administer the enema slowly into the rectum over 5-10 minutes while the patient is lying on their side. Allow the enema solution to remain in the body for more than 1 hour. Do this once every night.

[0038] Example 3: Small-sample clinical efficacy trial of a traditional Chinese medicine enema formula

[0039] A small-sample clinical observation was conducted on 15 patients with ulcerative colitis of the rectum or left colon, with lesions not exceeding the sigmoid colon, exhibiting the damp-heat syndrome of the large intestine. After 8 weeks of treatment with the traditional Chinese medicine enema formula from Example 1 of this invention, 11 patients achieved clinical remission, resulting in a clinical remission rate of 73.3%. In contrast, the clinical remission rate of mesalazine enema solution is approximately 70%. Furthermore, the traditional Chinese medicine enema solution is inexpensive, costing only 10% of the price of Western medicine enema drugs, and boasts good safety, few adverse reactions, and high patient acceptance, making it easy to promote clinically. It has significant clinical value in the treatment of ulcerative colitis.

[0040] Further animal experiments were conducted to verify the anti-inflammatory efficacy of the herbal enema formula of this invention. The results showed that, compared with DSS (dextrose sulfate sodium) induced ulcerative colitis model mice, the herbal enema formula of this invention can effectively reduce the disease activity index score, restore colon length, repair intestinal mucosal damage, and reduce inflammatory cell infiltration. Its efficacy is superior to the positive control drug mesalazine in some aspects.

[0041] Example 4: Clinical efficacy trial of traditional Chinese medicine enema formula

[0042] 1. General Information

[0043] (1) Inclusion criteria

[0044] ① Meets the diagnostic criteria for active ulcerative colitis, with clinical severity ranging from mild to moderate, and the lesion area extending to the rectum or left colon and not exceeding the sigmoid colon.

[0045] ②According to traditional Chinese medicine diagnosis, it belongs to the damp-heat syndrome of the large intestine.

[0046] ③ Age between 18 and 65 years old, gender not limited.

[0047] ④ Informed consent and voluntary participation. The process of obtaining informed consent should comply with GCP regulations.

[0048] (2) Exclusion criteria

[0049] ① Patients with severe illness.

[0050] ② Patients with infectious colitis such as chronic schistosomiasis, bacterial dysentery, amoebic dysentery, and intestinal tuberculosis, as well as non-infectious intestinal diseases such as Crohn's disease, ischemic enteropathy, and radiation enteritis.

[0051] ③ Patients with serious complications such as local stenosis, intestinal obstruction, intestinal perforation, rectal polyps, toxic megacolon, colon cancer, rectal cancer, and anal diseases.

[0052] ④ Pregnant or breastfeeding women.

[0053] ⑤ Individuals with severe primary heart, liver, lung, kidney, blood, or other serious diseases that affect their survival.

[0054] ⑥ Patients with disabilities as defined by law (blind, deaf, mute, intellectually disabled, mentally disabled, physically disabled).

[0055] ⑦ Suspected or confirmed history of alcohol or drug abuse.

[0056] ⑧ Other diseases that reduce the likelihood of enrollment or complicate enrollment, such as frequent changes in the work environment, may lead to loss to follow-up, according to the researcher's judgment.

[0057] ⑨ Individuals with allergic constitutions, a history of allergies to two or more drugs or foods, or allergies to any component of this drug.

[0058] ⑩ Patients who are participating in other drug clinical trials.

[0059] (3) Case selection: Sixty patients with mild to moderate ulcerative colitis in the active phase who visited the Digestive Center of Beijing Hospital of Traditional Chinese Medicine, affiliated to Capital Medical University, were selected and randomly divided into an experimental group and a control group using a random number table, with 30 patients in each group.

[0060] Ulcerative colitis is classified into active and remission phases based on disease activity. For the clinical severity grading of the active phase, the modified Truelove and Witts criteria (see Table 1) are recommended for assessment. These are simple, objective, accurate, and widely used standards for identifying the severity of UC.

[0061] Table 1. Modified Truelove and Witts classification criteria for disease severity.

[0062] Classification Bowel movements (times / day) blood in stool Pulse (beats / min) Body temperature(℃) hemoglobin Erythrocyte sedimentation rate (mm / h) Mild <4 Light or none normal normal normal <20 Severe ≥6 Heavy >90 >37.8 <75% of normal value >30

[0063] Note: Moderate severity falls between mild and severe.

[0064] The relevant studies in this embodiment included those that met the diagnostic criteria for active UC, were of mild to moderate severity, and had lesions in the rectum or left colon that did not extend beyond the sigmoid colon.

[0065] Traditional Chinese Medicine (TCM) syndrome differentiation criteria: Patients diagnosed with damp-heat syndrome of large intestine were included in the "Expert Consensus on TCM Diagnosis and Treatment of Ulcerative Colitis" (2017) formulated by the Spleen and Stomach Diseases Branch of the China Association of Traditional Chinese Medicine.

[0066] Main symptoms: ① Abdominal pain; ② Diarrhea with mucus and blood in the stool; ③ Tenesmus and burning sensation in the anus.

[0067] Secondary symptoms: ① fever; ② scanty and dark urine; ③ dry mouth, bitter taste, and bad breath.

[0068] Tongue and pulse: ① Red tongue with yellow, greasy coating; ② Slippery and rapid pulse.

[0069] If a patient presents with two of the above primary symptoms and two of the above secondary symptoms, a diagnosis can be made by referring to the tongue and pulse.

[0070] 2. Treatment methods

[0071] (1) Experimental group: The traditional Chinese medicine enema formula prepared in Example 1 of this invention was administered via enema. The formula was decocted twice and concentrated to 100 mL. It was then administered via rectal drip before bedtime (slowly dripped over 5-10 minutes) once every night. Enema method: Empty the bowels before the enema. The temperature of the enema solution should be (39±0.5)℃. First, the patient should lie on their left side to fully expose the buttocks. Lubricate the tip of the anal tube and insert the anal tube into the rectum 10-20 cm. Adjust the enema administration rate according to the patient's tolerance to ensure that the solution remains in the body for more than 1 hour.

[0072] (2) Control group: Mesalazine enema solution (4g / vial, manufactured by Vifor AG ZweigniederlassungMedichemie Ettingen, National Drug Approval Number H20150127) was administered, one vial each time, once every night. Enema method: Empty the bowels before enema, fully expose the buttocks, lubricate the tip of the anal tube, squeeze in the solution, and allow the solution to remain in the body for more than 1 hour.

[0073] (3) Treatment course: Both groups were treated for 8 weeks as one course of treatment.

[0074] (4) Regulations for combined medication / treatment

[0075] ① Combination therapy / treatment is permitted

[0076] During the observation period, the use of medications for underlying conditions such as coronary heart disease and diabetes is permitted. Examples include metoprolol, captopril, nifedipine, metformin, and acarbose. The physician should require the patient to bring all medications they are currently taking to follow-up appointments for review of any concomitant medications. Any medications or other treatments necessary to continue for concomitant conditions must be recorded in the study medical record, including the name of the medication (or other therapy), dosage, frequency of use, and duration, for analysis and reporting during the summary.

[0077] ② Contraindicated combined medication / treatment

[0078] In addition to the experimental drug, other medications for treating ulcerative colitis and other treatments related to this disease, such as hormones, biological agents, oral Chinese medicine, and acupuncture, are prohibited during the observation period.

[0079] 3. Observation indicators

[0080] (1) General Record Items

[0081] Subject's name, outpatient / inpatient status, trial start date, and contact information.

[0082] (2) Screening Indicators

[0083] 1) Biological indicators

[0084] Demographic characteristics: age, sex, weight, height; vital signs: body temperature, resting heart rate, respiration, blood pressure.

[0085] 2) Diagnostic indicators

[0086] Medical history, symptoms and signs, course of illness, severity of illness, tongue appearance, tongue coating, pulse. Colonoscopy and biopsy histological examination.

[0087] 3) Efficacy indicators

[0088] (1) Main efficacy evaluation indicators

[0089] ① Modified Mayo Criterion (including frequency of bowel movements, rectal bleeding, mucosal manifestations, and overall physician evaluation) (see Table 2) Table 2 Modified Mayo Criterion

[0090]

[0091]

[0092] Note: The total score is as follows: ≤2 points indicates symptom relief; 3-5 points indicates mild activity; 6-10 points indicates moderate activity; and 11-12 points indicates severe activity.

[0093] (2) Secondary efficacy evaluation indicators

[0094] ① Endoscopic Severity Index (UCEIS) score (including vascular texture, bleeding, erosion, and ulceration) (see Table 3)

[0095] Table 3 Endoscopic Severity Index (UCEIS) Scores

[0096]

[0097] ②Traditional Chinese Medicine Syndrome Scoring

[0098] Nine symptoms—diarrhea, bloody stools, abdominal pain, abdominal distension, fever, burning sensation in the anus, tenesmus, loss of appetite, and fatigue—are scored separately, and the sum of these nine symptoms is the TCM syndrome score.

[0099] ③ Quality of Life Score (IBDQ Score)

[0100] The patient's quality of life is assessed primarily from four dimensions: intestinal symptoms, systemic symptoms, emotional capacity, and social capacity.

[0101] 4. Effectiveness observation indicators and observation time points

[0102] (1) Symptoms, signs and TCM syndromes

[0103] Records were taken during follow-up at weeks 0, 2, 4, and 8.

[0104] (2) Quality of life score

[0105] Record once each in week 0 and week 8.

[0106] (3) Colonoscopy and pathological examination

[0107] The patients underwent examinations once before treatment and once after 8 weeks of treatment, and biopsies were taken for pathological tissue.

[0108] 5. Statistical methods

[0109] Data were processed using SPSS 20.0 statistical analysis software. For quantitative data, ... The data are categorized as follows: for normally distributed data, a t-test is used; for non-normally distributed data, a rank-sum test is used. For count data, a chi-square test is used. A p-value < 0.05 is considered statistically significant.

[0110] 6. Results

[0111] (1) Study population

[0112] A total of 72 patients were screened, and 60 were randomly enrolled, including 30 in the experimental group and 30 in the control group. During the trial, 2 patients dropped out of the experimental group (both due to lack of efficacy) and 4 patients dropped out of the control group (3 due to lack of efficacy and 1 due to adverse reaction).

[0113] (2) Evaluation of therapeutic effect

[0114] ① Improved Mayo rating

[0115] The differences in modified Mayo scores before and after treatment in the experimental group and the control group were 3.68±1.42 and 3.31±1.81, respectively, both of which significantly reduced the modified Mayo score (P<0.001). However, there was no statistically significant difference in the score difference between the two groups, indicating that the experimental group and the control group were equally effective in reducing the modified Mayo score (see Table 4).

[0116] Table 4 Comparison of modified Mayo scores between the two groups before and after treatment.

[0117] Group Number of examples Before treatment After 8 weeks of treatment Difference in scores before and after treatment experimental group 28 5.82±1.52 2.14±0.89*** 3.68±1.42 control group 26 5.81±1.58 2.50±1.79*** 3.31±1.81

[0118] Note: Compared with before treatment, ***P<0.001

[0119] ②Traditional Chinese Medicine Syndrome Scoring

[0120] The differences in TCM syndrome scores before and after treatment in the experimental group and the control group were 9.07±3.15 and 9.12±3.53, respectively, both of which significantly reduced the TCM syndrome scores (P<0.001); however, there was no statistically significant difference in the scores between the two groups, indicating that the experimental group and the control group were comparable in improving TCM syndrome scores, as shown in Table 5.

[0121] Table 5 Comparison of TCM syndrome scores before and after treatment in the two groups

[0122] Group Number of examples Before treatment After 8 weeks of treatment Difference in scores before and after treatment experimental group 28 11.11±3.41 2.04±2.10*** 9.07±3.15 control group 26 13.42±4.31 4.31±3.85*** 9.12±3.53

[0123] Note: Compared with before treatment, ***P<0.001

[0124] ③UCEIS Endoscopy Score

[0125] The differences in UCEIS scores before and after treatment in the experimental group and the control group were 1.57±1.20 and 1.54±1.24, respectively, both of which significantly reduced the UCEIS endoscopy score (P<0.001). However, there was no statistically significant difference in the score difference between the two groups, indicating that the experimental group and the control group had comparable efficacy in reducing the UCEIS endoscopy score (see Table 6).

[0126] Table 6 Comparison of UCEIS Endoscopy Scores

[0127] Group Number of examples Before treatment After 8 weeks of treatment Difference in scores before and after treatment experimental group 28 3.54±0.79 1.96±1.11*** 1.57±1.20 control group 26 3.50±0.91 1.96±1.54*** 1.54±1.24

[0128] Note: Compared with before treatment, ***P<0.001

[0129] ④ Quality of Life Score (IBDQ)

[0130] The differences in quality of life (IBDQ) scores before and after treatment in the experimental group and the control group were 25.32±22.81 and 23.38±19.78, respectively, both of which significantly improved the IBDQ score (P<0.001). However, there was no statistically significant difference in the score difference between the two groups, indicating that the experimental group and the control group had comparable efficacy in improving the IBDQ score (see Table 7).

[0131] Table 7 Comparison of Quality of Life Scores (IBDQ)

[0132] Group Number of examples Before treatment After 8 weeks of treatment Difference in scores before and after treatment experimental group 28 175.43±26.07 200.75±22.92*** 25.32±22.81 control group 26 163.92±28.11 187.31±17.62*** 23.38±19.78

[0133] Note: Compared with before treatment, ***P<0.001.

[0134] (3) Adverse reaction observation

[0135] During the treatment, no adverse reactions were observed in the experimental group; in the control group, one patient developed a rash after two weeks of medication, which resolved spontaneously after discontinuation of the medication, and no abnormalities were observed in liver or kidney function.

Claims

1. A traditional Chinese medicine enema solution for treating active ulcerative colitis, made from the following raw materials in parts by weight: Coptis chinensis 8-15 parts, Scutellaria baicalensis charcoal 10-20 parts, Toona sinensis root bark charcoal 8-15 parts, donkey-hide gelatin beads 8-15 parts, Indigo naturalis 5-8 parts, Ampelopsis japonica 8-15 parts, Astragalus membranaceus raw 10-20 parts, Halloysite 8-15 parts, Panax notoginseng powder 2-5 parts.

2. The traditional Chinese medicine enema solution according to claim 1, characterized in that: The herbal enema solution is made from the following raw materials in parts by weight: Coptis chinensis 10-15 parts, Scutellaria baicalensis charcoal 15-20 parts, Toona sinensis root bark charcoal 10-15 parts, donkey-hide gelatin beads 10-15 parts, Indigo naturalis 6-8 parts, Ampelopsis japonica 10-15 parts, Astragalus membranaceus raw 15-20 parts, Halloysite 10-15 parts, Panax notoginseng powder 3-5 parts.

3. The traditional Chinese medicine enema solution according to claim 1, characterized in that: The herbal enema solution is made from the following raw materials in parts by weight: Coptis chinensis 10 parts, Scutellaria baicalensis charcoal 15 parts, Toona sinensis root bark charcoal 10 parts, donkey-hide gelatin beads 10 parts, Indigo naturalis 6 parts, Ampelopsis japonica 10 parts, Astragalus membranaceus 15 parts, Halloysite 10 parts, Panax notoginseng powder 3 parts.

4. The traditional Chinese medicine enema solution according to any one of claims 1-3, characterized in that: The herbal enema solution is a decoction.

5. A method for preparing the traditional Chinese medicine enema solution according to any one of claims 1-4, comprising the following steps: S1. Mix all the raw materials except Panax notoginseng powder, add water to soak; then heat to a boil and simmer over low heat, filter to obtain the first extract and dregs; S2. Add water to the dregs, heat and boil, then simmer over low heat, and filter to obtain the second extract. S3. Combine the first extract and the second extract, heat to concentrate, let stand, filter to remove precipitate and obtain drug solution; S4. Add Panax notoginseng powder to the medicinal liquid and mix well to obtain the traditional Chinese medicine enema liquid.

6. The method of claim 5, wherein: In step S1, the soaking time is 30-60 minutes; The simmering time is 15-20 minutes.

7. The production method according to claim 5 or 6, characterized by: In step S2, the simmering time is 15-20 minutes.

8. A drug for treating active ulcerative colitis, wherein the active ingredient is the traditional Chinese medicine enema solution described in any one of claims 1-4.

9. The use of the traditional Chinese medicine enema solution according to any one of claims 1-4 in the preparation of a medicament for treating the active phase of ulcerative colitis.

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