Traditional Chinese medicine enema for treating active ulcerative colitis

Abstract

The invention discloses a traditional Chinese medicine enema for treating active ulcerative colitis. The traditional Chinese medicine enema liquid is prepared from the following raw materials in parts by mass: 8-15 parts of coptis chinensis, 10-20 parts of charred scutellaria baicalensis, 8-15 parts of charred cortex ailanthi, 8-15 parts of colla corii asini beads, 5-8 parts of indigo naturalis, 8-15 parts of ampelopsis japonica, 10-20 parts of raw astragalus membranaceus, 8-15 parts of red halloysite and 2-5 parts of pseudo-ginseng powder. When the traditional Chinese medicine enema liquid is used, an enema bag is used for rectum instillation enema, 100 mL of the enema liquid is used each time, excrement is emptied before enema, the temperature of the enema liquid is preferably (39 + / -0.5) DEG C, side-lying position rectum instillation (slow instillation in 5-10 minutes) is carried out, and the enema liquid is kept in the body for more than 1 hour once every night. According to the traditional Chinese medicine enema formula, the medicine can directly reach a disease site, so that the medicine can be better absorbed to promote intestinal mucosa repair, and the effects of relieving inflammatory response and promoting sore and ulcer surface healing are achieved; meanwhile, the first-pass effect of oral administration of the medicine is avoided, stimulation to the stomach is relieved, and the risk of toxic and side effects caused by long-term oral administration of the medicine is reduced.

Description

Technical Field

[0001] The invention relates to a traditional Chinese medicine enema solution for treating active stage ulcerative colitis, belonging to the technical field of traditional Chinese medicines. Background Art

[0002] Ulcerative colitis (UC) is a chronic nonspecific intestinal inflammatory disease with abdominal pain, diarrhea, bloody stools and tenesmus as the main clinical manifestations. At present, the etiology and pathogenesis of this disease have not been fully elucidated. Commonly used Western medicine treatments in clinical practice include aminosalicylic acids, glucocorticoids, immunosuppressants, and biological agents, but the efficacy in terms of rapid induction of remission, promotion of deep mucosal healing, and prevention of recurrence is far from satisfactory. In addition, long-term maintenance of medication consumes a lot of medical resources and has many adverse reactions.

[0003] Traditional Chinese medicine believes that this disease belongs to the category of "resting diarrhea", "chronic diarrhea" and "intestinal diarrhea". Weak spleen is the root cause of the disease. Damp-heat in the intestines and qi stagnation and blood stasis are the most important pathological characteristics of UC in the active period, and are also the key links that cause the disease to recur and be difficult to cure. The onset of UC generally follows the law of backflow development. The rectum and the left colon are most susceptible to involvement and the degree of lesions is more serious. Enema treatment with traditional Chinese medicine is one of the commonly used external treatment methods of traditional Chinese medicine. It is widely used in the treatment of UC for its simplicity, convenience, effectiveness and low cost. Enema allows the drug to come into direct contact with the intestinal ulcer surface, so that it can be better absorbed to repair the intestinal mucosa, play a role in reducing inflammatory reactions and promoting the healing of ulcer surfaces, but the market currently lacks local dosage forms such as traditional Chinese medicine enema solutions with definite efficacy. Therefore, it is very necessary to develop innovative traditional Chinese medicine enema drugs for the treatment of ulcerative colitis based on clinical efficacy. Summary of the invention

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

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

[0006] 8-15 parts of coptis root, 10-20 parts of scutellaria baicalensis charcoal, 8-15 parts of toona root bark charcoal, 8-15 parts of donkey hide gelatin beads, 5-8 parts of indigo, 8-15 parts of white ampel, 10-20 parts of raw astragalus, 8-15 parts of red ochre, and 2-5 parts of notoginseng powder.

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

[0008] 10-15 parts of coptis root, 15-20 parts of scutellaria baicalensis charcoal, 10-15 parts of toona root bark charcoal, 10-15 parts of donkey hide gelatin beads, 6-8 parts of indigo, 10-15 parts of white ampel, 15-20 parts of raw astragalus, 10-15 parts of red ochre, and 3-5 parts of notoginseng powder.

[0009] Further preferably, the Chinese medicine enema solution is made of the following raw materials in parts by weight:

[0010] 10 parts of coptis root, 15 parts of scutellaria baicalensis charcoal, 10 parts of toona root bark charcoal, 10 parts of donkey hide gelatin beads, 6 parts of indigo, 10 parts of white ampelopsis, 15 parts of raw astragalus, 10 parts of red ochre, and 3 parts of notoginseng powder.

[0011] The Chinese medicine enema solution of the present invention is preferably a water decoction.

[0012] When using the Chinese medicine enema solution of the present invention, an enema bag is used for rectal drip enema, 100 mL each time, the stool is emptied before enema, the enema solution temperature is preferably (39±0.5)°C, and the enema solution is dripped rectum in the lateral position (slowly dripped in 5-10 minutes), so that the enema solution is retained in the body for more than 1 hour, once every night.

[0013] The prescription of the Chinese medicine enema solution of the present invention is based on the pathological changes of damp-heat in the intestines and viscera, qi stagnation and blood stasis, blood rot and flesh rot in the active stage of ulcerative colitis. Weak spleen and stomach are the root of its onset, followed by pathological products such as dampness, blood stasis, and heat toxicity. Blood stasis runs through the whole process of this disease. It is appropriate to combine strengthening the body with removing evil, clearing away heat and detoxifying, invigorating the spleen and removing dampness, and removing blood stasis and stopping dysentery. The lesions of ulcerative colitis mostly start in the rectum and can develop retrogradely to the proximal colon and the whole colon. Chinese medicine enema is a traditional Chinese medicine medication method. Enema can make the medicine directly reach the diseased area and exert the curative effect. According to the characteristics of ulcerative colitis that is prone to long-term recurrence and the problems of poor efficacy and high price of existing drugs, after a large number of clinical observations in the early stage and combined with Chinese medicine experience, the prescription is continuously optimized to provide the Chinese medicine enema prescription for treating the active stage of ulcerative colitis of the present invention.

[0014] Formula analysis of the Chinese medicine enema solution of the present invention: the Chinese medicine enema composition for treating the active stage of ulcerative colitis of the present invention takes coptis root and scutellaria baicalensis charcoal as the main medicines. Coptis root and scutellaria baicalensis are bitter and cold in nature, have the effects of clearing away heat and dampness, purging fire and detoxifying, and the fried scutellaria baicalensis charcoal can enhance the hemostatic power; white mulberry root is bitter and slightly cold in taste, can clear away heat and detoxify, eliminate carbuncle and disperse knot, astringe sore and promote tissue regeneration; Indigo naturalis is salty and cold, and enhances the blood cooling and hemostatic power of the main medicine; Chinese toon root bark charcoal is bitter and slightly cold, and enhances the hemostatic and dysentery-stopping power; red ochre is sweet, sour, astringent and warm, astringes the intestines and stops diarrhea, astringes sore and promotes tissue regeneration, and the four are altogether the ministerial medicines; Panax notoginseng powder is sweet and warm, can dissipate blood stasis and stop bleeding, promote blood circulation and stop pain, and donkey-hide gelatin is sweet and flat in nature, can nourish blood and stop bleeding, and the two are altogether the adjuvants; raw astragalus root can detoxify and discharge pus, astringe sore and promote tissue regeneration, and has the effects of invigorating qi and raising yang, promoting body fluid and nourishing blood, and is the guiding medicine. The combination of these medicines can clear away heat and detoxify, strengthen the spleen and eliminate dampness, and remove blood stasis and stop dysentery.

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

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

[0017] S2, adding water to the medicinal residue, heating and boiling, then decocting over low heat, and filtering to obtain a second extract;

[0018] S3, combining the first extract and the second extract, heating and concentrating, standing and filtering to remove precipitate to obtain a medicinal solution;

[0019] S4, adding Panax notoginseng powder to the medicinal liquid and mixing well to obtain the Chinese medicinal enema liquid.

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

[0021] The time for simmering over low heat is 15-20 minutes.

[0022] In step S2, the slow-cooking 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 internal damp-heat accumulation in the intestines and viscera, qi stagnation and blood stasis, blood stagnation and flesh rot. Weak spleen and stomach are the root of the disease, which then produces pathological products such as dampness, blood stasis, and heat toxins. Blood stasis runs through the entire process of the disease. Treatment should be combined with strengthening the body and eliminating evil, and treating both the symptoms and the root causes. The Chinese medicine enema prescription of the present invention has the effects of clearing away heat and detoxification, strengthening the spleen and eliminating dampness, and removing blood stasis and stopping dysentery. This is used as a treatment principle, which is more in line with the clinical diagnosis and treatment rules of UC.

[0025] 2. The rectum and left colon are most susceptible to ulcerative colitis and the degree of lesions is more serious. Chinese medicine enema treatment is one of the commonly used external treatment methods in traditional Chinese medicine. It can exert a faster therapeutic effect on patients with UC, especially those with proximal colitis. The Chinese medicine enema of the present invention can make the drug reach the diseased area directly, so that it can be better absorbed and promote the repair of intestinal mucosa, play a role in reducing inflammatory response and promoting the healing of ulcer surface. At the same time, it avoids the first-pass effect of oral drugs, reduces irritation to the stomach, and reduces the risk of toxic and side effects caused by long-term oral drugs. In addition, enema has a wider range of applications, especially for patients who cannot swallow drugs. Compared with traditional oral methods, intestinal administration has a faster and more stable absorption rate, and the drug effect lasts longer. DETAILED DESCRIPTION

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

[0027] Unless otherwise specified, the materials and reagents used in the following examples can be obtained from commercial sources.

[0028] Example 1: Preparation of a Chinese herbal enema recipe for treating active ulcerative colitis

[0029] The amount of each raw material is as follows:

[0030] 10g of Coptis chinensis, 15g of charcoal of Scutellaria baicalensis, 10g of charcoal of Toona sinensis root bark, 10g of donkey-hide gelatin beads, 6g of Indigo naturalis, 10g of Bletilla striata, 15g of raw Astragalus, 10g of red ochre, and 3g of Panax notoginseng powder.

[0031] Prepared as follows:

[0032] Weigh each raw material medicine according to the formula, mix the other raw materials medicines except Panax notoginseng powder, add them into a casserole, add water to cover the surface of the medicine, soak for 50 minutes, then heat to boil and then simmer for 20 minutes, filter to obtain the first extract and the residue;

[0033] Add water to the residue and boil again, then simmer for 20 minutes, and filter to obtain the second extract;

[0034] The first extract and the second extract were mixed, concentrated to 120 ml by heating, allowed to stand and the precipitate was filtered out.

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

[0036] Example 2: Application of Chinese herbal enema prescription for treating active stage of ulcerative colitis

[0037] Use an enema bag for rectal drip enema, 100 mL each time. Empty the stool before enema. The enema solution temperature should be (39±0.5)℃. Rectal drip in the lateral position (slowly drip in 5-10 minutes) so that the enema solution remains in the body for more than 1 hour, once a night.

[0038] Example 3: Small sample clinical efficacy trial of Chinese medicine enema prescription

[0039] A small sample of 15 patients with ulcerative colitis with rectum or left colon and lesion range not exceeding sigmoid colon were collected for clinical observation. After 8 weeks of treatment with the Chinese medicine enema prescription in Example 1 of the present invention, 11 patients achieved clinical remission, with a clinical remission rate of 73.3%. The clinical remission rate of mesalazine enema solution was about 70%. In addition, the price of Chinese medicine enema solution was low, only 10% of the price of Western medicine enema drugs, with good safety, few adverse reactions, high patient acceptance, and convenient clinical promotion. It has very important clinical value for the treatment of ulcerative colitis.

[0040] The anti-inflammatory efficacy of the Chinese herbal enema prescription of the present invention was further verified through animal experiments. The results showed that compared with the ulcerative colitis model mice induced by DSS (dextran sulfate sodium), the Chinese herbal enema prescription of the present invention can effectively reduce the disease activity index score, restore colon length, repair intestinal mucosal damage, and reduce inflammatory cell infiltration. Its efficacy is better than that of the positive drug mesalazine in some aspects.

[0041] Example 4, Clinical efficacy test of Chinese medicine enema prescription

[0042] 1. General Information

[0043] (1) Inclusion criteria

[0044] ① Meet the diagnostic criteria for active ulcerative colitis, with the clinical severity being mild or moderate, and the lesion range being the rectum or left colon and not exceeding the sigmoid colon.

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

[0046] ③Age between 18 and 65, regardless of gender.

[0047] ④ Informed consent, 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 colon diseases such as chronic schistosomiasis, bacillary dysentery, amoebic dysentery, intestinal tuberculosis, and non-infectious intestinal diseases such as Crohn's disease, ischemic bowel disease, and radiation enteritis.

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

[0052] ④Pregnant and lactating women.

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

[0054] ⑥ Disabled patients stipulated by law (blind, deaf, dumb, intellectually disabled, mentally disabled, physically disabled).

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

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

[0057] ⑨ Those with allergic constitution, history of allergy to two or more drugs or foods; or those who are allergic to the ingredients of this drug.

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

[0059] (3) Case selection: A total of 60 patients with active mild to moderate ulcerative colitis who visited the Digestive Center of Beijing Hospital of Traditional Chinese Medicine, Capital Medical University were selected and randomly divided into an experimental group and a control group using a random number table, with 30 cases in each group.

[0060] Ulcerative colitis is divided into active phase and remission phase according to disease activity. The modified Truelove and Witts criteria (see Table 1) are recommended for clinical severity grading in the active phase, which is simple, objective, accurate, and the most widely used standard for identifying UC disease severity.

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

[0062] Classification Defecation (times / day) Blood in the stool Pulse (beats / min) Body temperature(℃) Hemoglobin ESR (mm / h) Mild <4 Light or no normal normal normal <20 Severe ≥6 Heavy >90 >37.8 <75% normal >30

[0063] Note: Moderate is between mild and severe

[0064] The relevant studies of this embodiment included patients who met the diagnosis of active UC, had mild or moderate severity, and had lesions in the rectum or left colon and did not exceed the sigmoid colon.

[0065] TCM syndrome standard: Patients with large intestine damp-heat syndrome were included according to the "Expert Consensus on TCM Diagnosis and Treatment of Ulcerative Colitis" (2017) formulated by the Spleen and Stomach Disease Branch of the Chinese Association of Traditional Chinese Medicine.

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

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

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

[0069] If the patient has two of the above main symptoms and two of the secondary symptoms, the diagnosis can be made by referring to the tongue and pulse.

[0070] 2. Treatment methods

[0071] (1) Test group: The Chinese medicine enema formula prepared in Example 1 of the present invention was administered enema, decocted twice, concentrated to 100 mL, and instilled into the rectum before going to bed (slowly instilled over 5-10 minutes), once every night. Enema method: empty the stool before enema, the enema solution temperature is preferably (39±0.5)°C, first take the left side lying position, fully expose the buttocks, lubricate the front end of the anal canal, insert the anal canal into the rectum 10-20 cm, and adjust the enema administration speed according to the patient's tolerance so that the drug solution is retained in the body for more than 1 hour.

[0072] (2) Control group: Mesalazine enema solution (4 g / vial, produced by Vifor AG ZweigniederlassungMedichemie Ettingen, National Medicine Approval No. H20150127) was administered, 1 vial each time, once every night. Enema method: Before enema, empty the stool, fully expose the buttocks, lubricate the front end of the anal canal, squeeze in the drug solution, and keep the drug solution in the body for more than 1 hour.

[0073] (3) Treatment course: One course of treatment was 8 weeks for both groups.

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

[0075] ①Combination medication / treatment is allowed

[0076] During the observation period, the use of drugs for the treatment of underlying diseases such as coronary heart disease and diabetes is allowed. Such as metoprolol, captopril, nifedipine, metformin, acarbose, etc. Doctors should require patients to bring all the drugs they are taking during follow-up visits to check the patients' concomitant medications. The drugs that must be continued for concomitant diseases or other treatments must be recorded in the research medical records, including the drug name (or other therapy name), dosage, number of times used, and time, so that they can be analyzed and reported in the summary.

[0077] ②Prohibited combined medication / treatment

[0078] Except for the experimental drugs, the use of other drugs for the treatment of ulcerative colitis and other treatments related to the treatment of this disease, such as hormones, biological drugs, oral Chinese medicine, acupuncture, etc., is 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 disease, severity of disease, tongue quality, tongue coating, pulse condition. Colonoscopy and biopsy histological pathological examination.

[0087] 3) Efficacy indicators

[0088] (1) Main efficacy evaluation indicators

[0089] ① Modified Mayo score (including bowel movement frequency, blood in stool, mucosal manifestations, and physician's overall evaluation) (see Table 2) Table 2 Modified Mayo score

[0090]

[0091]

[0092] Note: The sum of the total scores is ≤ 2 points for symptom relief; 3-5 points for mild activity; 6-10 points for moderate activity; 11-12 points for severe activity.

[0093] (2) Secondary efficacy evaluation indicators

[0094] ① Endoscopic severity index (UCEIS) score (including vascular texture, bleeding, erosion and ulcer) (see Table 3)

[0095] Table 3 Endoscopic severity index (UCEIS) score

[0096]

[0097] ② TCM syndrome scoring

[0098] The nine symptoms of diarrhea, bloody stools, abdominal pain, abdominal distension, fever, anal burning, tenesmus, poor appetite, and fatigue were scored separately, and the sum of the nine items was the TCM syndrome score.

[0099] ③ Quality of life score (IBDQ score)

[0100] The patients' quality of life is mainly assessed from four dimensions: intestinal symptoms, systemic symptoms, emotional ability, and social ability.

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

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

[0103] The data were recorded during follow-up at week 0, week 2, week 4, and week 8.

[0104] (2) Quality of life score

[0105] Record once at week 0 and week 8 respectively.

[0106] (3) Colonoscopy and pathological examination

[0107] The patients were examined once before treatment and once after 8 weeks of treatment, and pathological tissues were biopsied.

[0108] 5. Statistical methods

[0109] The data were processed using SPSS 20.0 statistical analysis software. When the data are normally distributed, the t test is used, and when they are not normally distributed, the rank sum test is used. The chi-square test is used for count data. P < 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 (2 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 reactions).

[0113] (2) Efficacy evaluation

[0114] ① Modified Mayo score

[0115] The differences in the 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 groups were able to significantly reduce the modified Mayo scores (P<0.001), but there was no statistically significant difference in the score differences between the two groups, indicating that the experimental group and the control group had equivalent therapeutic effects in reducing the modified Mayo scores (see Table 4).

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

[0117] Group Number of cases 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] ② TCM 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 score difference between the two groups, indicating that the experimental group was equivalent to the control group in improving the TCM syndrome scores, as shown in Table 5.

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

[0122] Group Number of cases 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 endoscopic 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 groups were able to significantly reduce the UCEIS endoscopic score (P<0.001), but there was no statistically significant difference in the score difference between the two groups, indicating that the experimental group and the control group had equivalent efficacy in reducing the UCEIS endoscopic score (see Table 6).

[0126] Table 6 Comparison of UCEIS endoscopic scores

[0127] Group Number of cases 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 the quality of life scores (IBDQ) before and after treatment in the experimental group and the control group were 25.32±22.81 and 23.38±19.78, respectively. Both groups were able to significantly improve the quality of life scores (IBDQ) (P<0.001), but there was no statistical difference in the score difference between the two groups, indicating that in terms of improving the quality of life scores (IBDQ), the experimental group and the control group had equivalent efficacy, see Table 7.

[0131] Table 7 Comparison of quality of life scores (IBDQ)

[0132] Group Number of cases 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) Observation of adverse reactions

[0135] During the treatment, no adverse reactions were observed in the experimental group; one patient in the control group developed a rash 2 weeks after taking the medicine, which recovered on its own after stopping the medicine, and no abnormal liver and kidney function was observed.

Claims

1. A Chinese medicine enema solution for treating active stage ulcerative colitis, prepared from the following raw materials in parts by weight: 8-15 parts of coptis root, 10-20 parts of scutellaria baicalensis charcoal, 8-15 parts of toona root bark charcoal, 8-15 parts of donkey hide gelatin beads, 5-8 parts of indigo, 8-15 parts of white ampel, 10-20 parts of raw astragalus, 8-15 parts of red ochre, and 2-5 parts of notoginseng powder.

2. The Chinese medicine enema solution according to claim 1, characterized in that: The Chinese medicine enema solution is made from the following raw materials in parts by weight: 10-15 parts of coptis root, 15-20 parts of scutellaria baicalensis charcoal, 10-15 parts of toona root bark charcoal, 10-15 parts of donkey hide gelatin beads, 6-8 parts of indigo, 10-15 parts of white ampel, 15-20 parts of raw astragalus, 10-15 parts of red ochre, and 3-5 parts of notoginseng powder.

3. The Chinese medicine enema solution according to claim 1, characterized in that: The Chinese medicine enema solution is made from the following raw materials in parts by weight: 10 parts of coptis root, 15 parts of scutellaria baicalensis charcoal, 10 parts of toona root bark charcoal, 10 parts of donkey hide gelatin beads, 6 parts of indigo, 10 parts of white ampelopsis, 15 parts of raw astragalus, 10 parts of red ochre, and 3 parts of notoginseng powder.

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

5. A method for preparing the Chinese medicine enema solution according to any one of claims 1 to 4, comprising the following steps: S1. Mix the other raw materials except Panax notoginseng powder, add water to soak; then heat to boil and simmer over low heat, filter to obtain the first extract and medicinal residue; S2, adding water to the medicinal residue, heating and boiling, then simmering over low heat, and filtering to obtain a second extract; S3, combining the first extract and the second extract, heating and concentrating, standing and filtering to remove precipitate to obtain a medicinal solution; S4, adding Panax notoginseng powder to the medicinal liquid and mixing well to obtain the Chinese medicinal enema liquid.

6. The preparation method according to claim 5, characterized in that: In step S1, the soaking time is 30-60 minutes; The time for simmering over low heat is 15-20 minutes.

7. The preparation method according to claim 5 or 6, characterized in that: In step S2, the slow-cooking time is 15-20 minutes.

8. A medicine for treating active stage ulcerative colitis, wherein the active ingredient is the Chinese medicine enema solution according to any one of claims 1 to 4.

9. Use of the Chinese medicine enema solution according to any one of claims 1 to 4 in the preparation of a medicament for treating active stage ulcerative colitis.

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