Composite enema for treating enteritis and preparation method thereof

Abstract

The invention discloses a composite enema for treating enteritis and a preparation method thereof. The traditional Chinese medicine composition is a combined preparation of traditional Chinese medicines and western medicines and comprises traditional Chinese medicine extracts (coptis chinensis, golden cypress, pulsatilla chinensis and the like) with anti-inflammatory and anti-diarrhea functions, western medicine components (salazosulfapyridine, 5-aminosalicylic acid and the like) for inhibiting intestinal inflammation, active enzymes (pectinase, pancreatin, lactase and the like) for promoting intestinal health and dissolution promoting substances (glycerol, lecithin, hyaluronic acid and the like) for enhancing medicine permeation. The enema liquid also comprises a pH regulator and pure water as auxiliary materials. The enema liquid capable of efficiently treating enteritis is prepared by virtue of a specific proportion and a preparation process and comprises the following steps: dissolving and mixing, adding enzymes, adjusting pH, filtering and sterilizing, and filling and packaging. Wherein the coptis chinensis extract is prepared by specific extraction, concentration, drying and crushing processes. The enema provided by the invention has remarkable effects of resisting inflammation, stopping diarrhea, regulating intestinal functions and promoting intestinal mucosa repair, and provides a new treatment choice for enteritis patients.

Description

Technical Field

[0001] The invention belongs to the field of medicine, and specifically discloses a composite enema solution for treating enteritis and a preparation method thereof. Background Art

[0002] In the field of enteritis treatment, traditional therapies mostly rely on single-ingredient Western medicine or Chinese medicine preparations for enema treatment. Western medicine enema solutions, such as sulfasalazine and 5-aminosalicylic acid, can effectively inhibit intestinal inflammation and relieve intestinal spasms, but long-term use can easily lead to intestinal flora imbalance and drug tolerance problems. Chinese medicine enema solutions, such as extracts of Coptis chinensis, Phellodendron chinense, and Pulsatilla chinensis, have the advantages of anti-inflammatory, antidiarrheal, and intestinal function regulation, but their ingredients are complex, their mechanism of action is unclear, and their bioavailability is relatively low, which limits the breadth and effectiveness of their clinical application.

[0003] The enema solutions in the prior art often ignore the complementary advantages of the combination of Chinese and Western medicines, and fail to fully utilize the synergistic effect of their respective components in the treatment of enteritis. At the same time, most enema solutions lack active enzyme components for decomposing harmful substances in the intestine, absorbing nutrients, and enhancing intestinal immunity, resulting in limited therapeutic effects and easy recurrence. In addition, the stability and bioavailability of enema solutions are also key factors restricting their efficacy. Many enema solutions lack effective dissolution-promoting substances, resulting in poor drug permeability and difficulty in reaching the lesion site, thereby affecting the therapeutic effect. Summary of the invention

[0004] In view of the deficiencies of the prior art, the present invention proposes a compound enema solution for treating enteritis and a preparation method thereof; the above-mentioned compound enema solution realizes the organic combination of Chinese and Western medicine ingredients through scientific proportioning, and at the same time adds appropriate amounts of active enzymes and dissolution-promoting substances to improve the stability and bioavailability of the drugs, ensuring that the drugs can penetrate deeply into the lesions and exert the best therapeutic effect.

[0005] The present invention includes the following technical solutions:

[0006] A compound enema solution for treating enteritis, which is a combination of Chinese and Western medicines and contains the following effective ingredients:

[0007] Traditional Chinese medicine ingredients: at least one plant extract having anti-inflammatory, antidiarrheal and intestinal regulating functions, preferably, the plant extract is selected from Coptis chinensis extract, Phellodendron chinense extract, Pulsatilla chinensis extract, Portulaca oleracea extract or a combination of any two or more thereof;

[0008] Western medicine ingredients: comprising at least one Western medicine ingredient capable of inhibiting intestinal inflammation, relieving intestinal spasm and promoting intestinal mucosal repair. Preferably, the Western medicine ingredient is selected from at least one of sulfasalazine, 5-aminosalicylic acid, metronidazole, dexamethasone or pharmaceutically acceptable salts, esters and derivatives thereof;

[0009] Active enzyme: comprising at least one active enzyme capable of decomposing harmful substances in the intestine, promoting the absorption of nutrients and enhancing intestinal immunity. Preferably, the active enzyme is selected from at least one of cellulase, pectinase, pancreatin or lactase;

[0010] Solubility-promoting substance: at least one solubility-promoting substance capable of promoting drug penetration, enhancing drug stability and bioavailability. Preferably, the solubility-promoting substance is selected from at least one of glycerol, polyethylene glycol, lecithin or hyaluronic acid.

[0011] Furthermore, the above-mentioned compound enema solution for treating enteritis also includes auxiliary materials, and the auxiliary materials include pH regulator and pure water.

[0012] Furthermore, in the above-mentioned compound enema solution for treating enteritis, the traditional Chinese medicine ingredients consist of Coptis chinensis extract, Phellodendron amurense extract, and Pulsatilla scabra extract.

[0013] Furthermore, in the above-mentioned compound enema solution for treating enteritis, the western medicine ingredients consist of sulfasalazine and 5-aminosalicylic acid.

[0014] Furthermore, in the above-mentioned composite enema solution for treating enteritis, the active enzymes consist of pectinase, pancreatic enzyme and lactase.

[0015] Furthermore, in the above-mentioned composite enema solution for treating enteritis, the dissolution-promoting substance consists of glycerol, lecithin and hyaluronic acid.

[0016] Furthermore, the above-mentioned composite enema solution for treating enteritis is composed of the following ingredients in mass percentage: 0.5-1wt% of Coptis chinensis extract, 0.2-0.5wt% of Phellodendron chinense extract, 0.1-0.4wt% of Pulsatilla scabra extract, 0.5-1wt% of sulfasalazine, 0.2-0.4wt% of 5-aminosalicylic acid, 3-6wt% of glycerol, 0.5-1wt% of lecithin, 2-4wt% of hyaluronic acid, appropriate amounts of active enzymes and pH regulators, and the balance is pure water.

[0017] Furthermore, the above-mentioned composite enema solution for treating enteritis contains 500-1000U / mL of pectinase, 300-500U / mL of pancreatic enzyme and 200-400U / mL of lactase.

[0018] The present invention also discloses a method for preparing the composite enema solution for treating enteritis, comprising the following steps:

[0019] S1 Dissolution and Mixing:

[0020] At room temperature, dissolve the coptis root extract, phellodendron amurense extract, pulsatilla scabra extract, sulfasalazine and 5-aminosalicylic acid in an appropriate amount of pure water; add glycerin, lecithin and hyaluronic acid to the above solution and stir evenly;

[0021] S2 enzyme addition:

[0022] At room temperature, slowly add pectinase, pancreatin and lactase to the above mixed solution, and control the adding speed to avoid excessive local concentration leading to enzyme inactivation;

[0023] S3pH Adjustment:

[0024] At room temperature, use a pH adjuster to adjust the pH of the enema solution to pH 6.5-7.5;

[0025] S4 Filtration Sterilization:

[0026] Filter the enema solution through a 0.22 μm sterile filter membrane to remove bacteria and other impurities;

[0027] S5 filling and packaging:

[0028] Fill the sterilized enema solution into a sterile container.

[0029] Furthermore, in the preparation method of the composite enema solution for treating enteritis, the Rhizoma Coptidis extract is prepared by the following steps:

[0030] (1) Raw material processing:

[0031] The coptis root is cleaned to remove dirt and impurities on the surface, and the cleaned coptis root is crushed to obtain uniform coptis root powder;

[0032] (2) Extraction:

[0033] Adding coptis root powder into an extraction tank, adding 70%-80% volume concentration of ethanol aqueous solution, and performing reflux extraction; the extraction temperature is controlled within the range of 60-80° C., and after the extraction is completed, filtering is performed to obtain coptis root extract;

[0034] (3) Concentration:

[0035] The extracted Coptis chinensis extract was concentrated to 1.05-1.1 g / mL, and the excess solvent was removed;

[0036] (4) Drying:

[0037] The concentrated Coptis chinensis extract is dried by spray drying until the water content is less than 10%, thereby obtaining Coptis chinensis extract powder;

[0038] (5) Crushing and screening:

[0039] The dried Coptis chinensis extract powder is further ground and passed through a 200-400 mesh sieve to obtain the Coptis chinensis extract.

[0040] Compared with the prior art, the present invention has the following beneficial effects:

[0041] The present invention proposes a compound enema solution for treating enteritis and a preparation method thereof. The enema solution, through a carefully designed Chinese and Western medicine combination formula, gives full play to the anti-inflammatory, antidiarrheal and intestinal function regulating effects of Chinese medicine ingredients such as coptis root extract, phellodendron chinense extract, and pulsatilla striata extract, and combines the advantages of Western medicine ingredients such as sulfasalazine and 5-aminosalicylic acid in inhibiting intestinal inflammation, relieving intestinal spasm and promoting intestinal mucosal repair. This combination of Chinese and Western medicine not only enhances the therapeutic effect, but also reduces the side effects that may be caused by a single ingredient, and improves the safety and effectiveness of the drug.

[0042] In addition, the above enema solution is specially added with active enzyme ingredients, such as pectinase, pancreatin and lactase, which can decompose harmful substances in the intestine, promote the absorption of nutrients, and enhance intestinal immunity, thereby further improving the treatment effect and accelerating the patient's recovery process. At the same time, the addition of soluble substances such as glycerol, lecithin and hyaluronic acid effectively promotes the penetration of drugs, enhances the stability and bioavailability of drugs, and ensures that the drugs can penetrate deep into the lesions and give full play to their therapeutic effects. BRIEF DESCRIPTION OF THE DRAWINGS

[0043] Figure 1 Comparison of the number of cured cases in the test case;

[0044] Figure 2 Comparison of the number of valid cases in the test cases;

[0045] Figure 3 Comparison of the number of invalid cases in the test cases;

[0046] Figure 4 Comparison of the effective rates (%) among the test cases. DETAILED DESCRIPTION

[0047] A compound enema solution for treating enteritis, which is a combination of Chinese and Western medicines and consists of the following ingredients:

[0048] 0.5-1wt% of Coptis chinensis extract, 0.2-0.5wt% of Phellodendron chinense extract, 0.1-0.4wt% of Pulsatilla chinensis extract, 0.5-1wt% of sulfasalazine, 0.2-0.4wt% of 5-aminosalicylic acid, 3-6wt% of glycerol, 0.5-1wt% of lecithin, 2-4wt% of hyaluronic acid, appropriate amount of active enzyme and pH regulator, and the balance is pure water;

[0049] The enema solution contains 500-1000U / mL of pectinase, 300-500U / mL of pancreatic enzyme and 200-400U / mL of lactase;

[0050] The above-mentioned compound enema solution is prepared by the following steps:

[0051] S1 Dissolution and Mixing:

[0052] At room temperature, dissolve the coptis root extract, phellodendron amurense extract, pulsatilla scabra extract, sulfasalazine and 5-aminosalicylic acid in an appropriate amount of pure water; add glycerin, lecithin and hyaluronic acid to the above solution and stir evenly;

[0053] S2 enzyme addition:

[0054] At room temperature, slowly add pectinase, pancreatin and lactase to the above mixed solution, and control the adding speed to avoid excessive local concentration leading to enzyme inactivation;

[0055] S3pH Adjustment:

[0056] At room temperature, use a pH adjuster to adjust the pH of the enema solution to pH 6.5-7.5;

[0057] S4 Filtration Sterilization:

[0058] Filter the enema solution through a 0.22 μm sterile filter membrane to remove bacteria and other impurities;

[0059] S5 filling and packaging:

[0060] Fill the sterilized enema solution into a sterile container.

[0061] The Rhizoma Coptidis extract is prepared by the following steps:

[0062] (1) Raw material processing:

[0063] The coptis root is cleaned to remove dirt and impurities on the surface, and the cleaned coptis root is crushed to obtain uniform coptis root powder;

[0064] (2) Extraction:

[0065] Adding coptis root powder into an extraction tank, adding 70%-80% volume concentration of ethanol aqueous solution, and performing reflux extraction; the extraction temperature is controlled within the range of 60-80° C., and after the extraction is completed, filtering is performed to obtain coptis root extract;

[0066] (3) Concentration:

[0067] The extracted Coptis chinensis extract was concentrated to 1.05-1.1 g / mL, and the excess solvent was removed;

[0068] (4) Drying:

[0069] The concentrated Coptis chinensis extract is dried by spray drying until the water content is less than 10%, thereby obtaining Coptis chinensis extract powder;

[0070] (5) Crushing and screening:

[0071] The dried Coptis chinensis extract powder is further ground and passed through a 200-400 mesh sieve to obtain the Coptis chinensis extract.

[0072] The preparation methods of the Phellodendron chinense extract and Pulsatilla chinensis extract are the same as those of the above-mentioned Coptis chinensis extract.

[0073] The technical solutions in the embodiments of the present invention are described clearly and completely below. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0074] Example 1

[0075] A compound enema solution for treating enteritis, which is a combination of Chinese and Western medicines and consists of the following ingredients:

[0076] 0.5wt% of Coptis chinensis extract, 0.2wt% of Phellodendron chinense extract, 0.1wt% of Pulsatilla chinensis extract, 0.5wt% of sulfasalazine, 0.2wt% of 5-aminosalicylic acid, 3wt% of glycerol, 0.5wt% of lecithin, 2wt% of hyaluronic acid, appropriate amount of active enzyme and pH regulator, and the balance is pure water;

[0077] The enema solution contains 500 U / mL of pectinase, 300 U / mL of pancreatic enzyme and 200 U / mL of lactase.

[0078] The above-mentioned compound enema solution is prepared by the following steps:

[0079] S1 Dissolution and Mixing:

[0080] At room temperature, dissolve the coptis root extract, phellodendron amurense extract, pulsatilla scabra extract, sulfasalazine and 5-aminosalicylic acid in an appropriate amount of pure water; add glycerin, lecithin and hyaluronic acid to the above solution and stir evenly;

[0081] S2 enzyme addition:

[0082] At room temperature, slowly add pectinase, pancreatin and lactase to the above mixed solution, and control the adding speed to avoid excessive local concentration leading to enzyme inactivation;

[0083] S3pH Adjustment:

[0084] At room temperature, use a pH adjuster to adjust the pH of the enema solution to pH 6.5-7.5;

[0085] S4 Filtration Sterilization:

[0086] Filter the enema solution through a 0.22 μm sterile filter membrane to remove bacteria and other impurities;

[0087] S5 filling and packaging:

[0088] Fill the sterilized enema solution into a sterile container.

[0089] The Rhizoma Coptidis extract is prepared by the following steps:

[0090] (1) Raw material processing:

[0091] The coptis root is cleaned to remove dirt and impurities on the surface, and the cleaned coptis root is crushed to obtain uniform coptis root powder;

[0092] (2) Extraction:

[0093] Adding coptis root powder into an extraction tank, adding 70%-80% volume concentration of ethanol aqueous solution, and performing reflux extraction; the extraction temperature is controlled within the range of 60-80° C., and after the extraction is completed, filtering is performed to obtain coptis root extract;

[0094] (3) Concentration:

[0095] The extracted Coptis chinensis extract was concentrated to 1.05-1.1 g / mL, and the excess solvent was removed;

[0096] (4) Drying:

[0097] The concentrated Coptis chinensis extract is dried by spray drying until the water content is less than 10%, thereby obtaining Coptis chinensis extract powder;

[0098] (5) Crushing and screening:

[0099] The dried Coptis chinensis extract powder is further ground and passed through a 200-400 mesh sieve to obtain the Coptis chinensis extract.

[0100] The preparation methods of the Phellodendron chinense extract and Pulsatilla chinensis extract are the same as those of the above-mentioned Coptis chinensis extract.

[0101] Example 2

[0102] A compound enema solution for treating enteritis, which is a combination of Chinese and Western medicines and consists of the following ingredients:

[0103] 0.75wt% of Coptis chinensis extract, 0.35wt% of Phellodendron chinense extract, 0.25wt% of Pulsatilla chinensis extract, 0.75wt% of sulfasalazine, 0.3wt% of 5-aminosalicylic acid, 4.5wt% of glycerol, 0.75wt% of lecithin, 3wt% of hyaluronic acid, appropriate amount of active enzyme and pH regulator, and the balance is pure water;

[0104] The enema solution contains 750 U / mL of pectinase, 400 U / mL of pancreatic enzyme and 300 U / mL of lactase.

[0105] The preparation method is the same as that of Example 1

[0106] Example 3

[0107] A compound enema solution for treating enteritis, which is a combination of Chinese and Western medicines and consists of the following ingredients:

[0108] 1wt% of Coptis chinensis extract, 0.5wt% of Phellodendron chinense extract, 0.4wt% of Pulsatilla truncatula extract, 1wt% of sulfasalazine, 0.4wt% of 5-aminosalicylic acid, 6wt% of glycerol, 1wt% of lecithin, 4wt% of hyaluronic acid, appropriate amount of active enzyme and pH regulator, and the balance is pure water;

[0109] The enema solution contains 1000 U / mL of pectinase, 500 U / mL of pancreatic enzyme and 400 U / mL of lactase.

[0110] The preparation method is the same as that of Example 1

[0111] Comparative Example 1

[0112] A compound enema solution for treating enteritis, comprising the following ingredients:

[0113] Sulfasalazine 0.75wt%, 5-aminosalicylic acid 0.3wt%, glycerol 4.5wt%, lecithin 0.75wt%, hyaluronic acid 3wt%, appropriate amount of active enzyme and pH regulator, the balance is pure water;

[0114] The enema solution contains 750 U / mL of pectinase, 400 U / mL of pancreatic enzyme and 300 U / mL of lactase.

[0115] The preparation method is the same as that of Example 1

[0116] Compared with Example 2, 0.75 wt% of Coptis chinensis extract, 0.35 wt% of Phellodendron chinense extract and 0.25 wt% of Pulsatilla striata extract are not contained, and the rest are the same as Example 2.

[0117] Comparative Example 2

[0118] A compound enema solution for treating enteritis, comprising the following ingredients:

[0119] 0.75wt% of Coptis chinensis extract, 0.35wt% of Phellodendron chinense extract, 0.25wt% of Pulsatilla striata extract, 4.5wt% of glycerol, 0.75wt% of lecithin, 3wt% of hyaluronic acid, appropriate amount of active enzyme and pH regulator, and the balance is pure water;

[0120] The enema solution contains 750 U / mL of pectinase, 400 U / mL of pancreatic enzyme and 300 U / mL of lactase.

[0121] The preparation method is the same as that of Example 1

[0122] Compared with Example 2, 0.75 wt % of sulfasalazine and 0.3 wt % of 5-aminosalicylic acid are not contained, and the rest are the same as Example 2.

[0123] Comparative Example 3

[0124] A compound enema solution for treating enteritis, comprising the following ingredients:

[0125] 0.75wt% of Coptis chinensis extract, 0.35wt% of Phellodendron chinense extract, 0.25wt% of Pulsatilla chinensis extract, 0.75wt% of sulfasalazine, 0.3wt% of 5-aminosalicylic acid, 4.5wt% of glycerol, 0.75wt% of lecithin, 3wt% of hyaluronic acid, pH regulator, and the balance is pure water;

[0126] The preparation method is the same as that of Example 1

[0127] Compared with Example 2, no active enzyme is contained, and the rest is the same as Example 2.

[0128] Comparative Example 4

[0129] Commercially available enema solution (Huayu Sanjie enema solution)

[0130] Test Example 1

[0131] In this test case, we included 160 patients with colitis as the analysis objects, of which 115 were male patients and 35 were female patients. The age span of the patients was large, ranging from the youngest age of 27 to the highest age of 69 years old. The average age was calculated to be 46.5 years old, with a standard deviation of 11.2 years. All selected patients were diagnosed with ulcerative colitis through colonoscopy.

[0132] In order to compare the efficacy, we randomly and evenly allocated these 160 patients into 8 groups: a test group (Examples 1-3 and Comparative Examples 1-4) and a control group (normal saline).

[0133] For the patients in the experimental group, we adopted a specific enema treatment method. First, the patients were asked to empty their intestines before enema. Then, enema solution (maintained at a temperature between 18°C ​​and 25°C) was used, with a volume of about 85 mL each time. The patient took a left knee-bent lying position with the buttocks appropriately raised. The enema solution was slowly sent into the rectum about 8 cm deep through a disposable catheter, and the position was maintained for 15 minutes. This treatment process was performed once a day, and 20 consecutive times constituted a course of treatment.

[0134] After the treatment, the efficacy was determined according to the following criteria:

[0135] Cure: Clinical symptoms disappear, and colonoscopy examination shows that the mucosa is generally normal;

[0136] Effective: Clinical symptoms basically disappeared, and colonoscopy revealed mild inflammation of the mucosa;

[0137] Ineffective: No improvement in clinical symptoms, endoscopic and pathological examinations.

[0138] The results are shown in Table 1 and Figure 1-Figure 4 .

[0139] Table 1 Comparison of efficacy in colitis

[0140] cure efficient invalid Effectiveness (%) Example 1 15 5 0 100 Example 2 17 3 0 100 Example 3 17 2 1 95 Comparative Example 1 12 4 4 80 Comparative Example 2 9 3 8 60 Comparative Example 3 13 4 3 85 Comparative Example 4 10 6 4 80 Comparison Example 5 3 12 40

[0141] It can be seen from Table 1 above that the therapeutic efficacy of Examples 1-3 reached 100%, which is significantly higher than the results of the comparative examples and control examples, proving that the enema solution of the present invention has a good therapeutic effect on ulcerative colitis. From the comparison between Example 2 and Comparative Examples 1-3, it can be seen that the Chinese medicine combination of Coptis chinensis extract, Phellodendron chinense extract, and Pulsatilla scutellaria extract, as well as the active enzyme combination of pectinase, pancreatin and lactase, when used in combination with the Western medicine sulfasalazine and 5-aminosalicylic acid, can achieve good synergistic effects.

[0142] At the same time, we studied the cases cured in the above-mentioned Examples 1-3 and Comparative Examples 1-3 and tracked their recurrence rates. In Examples 1-3, 49 patients were cured, 5 of whom were lost, and the actual number of patients was 44; in Comparative Examples 1-3, 34 patients were cured, 3 of whom were lost, and the actual number of patients was 31. The results are shown in Table 2 below.

[0143] Table 2 Recurrence rate statistics.

[0144]

[0145] From the results in Table 2, it can be seen that the recurrence rate of the cured patients in Examples 1-3 within one year is only half of that in the control group. The enema treatment of the present invention has a relatively long-term and stable therapeutic effect.

[0146] In summary, the present invention proposes a composite enema solution for treating enteritis and a preparation method thereof; the composite enema solution realizes the organic combination of Chinese and Western medicine ingredients through scientific proportioning, and at the same time adds appropriate amounts of active enzymes and dissolution-promoting substances to improve the stability and bioavailability of the drug, ensuring that the drug can penetrate deeply into the lesion and exert the best therapeutic effect.

[0147] The above are limited to several preferred embodiments of the present invention, and the description is relatively specific and detailed, but it cannot be understood as limiting the scope of the present invention. It should be pointed out that for ordinary technicians in this field, several modifications and improvements can be made without departing from the concept of the present invention, which all belong to the protection scope of the present invention.

Claims

1. A compound enema solution for treating enteritis, characterized in that: This enema solution is a combination of Chinese and Western medicine, containing the following active ingredients: Traditional Chinese medicine ingredients: at least one plant extract having anti-inflammatory, antidiarrheal and intestinal regulating functions, preferably, the plant extract is selected from Coptis chinensis extract, Phellodendron chinense extract, Pulsatilla chinensis extract, Portulaca oleracea extract or a combination of any two or more thereof; Western medicine ingredients: comprising at least one Western medicine ingredient capable of inhibiting intestinal inflammation, relieving intestinal spasm and promoting intestinal mucosal repair. Preferably, the Western medicine ingredient is selected from at least one of sulfasalazine, 5-aminosalicylic acid, metronidazole, dexamethasone or pharmaceutically acceptable salts, esters and derivatives thereof; Active enzyme: comprising at least one active enzyme capable of decomposing harmful substances in the intestine, promoting the absorption of nutrients and enhancing intestinal immunity. Preferably, the active enzyme is selected from at least one of cellulase, pectinase, pancreatin or lactase; Solubility-promoting substance: at least one solubility-promoting substance capable of promoting drug penetration, enhancing drug stability and bioavailability. Preferably, the solubility-promoting substance is selected from at least one of glycerol, polyethylene glycol, lecithin or hyaluronic acid.

2. A compound enema solution for treating enteritis according to claim 1, characterized in that: The compound enema solution also includes auxiliary materials, which include a pH regulator and pure water.

3. A compound enema solution for treating enteritis according to claim 1, characterized in that: The traditional Chinese medicine ingredients consist of coptis root extract, phellodendron amurense extract and pulsatilla scabra extract.

4. A compound enema solution for treating enteritis according to claim 1, characterized in that: The western medicine component consists of sulfasalazine and 5-aminosalicylic acid.

5. The compound enema solution for treating enteritis according to claim 1, characterized in that: The active enzymes consist of pectinase, pancreatin and lactase.

6. A compound enema solution for treating enteritis according to claim 1, characterized in that: The dissolution-promoting substance consists of glycerol, lecithin and hyaluronic acid.

7. The compound enema solution for treating enteritis according to claim 1, characterized in that: The invention is composed of the following ingredients in percentage by mass: 0.5-1wt% of Coptis chinensis extract, 0.2-0.5wt% of Phellodendron chinense extract, 0.1-0.4wt% of Pulsatilla truncatula extract, 0.5-1wt% of sulfasalazine, 0.2-0.4wt% of 5-aminosalicylic acid, 3-6wt% of glycerol, 0.5-1wt% of lecithin, 2-4wt% of hyaluronic acid, appropriate amounts of active enzymes and pH regulators, and the balance is pure water.

8. The compound enema solution for treating enteritis according to claim 7, characterized in that: The enema solution contains 500-1000U / mL of pectinase, 300-500U / mL of pancreatic enzyme and 200-400U / mL of lactase.

9. The method for preparing the composite enema solution according to any one of claims 1 to 8, characterized in that: The following steps are involved: S1 Dissolution and Mixing: At room temperature, dissolve the coptis root extract, phellodendron amurense extract, pulsatilla scabra extract, sulfasalazine and 5-aminosalicylic acid in an appropriate amount of pure water; add glycerin, lecithin and hyaluronic acid to the above solution and stir evenly; S2 enzyme addition: At room temperature, slowly add pectinase, pancreatin and lactase to the above mixed solution, and control the adding speed to avoid excessive local concentration leading to enzyme inactivation; S3 pH Adjustment: At room temperature, use a pH adjuster to adjust the pH of the enema solution to pH 6.5-7.5; S4 Filtration Sterilization: Filter the enema solution through a 0.22 μm sterile filter membrane to remove bacteria and other impurities; S5 filling and packaging: Fill the sterilized enema solution into a sterile container.

10. The method for preparing the composite enema solution according to claim 9, characterized in that: The Rhizoma Coptidis extract is prepared by the following steps: (1) Raw material processing: The coptis root is cleaned to remove dirt and impurities on the surface, and the cleaned coptis root is crushed to obtain uniform coptis root powder; (2) Extraction: Adding coptis root powder into an extraction tank, adding 70%-80% volume concentration of ethanol aqueous solution, and performing reflux extraction; the extraction temperature is controlled within the range of 60-80° C., and after the extraction is completed, filtering is performed to obtain coptis root extract; (3) Concentration: The extracted Coptis chinensis extract was concentrated to 1.05-1.1 g / mL, and the excess solvent was removed; (4) Drying: The concentrated Coptis chinensis extract is dried by spray drying until the water content is less than 10%, thereby obtaining Coptis chinensis extract powder; (5) Crushing and screening: The dried Coptis chinensis extract powder is further ground and passed through a 200-400 mesh sieve to obtain the Coptis chinensis extract.

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