Pharmaceutical composition for treating enteritis as well as preparation method and application thereof

Abstract

The invention discloses a pharmaceutical composition for treating enteritis and a preparation method and application thereof, the composition comprises a plurality of effective components such as 5-aminosalicylic acid, metronidazole, berberine extract and the like, and the composition is prepared according to a specific weight ratio. Wherein the berberine extract is prepared through modern extraction methods such as enzymolysis pretreatment and ultrasonic extraction, and the release efficiency and purity of berberine are improved. The anti-inflammatory active polypeptide is obtained by compounding lactoferrin peptide and glutathione, and the zinc element supplement is formed by compounding zinc sulfate and zinc gluconate, so that the treatment effect of the medicine is enhanced. The invention also provides a preparation method of the pharmaceutical composition and an enteric capsule containing the composition. The pharmaceutical composition is especially suitable for treating autoimmune enteritis, and plays a therapeutic role through multiple mechanisms of regulating intestinal microecology, relieving inflammatory response, promoting intestinal mucosa repair and the like.

Description

Technical Field

[0001] The invention belongs to the field of biomedicine, and specifically discloses a pharmaceutical composition for treating enteritis, a preparation method and an application thereof. Background Art

[0002] Enteritis, as a widespread disease of the digestive system, has a complex and diverse pathogenesis, covering a variety of causes such as infectious (such as bacteria, viruses, parasites, fungi) and non-infectious (such as autoimmune). Among them, autoimmune enteritis, especially ulcerative colitis and Crohn's disease, has a relatively large difficulty in treatment because its pathogenesis involves abnormal reactions of the immune system, resulting in persistent damage to the intestinal mucosa, and has become a difficult problem in clinical practice.

[0003] Patients with autoimmune enteritis often face symptoms such as long-term abdominal pain, diarrhea, weight loss, and malnutrition, which seriously affect their quality of life. Existing treatments mainly include immunosuppressants (such as glucocorticoids, azathioprine, etc.), biological agents (such as anti-tumor necrosis factor-α antibodies), and symptomatic drugs. However, these drugs may have serious side effects, easy recurrence, high treatment costs, or require long-term medication to maintain a stable condition, which brings heavy economic and psychological burdens to patients.

[0004] In traditional treatments, anti-inflammatory drugs such as 5-aminosalicylic acid can alleviate intestinal inflammation to a certain extent, but it is difficult to fundamentally solve the root cause of autoimmune enteritis - abnormal activation of the immune system. At the same time, antibiotics such as metronidazole are effective in bacterial enteritis, but they are ineffective in autoimmune enteritis and may even aggravate intestinal flora imbalance due to abuse.

[0005] In recent years, with the in-depth study of intestinal microecology and immune regulation mechanisms, people have gradually realized that multi-target comprehensive treatment, such as regulating intestinal microecology, inhibiting abnormal immune responses, and promoting intestinal mucosal repair, may be an effective way to solve autoimmune enteritis. Therefore, the development of a drug composition that combines multiple effects such as anti-inflammatory, immune regulation, and intestinal mucosal protection has become a hot topic in current research.

[0006] In addition, the development of modern extraction technologies, such as enzymatic pretreatment and ultrasonic extraction, has made it possible to extract active ingredients from natural medicines efficiently and purely. The application of these technologies not only improves the purity and activity of drugs, but also reduces impurities and side effects, opening up new paths for drug research and development, especially natural drug research and development. Summary of the invention

[0007] In view of the shortcomings of the prior art, the present invention proposes a pharmaceutical composition for treating enteritis, a preparation method and an application thereof, especially for the treatment needs of autoimmune enteritis, combining a variety of ingredients with anti-inflammatory, immunomodulatory, intestinal mucosal protection and other effects, and adopts modern extraction technology to prepare key ingredients, aiming to provide a drug for treating enteritis with a scientific formula, significant efficacy and few side effects, bringing new treatment hope for patients with autoimmune enteritis.

[0008] The present invention includes the following technical solutions:

[0009] A pharmaceutical composition for treating enteritis, comprising the following components by weight:

[0010] 10 parts of 5-aminosalicylic acid

[0011] Metronidazole 2-10 parts

[0012] 3-15 parts of berberine extract

[0013] 1-8 parts of dipotassium glycyrrhizinate

[0014] 4-12 servings of Curcumin

[0015] Aloe polysaccharide 2-10 parts

[0016] Fucoidan 1-6 parts

[0017] 2-8 servings of Spirulina powder

[0018] 0.5-5 parts of peptides with anti-inflammatory activity

[0019] Zinc supplement 0.1-3 parts.

[0020] Furthermore, in the above-mentioned pharmaceutical composition for treating enteritis, the berberine extract is prepared by the following steps:

[0021] 1) Raw material preparation: fresh rhizomes of Coptis chinensis are selected as raw materials, cleaned, impurities removed, cut into pieces of appropriate size, dried, ground into powder and passed through a 50-mesh sieve;

[0022] 2) Enzymatic pretreatment: adding the coptis powder to a solution containing a specific enzyme preparation, wherein the enzyme preparation is selected from one or more combinations of cellulase, pectinase, and hemicellulase, and the enzymatic hydrolysis temperature is controlled at 30° C. to 50° C. for 1 to 4 hours to destroy the cell wall structure and improve the release efficiency of berberine;

[0023] 3) Ultrasonic extraction: Place the enzymatically hydrolyzed solution in an ultrasonic extractor, add an appropriate amount of extraction solvent ethanol, adjust the ultrasonic frequency to 20kHz to 40kHz, and extract for 10 minutes to 60 minutes, using the cavitation effect, mechanical vibration and thermal effect of ultrasound to promote the dissolution of berberine;

[0024] 4) Filtration and concentration: After the extraction is completed, the insoluble impurities are removed by filtering through 5 layers of gauze to obtain the berberine extract; then, the extract is concentrated to a suitable concentration by rotary evaporation;

[0025] 5) Purification and drying: The concentrated berberine extract is further purified by removing impurities through column chromatography and membrane separation technology to obtain a berberine extract with higher purity. The purified extract is vacuum dried to obtain a finished berberine extract.

[0026] Furthermore, in the above-mentioned pharmaceutical composition for treating enteritis, the solution in step 2) contains 200-400U / mL of cellulase, 100-200U / mL of pectinase, and 50-100U / mL of hemicellulase; the enzymolysis temperature is 37-40°C, and the enzymolysis time is 2h; the mass-to-volume ratio of the Coptis chinensis powder fish solution is 1:3-8g / mL.

[0027] Furthermore, in the above-mentioned pharmaceutical composition for treating enteritis, in the 3) ultrasonic extraction, the concentration of ethanol in the extract is 20% v / v; the volume of the solution is 10-20L, and the ultrasonic power is 500-1000W.

[0028] Furthermore, in the above-mentioned pharmaceutical composition for treating enteritis, the anti-inflammatory active polypeptide is obtained by compounding lactoferrin peptide and glutathione in a mass ratio of 2:1.

[0029] Furthermore, in the above-mentioned pharmaceutical composition for treating enteritis, the zinc supplement is obtained by compounding zinc sulfate and zinc gluconate in a mass ratio of 1:2.

[0030] The present invention also discloses a method for preparing the above-mentioned pharmaceutical composition, which is characterized by being prepared by the following steps:

[0031] Prepare the raw materials according to weight proportions, mix all the raw materials evenly, grind and crush them through a 100-mesh sieve, and use mechanical stirring or air flow mixing to ensure mixing uniformity; make the mixed raw materials into granules, and add appropriate amounts of ultrapure water and excipients, such as microcrystalline cellulose and lactose, to improve the formability and fluidity of the granules.

[0032] The invention also discloses an enteric-coated capsule for treating enteritis, which contains the above-mentioned pharmaceutical composition.

[0033] Furthermore, the above-mentioned enteric-coated capsule contains pharmaceutically acceptable excipients.

[0034] Furthermore, the present invention discloses the use of the above-mentioned pharmaceutical composition or enteric-coated capsule in the preparation of a method for treating autoimmune enteritis.

[0035] Compared with the prior art, the present invention has the following beneficial effects:

[0036] The present invention proposes a pharmaceutical composition for treating enteritis, a preparation method and an application thereof, which significantly improves the therapeutic effect by combining a variety of ingredients with anti-inflammatory, antibacterial, immunomodulatory and other effects, and conducting comprehensive treatment for a variety of pathogenesis of enteritis, especially for autoimmune enteritis. At the same time, by using precise ingredient ratios and modern extraction technology, the side effects of traditional therapeutic drugs, such as intestinal flora imbalance and increased drug resistance, are reduced, thereby improving the patient's treatment compliance and quality of life. In addition, specific ingredients in the pharmaceutical composition can also regulate intestinal microecology, help restore the balance of intestinal flora, enhance intestinal immunity, and further promote the recovery of enteritis and prevent recurrence. Advanced preparation processes, such as enzymatic pretreatment and ultrasonic extraction, are used to improve the purity and activity of the drug, reduce production costs, and provide a variety of dosage forms such as enteric-coated capsules to meet the medication needs of different patients. BRIEF DESCRIPTION OF THE DRAWINGS

[0037] Figure 1 Weight changes of mice in the test cases;

[0038] Figure 2 Changes in the DAI index of mice in the test case. DETAILED DESCRIPTION

[0039] A pharmaceutical composition for treating enteritis, comprising the following components by weight:

[0040] 10 parts of 5-aminosalicylic acid

[0041] Metronidazole 2-10 parts

[0042] 3-15 parts of berberine extract

[0043] 1-8 parts of dipotassium glycyrrhizinate

[0044] 4-12 servings of Curcumin

[0045] Aloe polysaccharide 2-10 parts

[0046] Fucoidan 1-6 parts

[0047] 2-8 servings of Spirulina powder

[0048] 0.5-5 parts of peptides with anti-inflammatory activity

[0049] Zinc supplement 0.1-3 parts.

[0050] The berberine extract is prepared by the following steps:

[0051] 1) Raw material preparation: fresh rhizomes of Coptis chinensis are selected as raw materials, cleaned, impurities removed, cut into pieces of appropriate size, dried, ground into powder and passed through a 50-mesh sieve;

[0052] 2) Enzymatic pretreatment: adding the coptis powder to a solution containing a specific enzyme preparation, wherein the enzyme preparation is selected from one or more combinations of cellulase, pectinase, and hemicellulase, and the enzymatic hydrolysis temperature is controlled at 30° C. to 50° C. for 1 to 4 hours to destroy the cell wall structure and improve the release efficiency of berberine;

[0053] 3) Ultrasonic extraction: Place the enzymatically hydrolyzed solution in an ultrasonic extractor, add an appropriate amount of extraction solvent ethanol, adjust the ultrasonic frequency to 20kHz to 40kHz, and extract for 10 minutes to 60 minutes, using the cavitation effect, mechanical vibration and thermal effect of ultrasound to promote the dissolution of berberine;

[0054] 4) Filtration and concentration: After the extraction is completed, the insoluble impurities are removed by filtering through 5 layers of gauze to obtain the berberine extract; then, the extract is concentrated to a suitable concentration by rotary evaporation;

[0055] 5) Purification and drying: The concentrated berberine extract is further purified by removing impurities through column chromatography and membrane separation technology to obtain a berberine extract with higher purity. The purified extract is vacuum dried to obtain a finished berberine extract.

[0056] The solution in step 2) contains 300 U / mL of cellulase, 150 U / mL of pectinase, and 75 U / mL of hemicellulase; the enzymolysis temperature is 37-40° C., and the enzymolysis time is 2 hours; the mass-to-volume ratio of the coptis chinensis powder fish solution is 1:5 g / mL.

[0057] In the ultrasonic extraction 3), the concentration of ethanol in the extract is 20% v / v; the solution is 15 L, and the ultrasonic power is 750 W.

[0058] The anti-inflammatory active polypeptide is obtained by compounding lactoferrin peptide and glutathione in a mass ratio of 2:1.

[0059] The zinc element supplement is obtained by compounding zinc sulfate and zinc gluconate in a mass ratio of 1:2.

[0060] The preparation method of the above-mentioned pharmaceutical composition is prepared by the following steps:

[0061] Prepare the raw materials according to weight proportions, mix all the raw materials evenly, grind and crush them through a 100-mesh sieve, and use mechanical stirring or air flow mixing to ensure mixing uniformity; make the mixed raw materials into granules, and add appropriate amounts of ultrapure water and excipients, such as microcrystalline cellulose and lactose, to improve the formability and fluidity of the granules.

[0062] 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.

[0063] Example 1

[0064] A pharmaceutical composition for treating enteritis, comprising the following components by weight:

[0065] 10 parts of 5-aminosalicylic acid

[0066] Metronidazole 2 parts

[0067] 3 parts of berberine extract

[0068] 1 part dipotassium glycyrrhizinate

[0069] 4 parts of curcumin

[0070] 2 parts of aloe polysaccharide

[0071] 1 portion of Fucoidan

[0072] 2 servings of Spirulina powder

[0073] 0.5 parts of peptides with anti-inflammatory activity

[0074] Zinc supplement 0.1 parts.

[0075] The berberine extract is prepared by the following steps:

[0076] 1) Raw material preparation: fresh rhizomes of Coptis chinensis are selected as raw materials, cleaned, impurities removed, cut into pieces of appropriate size, dried, ground into powder and passed through a 50-mesh sieve;

[0077] 2) Enzymatic pretreatment: adding the coptis powder to a solution containing a specific enzyme preparation, wherein the enzyme preparation is selected from one or more combinations of cellulase, pectinase, and hemicellulase, and the enzymatic hydrolysis temperature is controlled at 30° C. to 50° C. for 1 to 4 hours to destroy the cell wall structure and improve the release efficiency of berberine;

[0078] 3) Ultrasonic extraction: Place the enzymatically hydrolyzed solution in an ultrasonic extractor, add an appropriate amount of extraction solvent ethanol, adjust the ultrasonic frequency to 20kHz to 40kHz, and extract for 10 minutes to 60 minutes, using the cavitation effect, mechanical vibration and thermal effect of ultrasound to promote the dissolution of berberine;

[0079] 4) Filtration and concentration: After the extraction is completed, the insoluble impurities are removed by filtering through 5 layers of gauze to obtain the berberine extract; then, the extract is concentrated to a suitable concentration by rotary evaporation;

[0080] 5) Purification and drying: The concentrated berberine extract is further purified by removing impurities through column chromatography and membrane separation technology to obtain a berberine extract with higher purity. The purified extract is vacuum dried to obtain a finished berberine extract.

[0081] The solution in step 2) contains 300 U / mL of cellulase, 150 U / mL of pectinase, and 75 U / mL of hemicellulase; the enzymolysis temperature is 37-40° C., and the enzymolysis time is 2 hours; the mass-to-volume ratio of the coptis chinensis powder fish solution is 1:5 g / mL.

[0082] In the ultrasonic extraction 3), the concentration of ethanol in the extract is 20% v / v; the solution is 15 L, and the ultrasonic power is 750 W.

[0083] The anti-inflammatory active polypeptide is obtained by compounding lactoferrin peptide and glutathione in a mass ratio of 2:1.

[0084] The zinc element supplement is obtained by compounding zinc sulfate and zinc gluconate in a mass ratio of 1:2.

[0085] Example 2

[0086] A pharmaceutical composition for treating enteritis, comprising the following components by weight:

[0087] 10 parts of 5-aminosalicylic acid

[0088] Metronidazole 5 parts

[0089] Berberine Extract 10 parts

[0090] 4 parts of dipotassium glycyrrhizinate

[0091] 8 servings of Curcumin

[0092] Aloe polysaccharide 5 parts

[0093] 3 parts of Fucoidan

[0094] 4 servings of Spirulina powder

[0095] 2.5 servings of peptides with anti-inflammatory activity

[0096] 1 serving of zinc supplement.

[0097] The berberine extract is prepared by the following steps:

[0098] 1) Raw material preparation: fresh rhizomes of Coptis chinensis are selected as raw materials, cleaned, impurities removed, cut into pieces of appropriate size, dried, ground into powder and passed through a 50-mesh sieve;

[0099] 2) Enzymatic pretreatment: adding the coptis powder to a solution containing a specific enzyme preparation, wherein the enzyme preparation is selected from one or more combinations of cellulase, pectinase, and hemicellulase, and the enzymatic hydrolysis temperature is controlled at 30° C. to 50° C. for 1 to 4 hours to destroy the cell wall structure and improve the release efficiency of berberine;

[0100] 3) Ultrasonic extraction: Place the enzymatically hydrolyzed solution in an ultrasonic extractor, add an appropriate amount of extraction solvent ethanol, adjust the ultrasonic frequency to 20kHz to 40kHz, and extract for 10 minutes to 60 minutes, using the cavitation effect, mechanical vibration and thermal effect of ultrasound to promote the dissolution of berberine;

[0101] 4) Filtration and concentration: After the extraction is completed, the insoluble impurities are removed by filtering through 5 layers of gauze to obtain the berberine extract; then, the extract is concentrated to a suitable concentration by rotary evaporation;

[0102] 5) Purification and drying: The concentrated berberine extract is further purified by removing impurities through column chromatography and membrane separation technology to obtain a berberine extract with higher purity. The purified extract is vacuum dried to obtain a finished berberine extract.

[0103] The solution in step 2) contains 300 U / mL of cellulase, 150 U / mL of pectinase, and 75 U / mL of hemicellulase; the enzymolysis temperature is 37-40° C., and the enzymolysis time is 2 hours; the mass-to-volume ratio of the coptis chinensis powder fish solution is 1:5 g / mL.

[0104] In the ultrasonic extraction 3), the concentration of ethanol in the extract is 20% v / v; the solution is 15 L, and the ultrasonic power is 750 W.

[0105] The anti-inflammatory active polypeptide is obtained by compounding lactoferrin peptide and glutathione in a mass ratio of 2:1.

[0106] The zinc element supplement is obtained by compounding zinc sulfate and zinc gluconate in a mass ratio of 1:2.

[0107] Example 3

[0108] A pharmaceutical composition for treating enteritis, comprising the following components by weight:

[0109] 10 parts of 5-aminosalicylic acid

[0110] Metronidazole 10 parts

[0111] Berberine Extract 15 parts

[0112] 8 parts of dipotassium glycyrrhizinate

[0113] Curcumin 12 parts

[0114] Aloe polysaccharide 10 parts

[0115] 6 portions of Fucoidan

[0116] 8 servings of Spirulina powder

[0117] 5 servings of peptides with anti-inflammatory activity

[0118] 3 servings of zinc supplement.

[0119] The berberine extract is prepared by the following steps:

[0120] 1) Raw material preparation: fresh rhizomes of Coptis chinensis are selected as raw materials, cleaned, impurities removed, cut into pieces of appropriate size, dried, ground into powder and passed through a 50-mesh sieve;

[0121] 2) Enzymatic pretreatment: adding the coptis powder to a solution containing a specific enzyme preparation, wherein the enzyme preparation is selected from one or more combinations of cellulase, pectinase, and hemicellulase, and the enzymatic hydrolysis temperature is controlled at 30° C. to 50° C. for 1 to 4 hours to destroy the cell wall structure and improve the release efficiency of berberine;

[0122] 3) Ultrasonic extraction: Place the enzymatically hydrolyzed solution in an ultrasonic extractor, add an appropriate amount of extraction solvent ethanol, adjust the ultrasonic frequency to 20kHz to 40kHz, and extract for 10 minutes to 60 minutes, using the cavitation effect, mechanical vibration and thermal effect of ultrasound to promote the dissolution of berberine;

[0123] 4) Filtration and concentration: After the extraction is completed, the insoluble impurities are removed by filtering through 5 layers of gauze to obtain the berberine extract; then, the extract is concentrated to a suitable concentration by rotary evaporation;

[0124] 5) Purification and drying: The concentrated berberine extract is further purified by removing impurities through column chromatography and membrane separation technology to obtain a berberine extract with higher purity. The purified extract is vacuum dried to obtain a finished berberine extract.

[0125] The solution in step 2) contains 300 U / mL of cellulase, 150 U / mL of pectinase, and 75 U / mL of hemicellulase; the enzymolysis temperature is 37-40° C., and the enzymolysis time is 2 hours; the mass-to-volume ratio of the coptis chinensis powder fish solution is 1:5 g / mL.

[0126] In the ultrasonic extraction 3), the concentration of ethanol in the extract is 20% v / v; the solution is 15 L, and the ultrasonic power is 750 W.

[0127] The anti-inflammatory active polypeptide is obtained by compounding lactoferrin peptide and glutathione in a mass ratio of 2:1.

[0128] The zinc element supplement is obtained by compounding zinc sulfate and zinc gluconate in a mass ratio of 1:2.

[0129] Comparative Example 1

[0130] A pharmaceutical composition for treating enteritis, which does not contain berberine extract and curcumin, and is the same as Example 2 in other respects.

[0131] Comparative Example 2

[0132] A pharmaceutical composition for treating enteritis, which does not contain aloe polysaccharide, fucoidan and spirulina powder, and the rest is the same as Example 2.

[0133] Comparative Example 3

[0134] A pharmaceutical composition for treating enteritis, which does not contain a polypeptide with anti-inflammatory activity, and is otherwise the same as Example 2.

[0135] Comparative Example 4

[0136] A pharmaceutical composition for treating enteritis, wherein the polypeptide contains only glutathione, and the rest is the same as in Example 2 above.

[0137] Comparative Example 5

[0138] The active ingredient in commercially available Changyanning capsules.

[0139] Test Case

[0140] Efficacy in mice with ulcerative colitis

[0141] 1) Establishment of ulcerative colitis model

[0142] C57BL / 6 male mice weighing 20-25 g were selected, and the internationally accepted ulcerative colitis modeling method was used. After the mice were adaptively raised for one week, 3% DSS solution was freely drunk for 7 days to induce the ulcerative colitis model.

[0143] 2) Grouping:

[0144] (No modeling) Negative control group (10 rats) were allowed to eat freely and were gavaged with normal saline (2 mL);

[0145] The positive control group (10 mice) was given 3% DSS solution and fed ad libitum. At the same time, the mice were gavaged with normal saline (2 mL).

[0146] The experimental group (10 mice in each group) was given 3% DSS solution and ad libitum diet, and drug was administered intragastricly (2 mL, 2 mg / mL).

[0147] 3) Testing:

[0148] On the 10th day of treatment, the average body weight of mice in each group was measured, and the DAI index of mice was calculated (2, 4, 8, 10 days)

[0149] The results are as follows Figure 1-2 And as shown in Table 1.

[0150] Table 1 The efficacy on ulcerative colitis mice

[0151] Weight (g) DAI Index(2) DAI Index(4) DAI Index(8) DAI Index(10) Negative control group 28.2 0.000 0.000 0.000 0.000 Positive control group 18.3 0.563 1.455 2.982 4.231 Example 1 24.8 0.343 0.762 1.212 0.862 Example 2 25.7 0.294 0.645 1.182 0.754 Example 3 26.4 0.282 0.623 1.083 0.673 Comparative Example 1 21.8 0.543 1.232 1.567 2.048 Comparative Example 2 20.9 0.598 1.321 1.437 1.873 Comparative Example 3 22.1 0.432 0.843 1.546 1.032 Comparative Example 4 23.7 0.394 0.984 1.344 0.934 Comparative Example 5 22.3 0.465 1.321 2.302 1.832

[0152] From the data in Table 1 above, it can be seen that the pharmaceutical composition prepared by the present invention can significantly improve the weight suppression of mice with ulcerative colitis. From the comparison between Examples 1-3 and Comparative Examples 1-5, it can be seen that the combination of berberine and curcumin, the combination of aloe polysaccharide, fucoidan and spirulina powder, and the combination of lactoferrin peptide and glutathione can all synergistically increase the weight of mice with ulcerative colitis. The same conclusion can be drawn from the DAI index of mice. The present invention combines a variety of ingredients with anti-inflammatory, antibacterial, and immunomodulatory effects, and comprehensively treats a variety of pathogenesis of enteritis, especially autoimmune enteritis, to significantly improve the therapeutic effect.

[0153] 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 pharmaceutical composition for treating enteritis, characterized in that: The following ingredients are included by weight: 10 parts of 5-aminosalicylic acid Metronidazole 2-10 parts 3-15 parts of berberine extract 1-8 parts of dipotassium glycyrrhizinate 4-12 servings of Curcumin Aloe polysaccharide 2-10 parts Fucoidan 1-6 parts 2-8 servings of Spirulina powder 0.5-5 parts of peptides with anti-inflammatory activity Zinc supplement 0.1-3 parts.

2. The pharmaceutical composition for treating enteritis according to claim 1, characterized in that: The berberine extract is prepared by the following steps: 1) Raw material preparation: fresh rhizomes of Coptis chinensis are selected as raw materials, cleaned, impurities removed, cut into pieces of appropriate size, dried, ground into powder and passed through a 50-mesh sieve; 2) Enzymatic pretreatment: adding the coptis powder to a solution containing a specific enzyme preparation, wherein the enzyme preparation is selected from one or more combinations of cellulase, pectinase, and hemicellulase, and the enzymatic hydrolysis temperature is controlled at 30° C. to 50° C. for 1 to 4 hours to destroy the cell wall structure and improve the release efficiency of berberine; 3) Ultrasonic extraction: Place the enzymatically hydrolyzed solution in an ultrasonic extractor, add an appropriate amount of extraction solvent ethanol, adjust the ultrasonic frequency to 20kHz to 40kHz, and extract for 10 minutes to 60 minutes, using the cavitation effect, mechanical vibration and thermal effect of ultrasound to promote the dissolution of berberine; 4) Filtration and concentration: After the extraction is completed, the insoluble impurities are removed by filtering through 5 layers of gauze to obtain the berberine extract; then, the extract is concentrated to a suitable concentration by rotary evaporation; 5) Purification and drying: The concentrated berberine extract is further purified by removing impurities through column chromatography and membrane separation technology to obtain a berberine extract with higher purity. The purified extract is vacuum dried to obtain a finished berberine extract.

3. The pharmaceutical composition for treating enteritis according to claim 2, characterized in that: The solution in step 2) contains 200-400 U / mL of cellulase, 100-200 U / mL of pectinase, and 50-100 U / mL of hemicellulase; the enzymolysis temperature is 37-40°C, and the enzymolysis time is 2 hours; the mass-to-volume ratio of the coptis chinensis powder fish solution is 1:3-8 g / mL.

4. The pharmaceutical composition for treating enteritis according to claim 2, characterized in that: In the above 3) ultrasonic extraction, the concentration of ethanol in the extract is 20% v / v; the volume of the extract is 10-20 L, and the ultrasonic power is 500-1000 W.

5. The pharmaceutical composition for treating enteritis according to claim 1, characterized in that: The anti-inflammatory active polypeptide is obtained by compounding lactoferrin peptide and glutathione in a mass ratio of 2:

1.

6. The pharmaceutical composition for treating enteritis according to claim 1, characterized in that: The zinc element supplement is obtained by compounding zinc sulfate and zinc gluconate in a mass ratio of 1:

2.

7. The method for preparing the pharmaceutical composition according to any one of claims 1 to 6, characterized in that: Prepared by the following steps: Prepare the raw materials according to weight proportions, mix all the raw materials evenly, grind and crush them through a 100-mesh sieve, and use mechanical stirring or air flow mixing to ensure mixing uniformity; make the mixed raw materials into granules, and add appropriate amounts of ultrapure water and excipients, such as microcrystalline cellulose and lactose, to improve the formability and fluidity of the granules.

8. An enteric-coated capsule for treating enteritis, characterized in that: A pharmaceutical composition comprising the pharmaceutical composition according to any one of claims 1 to 6.

9. The enteric-coated capsule according to claim 8, characterized in that: Contains pharmaceutically acceptable excipients.

10. Use of the pharmaceutical composition according to any one of claims 1 to 6 in the preparation of a drug for treating autoimmune enteritis.

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