Anti-ulcerative colitis pharmaceutical composition containing liquiritin and atractylenolide I

Abstract

The invention relates to the technical field of medicines, in particular to an anti-ulcerative colitis pharmaceutical composition containing liquiritin and atractylenolide I. The pharmaceutical composition comprises active components or pharmaceutically acceptable salts, tautomers, stereoisomers and pharmaceutic adjuvants of the active components, and the active components comprise liquiritin and atractylenolide I. The invention further provides a preparation method of the anti-ulcerative colitis pharmaceutical composition containing liquiritin and atractylenolide I. Compared with the prior art, the invention firstly discloses that the combination of liquiritin and atractylenolide I has obvious curative effects on improving intestinal tissue lesion of ulcerative colitis disease, reducing sexual cell infiltration of colitis and improving colon and cecum states of UC mice, has no toxic or side effect, is not easy to generate tolerance, and has no toxic or side effect. The discovery has great influence on the research and treatment of ulcerative colitis diseases, and has clinical practical value.

Description

Technical Field

[0001] The present invention relates to the field of pharmaceutical technology, and particularly relates to an anti-ulcerative colitis pharmaceutical composition containing liquiritin and atractylenolide I. Background Art

[0002] Inflammatory bowel disease (IBD) is a group of non-specific chronic gastrointestinal inflammatory diseases, the etiology and pathogenesis of which have not been fully elucidated. Clinically, it is divided into two categories: Crohn's disease (CD) and ulcerative colitis (UC). Crohn's disease, also known as segmental colitis, granulomatous ileitis or ileocolitis, is characterized by lesions mostly in the terminal ileum and adjacent colon, but the entire digestive tract from the mouth to the anus can be involved, showing segmental or skip distribution. Clinically, it is characterized by diarrhea, abdominal pain, weight loss, abdominal mass, fistula formation and intestinal obstruction, and may be accompanied by extraintestinal lesions such as fever, anemia, nutritional disorders, and joint, skin, eye, oral mucosa, liver, etc. Ulcerative colitis is a chronic non-specific inflammatory disease of the colon and rectum, with lesions limited to the large intestine mucosa and submucosa. The lesions are mostly located in the sigmoid colon and rectum, and can also extend to the descending colon or even the entire colon. The course of the disease is long and often relapses. The clinical symptoms are mainly diarrhea, discharging stools containing blood, pus and mucus, often accompanied by paroxysmal colonic spasm pain, tenesmus, and relief after defecation.

[0003] Currently, Western medicine often selects aminosalicylate preparations, such as sulfasalazine and mesalazine, for the treatment of inflammatory bowel disease. According to different severities, immunosuppressants are usually used to relieve symptoms, such as prednisone, azathioprine, methotrexate, 6-mercaptopurine, etc. Steroid drugs are also often used to control the sudden onset of the disease and have been used as maintenance agents. The above drugs have obvious limitations in action and obvious adverse reactions. Long-term use will reduce the tolerance of patients. The traditional Chinese medicine treatment of ulcerative colitis has a long history in China, and modern research has also confirmed that many Chinese herbal medicines have the effect of anti-ulcerative colitis, especially the classical prescriptions in traditional medicine, which have been clinically verified for thousands of years and have definite curative effects. However, due to the direct decoction of traditional prescriptions, the ingredients are complex and unclear, making it difficult to carry out quality control; some modern dosage forms are mostly crude extracts, with relatively low effective ingredient content, and have disadvantages such as large dosage and insignificant curative effect. Based on literature research and the research accumulation of the research group, in this study, liquiritin and atractylenolide I were combined and used to control inflammatory bowel disease, and relevant research was carried out, which is of great significance for the development of anti-ulcerative colitis drugs. Summary of the Invention

[0004] In view of the deficiencies of the prior art, the present invention combines liquiritin and atractylenolide I and conducts a bioactivity study on them, and finds that it can improve the state of the colon and cecum of UC mice, increase the colon length, and reduce the infiltration of inflammatory cells in the colon, thereby improving the pathological changes of UC intestinal tissue.

[0005] One of the purposes of the present invention is to provide a pharmaceutical composition for treating ulcerative colitis, which includes an active ingredient or its pharmaceutically acceptable salt, tautomer, stereoisomer and pharmaceutical excipients. Among them, the active ingredient is composed of liquiritin and atractylenolide I.

[0006] Further, the weight ratio of liquiritin to atractylenolide I is (1-10):(1-10); or (1-10):(1-5); or (1-10):(1-3); or (1-5):1; or (1-3):1; or 1:1.

[0007] Further, the active ingredient can be separately applied to the preparation of the pharmaceutical composition and can be used in combination with other components having anti-inflammatory activity. Among them, the active ingredient is composed of liquiritin and atractylenolide I.

[0008] Further, the pharmaceutical composition does not contain other active ingredients having anti-inflammatory activity except liquiritin and atractylenolide I.

[0009] Further, the excipients include one or more of solvents, disintegrants, flavoring agents, preservatives, colorants, binders, lubricants, diluents and drug carriers.

[0010] Further, the excipients include one or more of solvents, disintegrants, flavoring agents, preservatives, colorants, binders, lubricants, diluents and drug carriers.

[0011] Those skilled in the art fully understand that excipients (such as pharmaceutical excipients) include solvents, propellants, solubilizers, cosolvents, emulsifiers, colorants, binders, disintegrants, fillers, lubricants, wetting agents, osmotic pressure regulators, stabilizers, glidants, flavoring agents, preservatives, suspending agents, coating materials, fragrances, antiadhesives, chelating agents, penetration enhancers, pH regulators, buffers, plasticizers, surfactants, foaming agents, defoaming agents, thickeners, clathrates, humectants, absorbents, diluents, flocculants and deflocculants, filter aids, and release retardants.

[0012] Among them, the diluent can be mannitol, sucrose, lactose, sorbitol, xylitol, polyethylene glycol, propylene One or more of diols, vegetable oils, and mineral oils; the disintegrant can be one or more of sodium carboxymethylcellulose cross-linked, colloidal silica, and citric acid; the binder can be one or more of starch paste, ethanol, water, and polyvinylpyrrolidone solution; the preservative can be one or more of ethyl p-hydroxybenzoate, propyl hydroxybenzoate, sorbic acid, potassium sorbate, calcium propionate, sodium dehydroacetate, sodium diacetate, and sodium lactate; the antioxidant can be one or more of ethylenediaminetetraacetic acid, disodium ethylenediaminetetraacetate, dibutylhydroxytoluene, glycine, inositol, ascorbic acid, sodium ascorbate, lecithin, malic acid, hydroquinone, citric acid, succinic acid, and sodium metabisulfite; the flavoring agent can be one or more of aspartame, sucrose, xylitol, steviol glycosides, sodium cyclamate, sorbitol, cocoa, pure vanilla, vanillin, ethyl vanillin, chocolate, malt, and mint; the suspending agent can be one or more of xanthan gum, polyvinylpyrrolidone, sodium alginate, aluminum stearate, and hydrogenated vegetable oil; the emulsifier can be one or more of alkyl sulfates, soaps, dodecylbenzenesulfonates, lactate esters, sulfosuccinate esters, monoglyceride sulfonates, phosphate esters, siloxanes, and taurates.

[0013] Furthermore, the dosage form includes any one of tablets, capsules, pills, powders, ointments, pills, suspensions, powders, injections, sustained-release preparations, and controlled-release preparations.

[0014] Among them, the drug is administered through gastrointestinal and non-gastrointestinal administration routes.

[0015] In particular, the non-gastrointestinal administration route is selected from injection administration, respiratory administration, skin administration, mucosal administration, or cavity administration.

[0016] Among them, the non-gastrointestinal administration preparations are selected from injections, sprays, aerosols, patches, etc.

[0017] In particular, the gastrointestinal administration preparations are selected from tablets, capsules, powders, granules, pills, solutions, emulsions, or syrups, etc.

[0018] Furthermore, the drug with hypoglycemic activity provided by the present invention can be used in combination with components having other hypoglycemic activities.

[0019] The pharmaceutical composition of the invention contains 0.1 - 90%wt of the active ingredient.

[0020] The pharmaceutical composition can be prepared according to methods known in the art. For this purpose, if necessary, the active ingredient can be combined with one or more solid or liquid pharmaceutical excipients and / or adjuvants to form a suitable administration form or dosage form for human use.

[0021] In addition, if necessary, colorants, preservatives, flavors, flavor correctors, sweeteners or other materials can also be added to the pharmaceutical preparation.

[0022] The second object of the present invention is to provide the use of liquiritin and atractylenolide I in the preparation of a pharmaceutical composition for treating ulcerative colitis, wherein the weight ratio of liquiritin to atractylenolide I is (1 - 10):(1 - 10); In some specific embodiments, the weight ratio of liquiritin to atractylenolide I is (1 - 10):(1 - 5); in some specific embodiments, the weight ratio of liquiritin to atractylenolide I is (1 - 10):(1 - 3); in some specific embodiments, the weight ratio of liquiritin to atractylenolide I is (1 - 5):1; In some specific embodiments, the weight ratio of liquiritin to atractylenolide I is (1 - 3):1; In some preferred embodiments, the weight ratio of liquiritin to atractylenolide I is 1:1.

[0023] Furthermore, the following uses are also within the protection scope of the present invention: Liquiritin and atractylenolide I as active ingredients can be jointly used in the preparation of the pharmaceutical composition, or can be compounded with other components having anti-inflammatory activity; The pharmaceutical composition does not contain other active ingredients having anti-inflammatory activity except liquiritin and atractylenolide I; The pharmaceutical composition uses liquiritin and atractylenolide I as active ingredients and is made into a pharmaceutically acceptable dosage form with pharmaceutically acceptable excipients.

[0024] Furthermore, the excipients include one or more of solvents, disintegrants, flavor correctors, preservatives, colorants, binders, lubricants, diluents and drug carriers.

[0025] Those skilled in the art fully understand that excipients (such as pharmaceutical excipients) include solvents, propellants, solubilizers, cosolvents, emulsifiers, colorants, binders, disintegrants, fillers, lubricants, wetting agents, osmotic pressure regulators, stabilizers, glidants, flavor correctors, preservatives, suspending agents, coating materials, fragrances, antiadhesives, chelating agents, penetration enhancers, pH value regulators, buffers, plasticizers, surfactants, foaming agents, defoaming agents, thickeners, clathrates, humectants, absorbents, diluents, flocculants and deflocculants, filter aids, and release retardants.

[0026] Among them, the diluent can be mannitol, sucrose, lactose, sorbitol, xylitol, polyethylene glycol, propylene One or more of diols, vegetable oils, and mineral oils; the disintegrant can be one or more of croscarmellose sodium, colloidal silicon dioxide, and citric acid; the binder can be one or more of starch paste, ethanol, water, and povidone alcohol solution; the preservative can be one or more of ethyl p-hydroxybenzoate, propyl hydroxybenzoate, sorbic acid, potassium sorbate, calcium propionate, sodium dehydroacetate, sodium diacetate, and sodium lactate; the antioxidant can be one or more of ethylenediaminetetraacetic acid, disodium ethylenediaminetetraacetate, dibutylhydroxytoluene, glycine, inositol, ascorbic acid, sodium ascorbate, lecithin, malic acid, hydroquinone, citric acid, succinic acid, and sodium metabisulfite; the flavoring agent can be one or more of aspartame, sucrose, xylitol, stevioside, sodium cyclamate, sorbitol, cocoa, pure vanilla, vanillin, ethyl vanillin, chocolate, malt, and mint; the suspending agent can be one or more of xanthan gum, polyvinylpyrrolidone, sodium alginate, aluminum stearate, and hydrogenated vegetable oil; the emulsifier can be one or more of alkyl sulfates, soaps, dodecylbenzenesulfonates, lactate esters, sulfosuccinates, monoglyceride sulfonates, phosphate esters, siloxanes, and taurates.

[0027] The dosage of the pharmaceutical composition of the present invention depends on many factors, such as the sex, age, weight, and individual response of the patient or animal, the route of administration, and the frequency of administration. The above dosage can be administered in a single dosage form or divided into several, for example, two, three, or four dosage forms. The dosage level must be selected according to the specific route of administration, the severity of the condition being treated, and the condition and medical history of the patient to be treated. However, it is the practice in the art to start with a dosage lower than the level required to achieve the desired therapeutic effect and gradually increase the dosage until the desired effect is obtained.

[0028] It should be recognized that the total daily dosage of the pharmaceutical composition of the present invention must be determined by the attending physician within the scope of sound medical judgment. For any specific patient, the specific therapeutically effective dosage level must depend on a variety of factors, including the disorder being treated and the severity of that disorder; the specific composition employed; the age, weight, general health, sex, and diet of the patient; the time of administration, route of administration, and excretion rate; the duration of treatment; the drugs used in combination with or concurrently with; and similar factors well known in the medical art. For example, it is the practice in the art to start with a dosage lower than the level required to achieve the desired therapeutic effect and gradually increase the dosage until the desired effect is obtained.

[0029] Generally speaking, the pharmaceutical composition of the present invention is used in mammals, especially humans, in terms of the active ingredient The dosage can be between 1 - 1000 mg / kg body weight / day, such as between 1 - 500 mg / kg body weight / day, such as between 50 - 500 mg / kg body weight / day, or 100 - 500 mg / kg, or 150 - 500 mg / kg, or 200 - 500 mg / kg, or 250 - 500 mg / kg.

[0030] Compared with the prior art, the present invention for the first time discloses that the combination of liquiritin and atractylenolide I has a significant curative effect on improving intestinal tissue lesions of ulcerative colitis, reducing infiltration of inflammatory cells in the colon, and improving the states of the colon and cecum of UC mice, and has no toxic side effects and is not prone to produce tolerance. This discovery will have a significant impact on the research and treatment of ulcerative colitis and has clinical practical value. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] Figure 1 Effect of the present invention on the disease activity index of UC mice; 1A is a graph of the change in mouse body weight; 1B is a graph of the change in the disease activity index of mice; Figure 2 Effect of the present invention on the intestinal tissue morphology of UC mice; 2A is a graph of the colon state of mice; 2B is a graph of the change in the colon length of mice; compared with the normal control group, #P < 0.05, P < 0.001; compared with the model group, *P < 0.05 Figure 3 Graph of the HE staining result of the intestinal tissue of mice of the present invention; Figure 4 Graph of the alcian blue staining of the intestinal tissue of mice of the present invention; Figure 5 Effect of the present invention on the spleen index of mice; 5A is a graph of the change in the food intake of mice; 5B is a graph of the change in the water intake of mice; 5C is a graph of the change in the spleen index of mice; compared with the normal control group, P < 0.001; compared with the model group, *P < 0.05, **P < 0.01. DETAILED DESCRIPTION OF THE INVENTION

[0032] To enable those skilled in the art to better understand the technical solution of the present invention, the present invention will be described in detail below in conjunction with specific embodiments. The experimental methods without specific conditions noted in the following examples are generally in accordance with conventional conditions or conditions recommended by the manufacturer. The test materials used in the following examples are, unless otherwise specified, obtained from regular biochemical reagent stores. Unless otherwise stated, percentages and parts are calculated by weight. Unless otherwise defined, all professional and scientific terms used herein have the same meaning as those familiar to those skilled in the art. In addition, any methods and materials similar or equivalent to the described content can be applied to the present invention. The preferred implementation methods and materials described herein are for illustrative purposes only.

[0033] In the ranges disclosed herein, the endpoints and any values are not limited to the exact ranges or values. These ranges or values should be understood to include values close to these ranges or values. For numerical ranges, between the endpoint values of each range, between the endpoint values and individual point values of each range, and between individual point values, they can be combined with each other to obtain one or more new numerical ranges, and these numerical ranges should be regarded as specifically disclosed herein.

[0034] The technical solution of the present invention will be further described in detail below in conjunction with specific embodiments and drawings. It should be understood that the following embodiments are only used to explain the present invention and are not used to limit the present invention.

[0035] Example 1 25 parts by weight of liquiritin and 25 parts by weight of atractylenolide I.

[0036] Example 2 40 parts by weight of liquiritin and 10 parts by weight of atractylenolide I.

[0037] Example 3 35 parts by weight of liquiritin and 15 parts by weight of atractylenolide I.

[0038] Example 4 30 parts by weight of liquiritin and 20 parts by weight of atractylenolide I.

[0039] Example 5 45 parts by weight of liquiritin and 5 parts by weight of atractylenolide I.

[0040] Investigate the synergistic protective effect of the traditional Chinese medicine composition on DSS-induced anti-ulcerative colitis mice The experimental data were described as mean ± standard deviation or median (interquartile range). SPSS software was used for statistical analysis of the data. One-way analysis of variance was used when multiple groups of data conformed to a normal distribution, and LSD or Tamhenian T2 test was used for pairwise comparison; when the data did not conform to a normal distribution, non-parametric rank sum test such as Kruskal-Wallis test was used. P < 0.05 was considered statistically significant.

[0041] Experimental animals: SPF-grade male BALB / c mice, 7 - 8 weeks old, 60 mice, purchased from Zhuhai Biosystems Co., Ltd.

[0042] Drug sources: Dextran sulfate sodium (M.W. 36000 - 50000), purchased from MP Biomedicals; Atractylenolide I (purity: ≥98%), from Chengdu Phytochemical Co., Ltd.; Liquiritin, purchased from Chengdu Phytochemical Co., Ltd.; Hematoxylin solution, from Wuhan Sevier Biotechnology Co., Ltd., purchased from Hefei Bomei Biotechnology Co., Ltd., product number: YE2080; Hydrochloric acid, from Chengdu Kelong Chemical Co., Ltd., product number: 7647 - 01 - 0; Neutral balsam, Biosharp, product number: BL704A; Sirius red solution, from Beijing Solarbio Science & Technology Co., Ltd., product number: G1472; Alcian blue staining solution, from Beijing Regen Biotechnology Co., Ltd. Experimental methods: The BALB / c mice were randomly divided into 6 groups, with 10 mice in each group: normal control group, model group, mesalazine group (400 mg / kg), liquiritin group (50 mg / kg), atractylenolide I group (50 mg / kg), and combined use group of liquiritin and atractylenolide I (liquiritin 25 mg / kg + atractylenolide I 25 mg / kg). Except for the normal control group, the other groups were given 4% DSS distilled water for free drinking for 10 days and then changed to free drinking of distilled water for 4 days to induce a mouse model of ulcerative colitis. The normal group and the model group were intragastrically administered distilled water at 0.2 mL / 10 g, and the other groups were intragastrically administered mesalazine, liquiritin, atractylenolide I group, and liquiritin + atractylenolide I, respectively, once a day for 14 consecutive days.

[0043] (1) Investigate the effect of drug administration on the disease activity index (DAI) of mice Observe the diarrhea situation of mice every day and record it; collect the feces of mice and detect the fecal blood situation using a fecal occult blood kit, and evaluate the fecal blood situation at different degrees according to the instructions; calculate the percentage of body weight loss of mice and score it (as shown in Table 1). The disease activity index of mice is the average of the percentage of body weight loss score, diarrhea situation score, and fecal blood situation score of mice, that is: mouse disease activity index = (mouse body weight loss percentage score + diarrhea situation score + fecal blood situation score) / 3.

[0044] Table 1 Scoring criteria for the disease activity index of mice

[0045] As Figure 1 shown in A, compared with the normal group, the body weight of the mice in the model group showed a significant decrease from the 6th day, reached the lowest on the 11th day, and then slowly recovered; compared with the model group, the trend of body weight loss in the mice after administration of mesalazine, liquiritin, and atractylenolide I was improved; and compared with the administration of liquiritin or atractylenolide I alone, the combined use of liquiritin and atractylenolide showed a more obvious improvement effect. The disease activity index can reflect the severity of enteritis in mice. The results are as Figure 1 shown in B. The disease activity index of the mice in the normal group was zero. Compared with the normal control group, the disease activity index of the mice in the model group first increased, reached the peak on the 9th day, and then slowly decreased; compared with the model group, the disease activity index decreased after the administration of the compounds. Among them, the combined use of liquiritin and atractylenolide could significantly reduce the disease activity index of the mice, indicating that it could relieve the symptoms of DSS-induced UC mice.

[0046] (2) Investigate the effects of drug administration on the morphological changes of the colon and the length of the colorectum in mice Dissect the large intestine of the mice, observe its morphology and take pictures; measure the length of the colon with a ruler and record. The experimental results are respectively as Figure 2 shown.

[0047] Figure 2 As can be seen in, compared with the normal group, the cecum of the mice in the model group was atrophied, the cecal contents were reduced, the colon was shortened and showed bleeding, swelling, and easy breakage; compared with the mice in the model group, the status of the colon and cecum was improved after the administration of mesalazine, liquiritin, and atractylenolide I, and the colon length increased; and there was a statistically significant difference between the model group and the combined use group of liquiritin and atractylenolide.

[0048] (3) Effects of drug administration on the histopathology of the intestinal tissue of mice H&E staining of colon tissue: Take about 1.5 cm of the mouse colon, fix it with 10% neutral formaldehyde for 24 h, and then dehydrate the fixed tissue with a fully automatic dehydrator. The dehydration procedure is as follows: 75% ethanol for 2 h, 85% ethanol for 1 h, 95% ethanol for 1 h, absolute ethanol I for 20 min, absolute ethanol II for 20 min, absolute ethanol III for 20 min, absolute ethanol IV for 20 min, clearing agent I for 25 min, clearing agent II for 30 min, paraffin I for 30 min, paraffin II for 1 h, paraffin III for 1 h. After dehydration, embed the tissue, and then section it with a paraffin slicer. The section thickness is about 4 μm. After dewaxing the section, place it in hematoxylin solution for staining for 5 - 10 min, and then rinse it with running tap water; place it in hydrochloric acid alcohol solution for differentiation for about 3 s and then rinse it with running tap water; then soak it in bluing solution for about 1 min and then rinse it with running tap water; place the section in eosin solution for staining for 3 min and then perform gradient dehydration; drop neutral gum, cover with a coverslip; after air-drying at room temperature, observe the pathological changes of the colon tissue under the microscope (see Figure 3 ).

[0049] As Figure 3 shown, the colon tissue structure of the normal group mice was intact, the intestinal glands and crypts were arranged neatly, the epithelial cells had no obvious damage, there was no obvious inflammatory cell infiltration, and no edema occurred; a large number of epithelial cells in the model group mice apoptosed, showing severe erosion and ulcers, and a large number of inflammatory cells infiltrated into the lamina propria, submucosa, and muscularis; after administration of mesalazine, liquiritin, and atractylenolide I, the pathological state of the mice colon improved, and the inflammatory cell infiltration decreased. Consistent with this, compared with the normal group, the pathological score of the colon tissue of the model group mice increased, and the difference was statistically significant; after administration of mesalazine, liquiritin, and atractylenolide I, the pathological score decreased, and the combined use of liquiritin and atractylenolide I had the most obvious improvement effect.

[0050] Alcian blue staining of colon tissue: Take about 1.5 cm of mouse colon, fix it with 10% neutral formaldehyde for 24 h, and then dehydrate the fixed tissue with an automatic dehydrator. The dehydration procedure is as follows: 75% ethanol for 2 h, 85% ethanol for 1 h, 95% ethanol for 1 h, absolute ethanol I for 20 min, absolute ethanol II for 20 min, absolute ethanol III for 20 min, absolute ethanol IV for 20 min, clearing agent I for 25 min, clearing agent II for 30 min, paraffin I for 30 min, paraffin II for 1 h, paraffin III for 1 h. After dehydration, embed the tissue, and then cut sections with a paraffin slicer. The section thickness is about 4 μm. Dewax the sections, soak them in Alcian acidifying solution for 3 min, and then stain them in Alcian staining solution for 15 - 30 min. Rinse the sections in running water for 5 min, then counterstain them in nuclear fast red staining solution for 10 min, rinse them in running water for 1 min, and then dehydrate them; drop neutral gum, cover with a cover slip; after air-drying at room temperature, observe the goblet cells and mucus in the colon tissue under a microscope (see Figure 4 ).

[0051] Figure 4 As can be seen in ,

[0052] , the goblet cells in the colon of normal group mice are normal, while those in the model group mice are significantly reduced or even disappeared; after administration of mesalazine, liquiritin, and atractylenolide I, the goblet cells that produce mucus increase.

[0052] (4) Investigate the effect of drug administration on the spleen index of mice Observe the food and water intake of mice every day and record the results. The results are as shown in Figure 5 Figure A - 5B. There is no significant difference in food and water intake among mice in each group; UC mice induced by DSS will show splenomegaly. As shown in Figure 5C, compared with the normal group, the spleen index of model group mice is significantly increased; after administration of mesalazine, liquiritin, and atractylenolide I, the spleen index is significantly reduced, and the difference is statistically significant.

[0053] Finally, it should be noted that the above description is only the preferred embodiment of the present invention. Those skilled in the art, under the inspiration of the present invention, can make various similar representations without departing from the purpose and claims of the present invention. Such transformations all fall within the protection scope of the present invention.

Claims

1. A pharmaceutical composition for treating ulcerative colitis, characterized in that, It comprises an active ingredient or its pharmaceutically acceptable salt, tautomer, stereoisomer and pharmaceutical excipients, wherein the active ingredient consists of liquiritin and atractylenolide I.

2. The pharmaceutical composition according to claim 1, wherein The weight ratio of liquiritin to atractylenolide I is (1 - 10):(1 - 10); or (1 - 10):(1 - 5); or (1 - 10):(1 - 3); or (1 - 5):1; or (1 - 3):1; or 1:

1.

3. The pharmaceutical composition according to claim 1, characterized in that, The active ingredient can be used alone in the preparation of the pharmaceutical composition, or can be used in combination with other components having anti-inflammatory activity, wherein the active ingredient consists of liquiritin and atractylenolide I.

4. The pharmaceutical composition according to claim 1, wherein The pharmaceutical composition does not contain other active ingredients having anti-inflammatory activity except liquiritin and atractylenolide I.

5. The pharmaceutical composition according to any one of claims 1-4, characterized in that: The excipients include one or more of a solvent, a disintegrant, a flavoring agent, a preservative, a coloring agent, a binder, a lubricant, a diluent and a drug carrier.

6. The pharmaceutical composition according to claim 1, which is an oral dosage form or an injection dosage form, and can also adopt a controlled release or sustained release dosage form well known in the modern pharmaceutical industry.

7. Use of liquiritin and atractylenolide I in the preparation of a pharmaceutical composition for treating ulcerative colitis, wherein, The weight ratio of liquiritin to atractylenolide I is (1 - 10):(1 - 10); or (1 - 10):(1 - 5); or (1 - 10):(1 - 3); or (1 - 5):1; or (1 - 3):1; or 1:

1.

8. The application according to claim 7, wherein Liquiritin and atractylenolide I as the active ingredients can be used in combination in the preparation of the pharmaceutical composition, or can be used in combination with other components having anti-inflammatory activity.

9. The application according to claim 7, characterized in that The pharmaceutical composition does not contain other active ingredients having anti-inflammatory activity except liquiritin and atractylenolide I.

10. The application according to claim 7, wherein The pharmaceutical composition uses liquiritin and atractylenolide I as the active ingredients and is made into a pharmaceutically acceptable dosage form with pharmaceutically acceptable excipients.

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