Atractylodes lactone iii pharmaceutical composition for preventing and treating ulcerative colitis and application thereof
Patent Information
- Application Number
- CN202611364836.9
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2026-09-04
- Publication Date
- 2026-10-20
AI Technical Summary
[0005]为解决上述技术问题，提供一种防治溃疡性结肠炎的白术内酯III药物组合物及其应用，本技术方案解决了上述UC中药专利多为复方或提取物，活性物质分散，不利于质量控制、白术内酯III相关研究聚焦单一机制的问题
[0026]本发明以白术内酯III为核心活性单体，解决了现有UC中药专利多为复方、提取物，活性物质基础分散，难以明确药效归属及质量控制的技术痛点，可精准发挥白术内酯III抗炎、保护肠黏膜、改善氧化应激及调节肠道屏障的作用，其能抑制MMP-9基因过度活化以减少肠道通透性，上调ZO-1、钙黏蛋白等肠道屏障相关蛋白，修复肠黏膜损伤；较现有复方或提取物类技术方案具有活性成分明确、便于质量控制和药效评价。
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Abstract
Description
Technical Field
[0001] This invention relates to the field of pharmaceutical technology, specifically to a pharmacolactone III pharmaceutical composition for the prevention and treatment of ulcerative colitis and its application. Background Technology
[0002] Ulcerative colitis (UC) is a chronic, relapsing inflammatory bowel disease affecting the colonic and rectal mucosa. Clinical manifestations include diarrhea, mucus and bloody stools, etc., with a prolonged course that severely impacts patients' quality of life. Its pathogenesis is related to multiple factors, including inflammatory abnormalities and damage to the intestinal epithelial barrier. The pathological mechanism is complex, and current treatment options struggle to balance efficacy, safety, and long-term maintenance requirements.
[0003] Currently, the main clinical treatments for ulcerative colitis (UC) include 5-aminosalicylic acids, glucocorticoids, immunosuppressants, biologics, and JAK inhibitors. 5-aminosalicylic acids are first-line treatment for mild to moderate UC; those who do not respond well to them require glucocorticoids, while moderate to severe cases often require biologics or JAK inhibitors. However, these drugs all have significant limitations: 5-aminosalicylic acids may impair kidney function, requiring monitoring; TNF inhibitors carry risks of serious infections and malignancies; and JAK inhibitors carry risks of cardiovascular events and thrombosis, making them unsuitable for long-term UC treatment.
[0004] In the field of traditional Chinese medicine, Atractylodes macrocephala and its active ingredients have attracted attention due to their anti-inflammatory and intestinal mucosal protective effects. Reviews indicate that atractylodes lactone compounds have potential in treating ulcerative colitis (UC). However, existing technologies still have gaps: firstly, most UC-related TCM patents are compound formulas or extracts, with dispersed active substances, which is not conducive to quality control; secondly, research on atractylodes lactone III focuses on single mechanisms and lacks systematic efficacy evaluation; and thirdly, there is a translational gap between existing technologies and drug development, requiring the improvement of solutions based on single components that consider both efficacy and pharmaceutical feasibility. In response, we propose a atractylodes lactone III drug composition for the prevention and treatment of ulcerative colitis and its application. Summary of the Invention
[0005] To address the aforementioned technical problems, this invention provides a pharmacolactone III pharmaceutical composition for the prevention and treatment of ulcerative colitis and its application. This technical solution solves the problems that most of the aforementioned UC traditional Chinese medicine patents are compound preparations or extracts, with dispersed active substances, which is not conducive to quality control, and that research on pharmacolactone III focuses on a single mechanism.
[0006] To achieve the above objectives, the technical solution adopted by the present invention is as follows: a pharmaceutical composition of atractylodes lactone III for the prevention and treatment of ulcerative colitis, which is composed of the following parts: 1-50 parts of atractylodes lactone III, 1-20 parts of carboxymethyl cellulose solution, 1-22 parts of traditional Chinese medicine extract, 1-30 parts of pharmaceutical excipients and 1-300 parts of distilled water.
[0007] Preferably, the specific proportions of the pharmaceutical composition are: 30 parts of atractylodes lactone III, 15 parts of carboxymethyl cellulose solution, 20 parts of traditional Chinese medicine extract, 22 parts of pharmaceutical excipients, and 150 parts of distilled water.
[0008] Preferably, the carboxymethyl cellulose solution is an anionic carboxymethyl cellulose solution.
[0009] Preferably, the herbal extracts include Coptis chinensis extract, Saposhnikovia divaricata extract, and Paeonia lactiflora extract.
[0010] Preferably, the pharmaceutical excipients include fillers, binders, lubricants, and solvents.
[0011] Preferably, the filler is one of microcrystalline cellulose, lactose, and starch; the binder is one of povidone and hydroxypropyl methylcellulose; the lubricant is one of magnesium stearate and talc; and the solvent is ethanol.
[0012] Preferably, the preparation steps of the pharmaceutical composition are as follows:
[0013] S1. Take the prescribed amount of atractylodes lactone III raw material and pharmaceutical excipients, dry them and sieve them for later use; take the Chinese herbal extract, remove impurities by sieving, place it in a beaker, add distilled water, stir until dissolved to obtain the Chinese herbal extract for later use.
[0014] S2. Add distilled water to a sterile mixing tank, start stirring, add pretreated atractylodes lactone III and continue stirring to form an aqueous solution of atractylodes lactone III. Add the prepared Chinese herbal extract, carboxymethyl cellulose solution and pharmaceutical excipients to the aqueous solution of atractylodes lactone III and continue stirring to obtain a drug mixture.
[0015] S3. Transfer the drug mixture into a homogenizer, adjust the homogenization pressure to 20-30MPa, and homogenize for 30-40 minutes.
[0016] S4. After homogenization, put the drug mixture back into the sterile mixing tank, check the pH value of the mixture, adjust the pH value to 6.5-7.5 using an adjuster, slowly pass the pH-adjusted drug mixture through a sterile filter membrane for filtration, and collect the filtrate in a sterile storage tank.
[0017] S5. Based on clinical needs, the filtrate is prepared into a suitable dosage form to obtain a pharmaceutical composition;
[0018] S6. Sterilize the drug composition, conduct quality inspection after sterilization, and package and store qualified products.
[0019] Preferably, in step S2, the stirring speed is 150-200 r / min; the stirring time after adding the pretreated atractylodes lactone III is 20-30 min; and the stirring time after adding the prepared herbal extract, carboxymethyl cellulose solution and pharmaceutical excipients is 22-44 min.
[0020] Preferably, suitable dosage forms in step S5 include enemas, granules, and capsules;
[0021] The preparation of the enema involves dispensing the filtrate into sterile enema bags, with the size of each bag determined according to the clinical dosage. After dispensing, the enema bags are sealed and labeled with the drug name, specifications, batch number, and expiration date.
[0022] Granules are produced by transferring the filtrate into a spray dryer, setting the inlet air temperature to 120-130℃ and the outlet air temperature to 60-70℃, spray drying to produce dried granules, passing the granules through an 80-mesh sieve to screen for uniform granules, and dispensing them into aseptic granule packaging and sealing them.
[0023] The capsule formulation is made by uniformly mixing spray-dried granules with lubricant, filling capsules with a sterile capsule filling machine, polishing and screening after filling, removing unqualified capsules, and sealing.
[0024] Application of a pharmacolactone III pharmaceutical composition for the prevention and treatment of ulcerative colitis, wherein the pharmacolactone III pharmaceutical composition is used in the treatment of ulcerative colitis.
[0025] Compared with the prior art, the beneficial effects of the present invention are as follows:
[0026] This invention uses atractylodes lactone III as the core active monomer, solving the technical pain points of existing UC Chinese medicine patents, which are mostly compound formulas and extracts with dispersed active substances, making it difficult to clarify the efficacy attribution and quality control. It can precisely exert the anti-inflammatory, intestinal mucosal protective, oxidative stress improvement and intestinal barrier regulation effects of atractylodes lactone III. It can inhibit the excessive activation of MMP-9 gene to reduce intestinal permeability, upregulate intestinal barrier-related proteins such as ZO-1 and cadherin, and repair intestinal mucosal damage. Compared with existing compound or extract-based technical solutions, it has clear active ingredients, facilitates quality control and efficacy evaluation. Attached Figure Description
[0027] Figure 1 This is a flowchart of the preparation steps of the present invention. Detailed Implementation
[0028] The following description is intended to disclose the invention and enable those skilled in the art to implement it. The preferred embodiments described below are merely examples, and other obvious variations will occur to those skilled in the art.
[0029] Example 1
[0030] A pharmaceutical composition (enema) of atractylodes lactone III for the prevention and treatment of ulcerative colitis.
[0031] Raw material formula (by weight)
[0032] 30 parts of atractylodes lactone III, 15 parts of anionic carboxymethyl cellulose solution, 20 parts of traditional Chinese medicine extract, 22 parts of pharmaceutical excipients, and 150 parts of distilled water.
[0033] Preparation steps
[0034] S1. Take the prescribed amount of atractylodes lactone III raw material and pharmaceutical excipients, dry them in an 85℃ drying oven for 2.5 hours, and after drying, sieve them through a 100-mesh sieve to remove impurities and clumps, and set aside; take the Chinese herbal extract, sieve it through a 100-mesh sieve to remove impurities, place it in a sterile beaker, add 10 parts of distilled water, and stir with a glass rod until completely dissolved to obtain the Chinese herbal extract, and set aside;
[0035] S2. Add the remaining 140 parts of distilled water to a sterile mixing tank, turn on the stirring device, adjust the stirring speed to 180 r / min, slowly add the pretreated atractylodes lactone III, and continue stirring for 25 min until atractylodes lactone III is completely dissolved to form a homogeneous atractylodes lactone III aqueous solution; then, add the prepared traditional Chinese medicine extract, anionic carboxymethyl cellulose solution and pretreated pharmaceutical excipients to the atractylodes lactone III aqueous solution in sequence, maintain the stirring speed of 180 r / min, and continue stirring for 33 min to obtain a homogeneous drug mixture;
[0036] S3. Transfer the above drug mixture into a sterile homogenizer, adjust the homogenization pressure to 25MPa, homogenize for 35min, and ensure that the drug mixture has uniform particle size and no obvious clumping or stratification.
[0037] S4. After homogenization, the drug mixture is returned to the sterile mixing tank. The pH value of the mixture is measured with a pH meter. The pH value is adjusted to 7.0 with dilute hydrochloric acid. A sterile filter membrane with a pore size of 0.22μm is installed on the sterile filtration device. The drug mixture with the adjusted pH value is slowly filtered through the filter membrane to remove trace impurities and undissolved particles. The filtrate is collected in a sterile storage tank.
[0038] S5. Based on the clinical needs of enema treatment, the filtrate is prepared as an enema agent: The sterile filtrate is dispensed into sterile enema bags, each bag containing 150ml. After dispensing, the enema bags are sealed and labeled with a label that clearly indicates the drug name "Atractylodes lactone III drug composition for the prevention and treatment of ulcerative colitis (enema agent)", specification 150ml / bag, batch number 2026001, and shelf life 24 months.
[0039] S6. Place the dispensed and sealed enema solution in a moist heat sterilization device and sterilize at 121℃ for 25 minutes. After sterilization, cool to room temperature. Take a sample of the sterilized enema solution and conduct quality tests such as appearance, identification, sterility, pH value, and content determination. After passing the tests, use sterile packaging materials for outer packaging and store in a cool, dry, and ventilated place at 2-8℃.
[0040] Example 2
[0041] A pharmaceutical composition (granules) of atractylodes lactone III for the prevention and treatment of ulcerative colitis.
[0042] Raw material formula (by weight)
[0043] 10 parts of atractylodes lactone III, 8 parts of anionic carboxymethyl cellulose solution, 10 parts of traditional Chinese medicine extract, 15 parts of pharmaceutical excipients, and 80 parts of distilled water.
[0044] Preparation steps
[0045] S1. Take the prescribed amount of atractylodes lactone III raw material and pharmaceutical excipients, dry them in an 80℃ drying oven for 2 hours, and after drying, sieve them through a 100-mesh sieve for later use; take the Chinese herbal extract, sieve it through a 100-mesh sieve to remove impurities, place it in a sterile beaker, add 5 parts of distilled water, stir until completely dissolved, and obtain the Chinese herbal extract for later use.
[0046] S2. Add the remaining 75 parts of distilled water to a sterile mixing tank, turn on the stirring device, adjust the stirring speed to 150 r / min, slowly add the pretreated atractylodes lactone III, and continue stirring for 20 min to form an aqueous solution of atractylodes lactone III; then add the prepared Chinese herbal extract, anionic carboxymethyl cellulose solution and pharmaceutical excipients, maintain the stirring speed of 150 r / min, and continue stirring for 22 min to obtain a homogeneous drug mixture;
[0047] S3. Transfer the drug mixture into a sterile homogenizer, adjust the homogenization pressure to 20MPa, homogenize for 30 minutes to ensure that the mixture is uniform and fine.
[0048] S4. After homogenization, the drug mixture is returned to the sterile mixing tank, the pH value is tested, the pH value is adjusted to 6.5 with dilute sodium hydroxide, filtered with a 0.22μm sterile filter membrane, and the filtrate is collected in a sterile storage tank.
[0049] S5. Based on the need for oral administration, the filtrate is prepared into granules: The sterile filtrate is transferred into a spray dryer, the inlet air temperature is set to 120℃ and the outlet air temperature is set to 60℃, and spray drying is performed to produce dried granules; the dried granules are passed through an 80-mesh sieve to screen for granules with uniform particle size, and the qualified granules are packaged into sterile granule packaging, 5g per bag, and sealed.
[0050] S6. Place the packaged granules in a dry heat sterilization device and sterilize at 160℃ for 2 hours. After cooling to room temperature, conduct a quality inspection. Once the inspection is passed, affix a label with relevant information and store in a cool, dry place.
[0051] Example 3
[0052] A pharmaceutical composition (capsules) of atractylodes lactone III for the prevention and treatment of ulcerative colitis.
[0053] Raw material formula (by weight)
[0054] 50 parts of atractylodes lactone III, 20 parts of anionic carboxymethyl cellulose solution, 22 parts of traditional Chinese medicine extract, 30 parts of pharmaceutical excipients, and 300 parts of distilled water;
[0055] Preparation steps
[0056] S1. Take the prescribed amount of atractylodes lactone III raw material and pharmaceutical excipients, place them in a 100℃ drying oven and dry for 3 hours. After drying, sieve through a 120-mesh sieve and set aside. Take the Chinese herbal extract, sieve through a 100-mesh sieve to remove impurities, place it in a sterile beaker, add 10 parts of distilled water, stir until completely dissolved, and obtain the Chinese herbal extract for use.
[0057] S2. Add the remaining 290 parts of distilled water to a sterile mixing tank, turn on the stirring device, adjust the stirring speed to 200 r / min, slowly add the pretreated atractylodes lactone III, and continue stirring for 30 min to form an aqueous solution of atractylodes lactone III; then add the prepared Chinese herbal extract, anionic carboxymethyl cellulose solution and pharmaceutical excipients, maintain the stirring speed of 200 r / min, and continue stirring for 44 min to obtain a homogeneous drug mixture;
[0058] S3. Transfer the drug mixture into a sterile homogenizer, adjust the homogenization pressure to 30MPa, homogenize for 40min, and ensure that the particle size of the mixture meets the requirements.
[0059] S4. After homogenization, the drug mixture is returned to the sterile mixing tank, the pH value is checked and adjusted to 7.5, filtered with a 0.22μm sterile filter membrane, and the filtrate is collected in a sterile storage tank.
[0060] S5. Based on the need for oral administration, the filtrate is prepared into capsules: The sterile filtrate is transferred into a spray dryer, with the inlet air temperature set at 130℃ and the outlet air temperature at 70℃, and spray dried to produce dry granules; the dry granules are mixed evenly with the prescribed amount of magnesium stearate, and filled into capsules using a sterile capsule filling machine. Each capsule contains 50mg of atractylodes lactone III. After filling, the capsules are polished, screened, and unqualified capsules are removed and sealed for packaging.
[0061] S6. Place the sealed capsules in a dry heat sterilization device and sterilize at 170℃ for 3 hours. After cooling to room temperature, conduct a quality inspection. If the inspection is qualified, affix a label with relevant information and store in a sterile environment at 2-8℃.
[0062] Example 4
[0063] Application of a pharmacolactone III pharmaceutical composition for the prevention and treatment of ulcerative colitis
[0064] Preparation of Atractylodes lactone III Dosage Form
[0065] In this section, atractylodes lactone III (AT III) is used as the active ingredient, and 0.5% carboxymethyl cellulose solution is used as the drug delivery carrier to prepare a suspension or solution for oral administration.
[0066] The dosage concentrations of atractylodes lactone III in the low-dose, medium-dose, and high-dose groups were set at 5 mg / kg / d, 10 mg / kg / d, and 20 mg / kg / d, respectively. The dosage of the positive control group (5-ASA) was 400 mg / kg / d. The blank control group, the atractylodes lactone III monotherapy group, and the model group were all administered an equal volume of 0.5% carboxymethyl cellulose solution by gavage.
[0067] Verification of the application of atractylodes lactone III in the preparation of drugs for the prevention and / or treatment of ulcerative colitis
[0068] Laboratory animals and grouping
[0069] Seventy C57BL / 6 mice were selected and, after one week of acclimatization feeding, were randomly divided into seven groups of ten mice each, as follows:
[0070] Blank control group (Ctrl group);
[0071] Atractylodes lactone III monotherapy group (Ctrl+AT III group).
[0072] DSS-induced ulcerative colitis model group (Model group);
[0073] Positive drug group (5-ASA group);
[0074] Low-dose intervention group of atractylodes lactone III (AT III-L group).
[0075] Atractylodes lactone III medium-dose intervention group (AT III-M group).
[0076] High-dose intervention group of atractylodes lactone III (AT III-H group).
[0077] The feeding and handling of the laboratory animals were carried out in accordance with the National Laboratory Animal Welfare Guidelines and Laboratory Animal Ethics Standards.
[0078] Model building
[0079] Except for the Ctrl group and Ctrl+AT III group, which had normal access to drinking water, all other groups of mice had free access to distilled water containing 3% DSS for 7 consecutive days to establish a mouse model of ulcerative colitis.
[0080] Administration method
[0081] Drug intervention was administered concurrently during modeling. Specifically: the Ctrl group, Ctrl+AT III group, and Model group were administered 0.5% carboxymethyl cellulose solution by gavage; the 5-ASA group was administered 5-ASA solution by gavage; and the AT III-L group, AT III-M group, and AT III-H group were administered the corresponding dose of atractylodes lactone III solution by gavage. All groups were administered the medication by gavage for 7 consecutive days, once daily, with the administration time kept as consistent as possible.
[0082] Sample collection
[0083] On day 8, mice in each group were processed and samples were collected. Blood and colon tissue samples were collected from the mice, and the colon length was recorded. At the same time, the spleen and thymus were harvested and weighed for subsequent related indicator detection.
[0084] Effects of atractylodes lactone III on general symptoms and organ indicators in mice with ulcerative colitis
[0085] Disease Activity Index (DAI) Evaluation
[0086] During the modeling and drug administration period, the mental state, activity level, fur condition, fecal characteristics, and bloody stools of mice in each group were observed daily, and weight changes were recorded. The Disease Activity Index (DAI) was calculated based on weight loss, fecal characteristics, and degree of bloody stools.
[0087] Weight, colon length and immune organ index testing
[0088] Record the changes in body weight of mice in each group before and after the experiment. After sacrifice, the colon was dissected and its length was measured; at the same time, the spleen and thymus were dissected and weighed, and the spleen index and thymus index were calculated.
[0089] The experimental results showed that, compared with the Model group, the Atractylodes lactone III intervention group, especially the high-dose group, could significantly improve the increased disease activity index, weight loss, colon shortening and abnormalities in related immune organ indices in mice.
[0090] Effects of atractylodes lactone III on colonic tissue damage and mucosal barrier
[0091] HE staining
[0092] Colon tissue was collected, fixed, dehydrated, embedded, sectioned, and stained with hematoxylin and eosin (HE). The histopathological changes of the colon tissue were observed under a microscope, including but not limited to: the integrity of the mucosal structure; the degree of epithelial damage; the arrangement of glands; the degree of inflammatory cell infiltration; and the degree of damage to the mucosa and submucosa.
[0093] The experimental results showed that, compared with the Model group, the Atractylodes lactone III intervention group could reduce the destruction of colonic mucosal structure, inflammatory cell infiltration and tissue damage, with the high-dose group showing more significant improvement.
[0094] AB-PAS staining
[0095] Colon tissue sections were stained with AB-PAS to observe the number of goblet cells and mucus secretion, in order to evaluate the degree of damage to the colonic mucus barrier.
[0096] The experimental results showed that, compared with the Model group, the Atractylodes lactone III intervention group could improve the damage to the colonic mucus layer and enhance goblet cells and mucus secretion.
[0097] IHC staining
[0098] Colon tissue sections were obtained for immunohistochemical staining to observe changes in the mouse intestinal tight junction proteins Claudin-1, Occludin, and ZO-1.
[0099] Experimental results showed that intervention with atractylodes lactone III could improve intestinal barrier function damage in model mice, suggesting that it has a supporting effect on atractylodes lactone III in improving colon tissue damage.
[0100] Effects of atractylodes lactone III on oxidative stress-related indicators
[0101] The levels of superoxide dismutase (SOD) and catalase (CAT) were detected using commercially available kits, and the specific detection methods were performed in accordance with the kit instructions.
[0102] The experimental results showed that, compared with the Model group, the Atractylodes lactone III intervention group could improve the abnormal oxidative stress-related indicators in mice with ulcerative colitis, as evidenced by the recovery of SOD and CAT levels towards normal, with the high-dose group showing a more significant improvement.
[0103] Effects of atractylodes lactone III on inflammation and apoptosis-related markers
[0104] Inflammation-related marker testing
[0105] The expression levels of IL-6, IL-10 and TNF-α inflammation-related markers were detected by RT-qPCR.
[0106] The experimental results showed that, compared with the Model group, the Atractylodes lactone III intervention group could regulate the abnormal expression of inflammatory factors, suggesting that it has the effect of improving the inflammatory response of ulcerative colitis, with the high-dose group showing more significant improvement.
[0107] Apoptosis-related index detection
[0108] The expression changes of apoptosis-related markers in Bax and Bcl2 cells were detected by RT-qPCR.
[0109] The experimental results showed that, compared with the Model group, the atractylodes lactone III intervention group improved the abnormal apoptosis-related indicators, suggesting that atractylodes lactone III has a positive effect on alleviating colon tissue damage and improving cell apoptosis imbalance.
[0110] Effects of atractylodes lactone III alone on normal animals
[0111] Set up Ctrl+AT III group, administer atractylodes lactone III alone under normal drinking water conditions, and compare with blank control group to observe changes in general condition, weight, tissue morphology and related test indicators.
[0112] The experimental results showed that, compared with the blank control group, no significant adverse effects were observed when atractylodes lactone III was administered alone, indicating that atractylodes lactone III has a good basis for application under the administration conditions of this embodiment.
[0113] Summarize
[0114] In summary, atractylodes lactone III can be used to prepare drugs for the prevention and / or treatment of ulcerative colitis. In a DSS-induced mouse model of ulcerative colitis, atractylodes lactone III improved disease activity index, body weight change, colon length, and abnormalities in spleen and thymus indices; reduced colonic histological damage and mucus barrier disruption; and improved abnormalities related to oxidative stress, inflammatory response, and apoptosis, with higher doses showing more significant improvements. Furthermore, no significant adverse effects were observed when atractylodes lactone III was administered alone in normal animals, suggesting its potential application value.
[0115] The foregoing has shown and described the basic principles, main features, and advantages of the present invention. Those skilled in the art should understand that the present invention is not limited to the above embodiments. The embodiments and descriptions in the specification are merely principles of the invention. Various changes and modifications can be made to the invention without departing from its spirit and scope, and all such changes and modifications fall within the scope of the claimed invention.
Claims
1. A pharmacolactone III pharmaceutical composition for the prevention and treatment of ulcerative colitis, characterized in that, It is composed of the following ingredients in parts: 1-50 parts of atractylodes lactone III, 1-20 parts of carboxymethyl cellulose solution, 1-22 parts of traditional Chinese medicine extract, 1-30 parts of pharmaceutical excipients, and 1-300 parts of distilled water.
2. The atractylodes lactone III pharmaceutical composition for the prevention and treatment of ulcerative colitis according to claim 1, characterized in that, The specific proportions of the pharmaceutical composition are as follows: 30 parts of atractylodes lactone III, 15 parts of carboxymethyl cellulose solution, 20 parts of traditional Chinese medicine extract, 22 parts of pharmaceutical excipients, and 150 parts of distilled water.
3. The atractylodes lactone III pharmaceutical composition for the prevention and treatment of ulcerative colitis according to claim 1, characterized in that: The carboxymethyl cellulose solution is an anionic carboxymethyl cellulose solution.
4. The atractylodes lactone III pharmaceutical composition for the prevention and treatment of ulcerative colitis according to claim 1, characterized in that: The herbal extracts include Coptis chinensis extract, Saposhnikovia divaricata extract, and Paeonia lactiflora extract.
5. The atractylodes lactone III pharmaceutical composition for the prevention and treatment of ulcerative colitis according to claim 1, characterized in that: The pharmaceutical excipients include fillers, binders, lubricants, and solvents.
6. The atractylodes lactone III pharmaceutical composition for the prevention and treatment of ulcerative colitis according to claim 5, characterized in that: The filler is one of microcrystalline cellulose, lactose, and starch; the binder is one of povidone and hydroxypropyl methylcellulose; the lubricant is one of magnesium stearate and talc; and the solvent is ethanol.
7. The atractylodes lactone III pharmaceutical composition for the prevention and treatment of ulcerative colitis according to claim 1, characterized in that, The preparation steps of the pharmaceutical composition are as follows: S1. Take the prescribed amount of atractylodes lactone III raw material and pharmaceutical excipients, dry them and sieve them for later use; take the Chinese herbal extract, remove impurities by sieving, place it in a beaker, add distilled water, stir until dissolved to obtain the Chinese herbal extract for later use. S2. Add distilled water to a sterile mixing tank, start stirring, add pretreated atractylodes lactone III and continue stirring to form an aqueous solution of atractylodes lactone III. Add the prepared Chinese herbal extract, carboxymethyl cellulose solution and pharmaceutical excipients to the aqueous solution of atractylodes lactone III and continue stirring to obtain a drug mixture. S3. Transfer the drug mixture into a homogenizer, adjust the homogenization pressure to 20-30MPa, and homogenize for 30-40 minutes. S4. After homogenization, put the drug mixture back into the sterile mixing tank, check the pH value of the mixture, adjust the pH value to 6.5-7.5 using an adjuster, slowly pass the pH-adjusted drug mixture through a sterile filter membrane for filtration, and collect the filtrate in a sterile storage tank. S5. Based on clinical needs, the filtrate is prepared into a suitable dosage form to obtain a pharmaceutical composition; S6. Sterilize the drug composition, conduct quality inspection after sterilization, and package and store qualified products.
8. The atractylodes lactone III pharmaceutical composition for the prevention and treatment of ulcerative colitis according to claim 7, characterized in that: In step S2, the stirring speed is 150-200 r / min; after adding the pretreated atractylodes lactone III, the stirring time is 20-30 min; after adding the prepared Chinese herbal extract, carboxymethyl cellulose solution and pharmaceutical excipients, the stirring time is 22-44 min.
9. The atractylodes lactone III pharmaceutical composition for the prevention and treatment of ulcerative colitis according to claim 7, characterized in that: Suitable dosage forms for step S5 include enemas, granules, and capsules; The preparation of the enema involves dispensing the filtrate into sterile enema bags, with the size of each bag determined according to the clinical dosage. After dispensing, the enema bags are sealed and labeled with the drug name, specifications, batch number, and expiration date. Granules are produced by transferring the filtrate into a spray dryer, setting the inlet air temperature to 120-130℃ and the outlet air temperature to 60-70℃, spray drying to produce dried granules, passing the granules through an 80-mesh sieve to screen for uniform granules, and dispensing them into aseptic granule packaging and sealing them. The capsule formulation is made by uniformly mixing spray-dried granules with lubricant, filling capsules with a sterile capsule filling machine, polishing and screening after filling, removing unqualified capsules, and sealing.
10. The application of a pharmacolactone III pharmaceutical composition for the prevention and treatment of ulcerative colitis, applicable to the pharmacolactone III pharmaceutical composition for the prevention and treatment of ulcerative colitis as described in any one of claims 1 to 9, characterized in that: The atractylodes lactone III pharmaceutical composition is used for the treatment of ulcerative colitis.