Pachymic acid pharmaceutical composition for preventing and treating ulcerative colitis and application thereof
Patent Information
- Application Number
- CN202611364850.9
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2026-09-04
- Publication Date
- 2026-10-27
AI Technical Summary
目前关于UC的治疗存在以下不足：其一，临床现有UC药物在疗效持续性、复发控制及长期使用安全性方面仍有不足；其二，与UC相关的天然药物专利多集中于复方、药材提取物或多成分组合，缺乏以单一明确活性成分为基础的、便于质量控制和重复验证的技术方案；其三，虽然茯苓酸已有其他药用用途公开，且在UC动物模型方面已有文献提示其潜在价值，但围绕其对疾病活动表现、结肠组织损伤、黏膜屏障状态、氧化应激、炎症反应及细胞凋亡等多个关键环节的系统性评价和应用转化，仍有进一步研究和完善空间
[0024]本发明以茯苓酸作为明确的单体活性成分，用于制备防治溃疡性结肠炎的药物，相较于现有复方、提取物或多成分组合技术方案，具有活性成分明确、药效基础相对清晰、便于质量控制和后续开发的特点；明确其可通过抑制cGAS-STING、NF-κB信号通路，减轻结肠上皮细胞损伤，抑制促炎因子释放，修复受损的肠道黏液屏障与肠上皮屏障，同时调节肠道细胞凋亡平衡、增强肠道抗氧化活性，从炎症抑制、屏障修复、抗氧化等多靶点发挥防治溃疡性结肠炎的作用，精准针对溃疡性结肠炎的病理机制起效。
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Abstract
Description
Technical Field
[0001] This invention relates to the field of pharmaceutical application technology, specifically to a poria cocos acid pharmaceutical composition for the prevention and treatment of ulcerative colitis and its application. Background Technology
[0002] Ulcerative colitis (UC) is a chronic intestinal disease characterized by persistent or recurrent inflammation of the colonic mucosa. Clinically, it commonly presents with diarrhea, bloody and mucous stools, abdominal pain, and tenesmus. The disease is protracted, prone to relapse, and in severe cases, can even affect a patient's nutritional status and quality of life. Current understanding suggests that the occurrence of UC is closely related to immune imbalance, disruption of the intestinal mucosal barrier function, increased oxidative stress, abnormal release of inflammatory factors, and dysregulation of apoptosis. Its pathogenesis is complex, therefore, current treatment strategies often struggle to simultaneously achieve efficacy, relapse control, and long-term safety.
[0003] Currently, drug treatment for ulcerative colitis (UC) mainly includes 5-aminosalicylic acids (5-ASAs), glucocorticoids, immunosuppressants, and biologics or JAK inhibitors. The American General Association (AGA) guidelines still consider 5-ASAs as an important foundational treatment for mild to moderate UC; however, for some patients, 5-ASAs alone are insufficient to achieve ideal remission. For moderate to severe or refractory patients, further use of anti-TNF biologics or JAK inhibitors is often necessary. The problem with existing treatments is that, on the one hand, efficacy varies significantly from person to person, and on the other hand, long-term or intensive treatment often comes with an additional safety burden. For example, the FDA label for infliximab explicitly warns of risks such as serious infections; for JAK inhibitors, the FDA also requires additional warnings regarding the risks of serious cardiovascular events, cancer, thrombosis, and death. Therefore, developing new candidate drugs with clearly defined components and a good foundation for application remains a realistic necessity.
[0004] In the field of natural medicine research, active ingredients derived from Poria cocos have attracted attention due to their potential for anti-inflammatory, immunomodulatory, and multi-target intervention. Poria cocos acid is one of the important triterpenoid monomers in Poria cocos. Currently, the treatment of ulcerative colitis (UC) has the following shortcomings: First, existing clinical UC drugs still have deficiencies in terms of sustained efficacy, relapse control, and long-term safety; second, most natural medicine patents related to UC focus on compound preparations, herbal extracts, or multi-component combinations, lacking technical solutions based on a single, clearly defined active ingredient that are easy to control in terms of quality and repeatability; third, although other medicinal uses of poria cocos acid have been disclosed, and literature suggests its potential value in UC animal models, further research and improvement are needed regarding its systematic evaluation and application translation in multiple key aspects such as disease activity, colonic tissue damage, mucosal barrier status, oxidative stress, inflammatory response, and apoptosis. Therefore, we propose a poria cocos acid drug composition for the prevention and treatment of ulcerative colitis and its application. Summary of the Invention
[0005] To solve the above-mentioned technical problems, a poria cocos acid pharmaceutical composition for the prevention and treatment of ulcerative colitis and its application are provided. This technical solution solves the aforementioned problems.
[0006] To achieve the above objectives, the technical solution adopted by the present invention is as follows: a poria cocos acid pharmaceutical composition for the prevention and treatment of ulcerative colitis, prepared from the following materials in the indicated proportions:
[0007] 100-500 parts of pachymic acid, 10-100 parts of carboxymethyl cellulose solution, 10-120 parts of pharmaceutical excipients, 10-100 parts of synergistic excipients, 10-50 parts of solvent, and 100-120 parts of purified water.
[0008] Preferably, the poria cocos acid is one of the following: poria cocos medicinal material, pure poria cocos acid, and new poria cocos acid.
[0009] Preferably, the carboxymethyl cellulose solution is a pharmaceutical-grade sodium carboxymethyl cellulose solution; the solvent is one of ethanol, methanol, ethyl acetate, and dichloromethane.
[0010] Preferably, the pharmaceutical excipients include starch, lactose, binders, disintegrants, plasticizers, pore-forming agents, lubricants, and antioxidants.
[0011] Preferably, the synergistic excipients include glutamine, astragalus polysaccharide, stir-fried atractylodes macrocephala, yam, and tangerine peel.
[0012] Preferably, the specific preparation steps of the poria cocos acid drug composition for preventing and treating ulcerative colitis are as follows:
[0013] S1. Pulverize and sieve the poria cocos acid for later use. Place the pharmaceutical excipients in a constant temperature drying oven for drying. Take the carboxymethyl cellulose solution, add purified water, place it in a magnetic stirrer, and stir at room temperature for 15-20 minutes until the solution is uniform, without precipitation or lumps. Prepare a carboxymethyl cellulose dilution for later use.
[0014] S2. Place the pretreated pachymic acid, pharmaceutical excipient powder, and synergistic excipients into a mixer, adjust the mixing speed to 200-300 r / min, and mix for 30-40 min. Add the prepared carboxymethyl cellulose dilution and solvent into the mixer, and stir at low speed for 20-25 min to fuse the liquid and solid components and obtain the composition.
[0015] S3. Based on actual clinical medication needs, the composition is shaped, including granule shaping, tablet shaping and capsule shaping.
[0016] S4. The molded composition is dried and sterilized, and the indicators are tested. After passing the test, it is packaged.
[0017] Preferably, in step S1, the pamoate is pulverized into 80-100 mesh fine powder, the drying temperature in the drying oven is 60-80℃, and the drying time is 2-3 hours.
[0018] Preferably, the low-speed stirring speed in step S2 is 100-150 r / min; during the stirring period, the machine is stopped every 10 minutes to observe the mixing uniformity.
[0019] Preferably, in step S3, the granulation process involves placing the composition in a gyratory granulator, using an 18-20 mesh sieve, and controlling the extrusion granulation pressure at 0.3-0.5 MPa to obtain uniform wet granules.
[0020] Tablet forming involves making the composition into wet granules, drying them, adding magnesium stearate, mixing them evenly, and then feeding them into a tableting machine. The tableting pressure is adjusted to 8-12 MPa, the tablet thickness is controlled at 2-3 mm, and the tablet weight difference is ≤±5%. Enteric coating is used, with a coating temperature of 40-50℃ and a coating thickness of 0.1-0.2 mm.
[0021] Capsule forming involves preparing the composition into dry granules with a particle size controlled between 0.5 and 1.0 mm, and then filling them with No. 0 or No. 1 empty capsules.
[0022] An application of a poria cocos acid pharmaceutical composition for the prevention and treatment of ulcerative colitis, wherein the poria cocos acid pharmaceutical composition is used in a drug for the prevention and treatment of ulcerative colitis.
[0023] Compared with the prior art, the beneficial effects of the present invention are as follows:
[0024] This invention uses pachymic acid as a clearly defined monomeric active ingredient to prepare a drug for the prevention and treatment of ulcerative colitis. Compared with existing compound, extract, or multi-component combination technologies, it has the advantages of clearly defined active ingredients, relatively clear pharmacodynamic basis, and ease of quality control and subsequent development. It is clearly defined that it can reduce colonic epithelial cell damage, inhibit the release of pro-inflammatory factors, and repair the damaged intestinal mucus barrier and intestinal epithelial barrier by inhibiting the cGAS-STING and NF-κB signaling pathways. At the same time, it can regulate the balance of intestinal cell apoptosis and enhance intestinal antioxidant activity. It exerts its effect on the prevention and treatment of ulcerative colitis from multiple targets such as inflammation suppression, barrier repair, and antioxidation, and works precisely against the pathological mechanism of ulcerative colitis. Attached Figure Description
[0025] Figure 1 This is a flowchart of the processing steps of the poria cocos acid pharmaceutical composition of the present invention. Detailed Implementation
[0026] 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.
[0027] Example 1
[0028] A pamoate drug composition (granules) for the prevention and treatment of ulcerative colitis.
[0029] Raw material formula
[0030] 300 parts of pachymic acid, 50 parts of carboxymethyl cellulose solution, 85 parts of pharmaceutical excipients, 75 parts of synergistic excipients, 30 parts of solvent, and 110 parts of purified water.
[0031] Preparation steps
[0032] S1. Pulverize the poria cocos acid and pass it through an 80-mesh sieve for later use; place the pharmaceutical excipients in a constant temperature drying oven, adjust the drying temperature to 70℃, and dry for 2.5 hours. After drying, set aside for later use; take the carboxymethyl cellulose solution, add purified water, place it in a magnetic stirrer, and stir at room temperature for 18 minutes until the solution is uniform, without precipitation or lumps, to prepare a carboxymethyl cellulose dilution for later use.
[0033] S2. Place the pretreated pachymic acid powder, pharmaceutical excipient powder, and synergistic excipients into a mixer, adjust the mixing speed to 250 r / min, and mix for 35 min. Add the prepared carboxymethyl cellulose dilution and solvent to the mixer, adjust the low-speed stirring speed to 120 r / min, and stir for 22 min. During stirring, stop the machine every 10 min to observe the mixing uniformity, ensuring that the liquid components and solid components are fully integrated to obtain the composition.
[0034] S3. Using a granulation method, the above composition is placed in a gyratory granulator, a 19-mesh sieve is selected, and the extrusion granulation pressure is controlled at 0.4 MPa to obtain uniform wet granules.
[0035] S4. The prepared wet granules are dried and sterilized. After drying, the particle size, moisture content and other indicators are tested. After passing the test, they are packaged to obtain the poria cocos acid drug composition granules for the prevention and treatment of ulcerative colitis.
[0036] Example 2: A poria cocos acid pharmaceutical composition (tablets) for the prevention and treatment of ulcerative colitis.
[0037] Raw material formula
[0038] 100 parts of pachymic acid, 10 parts of carboxymethyl cellulose solution, 50 parts of pharmaceutical excipients, 60 parts of synergistic excipients, 10 parts of solvent, and 100 parts of purified water.
[0039] Preparation steps
[0040] S1. Pulverize the poria cocos acid and pass it through an 80-mesh sieve for later use; place the pharmaceutical excipients in a constant temperature drying oven, adjust the drying temperature to 60℃, and dry for 3 hours. After drying, set aside for later use; take the carboxymethyl cellulose solution, add purified water, place it in a magnetic stirrer, and stir at room temperature for 15 minutes until the solution is uniform, without precipitation or lumps, to prepare a carboxymethyl cellulose dilution for later use.
[0041] S2. Place the pretreated pachymic acid powder, pharmaceutical excipient powder, and synergistic excipient into a mixer, adjust the mixing speed to 200 r / min, and mix for 40 min. Add the prepared carboxymethyl cellulose dilution and solvent into the mixer, adjust the low-speed stirring speed to 100 r / min, and stir for 25 min. During stirring, stop the machine every 10 min to observe the mixing uniformity, ensuring that the liquid components and solid components are fully integrated to obtain the composition.
[0042] S3. Using a tablet forming method, the above composition is first made into wet granules, dried, and then magnesium stearate is added. After mixing evenly, the mixture is fed into a tablet press, and the tableting pressure is adjusted to 8 MPa. The tablet thickness is controlled at 2 mm, and the tablet weight difference is ensured to be ≤ ±5%. Subsequently, an enteric coating process is used, with the coating temperature controlled at 40℃ and the coating thickness at 0.1 mm, to complete the tablet forming.
[0043] S4. The formed tablets are dried and sterilized. The tablet hardness, disintegration time, and content uniformity are tested. After passing the tests, the tablets are packaged to obtain the poria cocos acid drug composition tablets for the prevention and treatment of ulcerative colitis.
[0044] Example 3: A poria cocos acid pharmaceutical composition (capsule) for the prevention and treatment of ulcerative colitis.
[0045] Raw material formula (by weight parts)
[0046] 500 parts of pachymic acid, 100 parts of carboxymethyl cellulose solution, 100 parts of pharmaceutical excipients, 100 parts of synergistic excipients, 50 parts of solvent, and 120 parts of purified water.
[0047] Preparation steps
[0048] S1. Pulverize pachymic acid and pass it through a 100-mesh sieve for later use; place the pharmaceutical excipients in a constant temperature drying oven, adjust the drying temperature to 80℃, and dry for 2 hours. After drying, set aside for later use; take carboxymethyl cellulose solution, add purified water, place it in a magnetic stirrer, and stir at room temperature for 20 minutes until the solution is uniform, without precipitation or lumps, to prepare a carboxymethyl cellulose dilution for later use.
[0049] S2. Place the pretreated pachymic acid powder, pharmaceutical excipient powder, and synergistic excipients into a mixer, adjust the mixing speed to 300 r / min, and mix for 30 min. Add the prepared carboxymethyl cellulose dilution and solvent to the mixer, adjust the low-speed stirring speed to 150 r / min, and stir for 20 min. During stirring, stop the machine every 10 min to observe the mixing uniformity, ensuring that the liquid components and solid components are fully integrated to obtain the composition.
[0050] S3. Using a capsule forming method, the above composition is made into dry granules, the particle size is controlled between 0.5-1.0 mm, and No. 0 empty capsules are used for filling to ensure that the filling amount of each capsule meets the pharmaceutical standards.
[0051] S4. The filled capsules are dried and sterilized. The capsule weight difference and disintegration time are tested. After passing the test, they are packaged to obtain the poria cocos acid drug composition capsules for the prevention and treatment of ulcerative colitis.
[0052] Example 4: A poria cocos acid pharmaceutical composition (granules) for the prevention and treatment of ulcerative colitis.
[0053] Raw material formula
[0054] 200 parts of pachymic acid, 30 parts of carboxymethyl cellulose solution, 48 parts of pharmaceutical excipients, 50 parts of synergistic excipients, 20 parts of solvent, and 105 parts of purified water.
[0055] Preparation steps
[0056] S1. Pulverize the poria cocos acid and pass it through a 90-mesh sieve for later use; place the pharmaceutical excipients in a constant temperature drying oven, adjust the drying temperature to 75℃, and dry for 2.2 hours. After drying, set aside for later use; take the carboxymethyl cellulose solution, add purified water, place it in a magnetic stirrer, and stir at room temperature for 17 minutes until the solution is uniform, without precipitation or lumps, to prepare a carboxymethyl cellulose diluted solution for later use.
[0057] S2. Place the pretreated pachymic acid powder, pharmaceutical excipient powder, and synergistic excipients into a mixer, adjust the mixing speed to 220 r / min, and mix for 38 min. Add the prepared carboxymethyl cellulose dilution and solvent into the mixer, adjust the low-speed stirring speed to 130 r / min, and stir for 23 min. During stirring, stop the machine every 10 min to observe the mixing uniformity, ensuring that the liquid components and solid components are fully integrated to obtain the composition.
[0058] S3. Using a granulation method, the above composition is placed in a gyratory granulator, an 18-mesh sieve is selected, and the extrusion granulation pressure is controlled at 0.3 MPa to obtain uniform wet granules.
[0059] S4. The prepared wet granules are dried and sterilized. After drying, the particle size, moisture content and other indicators are tested. After passing the test, they are packaged to obtain the poria cocos acid drug composition granules for the prevention and treatment of ulcerative colitis.
[0060] Implementation 5: Verification of the application of pachymic acid in the preparation of drugs for the prevention and treatment of ulcerative colitis.
[0061] Laboratory animals and grouping
[0062] Seventy C57BL / 6 mice were used and subjected to a one-week acclimatization period. They were then randomly divided into seven groups of ten mice each. The dosages of pamoate (low, medium, and high doses) were set at 5 mg / kg / day, 10 mg / kg / day, and 20 mg / kg / day, respectively. The positive control drug 5-ASA was administered at a dosage of 400 mg / kg / day. The blank control group, the pamoate-only group, and the model group were administered an equal volume of 0.5% carboxymethyl cellulose solution by gavage.
[0063] (1) Blank control group (Ctrl group); (2) Poria cocos acid alone group (Ctrl+Pac group); (3) Ulcerative colitis model group (Model group); (4) Positive drug group (5-ASA group); (5) Poria cocos acid low dose group (Pac-L group); (6) Poria cocos acid medium dose group (Pac-M group); (7) Poria cocos acid high dose group (Pac-H group).
[0064] During the experiment, all animals were raised and handled in accordance with national requirements for laboratory animal welfare and ethical guidelines.
[0065] Establishment of an ulcerative colitis model
[0066] During the model building phase, the Ctrl group and the Ctrl+Pac group had free access to regular drinking water; the other groups were given distilled water containing 3% DSS for 7 consecutive days to establish a DSS-induced ulcerative colitis mouse model.
[0067] Administration method and intervention process
[0068] Drug intervention was administered concurrently with DSS modeling. Specific procedures were as follows:
[0069] The Ctrl group, Ctrl+Pac group, and Model group were administered 0.5% carboxymethyl cellulose solution by gavage;
[0070] The 5-ASA group was administered 5-ASA solution by gavage;
[0071] The Pac-L, Pac-M, and Pac-H groups were administered the corresponding doses of poria cocos acid preparations by gavage.
[0072] All groups were administered the medication by gavage once daily for 7 consecutive days. It was preferred to administer the medication at a relatively fixed time each day to minimize the impact of factors such as circadian rhythms on the experimental results.
[0073] Sample collection
[0074] On day 8, samples were collected from mice in each group. Samples included blood and colon tissue, colon length was measured, and the spleen and thymus were separated and weighed for subsequent general phenotypic, histological, and molecular marker analysis.
[0075] Effects of pachymic acid on the general condition and organ-related indicators of model mice
[0076] Disease Activity Index (DAI) Evaluation
[0077] During modeling and drug administration, the general condition of the mice was observed and recorded daily, including their mental state, activity level, coat condition, fecal characteristics, and fecal bleeding, as well as changes in body weight. The Disease Activity Index (DAI) was used to score each group of mice based on the degree of weight loss, fecal morphology, and fecal bleeding to comprehensively assess the severity of the disease.
[0078] Measurement of body weight, colon length, and immune organ index
[0079] After the experiment, the changes in body weight of mice in each group were compared, the colon was dissected and its length was measured, and the spleen and thymus were weighed. The spleen index and thymus index were further calculated to evaluate the model status and intervention effect.
[0080] Experimental results showed that intervention with pamoate acid improved the disease activity of model mice, especially the high-dose group, which showed significant effects in reducing disease activity, alleviating weight loss, improving colon shortening and abnormal organ indices.
[0081] Effects of pachymic acid on colonic tissue pathological damage and mucosal barrier
[0082] HE staining for histological changes in the colon
[0083] Colon tissue was taken, fixed, dehydrated, embedded in paraffin, sectioned, and stained with hematoxylin and eosin (HE). The integrity of the colonic mucosa, gland arrangement, inflammatory cell infiltration, and degree of damage to the mucosa and submucosa were observed under a microscope.
[0084] The results showed that the colon tissue of the model group mice had obvious pathological damage, while the degree of damage was reduced after intervention with poria cocos acid, and the improvement was more significant in the high-dose group.
[0085] AB-PAS staining to evaluate mucus barrier status
[0086] AB-PAS staining was performed on colon tissue sections to observe the number of goblet cells and mucus secretion, thereby evaluating the degree of damage to the intestinal mucus barrier.
[0087] The results showed that, compared with the model group, treatment with pachymic acid improved the damage to the mucus layer and helped restore goblet cells and mucus secretion.
[0088] Immunohistochemical detection of intestinal barrier-related proteins
[0089] Immunohistochemistry was used to detect changes in the expression of intestinal tight junction proteins Claudin-1, Occludin, and ZO-1 to evaluate the effect of pachymic acid on intestinal epithelial barrier function.
[0090] The results showed that pamoate intervention could improve the abnormal expression of intestinal barrier function-related proteins in model mice, suggesting that it has a certain protective effect against colonic mucosal barrier damage.
[0091] Effects of pachymic acid on oxidative stress-related indicators
[0092] The levels of superoxide dismutase (SOD) and catalase (CAT) in the relevant samples were determined using commercially available detection kits. The specific procedures were performed according to the kit instructions.
[0093] The results showed that, compared with the model group, the abnormal levels of SOD and CAT were improved after intervention with pachymic acid, suggesting that pachymic acid can alleviate the oxidative stress imbalance in ulcerative colitis to a certain extent, with the improvement trend being more obvious in the high-dose group.
[0094] Effects of pachymic acid on inflammation and apoptosis-related indicators
[0095] Inflammatory factor detection
[0096] The expression levels of inflammation-related markers such as IL-6, IL-10, and TNF-α were detected by RT-qPCR to evaluate the regulatory effect of pachymic acid on abnormal inflammatory responses.
[0097] The results showed that after intervention with pamoate, the abnormal expression of inflammation-related indicators in the model mice was improved, indicating that it has a regulatory effect on inflammatory responses.
[0098] Apoptosis-related index detection
[0099] The expression changes of apoptosis-related markers such as Bax and Bcl2 were detected by RT-qPCR to evaluate the effect of pamoate on the imbalance of apoptosis in colon tissue cells.
[0100] The results showed that after intervention with pamoate, the abnormalities of apoptosis-related indicators in the model mice could be improved to a certain extent, suggesting that it can regulate the abnormal cell apoptosis that accompanies the process of colon tissue damage. The improvement was more obvious in the high-dose group.
[0101] Effects of pamoate alone on normal animals
[0102] The Ctrl+Pac group was set up, and poria cocos acid was administered alone without DSS modeling. The changes in general condition, body weight, tissue morphology and related test indicators were compared with those of the blank control group.
[0103] The results showed that normal animals given pachymic acid alone did not show any significant adverse effects compared to the blank control group, indicating that pachymic acid has a good basis for application under the administration conditions of this embodiment.
[0104] In summary, this invention demonstrates that pachymic acid can be used to prepare drugs for the prevention and treatment of ulcerative colitis. Based on a DSS-induced mouse ulcerative colitis model, pachymic acid can improve disease activity, reduce pathological damage to colonic tissue, alleviate mucosal barrier damage, and regulate oxidative stress, inflammatory responses, and apoptosis-related abnormalities; the high-dose pachymic acid group showed more significant improvement compared to the model group. Furthermore, no significant adverse effects were observed when pachymic acid was administered alone in normal animals, suggesting its potential application value under the conditions described in this invention.
[0105] 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 poria cocos acid pharmaceutical composition for the prevention and treatment of ulcerative colitis, characterized in that, Prepared from the following parts of materials: 100-500 parts of pachymic acid, 10-100 parts of carboxymethyl cellulose solution, 10-120 parts of pharmaceutical excipients, 10-100 parts of synergistic excipients, 10-50 parts of solvent, and 100-120 parts of purified water.
2. The poria cocos acid pharmaceutical composition for the prevention and treatment of ulcerative colitis according to claim 1, characterized in that: The poria cocos acid is one of the following: poria cocos medicinal material, pure poria cocos acid, and new poria cocos acid.
3. The poria cocos acid pharmaceutical composition for the prevention and treatment of ulcerative colitis according to claim 1, characterized in that: The carboxymethyl cellulose solution is a pharmaceutical-grade sodium carboxymethyl cellulose solution; the solvent is one of ethanol, methanol, ethyl acetate, and dichloromethane.
4. The poria cocos acid pharmaceutical composition for the prevention and treatment of ulcerative colitis according to claim 1, characterized in that: The pharmaceutical excipients include starch, lactose, binders, disintegrants, plasticizers, pore-forming agents, lubricants, and antioxidants.
5. The poria cocos acid pharmaceutical composition for the prevention and treatment of ulcerative colitis according to claim 1, characterized in that: The synergistic excipients include glutamine, astragalus polysaccharide, stir-fried atractylodes macrocephala, yam, and tangerine peel.
6. The poria cocos acid pharmaceutical composition for preventing and treating ulcerative colitis according to claim 1, characterized in that, The specific preparation steps of the poria cocos acid drug composition for preventing and treating ulcerative colitis are as follows: S1. Pulverize and sieve the poria cocos acid for later use. Place the pharmaceutical excipients in a constant temperature drying oven for drying. Take the carboxymethyl cellulose solution, add purified water, place it in a magnetic stirrer, and stir at room temperature for 15-20 minutes until the solution is uniform, without precipitation or lumps. Prepare a carboxymethyl cellulose dilution for later use. S2. Place the pretreated pachymic acid, pharmaceutical excipient powder, and synergistic excipients into a mixer, adjust the mixing speed to 200-300 r / min, and mix for 30-40 min. Add the prepared carboxymethyl cellulose dilution and solvent into the mixer, and stir at low speed for 20-25 min to fuse the liquid and solid components and obtain the composition. S3. Based on actual clinical medication needs, the composition is shaped, including granule shaping, tablet shaping and capsule shaping. S4. The molded composition is dried and sterilized, and the indicators are tested. After passing the test, it is packaged.
7. The poria cocos acid pharmaceutical composition for preventing and treating ulcerative colitis according to claim 6, characterized in that: In step S1, the poria cocos acid is pulverized into 80-100 mesh fine powder, and the drying temperature in the drying oven is 60-80℃ for 2-3 hours.
8. The poria cocos acid pharmaceutical composition for preventing and treating ulcerative colitis according to claim 6, characterized in that: In step S2, the low-speed stirring speed is 100-150 r / min; during the stirring period, stop the machine every 10 minutes to observe the mixing uniformity.
9. The poria cocos acid pharmaceutical composition for preventing and treating ulcerative colitis according to claim 6, characterized in that: In step S3, the granulation process involves placing the composition in a gyratory granulator, using an 18-20 mesh sieve, and controlling the extrusion granulation pressure at 0.3-0.5 MPa to obtain uniform wet granules. Tablet forming involves making the composition into wet granules, drying them, adding magnesium stearate, mixing them evenly, and then feeding them into a tableting machine. The tableting pressure is adjusted to 8-12 MPa, the tablet thickness is controlled at 2-3 mm, and the tablet weight difference is ≤±5%. Enteric coating is used, with a coating temperature of 40-50℃ and a coating thickness of 0.1-0.2 mm. Capsule forming involves preparing the composition into dry granules with a particle size controlled between 0.5 and 1.0 mm, and then filling them with No. 0 or No. 1 empty capsules.
10. An application of a pamoate drug composition for the prevention and treatment of ulcerative colitis, applied to the pamoate drug composition for the prevention and treatment of ulcerative colitis according to any one of claims 1 to 9, characterized in that: Poria cocos acid drug composition is used in drugs for the prevention and treatment of ulcerative colitis.