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目的:对比不同粉碎工艺制得的熊去氧胆酸原料有关物质及胶囊体外溶出度,筛选最佳粉碎方式。方法:采用HPLC法对不同粉碎工艺制得的原料进行有关物质考察,选择有关物质符合要求的原料制备成胶囊进行体外溶出度评价,确定最佳粉碎工艺,并将此工艺下制得的自制品和市售品进行一致性评价。结果:通过粉碎原料有关物质考察及合格原料制得胶囊体外溶出度评价,得到原料最佳粉碎工艺:即采用球磨机粉碎原料3min。结合一致性评价结果,在水、pH 1.2盐酸溶液、pH 4.0磷酸盐缓冲液、pH 7.5磷酸盐缓冲液四种溶出介质中溶出曲线相似因子f_2均大于50,验证该粉碎工艺方法可行。结论:一致性评价结果表明,采用球磨机粉碎3 min原料制得的制剂与市售品体外溶出行为一致,说明该原料最佳粉碎方法合理,自制品与原研质量相当。
OBJECTIVE: To compare the dissolution rate of ursodeoxycholic acid material and capsule in vitro obtained by different crushing processes and screen the best way of crushing. Methods: The HPLC method was used to investigate the related materials of the raw materials obtained from different crushing processes. The raw materials that meet the requirements were selected to prepare capsules for in vitro dissolution evaluation. The optimal crushing process was determined and the prepared products Consistency evaluation with commercial products. Results: The evaluation of the in vitro dissolution of the capsules by the investigation of the relevant substances of the pulverized raw materials and the dissolution of the capsules in the qualified raw materials gave the optimum pulverization process of the raw materials: the pulverized raw materials were pulverized by a ball mill for 3 minutes. According to the results of consistency assessment, the similarity factors f 2 of the dissolution curves in water, pH 1.2 hydrochloric acid solution, pH 4.0 phosphate buffer solution and pH 7.5 phosphate buffer solution were greater than 50, which verified the feasibility of the pulverization process. CONCLUSION: The results of the consistency assessment show that the dissolution behavior of the preparations prepared by ball mill for 3 min is in good agreement with that of commercial products, indicating that the optimum grinding method of the raw materials is reasonable and the quality of self-made products is the same as the original one.