五种粉碎工艺对熊去氧胆酸胶囊有关物质和体外溶出度的影响

发布时间：2019-05-17 19:46

【摘要】：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。
[Abstract]:Objective: to compare the dissolution of ursodeoxycholic acid (ursodeoxycholic acid) and the dissolution of ursodeoxycholic acid (ursodeoxycholic acid) prepared by different grinding processes in vitro, and to screen the best crushing method. Methods: HPLC method was used to investigate the related substances of the raw materials prepared by different grinding processes. The capsules prepared from the raw materials which met the requirements were selected to evaluate the dissolution in vitro, and the optimum grinding process was determined. The consistency of the self-made products and the market products prepared by this process is evaluated. Results: through the investigation of the related substances of the grinding raw materials and the evaluation of the dissolution of the capsules prepared from the qualified raw materials in vitro, the optimum grinding process of the raw materials was obtained: the ball mill was used to crush the raw materials for 3 min. Combined with the results of consistency evaluation, the similarity factor f 鈮，

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