文档介绍：辛伐他汀片处方工艺筛选及溶出度一致性评价摘要本文以制剂的溶出度为指标,优化辛伐他汀片处方和制备工艺。以原研制剂为参比制剂, 采用?2 相似因子法进行辛伐他汀片溶出曲线的相似度评价,优化处方工艺。采用优化的工艺制备自制片在不同 pH 的溶出介质中溶出曲线与参比制剂相比,溶出行为相似。关键词辛伐他汀片处方工艺溶出曲线?2 相似因子中图分类号: ; 文献标识码:A 文章编号: 1006-1533 ( 2015 ) 05-0071-04 Scre ening of formulation for the preparation of simvastatin tablets and the consistency evaluation of their dissolubility GU Ting* , CHANG Yanling , DONG Jiali ( Shanghai Sine Wanxiang Pharmaceutical Co. Ltd. , Shanghai 201703 , China ) ABSTRACT The for mulation process for the preparation of simvastatin tablets was optimized with the dissolution as indicators. The similarity of the dissolution profile of simvastatin tablets was evaluated by ?2 similarity factor with the original preparation asa reference so as to optimize the formulation process. The dissolution profile of home-made simvastatin tablets prepared by the optimal process in the different pH of the dissolution media was similar to that of the reference preparation. KEY WORDS simvastatin tablets; formulation process; dissolution profile; ?2 similarity factor 辛伐他汀( simvastatin )是羟***戊二酰辅酶 A 还原酶抑制剂,它能抑制***戊酸( 内源性胆固醇合成的前体) 的合成, 从而抑制胆固醇的生成, 临床具有降脂作用明显、安全、副作用小等优点, 是治疗高脂血症的首选药物之一。市售部分产品与原研药存在一定差距, 主要体现在体外溶出度和体内生物等效性的指标上,这两项指标是反映药品等效的重要指标[1] 。用单点溶出度控制药物学溶出行为, 对很多产品而言不能全面准确地反映产品的溶出性能与内存质量,特别是不能反映出产品之间的质量差异[2] 。溶出度试验技术不仅已作为评价固体制剂内在质量的一种重要手段, 也是一种评价药物在体内释放和吸收的有效手段[3] ,是口服固体制剂内在品质呈现于外在的一种“表象”、“映射”、“载体