辛伐他汀片处方工艺筛选及溶出度一致性评价

Screening of formulation for the preparation of simvastatin tablets and the consistency evaluation of their dissolubility

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f2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p H的溶出介质中溶出曲线与参比制剂相比,溶出行为相似。

The formulation 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 f2 similarity factor with the original preparation as a reference so as to optimize the formulation process. The dissolution profile of home-made simvastatin tablets prepared by the optimal process in the different p H of the dissolution media was similar to that of the reference preparation.