具有区分力的溶出曲线  

The Dissolution Curve with Distinguishing Ability

作　　者：谢沐风[1] 

机构地区：[1]上海市食品药品检验所,上海201203

出　　处：《中国医药工业杂志》2014年第7期687-689,I0005,共4页Chinese Journal of Pharmaceuticals

摘　　要：溶出度试验在口服固体制剂品质评价和仿制药研发中愈来愈发挥出举足轻重的作用,而寻找到客观存在、并确定出最能体现原研制剂内在优良品质、具有区分力的溶出曲线才是该试验的重中之重,本文将就此展开论述。Dissolution test plays a very important role in the development of oral solid formulations.A critical dissolution condition for distinguishing the dissolution behaviors of the products should be found.The paper describes how to choose a critical dissolution condition for showing the inherent properties of different solid products.

关 键 词：原研制剂 仿制制剂 溶出曲线 区分力 

分 类 号：TQ460[化学工程—制药化工]