仿制药一致性评价中溶出度试验方法的探讨

The discussion of dissolution test methods in consistency evaluation for generics

通过分析仿制药一致性评价中采用的溶出度试验方法的现状,比较美国药典和中国药典中的溶出度试验方法,重点介绍美国药典中的溶出度试验方法的开发与验证,以期为仿制药一致性评价提供适宜的溶出度试验方法。参照美国药典相关要求构建溶出度试验方法可有效提高仿制药一致性评价的合规性和效率。

The dissolution test methods between Chinese Pharmacopoeia and United States Pharmacopoeia （USP） were compared by analyzing the current situation of the dissolution test methods adopted in consistency evaluation for generics and the development and validation of dissolution test methods in USP were focused on so as to provide suitable dissolution test methods for the consistency evaluation of generics. The dissolution test methods established by referring to the related requirements of USP can efectively improve the compliance and efciency of the consistency evaluation of generics.