采用激光衍射或散射技术测定原料药粒度及粒度分布的几点考虑

Some considerations on the application of laser diffraction or scattering method in the measurment of the particle size and distribution of API

目前药品上市注册申报资料中多采用激光衍射或散射技术测定需有严格控制要求的原料药粒度及粒度分布,而该部分资料普遍存在完整性和规范性的问题。本文结合相关法规、指导原则的要求以及近年的审评经验,阐述基于激光衍射或散射技术进行原料药粒度研究的一些考虑,旨在为后续的研究提供参考,以期有助于申请人提高申报资料质量。

The particle size and particle size distribution of API need to be strictly controlled and usually measured by laser diffraction or scattering method in drug marketing registration.However,this part of application dossiers are generally incomplete and non-standard.Based on the requirements of relevant regulations,guidelines and review experience in recent years,this paper expounds some considerations on the study of particle size of API,in order to provide some references for future research and help applicants to improve the quality of application dossiers.