摘要
药物杂质是反映药物质量的重要指标,其研究也贯穿着药物研发、生产以及销售的整个过程。随着分析仪器技术的不断发展,药物中杂质的研究技术以及杂质研究方法也在不断地更新。本文从药物杂质来源、杂质研究方法以及基因毒性杂质研究等方面重点讨论了分析技术的最新进展以及基因毒性杂质的确定方法,为药物分析工作者在杂质研究时提供技术上的参考。
Pharmaceutical impurities affect the quality of drugs, and their research is essential in drug develop- ment, production and sale. Recently, there have been tremendous advancements in instrumental techniques that allow rapid development of technologies and analytical methods in the research of pharmaceutical impurities. This review discusses the origins and analytical methods of pharmaceutical impurities including genotoxic impurities, and mainly describes the analytical techniques and strategies to assess the genotoxicity of impurities, providing technical references for the study of pharmaceutical impurities.
出处
《中国药科大学学报》
CAS
CSCD
北大核心
2015年第3期257-263,共7页
Journal of China Pharmaceutical University
关键词
药物杂质
分析技术
方法
基因毒性杂质
进展
pharmaceutical impurities
analytical techniques
method
genotoxic impurities
advance
