摘要
亚硝胺类杂质是一类具有潜在致突变性的化合物。近年来,多种药品中相继检出亚硝胺类杂质,此类杂质已成为监管机构、制药企业和患者关注的焦点。本文在查阅最新法规指南及相关文献基础上,总结了亚硝胺类杂质的来源、控制、限度及检测方法等方面的研究进展,并提出思考和展望,期望为药品研究和监管工作提供参考。
Nitrosamine-type impurities are a class of compounds with potential genotoxicity.In recent years,being detected in many drugs,nitrosamine impurities have become the focus of regulatory authorities and pharmaceutical manufacturers,as well as patients.By reviewing the latest legal guidelines and related literature,this paper summarizes the research progress in the sources,control,limits,and detection methods of nitrosamine impurities,then puts forward considerations and prospects,hoping to provide reference for the research and regulation of drug R&D.
作者
王功富
汤佳
WANG Gong-fu;TANG Jia(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China;Greater Bay Area Center for Drug Evaluation and Inspection of National Medical Products Administration,Shenzhen 518000,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2024年第3期221-228,共8页
Chinese Journal of New Drugs
关键词
亚硝胺类杂质
致突变性
监管
nitrosamine impurities
genotoxicity
regulatory
