摘要
药品中存在的遗传毒性杂质可能具有遗传毒性和致癌性而危害病人的健康,已成为制药企业、药品监管机构、病人和医师关注的焦点。本文通过分析遗传毒性杂质的医药工业来源、毒性机制和相关法规要求,为制药研发者更好地控制产品质量、评估新的合成路线、选择最佳合成路线、优化化学反应和产品纯化策略提供参考。
The genotoxic impurities in drugs may have genetical toxicity and carcinogenicity.The risk for patient health caused by genotoxic impurities in drugs has become the focus of attention by pharmaceutical manufacturers and regulatory authorities,as well as patients and doctors.Through analyses of pharmaceutical manufacturing sources,toxic mechanism and related regulatory requirements of genotoxic impurities,this paper would provide pharmaceutical researchers and manufacturers with better ways for quality control of products,evaluating new synthetic routes,selecting optimal synthetic routes and refining strategies for chemical reactions and product purification.
作者
刘晓丹
陆峰
何伍
LIU XiaoDan LU Feng HE Wu(Department of Drug Evaluation, Shanghai Center for Drug Evaluation and Inspection, Shanghai 201203 ,China Shanghai Center for Drug Evaluation and Inspection, Shanghai 201203, China Second Department of Chemistry,Center of Drug Evaluation,China Food and Drug Admistration,Bei）ing 100038,China)
出处
《药学服务与研究》
CAS
2017年第3期235-237,共3页
Pharmaceutical Care and Research
关键词
遗传毒性杂质
来源
质量控制
综述
genotoxic impurity
source
quality control
review
