浅析遗传毒性杂质在医药工业中的来源与控制  

Superficial analysis of sources and control of genotoxic impurities in pharmaceutical manufacturing

作　　者：刘晓丹 陆峰 何伍[3] 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)

机构地区：[1]上海药品审评核查中心药品审评部,上海201203 [2]上海药品审评核查中心,上海201203 [3]国家食品药品监督管理总局药品审评中心化学二部,北京100038

出　　处：《药学服务与研究》2017年第3期235-237,共3页Pharmaceutical Care and Research

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.

关 键 词：遗传毒性杂质 来源 质量控制 综述 

分 类 号：R95[医药卫生—药学]