药品中亚硝胺类杂质研究概述  

Overview of research on nitrosamine impurities in drugs

作　　者：丁嘉信 李荣荣 史乙伟 孙启泉 DING Jiaxin;LI Rongrong;SHI Yiwei;SUN Qiquan(State Key Laboratory of Advanced Drug Delivery and Release Systems,Shandong Luye Pharmaceutical Co.,Ltd.,Shandong Province,Yantai264003,China;Department of Pharmacy,Municipal Hospital of Yantai City Government,Shandong Province,Yantai264000,China)

机构地区：[1]山东绿叶制药有限公司先进药物递释系统全国重点实验室,山东烟台264003 [2]烟台市市直机关医院药剂科,山东烟台264000

出　　处：《中国当代医药》2025年第6期187-192,共6页China Modern Medicine

基　　金：山东省烟台市产业领军人才项目。

摘　　要：近年来,由于药品中亚硝胺类杂质的高致癌风险,对人体的健康和安全存在较大的隐患,引起了各国药品监管机构与制药企业对亚硝胺类杂质的高度关注。各国药品监管机构陆续发布了关于亚硝胺杂质的相关指南,指导进行亚硝胺杂质的风险评估及有效控制。本文介绍了亚硝胺类杂质的背景、形成的来源,结合国家药品监督管理局、美国食品药品监督管理局和欧洲药品管理局发布的当前与药品相关的亚硝胺杂质的各项指导原则,对亚硝胺杂质的控制,包括风险评估、控制限度及控制策略等方面进行阐述。本文旨在对亚硝胺杂质的最新监管政策和监管限度进展进行综述,以期为亚硝胺杂质的相关研究和控制提供借鉴和参考,实现药品中亚硝胺杂质的最小暴露。In recent years,due to the high carcinogenic risk of nitrosamine impurities in drugs,there is a great hidden danger to human health and safety,which has aroused the high attention of drug regulatory agencies and pharmaceutical companies in various countries.Drug regulatory agencies in various countries have successively issued relevant guidelines on nitrosamine impurities to guide the risk assessment and effective control of nitrosamine impurities.In this paper,the background and origin of nitrosamine impurities are introduced,and the control of nitrosamine impurities,including risk assessment,control limits and control strategies,is elaborated in combination with the current guidelines on nitrosamine impurities related to drugs issued by National Medical Products Administration,Food and Drug Administration and European Medicines Agency.The purpose of this paper is to review the latest regulatory policies and regulatory limits of nitrosamine impurities,in order to provide reference for the relevant research and control of nitrosamine impurities,and to achieve the minimum exposure of nitrosamine impurities in drugs.

关 键 词：亚硝胺类杂质 药品 致癌性 控制策略 

分 类 号：R97[医药卫生—药品]