化学药品中亚硝胺类杂质控制研究的新进展  

New Progress in the Control of Nitrosamine Impurities in Chemical Drugs

作　　者：刘璇 朱晶晶 陈正 王月莹 LIU Xuan;ZHU Jingjing;CHEN Zheng;WANG Yueying(Taizhou Huangyan District Center for ADR Monitoring,Taizhou 318020;Taizhou Institute for Food and Drug Control,Taizhou 317700;Taizhou Administration for Market Regulation,Taizhou 317700;Taizhou Pharmaceutical Association,Taizhou 317700)

机构地区：[1]台州市黄岩区药品不良反应监测中心,浙江台州318020 [2]台州市食品药品检验研究院,浙江台州317700 [3]台州市市场监督管理局,浙江台州317700 [4]台州市药学会,浙江台州317700

出　　处：《中国医药工业杂志》2024年第6期770-776,共7页Chinese Journal of Pharmaceuticals

摘　　要：鉴于在血管紧张素Ⅱ受体拮抗药、组胺2受体拮抗药、抗微生物药和抗糖尿病药等药品中陆续发现亚硝胺类杂质,全球药品监管机构明显加大了对该类杂质的监管力度。各国药品监管机构陆续颁布了相应的指南性文件,制定了风险评估方法,提出了药品中亚硝胺类杂质的控制策略。我国也陆续出台了一系列与国际接轨的指南性文件,对亚硝胺类杂质进行控制。但实际工作中,对于化学药品中亚硝胺类杂质的产生途径、风险评估和控制策略等尚存难点。文章主要介绍了化学药品中亚硝胺类杂质形成的亚硝化途径和可能原因,及该类杂质分析方法的总体要求,同时总结了各国药品监管机构提出的药品中亚硝胺类杂质的风险评估及控制策略,为亚硝胺类杂质的进一步研究和控制提供参考。In view of the discovery of nitrosamine impurities in angiotensin II receptor antagonists,histamine 2 receptor antagonists,antimicrobial drugs,antidiabetic drugs and other drugs,global regulatory agencies have significantly increased their supervision on nitrosamine impurities.Regulatory agencies in various countries have successively issued the corresponding guiding documents,developed risk assessment methods,and proposed control strategies for nitrosamine impurities in drugs.China has also successively introduced a series of guiding documents that are in line with the international standards to control nitrosamine impurities.However,in practical work,there are stil difficulties in the generation pathways,risk assessment,and control strategies for nitrosamine impurities.This article mainly introduces the possible nitrosation pathways and formation causes of nitrosamine impurities in chemical drugs,as well as the overall requirements for the analysis methods.And the risk assessment and control strategies for nitrosamine impurities in chemical drugs proposed by the regulatory agencies in various countries are summarized,which can provide a reference for further research and control of nitrosamine impurities.

关 键 词：亚硝胺类杂质 化学药品 质量控制 风险评估 控制策略 研究进展 

分 类 号：R917[医药卫生—药物分析学]