药物中基因毒性杂质检测方法研究进展

Advancesand analytical techniques of limitation of genotoxic impurities

基因毒性杂质由于对DNA的破坏作用而具有一定的致癌性,危害极大。因其结构众多,患者在服药过程中有摄入该类杂质的风险。部分国家对基因毒性杂质的限度控制已成为药品上市时必须考察的指标。本文概述了基因毒性杂质的基本概念、相关法规标准、部分杂质检测方法限度等内容,以期为控制药品中基因毒性杂质的含量提供参考和依据,保证患者用药安全。

Genotoxic impurities have a certain degree of carcinogenic impact because of its destructive effect on DNA. Due to a large structural diversity of such impurities, patients are at a high risk of taking medications. Limitation of genotoxic impurities has become an important index for pharmaceutical registration. Here basic concepts, regulatory stipulations and analytical approaches of genotoxic impurities are summarized to provide rationales for content control of genotoxic impurities in drugs and ensuring drug safety.