药物中磺酸酯类基因毒性杂质研究进展

刘雪薇 厉程 韩海云 张文鹏 陈东英

引用本文: 刘雪薇,  厉程,  韩海云,  张文鹏,  陈东英. 药物中磺酸酯类基因毒性杂质研究进展[J]. 色谱, 2018, 36(10): 952-961. doi: 10.3724/SP.J.1123.2018.05004 shu
Citation:  LIU Xuewei,  LI Cheng,  HAN Haiyun,  ZHANG Wenpeng,  CHEN Dongying. Advances on genotoxic impurities of sulfonate esters in pharmaceuticals[J]. Chinese Journal of Chromatography, 2018, 36(10): 952-961. doi: 10.3724/SP.J.1123.2018.05004 shu

药物中磺酸酯类基因毒性杂质研究进展

  • 基金项目:

    中国科学院药物创新研究院自主部署科研项目(CASIMM0120163011).

摘要: 该文概述了近10年来有关药物中基因毒性杂质监管指南的完善历程与相关检测方法的研究进展。介绍了基因毒性杂质从早期的完全避免到目前的阶段化毒理学关注阈值(TTC)的风险控制理念以及各主流监管机构的具体要求。作为一类重要的基因毒性杂质,磺酸酯主要来源于磺酸及衍生物与低级醇(如甲醇、乙醇、异丙醇等)之间发生的副反应,具有化学结构类型多样化的特点。该文较为详尽地介绍了磺酸酯的形成机理和文献所采用的液相色谱法和气相色谱法,并对色谱方法的选择、预处理方式、衍生化方法及相应痕量水平的灵敏度和回收率等进行了评述。由此期望为合理控制药物中磺酸酯类基因毒性杂质,为保证药物的质量安全性提供有益的指导意见。

English

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  • 收稿日期:  2018-05-03
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