化学创新药强制降解研究的一般考虑  

General considerations on the forced degradation studies of chemical innovative drugs

作　　者：许婷婷 章晓骅 XU Ting-ting;ZHANG Xiao-hua(Nanjing Chia-Tai Tianqing Pharmaceutical Company,Nanjing 210046,China)

机构地区：[1]南京正大天晴制药有限公司,南京210046

出　　处：《药物分析杂志》2024年第12期2148-2153,共6页Chinese Journal of Pharmaceutical Analysis

摘　　要：相比化学仿制药,化学创新药由于其结构新颖,降解途径未知等特点,在强制降解研究的主要降解产物归属,降解试验条件摸索,降解产物的致突变性研究等方面需更多尝试。目前,已有多篇针对药物强制降解研究的文献综述,但未对化学创新药的强制降解研究进行针对性的论述。本文参考国内外相关文献,并结合在药物研发中的实践,重点对化学创新药强制降解研究的主要降解产物归属,降解试验条件摸索及降解产物的致突变性等内容进行讨论,以期为药物研发人员提供一些借鉴。Compared to chemical generic drugs,more attempts should be made for chemical innovative drugs in the identification of major degradation products,the exploration of stress testing conditions,and the mutagenicity study of degradation products due to their novel structures and unknown degradation pathways.At present,many literature reviews on the forced degradation studies of drugs have been published,but there are almost no specific discussions for innovative drugs.This article is intended to discuss the identification of major degradation products,the exploration of experiment conditions,and the mutagenicity of degradation products based on the related literatures and research experiences in order to provide some references for researchers.

关 键 词：化学创新药 强制降解 一般考虑 降解试验条件 降解产物 致突变性 

分 类 号：R917[医药卫生—药物分析学]