质子泵抑制剂光学异构体药理毒理的研究评价  

Discussions on assess nonclinical issues of proton pump inhibitors optical isomers

作　　者：笪红远[1] 光红梅[1] 孙涛[1] 王庆利[1] 

机构地区：[1]国家食品药品监督管理总局药品审评中心,北京100038

出　　处：《中国临床药理学杂志》2014年第8期742-743,749,共3页The Chinese Journal of Clinical Pharmacology

基　　金：国家"重大新药创制"科技重大专项基金资助项目(2011ZX09304-001)

摘　　要：随着对手性药物认识不断深入和不对称合成技术、拆分技术的发展,手性药物市场逐年扩大,手性药物已经成为新分子实体研究开发的重要方向,质子泵抑制剂(PPI)的光学异构体也陆续获得批准上市。本文主要就PPI光学异构体的药理毒理内容和现阶段的注册申请评价思路进行讨论。With the deepening knowledge about chiral drugs and the de-velopment of asymmetric synthesis technology as well as splitting technol-ogy, chiral drug market has gradually expanded , and chiral drugs have led us to an important direction to study and develop new molecular enti-ties.Proton pump inhibitor （ PPI） optical isomers are approved to be on the market in succession.The article discusses pharmacodynamics , phar-macokinetics and safety assessment about the application for registration issues which of the PPI optical isomers mainly .

关 键 词：质子泵抑制剂 光学异构体 临床前评价 

分 类 号：R954[医药卫生—药学]