[关键词]
[摘要]
随着对手性药物认识的不断深入,不对称合成技术、拆分技术的飞速发展以及手性药物监管政策的日益完善,手性药物已成为新化学实体研发的重要方向。从手性药物的发展情况、手性药物的药理,毒理学特点,各国药品监管部门针对手性药物开发所颁布的指导原则的进展情况与我国手性药物安全性评价的现状几个方面进行综述总结,为手性药物的开发及其毒理学评价提供参考。
[Key word]
[Abstract]
With the deepening knowledge about chiral drugs and as a consequence of the rapid advances in chiral synthesis and separation technologies, combined with new regulatory policies for chiral pharmaceuticals, chiral drugs have become an important direction for research and development of new molecular entities. This study was performed to investigate the development of chiral drugs and outline the pharmacological and toxic characteristics of them. We then discussed different statements by drug regulatory authorities in the development and approval of stereoisomeric drugs along with the current status for the safety evaluation of stereoisomeric drugs in China, providing reference for the development of stereochemical issues as well as offering information for the toxicological evaluation of chiral drugs.
[中图分类号]
[基金项目]
重大新药创制专项支持基金(2018ZX09201017-005);中国医学科学院创新工程协同创新项目(2017-I2M-1-011)