隨著對手性藥物認(rèn)識的不斷深入，不對稱合成技術(shù)、拆分技術(shù)的飛速發(fā)展以及手性藥物監(jiān)管政策的日益完善，手性藥物已成為新化學(xué)實(shí)體研發(fā)的重要方向。從手性藥物的發(fā)展情況、手性藥物的藥理，毒理學(xué)特點(diǎn)，各國藥品監(jiān)管部門針對手性藥物開發(fā)所頒布的指導(dǎo)原則的進(jìn)展情況與我國手性藥物安全性評價的現(xiàn)狀幾個方面進(jìn)行綜述總結(jié)，為手性藥物的開發(fā)及其毒理學(xué)評價提供參考。

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.

重大新藥創(chuàng)制專項(xiàng)支持基金（2018ZX09201017-005）；中國醫(yī)學(xué)科學(xué)院創(chuàng)新工程協(xié)同創(chuàng)新項(xiàng)目（2017-I2M-1-011）