中药外用制剂新药非临床安全性评价中应关注的问题

Problems in nonclinical safety evaluation of external preparation of traditional Chinese medicine

本文对近年来申报的中药新药品种(非口服中药制剂,注射剂除外)存在问题进行了归纳,从受试物、局部及系统暴露、给药途径选择、经皮给药评价关注点、试验项目选择及非吸入性中药气雾剂变更抛射剂等方面介绍了现阶段对中药非口服制剂新药非临床安全性评价相关问题的认识和可能的解决方法,以及相关领域的共识。

In this article, we summarized the problems in new drug applications of external preparation of traditional Chinese medicine （TCM）. In aspects of the test, exposure, route of administration, key problems of transdermal administration, the experimental project and the propellent change of non inhalation aerosol of TCM, we tried to introduce our opinions, the possible solution for these problems and the common view in this field at the present stage.