外用中药创新药人体耐受性试验难点和要点探析  

The difficulties and key points of human tolerance trial of external innovative traditional Chinese medicine

作　　者：李美凤[1] 黄宇虹[1] 王保和[1] 李艳芬[1] 谷旭放[1] 王瑞华[1] LI Mei-feng;HUANG Yu-hong;WANG Bao-he;LI Yan-fen;GU Xu-fang;WANG Rui-hua(The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine,Tianjin 300250,China)

机构地区：[1]天津中医药大学第二附属医院,天津300250

出　　处：《中国新药杂志》2020年第16期1841-1844,共4页Chinese Journal of New Drugs

基　　金：国家“重大新药创制”科技重大专项资助项目(2018ZX09734002);天津市科技计划项目(17ZXXYSY00060)。

摘　　要：随着国家鼓励创新战略决策推进,中药创新药研发逐渐活跃,为外用中药创新药研发提供了契机。Ⅰ期临床耐受性试验是早期评价中药创新药安全性的主要环节。外用中药创新药给药途径特殊,试验设计通常不拘泥于传统,依制剂类型不同而有所侧重,确保能够科学、客观地评价药物安全性,评估机体对药物的最大耐受程度。本研究旨在梳理外用中药创新药中使用较广泛的皮肤贴剂、鼻腔给药制剂、阴道给药制剂3种常见外用制剂的健康人体耐受性试验中涉及的难点、要点进行总结分析,为国内中药创新药外用制剂研发和临床研究提供有益参考。With the moving onwards of the national strategy of encouraging innovation,the research and development of innovative traditional Chinese medicines(TCM)is increasing and becoming more active.The phaseⅠclinical tolerance trial is a major research to evaluate the safety of innovative TCM at early stage.The design of the tolerance trials of topical TCM preparations is often special due to the administration routes.The purpose of this article is to summarize and analyze the difficulties and key points involved in the tolerance test of three common topical TCM dosage forms in healthy human:skin patch,nasal cavity and vaginal suppository,so as to provide beneficial reference for early clinical trials in the research and development of innovative TCM.

关 键 词：外用制剂 中药创新药 耐受性试验 技术难点和要点 质量控制 

分 类 号：R95[医药卫生—药学]