[关键词]
[摘要]
2018年11月6日,国家药监局发布《证候类中药新药临床研究技术指导原则》,阐明了证候类中药新药的处方来源、基本要求、临床定位、证候诊断、基本研究思路及试验设计、有效性及安全性评价、试验质量控制与数据管理、说明书撰写原则等。以《证候类中药新药临床研究技术指导原则》为主线,通过梳理相关政策法规,探讨"证候类中药新药"开发的机遇和可能遇到的困难,为"中医临床验方"及不在《古代经典名方目录》中的"传统经方"按照"证候类中药新药"开发提供实施路径参考。
[Key word]
[Abstract]
The State Food and Drug Administration issued the"Guiding Principles for Clinical Research of New Drugs for Syndromes of Traditional Chinese Medicine"On November 6,2018,which clarified the prescription source,basic requirements,clinical orientation,syndrome diagnosis,basic research ideas of new Chinese medicines for syndromes.Test design,effectiveness and safety evaluation,test quality control and data management,manual writing principles,etc.This article takes the"Guidelines for Clinical Research of New Drugs for Syndrome Chinese Medicine"as the main line,combined with relevant policies and regulations to explore the opportunities and possible difficulties in the development of "New Drugs for Syndrome Chinese Medicine" ,which is the implementation path reference for "Chinese medicine clinical prescription" and the"traditional prescriptions "not in the Ancient Classics Catalogue in accordance with the development of the" New Drugs for Syndrome Chinese Medicine".
[中图分类号]
[基金项目]
山东省科技支撑项目“中医经典名方的二次开发”(项目编号2016CYJS08A01-9);天津市科技支撑计划项目“治疗2型糖尿病中药复方新药千金连黄片的临床前研究”(项目编号16YFZCSY00620);天津市科技支撑计划项目“治疗小儿急性咽喉炎中医经方新药小儿升麻合剂的临床前研究”(项目编号17YFZCSY00750)