加速中药院内制剂向新药高效转化研究  

Research on accelerating the efficient transformation of hospital preparations into Traditional Chinese Medicine new drugs

作　　者：王霞 高天乐 唐铭泽 韩燕星 蒋建东 WANG Xia;GAO Tian-le;TANG Ming-ze;HAN Yan-xing;JIANG Jian-dong

机构地区：[1]悦康药业集团股份有限公司,北京100176 [2]中国医学科学院北京协和医学院药物研究所天然药物活性物质与功能国家重点实验室,北京100050

出　　处：《中国医药生物技术》2024年第6期493-498,共6页Chinese Medicinal Biotechnology

基　　金：中国工程院战略研究与咨询项目(2023-XZ-88)。

摘　　要：中药院内制剂作为填补上市药品未满足临床需求的临床验方,蕴含着巨大的研发价值和潜力。本文旨在探讨如何利用院内制剂的独特优势,加速其向中药新药的转化进程。文章深入分析了院内制剂的管理要求特点,并据此挖掘了新药研发转化的改进方向。结合国家政策支持,本文提出了一套策略,旨在充分利用院内制剂的人用经验,缩短研发进程和投入,以促进其更快转化为新药上市,推动中医药的传承与发展。通过优化审评体系、减少非临床研究投入、加强沟通交流和风险管理等措施,有望显著缩短院内制剂向新药的转化周期。Traditional Chinese Medicine(TCM)hospital preparations,as clinical formulas that address unmet clinical needs not met by marketed drugs,hold significant research and development value and potential.This article aims to explore how to leverage the unique advantages of hospital preparations to accelerate their transformation into new TCM drugs.The article provides a thorough analysis of the current management requirements and characteristics of hospital preparations and,based on this analysis,identifies directions for improvement in new drug research and development transformation.In conjunction with the active support of national policies,this article proposes a set of strategies that fully utilize the human experience of hospital preparations to shorten the research and development process and investment,with the goal of promoting the rapid transformation of TCM hospital preparations into new drugs for market launch and further advancing the inheritance and development of TCM.

关 键 词：院内制剂 验方 新药 人用经验 

分 类 号：R283.6[医药卫生—中药学]