中药新药开发的现状及思考  

Current situation and reflection on the development of new traditional Chinese medicine

作　　者：白洁 马珂 谢浏娜 康雅倩 逯晶 BAI Jie;MA Ke;XIE Liu-na;KANG Ya-qian;LU Jing(School of Medicine,Hunan University of Traditional Chinese Medicine,Changsha 410208)

机构地区：[1]湖南中医药大学医学院,长沙410208

出　　处：《中南药学》2024年第7期1817-1821,共5页Central South Pharmacy

基　　金：国家自然科学基金青年科学基金项目(No.82104936);湖南省自然科学基金面上项目(No.2021JJ30498);湖南中医药大学中医学国内一流建设学科(No.49010200002002);国家中医药管理局中医眼科学重点学科建设项目(No.49021001005002)。

摘　　要：本文根据2021—2022年国家药品监督管理局发布的“中药新药获批数据”,发现上市许可的中药新药数量较少,而中药新药研发对中药的传承、中医临床治疗的帮助以及药企的生存都至关重要,因此对中药新药研发的问题、方法与政策等展开研究,从而提供开发思路。以期新药开发可以秉承“以中医药理论为基础,以临床价值为导向,重视人用经验,全过程质量控制”的理念,并凸显中药临床优势,紧跟时代步伐,创新中医药人才培养新机制,使中药新药研发领域得到更好的发展。Based on data released by the National Drug Administration from 2021 to 2022.The number of new traditional Chinese medicine approved for marketing was relatively small.This article reviewed the research and development of new traditional Chinese medicine which play a crucial role in the inheritance of new traditional Chinese medicine,the assistance of clinical treatment with traditional Chinese medicine,and the survival of pharmaceutical enterprises.Therefore,research is conducted on the issues,methods,and policies of new traditional Chinese medicine drug to provide ideas.The development of new drugs is expected to adhere to traditional Chinese medicine theory,guide by clinical value,emphasize human experience,and control the quality in the entire process.The clinical advantages of traditional Chinese medicine were highlighted,to keep pace with the times,innovate new mechanisms for cultivating traditional Chinese medicine talents,and promote faster development of new Chinese medicine.

关 键 词：中药新药 创新 临床 政策分析 

分 类 号：R28[医药卫生—中药学]