后疫情时代创新中药新药研发的策略与思考  

Strategy and Thinking of New Medicine Research and Development of Innovative Chinese Medicine

作　　者：韦忠红[1,2] 陆茵 Wei Zhonghong;Lu Yin(School of Pharmacy,Nanjing University of Chinese Medicine,Nanjing 210023,China;Jiangsu Key Laboratory for Pharmacology and Safety Evaluation of Chinese Materia Medicine,Nanjing 210023,China;Jiangsu Collaborative Innovation Center of Traditional Chinese Medicine(TCM)Prevention and Treatment of Tumor,Nanjing 210023,China)

机构地区：[1]南京中医药大学药学院,南京210023 [2]江苏省中药药效与安全性评价重点实验室,南京210023 [3]江苏省中医药防治肿瘤协同创新中心,南京210023

出　　处：《世界科学技术-中医药现代化》2022年第12期4644-4649,共6页Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology

基　　金：国家自然科学基金委员会国际(地区)合作与交流项目(81961128020):从深海微生物来源的天然产物中发现PD-1/PD-L1小分子抑制剂,负责人:陆茵;国家自然科学基金委员会面上项目(81973734):从“癌栓”介导的“免疫逃逸”关键环节研究活血化瘀药抑制肿瘤血行转移的整合协同机制,负责人:陆茵;国家自然科学基金委员会青年基金项目(82004124):基于特征菌群的发现研究茵栀黄治疗胆汁淤积性肝损伤的整合起效机制,负责人:韦忠红。

摘　　要：中药新药研发是中药企业生存与发展的决胜点。面临“低处果实已摘净”的现状,中药企业唯有立足于产品创新,提高产品的科技壁垒才能突破发展瓶颈。本文鉴于疫情期间中医药所表现出的优势与特色,秉持以中医药理论为基础、以临床价值为导向、以人用经验为启发,提出了针对新注册分类下不同新药注册类别的中药创新药研发路径。以期推动中药研究领域中的应用与发展,为中药新药的研发提供有效的研究范式。The research and development of Chinese medicine is the crux for the survival and development of Chinese medicine enterprises.Faced with the current situation of "low-hanging fruit has been removed",TCM enterprises can only break through the development bottleneck by basing themselves on product innovation and raising the technological barriers of products.In view of the advantages and characteristics of traditional Chinese medicine during the epidemic period,this paper,based on the theory of traditional Chinese medicine,guided by clinical value and inspired by human experience,proposed the research and development paths of traditional Chinese medicine innovative drugs for different new drug registration categories under the newly registered classification.In order to promote the application and development in the field of TCM research,and provide an effective research paradigm for the research and development of new TCM drugs.

关 键 词：中药新药 医院制剂 中药大品种 二次开发 

分 类 号：R284[医药卫生—中药学]