人工替代中药材及中药饮片的研究与思考  

Research and Considerations on the Artificial Substitution of Chinese Herbal Medicines and Herbal Pieces

作　　者：李新月 池秀莲[1] 程蒙[1] 苏芳芳 蒋超[1] 张卫[1] 张辰辰 杨光[1,2] LI Xin-yue;CHI Xiu-lian;CHENG Meng;SU Fang-fang;JIANG Chao;ZHANG Wei;ZHANG Chen-chen;YANG Guang(China Academy of Chinese Medical Sciences;College of Pharmacy,Hebei University of Chinese Medicine)

机构地区：[1]中国中医科学院 [2]河北中医药大学药学院

出　　处：《中国食品药品监管》2023年第11期36-43,共8页China Food & Drug Administration Magazine

基　　金：中国药品监管科学行动计划第二批重点项目(CI2021A03907);中国中医科学院科技创新工程项目(CI2021A03908);中国工程院战略研究与咨询项目(2022-XZ-14)。

摘　　要：随着大健康观念的普及,中药资源被广泛应用于食品、药品、化妆品等各大领域,资源消耗不断扩大。虽然中药材种植和养殖缓解了这一消耗的进程,但是仍有不少品种面临资源短缺问题。人工替代中药材及中药饮片作为解决中药资源短缺问题的重要途径之一,对其进行研发势在必行。本文总结中药资源变化,在梳理人工替代中药材及中药饮片的发展情况与政策变化的基础上,分析人工替代中药材及中药饮片研发的关键问题,即研发原则、研发意义、替代机制,对人工替代中药材及中药饮片的医理问题及监管使用提出可行性建议,以期为药品监管研究人员和管理人员提供可商榷的思路。With the popularity of the concept of great health,Chinese medicine resources find extensive applications in various sectors such as food,pharmaceuticals,and cosmetics,leading to an expanding resource consumption.Despite efforts in planting and breeding,numerous Chinese herbal varieties still face the challenge of resource shortage.The research and development of artificial substitution for Chinese herbal medicines and herbal pieces emerge as a vital strategy to address this issue.This paper provides an overview of changes in traditional Chinese medicine resources and analyzes key issues in their research and development,including principles,significance,and substitution mechanisms,based on the development and policy changes of artificial substitution of traditional Chinese medicinal materials and decoction pieces.Feasible suggestions are proposed for addressing medical and regulatory concerns related to the artificial substitution of Chinese herbal medicines and herbal pieces,aiming to provide valuable insights for researchers and regulatory professionals in the field.

关 键 词：中药 人工替代 资源变化 研发关键 政策监管 

分 类 号：R282[医药卫生—中药学]