关键词:  , 中药；中药监管；文献计量学；监管科学

Abstract:

Objective： To analyze the research hotspots and development trends of "traditional Chinese medicine （TCM） regulation" in China through bibliometric methods， and provide references for promoting the sustainable development of TCM regulation science in China.Methods： Relevant literatures on TCM regulation published from 2005 to 2023 were retrieved from CNKI and VIP databases， and the retrieval results were analyzed.Results： The number of published papers on TCM regulation research generally showed an increasing trend， and entered a rapid development stage after 2019. The core research groups were mainly composed of institutions such as the National Institutes for Food and Drug Control and the China Academy of Chinese Medical Sciences. The research hotspots gradually evolved with the promotion of policies： in the early stage， the focus was on the quality， safety and adverse reaction monitoring of Chinese herbal pieces. After 2019， the research shifted to the construction of the TCM regulation science system， with key attention paid to scientific regulation， full life cycle management and the application of intelligent technologies. The co-occurrence and burst analysis of keywords showed that the research hotspots had shifted from traditional quality regulation to the cross-integration of multiple disciplines， involving frontier fields such as regulation science， artificial intelligence， and blockchain technology.Conclusion： At present， TCM regulation science needs to strengthen multi-disciplinary collaborative innovation， improve the technical standards for full life cycle regulation， promote in-depth cooperation among the government， universities， research institutions， industries and users， and strengthen the research and development of intelligent regulatory tools to address the complex challenges in the inheritance， innovation and development of TCM. This will help to build a scientific TCM regulatory system with Chinese characteristics and provide references for the development of TCM regulation science.

Key words:  ,  , Traditional Chinese medicine； , Regulation of traditional Chinese medicine； , Bibliometrics； , Science of regulation