摘要
数字化技术为中药质量评价传统模式带来了革新。本文系统梳理了数字化驱动下的中药质量评价研究热点及其实践应用,从数据获取、模型构建、应用推广和市场接受多方面分析研判中药质量评价数字化面临的困难挑战,并提出针对性策略。针对当前中药质量领域存在的问题,提出了一系列创新构想,包括挖掘与应用中药药性数据、构建中药成分大数据库、融合数字化与新兴生物技术进行中药生物效应评价以及基于真实世界数据的临床智能评价。并在此基础上提出了构建基于“药性数据、化学成分分析、生物效应评估及临床评价”中药多维质量分析等级评价模型,希冀为中药质量评价的现代化、科学化和规范化提供有益参考。
Digital technology has revolutionized the traditional model of quality evaluation for traditional Chinese medicine(TCM).This article systematically reviews the research hotspots and practical applications of digital-driven quality evaluation of TCM.Simultaneously,this paper analyzes and assesses the challenges faced by the digitization of TCM quality evaluation from multiple perspectives,including data acquisition,model construction,application promotion and market acceptance,and puts forward targeted strategies.Addressing the existing issues in the field of TCM quality,this paper proposes a series of innovative concepts,including the mining and application of TCM property data,the construction of a large database of TCM components,the integration of digital technology and emerging biotechnology for biological effect evaluation of TCM and clinical intelligent evaluation based on real-world data.Based on these,it further proposes a multi-dimensional quality analysis model for grading TCM,which encompasses TCM property data,chemical composition analysis,biological effect assessment and clinical evaluation.It aims to provide a useful reference for the modernization,scientification,and standardization of TCM quality evaluation.
作者
栾永福
汪冰
白爱珍
解盈盈
刘洪超
崔伟亮
林永强
LUAN Yongfu;WANG Bing;BAI Aizhen;XIE Yingying;LIU Hongchao;CUI Weiliang;LIN Yongqiang(NMPA Key Laboratory for Quality Evaluation of Gelatin Products,Shandong Institute for Food and Drug Control,Shandong Engineering Laboratory for Standard Innovation and Quality Evaluation of TCM,Public Service Platporm of Industrial Technology,Jinan 250101,China;Tianjin University of Traditional Chinese Medicine,Tianjin 301617,China)
出处
《中国药品标准》
2025年第3期237-245,共9页
Drug Standards of China
基金
国家重点研发计划(中医药现代化专项)(2023YFC3504102)
山东省重点研发计划(重大科技创新工程)项目(2021CXGC010511)
泉城产业领军人才支持计划创新团队项目(MRJT2105)。
关键词
中药质量评价
数字化
药性
成分
生物效应
临床评价
等级评价
quality evaluation of traditional Chinese medicine
digital
medicinal properties
components
biological effects
clinical evaluation
grading evaluation
