摘要
人工智能(AI)正在以前所未有的深度重构药品质量控制体系,随着中药产业的快速发展,其质量监管问题愈发受到关注。中药的有效性与安全性直接影响到公众健康,因此,提升中药质量监管的科学性与有效性显得尤为重要。近年来AI技术在各个领域的应用逐渐深入,其中在中药质量监管中的潜力也逐渐被认可。目前,AI技术在中药的栽培种植、饮片真伪优劣鉴别、生产合规性审查、市场流通监测和风险评估检测等多个环节中展现了其优势。然而,尽管已有一些研究成果,仍存在技术应用不够普及、标准化程度低及数据共享不足等问题。本文旨在深入综述AI技术在中药质量监管中的创新应用,全面分析其有效性与未来前景,并结合国内外的研究成果,创新性地提出了“AI-数字感官-区块链”三元协同的质量控制范式,探讨未来可能的研究方向,以期推动中药质量监管的现代化进程,实现更高水平的安全保障和科学监管。
Artificial intelligence(AI)is reconstructing drug quality control systems with unprecedented depth.With the rapid development of the traditional Chinese medicine(TCM)industry,the quality regulation of TCM has garnered increasing attention.The efficacy and safety of TCM directly impact public health,making it imperative to enhance the scientific rigor and effectiveness of its quality control.In recent years,the application of AI technology has expanded across various fields,and its potential in TCM quality regulation has gradually been recognized.Currently,AI has demonstrated advantages in multiple stages of TCM production,including cultivation and planting,authenticity identification of decoction pieces,compliance review of manufacturing processes,market circulation monitoring,and risk assessment.However,despite existing research achievements,challenges such as limited technological adoption,low standardization,and insufficient data sharing persist.This paper provides an in-depth review of innovative AI applications in TCM quality control,comprehensively analyzes their effectiveness and future prospects,and proposes a novel“AI-Digital Sensory-Blockchain”tri-synergistic quality control paradigm based on domestic and international research advancements.Furthermore,it explores potential future research directions to advance the modernization of TCM quality regulation,thereby achieving higher levels of safety assurance and scientifically robust supervision.
作者
徐海洋
高燕
XU Haiyang;GAO Yan(Institute of Pharmaceutical Sciences,Shandong University of Traditional Chinese Medicine,National Administration of Traditional Chinese Medicine High-Level Key Discipline-Pharmacy of Traditional Chinese Medicine,Collaborative Innovation Center for Ecological Protection and High-Quality Development of Characteristic Traditional Chinese Medicine in the Yellow River Basin,Shandong Provincial Key Laboratory of Digital Traditional Chinese Medicine,Jinan 250355,China)
出处
《中国药品标准》
2025年第3期255-262,共8页
Drug Standards of China
基金
山东省科技型中小企业创新能力提升工程(2023TSGC0271)
山东中医药大学高等教育研究2022年度课题重点项目(GJYJZ202210)
2023年全国中药特色技术传承人才培训项目(T20234832005)。
关键词
人工智能
中药质量监管
栽培种植
饮片真伪
风险评估
质控范式
artificial intelligence
quality control of traditional Chinese medicine
cultivation and planting
authenticity identification of decoction pieces
risk assessment
quality control paradigm
