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基于《中国药典》2025年版的中药饮片标准升级战略与技术路径探析

Exploration of Strategic Upgrading and Technical Pathways for Chinese Herbal Decoction Piece Standards Based on the 2025 Edition of the Pharmacopoeia of the People’s Republic of China

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【作者】 聂心如殷放宙李良全郑阳阳梁云昊李昱季德陆兔林

【Author】 NIE Xin-ru;YIN Fang-zhou;LI Liang-quan;ZHENG Yang-yang;LIANG Yun-hao;LI Yu;JI De;LU Tu-lin;Nanjing University of Chinese Medicine;Nanjing University of Chinese Medicine,Research Center for Standardization and Normalization of Chinese Medicine Processing, Ministry of Education, China;

【通讯作者】 陆兔林;

【机构】 南京中医药大学南京中医药大学国家教育部中药炮制规范化及标准化工程研究中心

【摘要】 《中国药典》2025年版的实施标志着中药饮片标准体系建设进入新阶段。本文在梳理中药饮片产业现状与发展痛点的基础上,系统梳理了《中国药典》2025年版中中药饮片标准的修订背景、制度逻辑与技术变革,分析了该版药典在品种收载、质量通则、检测方法、安全性控制等方面的重要调整,体现出标准建设在确保安全的同时更加突出质量一致性与临床适用性的导向。在此基础上,本文进一步重点探讨了全过程质量控制、多模态融合检测、智能识别与数据决策等关键技术路径,解析了新一代中药饮片质控范式的数智化特征与构建要点。同时,面向《中国药典》2030年版规划及全球中医药市场的发展需求,中药饮片标准将加快从静态规范向动态协同、从国内适配向国际互认的跃升,构建具有中国特色、国际表达力与全球公信力的标准框架,助力中药饮片迈向全球化、现代化、智能化发展新阶段。

【Abstract】 The implementation of the 2025 edition of the Pharmacopoeia of the People’s Republic of China marks a new stage in the development of the standard system for Chinese herbal decoction pieces. Based on a thorough analysis of the current status of the industry and its key challenges, this paper systematically examines the revision background, institutional logic, and technological innovations of the 2025 edition’s decoction piece standards. Major adjustments in areas such as variety inclusion, general quality principles, analytical methods, and safety controls, reflecting a standards framework that, while ensuring safety, places greater emphasis on quality consistency and clinical applicability. On this basis, the paper further focuses on key technical pathways—end-to-end quality control, multimodal integrated testing, intelligent recognition, and data-driven decisionmaking—clarifying the digital-intelligence features and construction essentials of a new generation of quality-control paradigms for decoction pieces. Looking forward to the 2030 edition of the Pharmacopoeia and the demands of the global traditional Chinese medicine market, the standards for Chinese herbal decoction pieces are expected to evolve from static regulations to dynamic collaborative frameworks, and from domestic adaptation to international mutual recognition. This approach aims to establish a standard framework with Chinese characteristics, international expressiveness, and global credibility, propelling the modernization, globalization, and intelligent development of Chinese herbal decoction pieces.

【基金】 国家重点研发计划(2023YFC3504200)
  • 【文献出处】 中国食品药品监管 ,China Food & Drug Administration Magazine , 编辑部邮箱 ,2025年10期
  • 【分类号】R288
  • 【下载频次】119
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