中国中药杂志

2020, v.45(24) 6072-6080

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道地药材质量标准设计与应用
Design and application of quality standard of Dao-di herbs

赖长江生;魏旭雅;邱子栋;谭婷;
LAI Chang-jiang-sheng;WEI Xu-ya;QIU Zi-dong;TAN Ting;State Key Laboratory Breeding Base of Dao-di Herbs, National Resource Center for Chinese Materia Medica, China Academy of Chinese Medical Sciences;National Pharmaceutical Engineering Center (NPEC) for Solid Preparation in Chinese Herbal Medicine, Jiangxi University of Traditional Chinese Medicine;

摘要(Abstract):

道地药材作为质优效佳、为中医临床所公认的优质中药材,依然面临标准缺失的困境。该文围绕道地药材标准设计与应用这一关键科学问题,系统阐述了涵盖"四条原则、六项核心内容、三类关键方法"的道地药材质量标准通则。道地药材标准应该充分整合文献、生境、种植/养殖、加工/炮制、性状、化学-药理/毒理信息;按照"渊源清晰、产地明确、指标合理、优劣有度、检测多样"的要求,结合传统经验和现代科学技术,综合运用质量溯源管理系统、"辨状论质"方法、快检技术、药效与毒性物质控制方法,追求检测技术客观化、自动化和智能化;引入性状特征、化学成分和生物活性参数,统一药效/毒性指标、质量标志物、药典控制指标,划定合理范围,形成严谨的道地药材标准;开发简便的等级划分方法,便于优质优价政策实施。最终,新建立的道地药材标准有望引领国际标准,助推道地药材高质量发展。
Dao-di herbs, which are widely recognized as medicinal materials with a high quality and good efficacy in clinic, are now facing the dilemma of absence of standard. This study focused on a pivotal scientific problem of design and application of quality standard of Dao-di herbs, and systematically illustrated the general rules for the quality standard of Dao-di herbs involving "four rules, six core contents, and three key methods". The quality standard of Dao-di herbs shall be fully based on literatures as well as habitat, planting/breeding, processing, characters, chemical-pharmacological/toxic data. The common requirements for the quality standard of Dao-di herbs contain "clear source, explicit origin, rational indicator, gradable quality, and multiple detection methods". Notably, traditional experiences and modern techniques, quality tracing management system, "quality determination by distinguishing characters" method, rapid detection technology, effective/toxic substances control method, were comprehensively applied in this standard to purse the objectification, automation, and intellectualization of detection technology. Appearance characters, chemical components, and bioactive parameters, unified effective/toxic indicators, quality markers, and pharmacopeial control indicators and reasonable ranges were included in rigorous quality standards for Dao-di herbs. Besides, simple grading method shall be developed to guide the implementation of "high quality-high price" policy. Eventually, the new quality standards for Dao-di herbs will lead international standards and promote the high-quality development of Dao-di herbs.

关键词(KeyWords): 道地药材;质量标准;质量标志物;快速检测技术;国际标准;道地性
Dao-di herbs;quality standard;quality marker;rapid detection technology;international standard;geoherbalism

Abstract:

Keywords:

基金项目(Foundation): 国家重点研发计划项目(2018YFC1706104);; 中央级公益性科研院所基本科研业务费专项资金项目(ZZ13-YQ-090);; 国家自然科学基金项目(82074012);; 中国科协青年人才托举工程项目(CAST-2018-QNRC1-04);; 中央本级重大增减支项目(2060302)

作者(Author): 赖长江生;魏旭雅;邱子栋;谭婷;
LAI Chang-jiang-sheng;WEI Xu-ya;QIU Zi-dong;TAN Ting;State Key Laboratory Breeding Base of Dao-di Herbs, National Resource Center for Chinese Materia Medica, China Academy of Chinese Medical Sciences;National Pharmaceutical Engineering Center (NPEC) for Solid Preparation in Chinese Herbal Medicine, Jiangxi University of Traditional Chinese Medicine;

Email:

DOI: 10.19540/j.cnki.cjcmm.202027.601

参考文献(References):

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