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 Beijing 100700, China.
National Pharmaceutical Engineering Center (NPEC) for Solid Preparation in Chinese Herbal Medicine, Jiangxi University of Traditional Chinese Medicine Nanchang 330006, China.
Zhongguo Zhong Yao Za Zhi. 2020 Dec;45(24):6072-6080. doi: 10.19540/j.cnki.cjcmm.202027.601.
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.
道地药材在临床上被广泛公认为是质量高、疗效好的药材，但目前正面临着缺乏标准的困境。本研究聚焦于道地药材质量标准设计与应用这一关键科学问题，系统阐述了道地药材质量标准的“四规、六核心内容、三关键方法”。道地药材的质量标准应以文献以及产地、种植/养殖、加工、性状、化学-药理/毒理数据为充分依据。道地药材质量标准的共同要求包括“来源清晰、产地明确、指标合理、质量可分级、检测方法多样”。值得注意的是，本标准综合应用了传统经验与现代技术、质量追溯管理体系、“辨状论质”方法、快速检测技术、有效/有毒物质控制方法，以追求检测技术的客观化、自动化和智能化。道地药材严格的质量标准涵盖外观性状、化学成分、生物活性参数、统一的有效/有毒指标、质量标志物、药典控制指标及合理范围。此外，应制定简易分级方法，以指导“优质优价”政策的实施。最终，道地药材新的质量标准将引领国际标准，推动道地药材的高质量发展。
