道地药材质量标准设计与应用

Design and application of quality standard of Dao-di herbs

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.