“道地指数”的构建及其在中药材品质评控中的应用研究

The issue about quality evaluation and control for Chinese medicinal materials has been one of the key problems restricting. Currently, most of the evaluating indices are qualitativative and non-interrelated each other, as well as lacking in quantitative and comprehensive indices. These indices also have little relationship with safety and efficiency. Dao-Di herbs has been regarded as one of the most effective materials in diseases prevention and treatment for thousands of years,and it is a distinctive and comprehensive gold standard for quality evaluation and control of Chinese medicinal materials. In this project, we select the acontilateralis radix praeparata, salviae miltiorrhizae radix et rhizoma aconite and rhei radix et rhizoma as the model drugs. The investigation will be carried on with a set of technologies established yet in our lab for quality evaluation and control,as well as conventional analysis to discriminate Dao-Di herbs from non-Dao-Di herbs on five factors: relative history of producing areas, ecological suitability of producing areas, commercial specification and grade,golden rate of components, and biopotency /toxic potency. Besed on this, a novel evalutating a index-Dao-Di Index (DDI), weighted aggregate of above-mentioned five factors, will be established for quality evaluation and control of Chinese medicinal materials. This DDI will provide new insight on research pattern, methods, index and examples with significant reference value for taking a world leading role of quality evaluation standard for Chinese medicinal materials, and promoting the "species-quality-property-effect-usage" integration.

中药的质量控制和评价是制约中药现代化发展的关键问题之一。现行中药品质评控指标众多，但大多为定性的且彼此独立，与安全性有效性关联不紧密，缺少综合的、统一的和定量化的评控指标体系。道地药材一直是人们防病治病最有力的武器之一，也是一个可用于药材品质评控的独特的综合性的"金标准"。为此，本项目拟选取附子、丹参和大黄为代表，以道地性辨识为切入点，在常规分析检测的基础上，采取包括课题组近年来创建的多项品质评控技术和方法，定性定量刻画道地与非道地药材的"产区相对历史"、"产区生态适宜性"、"商品规格等级"、"成分黄金比例"和"生物效（毒）价"，进而为实现"我主人随，兼容并蓄"地建立主导国际的中药材质量控制与评价标准，促进中药品-质-性-效（毒）-用一体化与合理用药等提供具有重要参考价值的研究模式、方法、指标和示例。

道地药材品质辨识和评价缺少有效的方法和指标。传统的外观经验鉴别存在一定的局限性；个别指标性成分也不能作为道地药材的评价标准，其往往与道地药材的好坏缺乏必然的联系。为此，本课题提出并建立综合量化的中药评价体系来评价道地药材，构建基于产区相对历史、产地生态适宜性、商品规格等级、成分“特征比例”和生物效(毒)价五要素综合加权的中药材道地性与品质优劣度综合性评价指标-“道地综合指数”(Dao-Di index，DDI)，并在已示范用于大黄、丹参、附子和黄连等中药材的品质保证方法体系的研究中。结果表明，“道地综合指数”能够解决附子的产地加工、不同基源大黄的辩质用药、丹参栽培品种选育、黄连临床调剂等问题。建立加权的大黄、附子、黄连的道地综合指数，应用于道地药材的品质评价，从而实现了个别指标性成分向多指标综合加权的模式的转变。. 本项目发表论文17篇，包括SCI论文 4篇，F5000论文 1篇，其中杂志封面论文1篇；先后在中医药现代化国际大会、中药全球化联盟大会、世界中医药大会、国际传统药学大会、中国药学会年会等重要会议上进行专题报告50余次，受到了同行专家的广泛关注；根据本项目综合评价思路为基础，起草并制定了《中药品质评价方法指南》；申报国家专利和软件著作权4项，授权1项；培养硕、博士研究生10余名。