基于有效成分比例一致性的三维多组分中药质量评价研究——以丹参为例

Three-dimensional multi-component quality evaluation of Chinese medicine based on proportion consistency of active components: a study of Salvia miltiorrhiza

为了揭示中药有效成分含量比例一致性规律,探索中药质量评价新途径,该研究以丹参为例,对87篇文献中895个丹参药材样本中有效成分丹参酮Ⅱ;、隐丹参酮、丹参酮Ⅰ、丹酚酸B、迷迭香酸、咖啡酸和紫草酸等成分含量进行提取,对符合《中国药典》丹酚酸B和丹参酮(丹参酮Ⅱ;、丹参酮Ⅰ和隐丹参酮总含量)含量标准的样本进行了各有效成分间含量比例一致性分析,比较各成分间含量比例分布规律。结果发现丹参酮类组分间、丹酚酸类组分间以及丹参酮和丹酚酸间比例具有一定的稳定性,隐丹参酮和丹参酮Ⅱ;含量比例在0.1~1.7波动,迷迭香酸和丹酚酸B含量比例在0.02~0.14波动,而丹酚酸B和丹参酮Ⅱ;含量比例位于10~60,这说明不同组分间比例不是固定的,而是在一定范围内波动,同类组分间波动范围较小,不同类组分间波动范围较大,对于品种或产地固定的药材,其有效成分比例更为稳定。含量比例在波动范围外的样本一般都是不合格的药材。基于上述研究,作者提出“三维多组分”中药质量评价模式,“三维”是指从有效成分的种类、组分比例和含量3个角度准确评价中药材质量,“多组分”是指要同时考虑中药中多种成分信息,特别是质量标志物和等效组分群。中药组分比例可以作为中药质量评价的重要指标,越是品种或产地固定的药材,其有效成分比例越是稳定。

To reveal the law of the proportion consistency of the active components in Chinese medicine and explore a new way to evaluate the quality of Chinese medicine, the present study investigated the content of tanshinone Ⅱ;, cryptotanshinone, tanshinone Ⅰ, salvianolic acid B, rosmarinic acid, caffeic acid, and lithospermic acid in 895 samples of Salvia miltiorrhiza from 87 literature articles. The samples with salvianolic acid B and tanshinones(total content of tanshinone Ⅱ;, tanshinone Ⅰ, and cryptotanshinone) meeting the requirements of Chinese Pharmacopoeia were analyzed for proportion consistency of components, and the proportion distribution of components was compared. The results showed that the proportions in and between tanshinones and salvianolic acids were stable. The content ratios of cryptotanshinone to tanshinone Ⅱ;, rosmarinic acid to salvianolic acid B, and salvianolic acid B to tanshinone Ⅱ;fluctuated from 0.1 to 1.7, from 0.02 to 0.14, and from 10 to 60, respectively. It indicated that the content proportions of different components were not fixed, but fluctuated in a certain range. The fluctuation range of components in the same group was small, but that in different groups was large. The content proportions of active components were stable for Chinese medicinal materials with fixed varieties or origins. The samples whose content proportions were out of the fluctuation ranges were generally unqualified medicinal materials. We proposed a "three-dimensional multi-component" quality evaluation model of Chinese medicine based on the above findings. Specifically, "three-dimensional" means to accurately evaluate the quality of Chinese medicine from varieties, proportions, and content of active components, and "multi-component" means to highlight the information of multiple components in Chinese medicine, especially the quality markers and equivalent component groups. The proportion of components in Chinese medicine can be used as an important index for the quality evaluation of Chinese medicine. The proportions of active components are stable in Chinese medicinal materials with fixed varieties or places of origin.