基于层次分析-熵权法的气血和胶囊质量标志物研究

Identification of quality markers of Qixuehe Capsules based on analytic hierarchy process and entropy weight methods

气血和胶囊是针对引起妇女疾病的常见原因"气血失和"所研制而成的复方中成药,具有疏肝理气、活血化瘀及止痛的功效。由于其组方药味较多(15味)且具多重功效,对产品的质量控制一直是影响其可持续发展的瓶颈问题。因此,该研究采用课题组前期基于层次分析-熵权法所建立的中药质量标志物量化辨识体系,以气血和胶囊不同功效为切入点,计算整合气血和胶囊化学成分在多重有效性(疏肝理气、活血化瘀和止痛)、可测性及专属性等项目下的评分,同时兼顾复方配伍关系,最终发现阿魏酸、槲皮素、咖啡酸、山柰酚、芦丁、藁本内酯、洋川芎内酯Ⅰ、香草酸、原儿茶酸、绿原酸、迷迭香酸、洋川芎内酯A、没食子酸、延胡索乙素和丁香酚15种活性成分为气血和胶囊综合评分靠前的质量标志物。研究结果为气血和胶囊质量标准提升及标准化深入研究提供了科学证据,同时也为多功效的中药复方质量标志物量化辨识研究提供了方法学参考。

Qixuehe Capsules is a compound Chinese patent medicine developed for treating the disorder of Qi and blood(a common etiology of gynecological disease), which has remarkable effects on smoothing liver and regulating Qi, activating blood circulation, and relieving pain. However, due to its complex prescriptions(15 herbs) and multiple effects, the quality control of Qixuehe Capsules has always been a bottleneck problem limiting its sustainable development. Therefore, this study adopted the traditional Chinese medicine Q-markers quantitative identification system established previously by our research group based on the combination of analytic hierarchy process and entropy weight methods. With the different effects of Qixuehe Capsules as the entry point, the comprehensive scores of chemical ingre-dients in Qixuehe Capsules under the items of effectiveness(smoothing liver and regulating qi, activating blood circulation, and relieving pain), testability and specificity were calculated and integrated, respectively. Subsequently, through the analysis of compatibility relationship of Qixuehe Capsules, 15 active ingredients with high comprehensive scores were found to be the top Q-mar-kers of Qixuehe Capsules, including ferulic acid, quercetin, caffeic acid, kaempferol, rutin, Z-ligustilide, senkyunolide Ⅰ, vanillic acid, protocatechuic acid, chlorogenic acid, rosmarinic acid, senkyunolide A, gallic acid, tetrahydropalmatine and eugenol. Collectively, this study not only provided scientific evidence for further research on the improvement and standardization of quality standards of Qixuehe Capsules but also provided methodological references for the quantitative identification of Q-markers of multi-effect traditional Chinese medicine formulae.