益气活血颗粒质量标准研究

Study on Quality Standard of Yiqihuoxue Granules

目的:建立益气活血颗粒的质量控制方法。方法:以对照药材为对照,选用薄层色谱法(TLC)定性鉴别制剂中黄芪/炙黄芪、五味子、牡丹皮、莪术、丹参;分别采用高效液相色谱-蒸发光散射检测器(HPLC-ELSD)和高效液相-紫外检测器(HPLC-UV)法对益气活血颗粒中黄芪甲苷和毛蕊异黄酮苷进行定量测定。结果:处方中5味药材均能通过薄层色谱法检出,且斑点清晰,分离良好。黄芪甲苷和毛蕊异黄酮苷分别在进样量为2.32~37.04μg、19.62~314 ng呈良好线性关系,平均回收率分别为91.25%、93.59%,RSD分别为2.27%(n=6)、1.90%(n=6)。结论:研究建立的方法可有效用于益气活血颗粒的定性、定量控制。

Objective： To establish the quality standards for Yiqihuoxue Granules. Methods： Astragali Radix/Astra- gali Radix Praeparata Cure MeUe, Schisandrae Chinensis Fructus, Moutan Cortex, Gurcumae Rhizoma and Salviae Mihiorrhi- zae Radix et Rhizoma were identified by TLC. The content of Astragaloside IV and calycosin-7-glucosidde were determined by HPLC-ELSD and HPLC-UV. Results： Five herbs could be identified by TLC, the spots were clear and weU-separated. The lin- ear range of Astragaloside IV was 2. 32-37.04 μg, the average recovery was 91.25%, RSD = 2. 27% （ n = 6）. The linear range of calycosin-7-glueoside was 19.62-314 ng, the average recovery was 93.59-%, RSD = 1.90% （n =6）. Condusion： The method is simple and accurate, it can be used for the quality control of Yiqihuoxue Granules.