益脑康宁滴丸定性定量方法的研究

Study of Qualitative and Quantitative Methods on Yinaokangning Dropping Pills

目的:研究益脑康宁滴丸中主要药物的鉴别和含量测定方法。方法:采用TLC法鉴别主要药物;采用HPLC-ELSD法测定制剂中黄芪甲苷的含量;色谱条件:Kromasi1C18(200mm×4.6mm,5μm)色谱柱;以乙腈-水(32:68)为流动相;流速为1.0ml·min^(-1);柱温为30℃结果:定性鉴别阴性对照无干扰,分离度高;黄芪甲苷在(2.10～6.30)μg范围内呈良好的线性关系,r=09999,平均加样回收率为99.64% , RSD为1.0%。结论:该实验所建立的鉴别方法专属性强,定量方法简便、准确、重现性好,可用于益脑康宁滴丸的质量控制。

Objective： To study the method of identification and content determination of the important component in Yinaokangning dropping pills .Methods： The major compounds in this drug were identified by the thin layer chromatographic method and the content of astragaloside Ⅳwas determined by HPLC-ELSD method.The chromatographic coniditions included that the Kromasil C18（200 mm×4. 6 mm,5μm） chromatographic column and mobile phase consisted of acetonitrile-water（32∶68）,the flow rate for 1. 0 ml·min^-1 and column temperature for 30℃. Results： The qualitative identification was of high resolution and f ree of interference of negative substance.Astragaloside IVshowed a good linearity range with 2. 10～6.30μg,r=0. 9999;the average recovery was 99. 64% with RSD 1. 0%. Conclusion： The method is simple,accurate and reproducible. It can be used to the quality control of Yinaokangning dropping pills.