安神静心胶囊的质量标准研究

Study on Quality Standard of Anshen Jingxin Capsules

目的:建立安神静心胶囊的质量控制方法。方法:用TLC法对丹参、石菖蒲、五味子进行定性鉴别;HPLC法测定安神静心胶囊中五味子醇甲的含量,采用Diamonsil C_(18)柱;以甲醇-水(62:38)为流动相;流速为1.0ml·min^(-1);柱温:35℃;检测波长为254nm。结果:TLC法检出了丹参、石菖蒲、五味子特征斑点,五味子醇甲进样量在0.05～10.43μg范围内线性关系良好,r=1.0000,平均加样回收率为100.3%,RSD为1.5%(n=9)。结论:所建立的方法简便、稳定、准确、重复性好,可作为本品的质量控制方法。

Objective：To establish the quality standard for Anshen Jingxin capsules.Method：TLC was applied to identify Salvia miltionhiza Bge,Acorus tatarinowii Schott and Schisandra chinensis（Turcz.）Baill in the formulation,and HPLC method was employed for the determination of schizandrin in Anshen Jingxin capsules with a Diamonsil C18column,methanol-water（62：38）as the mobile phase,flow rate of 1.0 ml·min^-1,column temperature of 35℃,and the detection wavelengh of 254nm.Result：The characteristic spots of Salvia miltionhiza Bge,Acorus tatarinowii Schott and Schisandra chinensis（Turca.）were detected by TLC.The linear range of schizandrin was 0.05-10.43μg（r=1.000 0）.The average recovery was 100.3%with RSD of 1.5%（n=9）.Conclusion：The method is simple,sensitive,accurate and reproducible,and it can be used for the quality control of this preparation.