利水消肿胶囊质量标准研究

Study on Quality Standards of Lishuixiaozhong Capsule

目的建立利水消肿胶囊的质量控制标准。方法采用薄层色谱法鉴别方中的桂枝、柴胡、白芍、益母草、泽泻;采用高效液相色谱法测定当归中阿魏酸的含量,色谱柱为Kromasil C18柱(250 mm×4.6 mm,5μm),检测波长为318 nm,流动相为乙腈-0.1%磷酸溶液(13∶87),流速为1.0 mL/min,柱温为室温,理论板数以阿魏酸峰计算不低于5 000。结果鉴别方法专属性强,定量方法简便、准确,阿魏酸进样量在25.15～201.2 ng范围内与峰面积线性关系良好,r=0.999 9,平均回收率为99.17%,RSD为0.95%(n=6)。结论该质量标准可有效地控制利水消肿胶囊的质量。

Objective To establish the quality control standard of Lishuixiaozhong Capsule. Methods TLC was performed to identify Ramulus Cinnamomi, Bupleuri Radix, Paeoniae Radix Alba, Leonuri Herba, Alismatis Rhizoma in the capsule preparations. HPLC was used to determine the content of ferulic acid. The chromatographic conditions were the Kromasil C18 column （250mm×4.6mm,5μm）, the detection wavelength was 318 nm, the mobile phasewas acetonitrile-0. 1% phosphoric acid（13 ： 87）, the flow rate was 1.0 mL/min, the column temperature was room temperature and the theoretical plate was no less than 5 000. Results The TLC identification was highly specific. The method of content determination was simple and accurate. The linearity of ferulic acid was obtained over the range of 25.15-201.2 ng（r=0. 999 9）. The average recovery rate of ferulic acid was 99. 17% with RSD of 0. 95% （ n = 6）. Conclusion This quality standard is effective in controlling the quality of Lishuixiaozhong Capsule.