金氏肾炎丸质量标准研究

Study on Quality Standard of Jinshishenyan Pills

目的建立金氏肾炎丸的质量控制方法。方法采用薄层色谱(TLC)法对金银花、黄柏进行定性鉴别,采用高效液相色谱(HPLC)法测定金氏肾炎丸中绿原酸、盐酸小檗碱的含量。结果薄层色谱斑点清晰,阴性对照无干扰。绿原酸的流动相:乙腈-0.4%磷酸(10∶90);检测波长:327 nm;绿原酸进样量在0.08～0.40μg之间线性关系良好,r=0.999 2(n=5),平均回收率为99.3%,RSD=1.41%(n=6)。盐酸小檗碱的流动相:乙腈-0.1%磷酸溶液(40∶60,每100 mL加十二烷基磺酸钠0.1 g);检测波长:265 nm;盐酸小檗碱进样量在0.065 2～0.326 0μg之间线性关系良好,r=0.999 2(n=5),平均回收率为100.5%,RSD=1.19%(n=6)。结论本研究建立的TLC和HPLC方法专属性强、重复性好,可用于金氏肾炎丸的质量控制。

Objective To establish the methods for quality control of Jinshishenyan pills （Flos Lonicerae daponicae, Cortex Phellodendri Chinensis）. Methods Flos Lonicerae Japonicae, Cortex Phellodendri Chinensis were identified by TLC. HPLC method for the determination of chlorogenic acid and berberine hydrochloride in Jinshishenyan pills were estabhshed. Result The spots on the TLC plate were clear. The negative control sample had no interference. The mobile phase of chlorogenic acid was acetonitrile-0.4% phosphoric acid （10 ： 90）, the dectection wavelength was 327 nm. There was good linearity in the range of 0.08-0.40 μg, r=0.9992 （n =5）. The average recovery was 99.3%, RSD was 1.41% （n =6）. The mobile phase of berberine hydrochloride was cetonitrile-0.1%H3PO4 （40 ： 60, adding 1 g sodium dodecylsulfonate per 100 mL）, the dectection wavelength was 265 nm. There was good hnearity in the range of 0.065 2- 0.326 0μg, r=0.999 2 （n =5）. The average recovery was 100.5%, RSD was 1.19% （n =6）. Conclusion The methods are simple, rapid, accurate and can be used for the quality control of Jinshishenyan pills.