HPLC法测定三黄片中盐酸小檗碱、大黄素和大黄酚含量的结果分析

目的:考察市售三黄片的质量。方法:以19批三黄片为样品,采用高效液相色谱法测定样品中盐酸小檗碱、大黄素和大黄酚的含量。色谱柱均为SysmetryC18柱,流动相为乙腈-0.05%十二烷基硫酸钠(含0.1%磷酸)=48:52和甲醇-0.1%磷酸溶液=85:15,流速均为1.0mL·min-1,检测波长为265nm和254nm,进样量为5μL和10μL,柱温均为35℃。结果:所有样品均符合规定,但产品质量存在较大差异。结论:需加大对市售三黄片的质量监督,确保临床用药安全、有效。

Analysis of Content Determination of Berberine Hydrochloride and Emodin and Chrysophanol of San- huang Tablets by HPLC

OBJECTIVE： To investigate the quality of Sanhuang tablets on the market. METHODS： Using 19 batches of San- huang tablets the sample, HPLC was used to determine the content of berberine hydrochloride, emodin and chrysophanol, and examination data were analyzed. The sample was determined on Sysmetry C,8 column with mobile phase consisted of acetonitrile-0.05 % dodecyl sulfate （containing 0.1% phosphoric acid） （48 ： 52） and methanol-0.1% phosphoric acid （85 ： 15） at a flow rate of 1.0 mL.min^-1. The column temperature was 35 ℃ and the detection wave length was set at 265 nm and 254 nm, and injection volume was 5 μL and 10 μL. RESULTS： All samples conformed to the standard, but there were great differences among product quality. CONCLUSION： We should strengthen the quality monitoring of Sanhuang tablets to guarantee the safe effective clinical drug use.