养心益肝片质量标准实验

Experiment on the quality standard of Yangxinyigan tablets

目的建立养心益肝片的质量标准和含量测定方法。方法采用薄层色谱法对处方中的灵芝、香附、墨旱莲进行定性鉴别,高效液相色谱法对处方中的君药陈皮的有效成分橙皮苷进行含量测定。色谱柱为Kromasil C_(18)(4.0mm×200mm,5μm),流动相为V(甲醇):V(水):V(醋酸)=35:65:6,检测波长283 nm,流速1.0 mL/min。结果薄层色谱鉴别特征斑点明显,橙皮苷在0.38～2.53μg范围内呈良好的线性关系,平均回收率为98.43%,相对标准偏差为2.17%。结论建立的方法能较好地控制养心益肝片的质量。

Objective To establish a quality standard for Yanxinyigan tablets. Methods Ganoderma lucidum Karst, Cyperus rotundus L. and Eclipta prostrata L. were identified by thin lay chromatography. The content of hesperidin in tablets was determined by high performance liquid chromatography, using a Kromasil Cls （4.0 mm×200mm, 5 μm） column, V （methanol） ： V （water） ： V （acetic acid）-35 ： 65 ： 6 as the mobile phase; the detection wavelength was at 283 nm and the flow rate was 1.0 mL/min. Results The thin lay chromatography spots developed were quite clear, and the linearity of hesperidin was shown in the range of 0.38-2.53 μg. The average recovery of hesperidin was 98.43% with relative standard deviation of 2.17%. Conclusion The method can be used in the quality control of Yangxinyigan tablets.