一测多评法测定京都念慈菴蜜炼川贝枇杷膏中苯甲醛和薄荷脑含量

Simultaneous Determination of Benzaldehyde and Menthol in Jingdu Niancian Milian Chuanbei Pipagao by Quantitative Analysis of Multi-components by Single Marker

目的:建立京都念慈菴蜜炼川贝枇杷膏一测多评的质量控制方法。方法:采用GC法,以苯甲醛为内标物,建立其与薄荷脑的相对校正因子进行含量测定,实现一测多评。同时对一测多评的计算与外标法实测值进行比较,并对不同色谱柱和不同仪器进行考察,评价一测多评法在复方制剂中应用的准确性与科学性。结果:建立的校正因子重现性良好,10批样品中苯甲醛和薄荷脑采用校正因子计算的含量值与外标法实测值之间无显著差异(相对偏差<2%)。结论:以苯甲醛、薄荷脑同步测定的一测多评法控制京都念慈菴蜜炼川贝枇杷膏的质量是可行的。

Objective：To establish a quality control method for Jingdu Niancian Milian Chuanbei Pipagao by quantitative analysis of multi-components by single marker （ QAMS） . Methods：GC was used with benzaldehyde as the internal standard,and the relative calibration factor of benzaldehyde and menthol was establish by GC and used for the content calculation of menthol by QAMS. Mean-while,the results of QAMS and those of the external standard method were compared. The effects of different instruments and chromato-graphic columns were studied to evaluate the accuracy and scientificity of QAMS applied in compound preparations. Results：No signif-icant differences in the quantitative results of benzaldehyde and menthol were found between the external standard method and QAMS. Conclusion：It is feasible and suitable to evaluate the quality of benzaldehyde and menthol in Jingdu Niancian Milian Chuanbei Pipagao by QAMS.