化积口服液定性定量方法研究

目的:建立化积口服液的定性定量方法。 方法:以TLC法对方中的红花进行定性鉴别:采用硅胶G薄层板,以环己烷-乙酸乙酯(5: 3)为展开剂,在紫外光灯(365 nm)下检视;以HPLC法测定化积口服液中红花的活性成分对香豆酸的含量:采用Diamonsil C₁₈(250 mm×4.6 mm,5 μm)色谱柱,以乙腈-0.5%磷酸(18: 82)为流动相,流速1.0 mL·min^-1,检测波长308 nm,柱温30℃。 结果:TLC鉴别,可检出红花;HPLC测定,对香豆酸进样量在0.02~0.42 μg范围内线性关系良好,平均回收率为99.8%(RSD=1.8%,n=6)。 结论:该法能准确鉴别出化积口服液中的红花,新增的对香豆酸含量测定方法经方法学考察,方法可行,可用于化积口服液质量控制。

Objective: To establish qualitative and quantitative methods to evaluate Huaji Koufuye. Methods: Flos Carthami was identified by thin layer chromatography(TLC).The analysis was performed on a silica gel G thin-layer plate with cyclohexane-ethyl acetate(5: 3)as the developing solvent,detected at an ultraviolet lamp(365 nm).The content of the active component in Huaji Koufuye,p-coumaric,was determined by HPLC,which was performed on a Diamonsil C₁₈(250 mm×4.6 mm,5 μm)column eluted with acetonitrile-0.5% phosphoric acid(18: 82)at the flow rate of 1.0 mL·min^-1,detected at a wavelength of 308 nm.The column temperature was at 30℃. Results: Flos Carthami could be identified by TLC.The injection sample of p-coumaric showed a good linear relationship in the range of 0.02-0.42 μg,the average recovery(n=6)was 99.8% with RSD of 1.8%. Conclusion: The method can identify Flos Carthami of Huaji Koufuye accurately,and the p-coumaric content determination method is a feasible method,which can be used for the quality control of Huaji Koufuye.

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