化积口服液定性定量方法研究

Study on qualitative and quantitative methods for Huaji Koufuye

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,5μm)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0.02～0.42μg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 aeetonitrile - 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 %. Conclu- sion： The method can identify Flos Carthami of Huaji Koufuye accurately, and the p - coumaric content determina- tion method is a feasible method, which can be used for the quality control of Huaji Koufuye.