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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 a qualitative and quantitative method of Hua Ji Oral Liquid. Methods: Qualitative identification of safflower in TLC was carried out by using silica gel G plate with cyclohexane-ethyl acetate (5: 3) as developing solvent under UV light (365 nm) HPLC method was used to determine the content of p-coumaric acid in Huayu oral solution: Diamonsil C18 (250 mm × 4.6 mm, 5 μm) column, acetonitrile-0.5% phosphoric acid (18:82) Flow rate 1.0 mL · min-1, detection wavelength 308 nm, column temperature 30 ℃. Results: The HPLC showed that there was a good linear relationship between the sample volume of coumarate and 0.02 ~ 0.42 μg with the average recovery of 99.8% (RSD = 1.8%, n = 6). Conclusion: The method can accurately identify safflower in Hua Ji Oral Liquid. The new method for the determination of p-coumaric acid is investigated by methodology and the method is feasible, which can be used to control the quality of oral liquid.