甘草酸铵类制剂中甘草酸差向异构体的分析

Analysis of 2 epimers in ammonium glycyrrhizinate drugs

目的:建立一种方法并依据这种方法分析甘草酸铵类制剂中18α-甘草酸和18β-甘草酸2种差向异构体的含量。方法:采用Kromasil C18(250 mm×4.6 mm,5μm)色谱柱,以0.05 mol·L-1磷酸盐缓冲液(调节pH至7.0)-乙腈(80∶20)为流动相,流速1 mL·min-1,检测波长252 nm。结果:18α-甘草酸和18β-甘草酸的线性范围分别为0.025～2.500 mg·mL-1(r=0.9990)和0.025～2.000 mg·mL-1(r=0.9990),平均加样回收率(n=9)分别为99.0%和102.5%。同一色谱图中,2个色谱峰间的分离度大于1.5。结论:所建方法可用于分析甘草酸铵类制剂中甘草酸差向异构体的含量,甘草酸铵类制剂中18α-甘草酸和18β-甘草酸比例不一,应完善标准加以控制。

Objective：To establish a method for the determination of 2 epimers[18α-glycyrrhizic acid（18α-GL）and 18β-glycyrrhizic acid（18β-GL）] in ammonium glycyrrhizinate drugs.Methods：Kromasil C18（250 mm×4.6 mm,5 μm）column was adopted,and the mobile phase consisted of 0.05 mol·L-1 PBS（pH 7.0）-acetonitrile（80∶20）at a flow rate of 1 mL·min-1.The detection wavelength was 252 nm.Results：：The linearity ranges of 18α-GL and 18β-GL were 0.025-2.500 mg·mL-1（r=0.9990）and 0.025-2.000 mg·mL-1（r=0.9990）.Good recoveries and resolutions had been got.Conclusion：An accurate method has been established to analyze epimers in ammonium glycyrrhizinate drugs,their standards should be enhanced as soon as possible.