玉泉丸的质量标准研究

Study on quality standard of YuQuan Pills

目的建立玉泉丸中葛根和天花粉的定性鉴别方法,及葛根素的含量测定方法。方法采用薄层色谱法鉴别葛根和天花粉;葛根素含量测定采用Shimadzu LC-10A高效液相色谱仪,以Shimadzu C18(4.6mm×250mm,5μm)为色谱柱;流动相为甲醇-0.1%磷酸溶液(75∶25);流速1.0mL·min-1,检测波长254nm。结果在薄层色谱中可以检出葛根、天花粉;葛根素在0.01803～0.9016μg(r=0.99993)范围内呈良好线性关系;样品平均回收率99.61%,RSD为0.67%。结论 TLC法可用于葛根和天花粉的定性分析;HPLC法可用于葛根的含量测定。TLC和HPLC分析的精密度、重现性和分离效果好,分析快速,适合于玉泉丸中葛根的质量控制。

OBJECTIVE To establish a qualitative method for identification of Puerariae Radix and Trichosanthis Radix and develop a method for determination of puerarin in YuQuan Pills.METHODS TLC was employed to identify Puerariae Radix and Trichosanthis Radix;HPLC was used to determine puerarin,with A Shimadzu C18 column（4.6mm×250mm,5μm）was used with a mobile phase of methanol-0.1%phosphoric acid solution（75∶25）,at a flow rate of 1.0mL·min-1.The detecting wavelength was set at 254nm.RESULTS Puerariae Radix and Trichosanthis Radix can be detected by TLC;Puerarin calibration curve was linear whthin the range of 0.01803～0.9016μg（r=0.99993）,and the average recovery of puerarin was 99.61%（RSD=0.67）.CONCLUSION The TLC method can be used for qualitative analysis of kudzu root and Radix Trichosanthis,The HPLC method can be used for the content determination of Puerarin.The TLC and HPLC method shows a good separation,reproducity and accuracy.It can be used for quantitative analysis of Radix Puerariae in YuQuan Pills.