镇癫开窍颗粒定性定量方法研究

Study on Qualitative and Quantitative Analysis of Zhendian Kaiqiao Granules

目的建立镇癫开窍颗粒的定性定量方法。方法采用薄层色谱法鉴别制剂中的龙胆、黄芩、大黄、白芍。采用HPLC对制剂中的龙胆苦苷、芍药苷进行含量测定,色谱柱为Phenomenex C18柱(250 mm×4.6 mm,5μm),流动相为甲醇-水(12∶88),流速为1.0 m L/min,检测波长为273 nm(龙胆苦苷)、230 nm(芍药苷),柱温为室温。结果薄层色谱能检出龙胆、黄芩、大黄、白芍。龙胆苦苷在2.396~11.980μg范围内呈良好的线性关系(r=0.999 6),平均加样回收率为99.72%(RSD=2.70%);芍药苷在2.728~13.640μg范围内呈良好的线性关系(r=0.999 0),平均加样回收率为98.74%(RSD=2.42%)。结论本研究所建立的方法简便、可靠、重复性好,可用于控制镇癫开窍颗粒的质量。

Objective To establish a method for qualitative and quantitative analysis of Zhendian Kaiqiao Granules.Methods Gentiane Radix et Rhizoma,Scuteliariae Radix,Rhei Radix et Rhizoma,Radices Paeoniae Alba in the preparation were identified by TLC.Gentiopicrin and paeoniflorin were determined by HPLC.The analysis was performed on a Phenomenex C18column(250mm×4.6mm,5μm),with the mobile phase of methyl alcohol-water(12:88).The flow rate was1.0mL/min and the column temperature was maintained at room temperature;the detection wavelengths were set at273nm(gentiopicrin)and230nm(paeoniflorin).Results Gentiane Radix et Rhizoma,Scuteliariae Radix,Rhei Radix et Rhizoma,Radices Paeoniae Alba could be detected by TLC.Gentiopicrin showed a good linear relationship at a range of2.396-11.980μg,r=0.9996.The average recovery was99.72%,and RSD was2.70%.Paeoniflorin showed a good linear relationship at a range of2.728-13.640μg,r=0.9990.The average recovery was98.74%,and RSD was2.42%.Conclusion The established method is simple,reliable and reproductive.The method can be used for control quality of Zhendian Kaiqiao Granules.