甘草查尔酮胶囊质量标准研究

Study on Quality Standard of Licorice Chalcone Capsules

目的:建立甘草查尔酮胶囊的质量标准。方法:采用薄层色谱法对甘草查尔酮胶囊进行薄层鉴别;采用高效液相色谱法测定甘草查尔酮A的含量。色谱柱Waters XTerra RP C_(18)(250 mm×4.6 mm,5μm);流动相乙腈-1%磷酸溶液(58∶42);体积流量1.0 mL/min;检测波长310 nm;柱温25℃。结果:甘草查尔酮胶囊薄层色谱图斑点清晰,阴性无干扰;甘草查尔酮A在0.05125~0.5125 mg内呈良好的线性关系(r=0.9999),平均回收率为100.76%,RSD为1.62%(n=6)。结论:本研究建立的甘草查尔酮胶囊的薄层鉴别方法及甘草查尔酮A含量测定方法,增强了该制剂的可控性,为医院制剂或新药研发提供了理论数据。

Objective:To establish the quality standard of licorice chalcone capsules.Methods:TLC was adopted to perform thin-layer identification of licorice chalcone capsules,HPLC was used to detect the contents of licochalcone A.Chromatographic column Waters XTerra RP C_(18)(250 mm×4.6 mm,5μm);mobile phase acetonitrile-1%phosphoric acid solution(58:42);volume flow:1.0 mL/min;detection wavelength:310 nm;column temperature:25℃.Results:TLC of licorice chalcone capsules presented clear spots,and it was negative without interference;licochalcone A showed good linear relationship between 0.05125 and 0.5125 mg(r=0.9999),average recovery rate was 100.76%,RSD was 1.62%(n=6).Conclusion:TLC of licorice chalcone capsules and content determination method of licochalcone A established in the study could enhance the controllability of the preparations,which could provide theoretical data for scientific research and development of the hospital preparations and new drugs.