前列宁颗粒中黄芪的质量标准

目的：建立前列宁颗粒中黄芪甲苷的HPLC—ELSD测定方法。方法：采用高效液相色谱-蒸发光散射法测定黄芪甲苷的含量。色谱条件：Shimadzu C18（4．6×250mm，5μm）为色谱柱；流动相为乙腈-水（3466）；流速1．0mL·min^-1，柱温为室温，进样量20μL。ELSD检测器条件：蒸发温度：45℃，N2压力：2．12Bar。结果：黄芪甲苷在3．97-19．85μg·L^-1（r=0．9998）范围内呈良好线性关系；重复性的RSD为1．07％。结论：方法精密度、重现性和分离效果好，分析快速，适合于前列宁颗粒中黄芪的质量控制。

Study on Radix Astragali Quality Standard in Qianliening Granule

Objective：To establish a HPLC-ELSD method for determination of Astragaloside Ⅳ in Qianliening granule.Methods：The content of astragaloside Ⅳ was determined by high-perform ante liquid ehromatography with evaporative light-scattering detection（HPLC-ELSD）; The chromatography condition was as follows ： Shimadzu C18 （4.6mm × 250 mm, 5 μm）;mobile phase was CH3CN-H2O（34：66） ; flow speed was 1.0 mL · min^-1 ： temperature of column was room temperature ; and the injection volume was 20 μL. The ELSD conditions were as follows： the temperature of drift tube was 45℃, the gaspressure was 2.12 bar. Results：Astragaloside calibration curve was linear whthin the range of 3.97-19.85 μg·L^-1（ r = 0.9998 ）,and the recurrene （RSD）was 1.07% . Conclusion：The RP-HPLC method shows a good separation,reprodueity and accuracy.It can be used for quantitative analysis of Qianliening granule.