肾衰康浓缩丸质量标准研究

目的：建立肾衰康浓缩丸质量控制方法。方法：采用TLC鉴别肾衰康浓缩丸中大黄、丹参;采用HPLC-ELSD对制剂中黄芪甲苷进行含量测定,流动相为乙腈-水（30：70）,流速：1 mL/min,柱温：28℃,漂移管温度：42℃,氮气：355kPa。结果：大黄、丹参的TLC鉴别斑点清晰、专属性强;黄芪甲苷在1.0μg-10.0μg之间呈良好的线性关系（r=0.9997,n=5）,平均回收率为99.81%,RSD为1.73%（n=6）。结论：所建立的方法简便准确、专属性强、重现性好,可作为控制肾衰康浓缩丸质量的方法。

Study on Quality Standard of Shenshuaikang Concentrated Pill

Objective： To establish the quality standard of Shenshuaikang concentrated pill.Methods： Salviae Miltiorrhizae Radis et Rhizoma,Rhei Radis et Rhizoma were identified by TLC.The content of Astragaloside IV was determined by HPLC.Hypersil-C18 column was used（4.6 mm×150 mm,5μm）.The mobile phase was consisted of acetonitrile-water（30：70）.The flow rate was 1.0 ml/min,and column temperature was at 28℃,The evaporation temperature was 42℃,Pressure of Nitrogen gas was 355kPa.Results： The spots on TLC plates were clear without interference.The linearity range of Astragaloside IV was 1.0μg～10.0μg,（r = 0.9997,n =5）.The average recovery of Astragaloside IV was 99.81%,and RSD was 1.73%（n = 6）.Conclusions： This method is accurate,reliable and reproducible,which can be used for the quality control of Shenshuaikang Concentrated Pill.