摘要
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。
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.
出处
《现代生物医学进展》
CAS
2011年第14期2767-2769,2782,共4页
Progress in Modern Biomedicine
关键词
肾衰康浓缩丸
黄芪甲苷
HPLC-ELSD
丹参
大黄
TLC
质量标准
Shenshuaikang Concentrated Pill
Astragaloside IV
HPLC-ELSD
Salviae Miltiorrhizae Radis et Rhizoma
Rhei Radis et Rhizoma
TLC
Quality standards
