黄芪保心合剂质量标准

摘要

Objective To establish a quality standard of huangqi baoxin mixture and improve its quality control system. Methods The qualitative analysis of Astragalus membranaceus,Salvia miltiorrhiza,Forsythia,and Angelica were performed by TLC.The content determination of astragalosideⅣin the huangqi baoxin mixture was conducted by HPLC-ELSD. Results As-tragalus membranaceus,Salvia miltiorrhiza,Forsythia,and Angelica in the huangqi baoxin mixture could be accurately identified by TLC.The linear range of astragaloside Ⅳ was 1.224-10.20 μg (r=0.999 5).RSDs of precision,stability,and reproducibility tests were lower than 3.0%;the recovery was 96.2%-102.9% with RSD at 2.20% (n=6). Conclusion The established quan-titative method is simple,accurate,and reliable with high specificity which can be used to control the quality of huangqi baoxin mixture.%目的 建立黄芪保心合剂质量标准,完善其质量控制体系.方法 采用薄层色谱法对制剂中黄芪、丹参、连翘、当归药材进行定性鉴别;高效液相色谱-蒸发光散射检测法对其主要有效成分之一黄芪甲苷进行定量分析.结果薄层色谱法可以准确对制剂中黄芪、丹参、连翘、当归进行定性鉴别;黄芪甲苷检测进样量线性范围为1.224~10.20 μg (r=0.9995);精密度、稳定性及重复性RSD<3.0%;加样回收率为96.2%~102.9%,RSD为2.20%(n=6).结论 所建立的定性方法专属性较高,定量方法简单,准确度及重复性较好,可用于黄芪保心合剂的质量控制.