黄芪保心合剂质量标准  

Quality Standard of Huangqi Baoxin Mixture

作　　者：吴炜 张培影[1,2] 陈永刚[2] 常星洁[2] 吴世强[2] 张嘉予 

机构地区：[1]南京中医药大学,南京210023 [2]江苏省徐州市中心医院,徐州221009 [3]郑州大学临床医学院,郑州450000

出　　处：《医药导报》2018年第3期341-344,共4页Herald of Medicine

摘　　要：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1.224~10.20μg(r=0.999 5);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。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 astragaloside Ⅳ in the huangqi baoxin mixture was conducted by HPLC-ELSD. Results Astragalus 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 quantitative method is simple,accurate,and reliable with high specificity which can be used to control the quality of huangqi baoxin mixture.

关 键 词：黄芪保心合剂 质量标准 色谱法 薄层 检测法 高效液相色谱-蒸发光散射 

分 类 号：R286[医药卫生—中药学] R927.1[医药卫生—中医学]