补肾蠲毒丸质量标准研究

摘要

Objective:To establish the quality standard for Bushen Juandu Pills.Methods:The Dioscoreae Rhizoma,Sophorae Flavescentis Radix,Bombyx Batryticatus and Curcumae Radix were identified by microscopic identification.The Cuscutae Semen,Polygoni Cuspidati Rhizoma et Rradix,Scutellariae Radix and Paeoniae Radix Rubra were identified by TLC,and the content of astragaloside was determined by HPLC-ELSD.Results:The microscopic characteristics were obvious,TLC spots were clear and strong specific.In the content determination method,astragaloside showed a good linear relationship at the range of 0.252 0-3.150 0 μg,r =0.999 6.The average recovery rate was 99.80％.Conclusion:The established method is accurate and reliable and easy to operate,it can be used for the quality control of Bushen Juandu pills.%目的:建立补肾蠲毒丸的质量控制标准.方法:采用显微鉴别法对山药、苦参、僵蚕、郁金进行定性鉴别,采用薄层色谱法对菟丝子、虎杖、黄芩、赤芍进行定性鉴别;采用高效液相色谱-蒸发光散射检测法(HPLC-ELSD)测定黄芪甲苷的含量.结果:本品显微鉴别特征明显,薄层色谱定性鉴别斑点清晰、专属性强;含量测定方法中,黄芪甲苷的量在0.252 0～ 3.150 0μg呈良好线性关系,相关系数r=0.999 6,平均回收率为99.80％.结论:所建立的方法准确可靠、易于操作,可用于补肾蠲毒丸的质量控制.