固冲止血颗粒质量标准研究

Study on quality standard of Guchong Zhixue granule

目的:建立固冲止血颗粒的质量标准。方法:采用薄层色谱法(TLC)鉴别炙黄芪、炒升麻、远志、三七、地黄、女贞子;采用高效液相色谱-蒸发光散射检测法(HPLC-ELSD)测定黄芪甲苷含量。结果:TLC色谱中检出炙黄芪、炒升麻、远志、三七、地黄、女贞子的特征斑点;黄芪甲苷在1.1～6.6μg范围内线性关系良好,平均回收率为97.34%,RSD为1.08%(n=6)。结论:本文建立的定性、定量方法简便、准确、可靠,可作为本制剂的质量控制方法。

Objective：To formulate the quality standard of Guchong Zhixue granule.Methods：Detecting the characteristic spots of Astragali radix praeparata cum melle,Cimicifugae rhizoma tostum,Polygalae radix,Notoginseng radix et rhizoma,Rehmanniae radix,Ligustri lucidi fructus using TLC.The content of Astragaloside Ⅳ was determined by HPLC-ELSD.Results：All characteristic spots were detected by TLC.The calibration curve of Astragaloside Ⅳ was linear within 1.1～6.6μg,the average recovery was 97.34%,RSD was 1.08%（n=6）.Conclusion：This qualitative and quantitative method was simple,precise and reliable,which could be used for quality control of the granule.