固冲止血颗粒质量标准研究  

Study on quality standard of Guchong Zhixue granule

作　　者：张学兰[1] 唐玉秋[2] 李慧芬[1] 唐超[1] 

机构地区：[1]山东中医药大学,济南250355 [2]山东省济南市中心医院,济南250013

出　　处：《中国新药杂志》2011年第13期1174-1178,共5页Chinese Journal of New Drugs

基　　金：国家"重大新药创制"科技重大专项(2009ZX09301-013);山东省济南市科技局项目(2005-48)

摘　　要：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.

关 键 词：固冲止血颗粒 质量标准 薄层色谱法 高效液相色谱-蒸发光散射检测法 黄芪甲苷 

分 类 号：R943.3[医药卫生—药剂学] R927.2[医药卫生—药学]