芪黄胶囊质量控制研究  

Quality Control Research of Qihuang Capsules

作　　者：梁旭明[1] 钟国跃[1] 张小梅[1] 蒋渝[1] 唐耀书[1] 

机构地区：[1]重庆市中药研究院,重庆400065

出　　处：《中药新药与临床药理》2011年第3期331-334,共4页Traditional Chinese Drug Research and Clinical Pharmacology

基　　金：科技部重大新药创制专项:芪黄胶囊治疗糖尿病肾病的新药研究(2009ZX09103-311);重庆市卫生局中医药科技项目(2009-2-169)

摘　　要：目的建立芪黄胶囊的质量控制方法。方法采用薄层色谱法对芪黄胶囊中女贞子、匙羹藤叶、青风藤、大黄进行定性鉴别,HPLC-ELSD法对制剂中黄芪甲苷进行含量测定。结果薄层鉴别分离度好,专属性强;黄芪甲苷线性范围为1.56～13.00μg(r=0.999 8),平均加样回收率为98.88%,RSD为2.68%。结论该方法简便、快速、准确、重现性好,能有效进行芪黄胶囊的质量控制。Objective To set up a method for the quality control of Qihuang Capsules.Methods Thin-layer chromatography was used to identify Fructus Ligustri Lucidi,Folium Gymnemae,Caulis Simonii,Radix et Rhizoma Rhei in Qihuang Capsules by TLC.HPLC-ELSD was used to determine astragaloside Ⅳ in Qihuang Capsules.Results The method of TLC showed a good separation and strong specificity.Astragaloside Ⅳ showed a good linear relationship within the range of 1.56 ～ 13.00 μg（r=0.9998）.The average recovery was 98.88 %,and RSD was 2.68 %（n=6）.Conclusion The established method is simple,accurate and reproducible,which can be used for the quality control of Qihuang Capsules.

关 键 词：芪黄胶囊 薄层鉴别 HPLC-ELSD 黄芪甲苷 

分 类 号：R284.1[医药卫生—中药学]