金鸡系列4个剂型药品的质量标准研究  

Study on Quality Standards of Jinji Series Four Dosage Forms

作　　者：王银红 罗疆南 李靖云 陈征 胡亮 罗艳 WANG Yinhong;LUO Jiangnan;LI Jingyun;CHEN Zheng;HU Liang;LUO Yan Hunan(Institute for Drug Control,Hunan Engineering and Technology Research Center for Pharmaceutical Quality Evaluation,Changsha Hunan 410001,China)

机构地区：[1]湖南省药品检验检测研究院,湖南省药品质量评价工程技术研究中心,湖南长沙410001

出　　处：《药品评价》2022年第22期1357-1361,共5页Drug Evaluation

基　　金：湖南省自然科学基金科药联合基金项目(2020JJ9012)。

摘　　要：目的:建立金鸡系列品种(金鸡片/颗粒/胶囊/丸)中统一的薄层色谱方法和含量测定方法。方法:采用薄层色谱法和高效液相色谱法对金鸡系列品种中六味药材的鉴别及含量测定方法进行研究。结果:建立并统一了金鸡系列品种中金樱根、鸡血藤、千斤拔、两面针四味药材的薄层色谱鉴别方法,修订了穿心莲和功劳木的薄层色谱方法,建立了金鸡系列品种(金鸡片/胶囊/丸)的含量测定方法。结论:建立的方法简便、准确、重复性好,能够较好地评价金鸡系列品种质量。Objective:To establish unified TLC methods and content determination method of jinji series(jinji tablets/granules/capsules/pills).Methods:TLC and HPLC methods were used to study the identification and content determination of six herbs in jinji series.Results:The TLC identification methods of the four medicinal materials of rosae laevigatae radix,spatholobi caulis,flemingiae radix and zanthoxyli radix,and the content determination method of jinji series varieties(jinji tablets/capsules/pills)were established and unified,the TLC methods of mahoniae caulis and andrographis herba were revised.Conclusion:The established methods is simple,accurate and repeatable,and can better evaluate the quality of jinji series.

关 键 词：金鸡系列品种 薄层色谱法 高效液相色谱法 金鸡片 金鸡胶囊 金鸡颗粒 金鸡丸 

分 类 号：R286.0[医药卫生—中药学]