肠康胶囊HPLC和TLC测定方法的改进  

Improvement of HPLC and TLC method for Changkang capsule

作　　者：李靖云 李瑞莲 罗疆南 LI Jingyu;LI Ruilian;LUO Jiangnan(Hunan Pharmaceutical Excipients Testing and Inspection Center,Hunan Engineering&Technology Research Center for Pharmaceutical Quality Evaluation,Hunan Institute for Drug Control,Changsha,Hunan,410001 P.R.China)

机构地区：[1]湖南省药品检验研究院湖南药用辅料检验检测中心湖南省药品质量评价工程技术中心

出　　处：《华西药学杂志》2020年第1期91-96,共6页West China Journal of Pharmaceutical Sciences

基　　金：国家药典委员会国家药品标准提高行动计划项目(编号:389)

摘　　要：目的改进并完善肠康胶囊的高效液相色谱法(HPLC)和薄层色谱法(TLC)测定方法。方法采用TLC法定性鉴别肠康胶囊中的盐酸小檗碱、木香、制吴茱萸;采用HPLC法测定方中盐酸小檗碱、木香中木香烃内酯和去氢木香内酯的含量。结果TLC斑点清晰、分离良好、阴性无干扰;盐酸小檗碱、木香烃内酯和去氢木香内酯的线性关系良好,线性范围分别为0.0220~0.5503μg(r^2=0.9998)、0.0431~4.3064μg(r^2=0.9999)、0.0766~2.8712μg(r^2=0.9999),平均加样回收率分别为99.57%、100.92%、98.54%,RSD分别为1.46%、1.65%、3.51%(n=6)。结论所用方法简便、准确、重复性好,可有效控制肠康胶囊产品的质量。OBJECTIVE To improve the HPLC and TLC method of Changkang capsules.METHODS TLC was used for the qualitative identification of berberine hydrochloride,Aucklandia Radix,processed Euodiae Fructus.The contents of berberine hydrochloride,costunolide and dehydrocostuslactone were determined by HPLC.RESULTS The TLC spots were clear and well-separated without any interference from the negative control.The linear relationships of calibration curves were favorable.Berberine hydrochloride,costunolide and dehydrocostuslactone were respectively with the concentration range of 0.0220-0.5503μg(r^2=0.9998),0.0431-4.3064μg(r^2=0.9999)and 0.0766-2.8712μg(r^2=0.9999).The average recoveries(n=6)of berberine hydrochloride,costunolide and dehydrocostuslactone were 99.57%,100.92% and 98.54%,and RSD were 1.46%,1.65% and 3.51%,respectively.CONCLUSION The method is simple and accurate with good reproducibility,and can be used for the quality control of Changkang capsules.

关 键 词：肠康胶囊 薄层色谱法 高效液相色谱法 吴茱萸 盐酸小檗碱 木香 木香烃内酯 去氢木香内酯 

分 类 号：R917[医药卫生—药物分析学]