益肾消肿丸中乌头碱限量检查方法和五味子醇甲含量测定研究  

Study on Inspection Method for Limited Quantity of Aconitine and Content Determination Method of Schisandrol in Yi-Shen Xiao-Zhong Pill

作　　者：贾秀凌 李木子[1] 邱琳[1] 刘莹[1] 

机构地区：[1]北京同仁堂股份有限公司科学研究所,北京100079

出　　处：《世界科学技术-中医药现代化》2015年第11期2296-2299,共4页Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology

基　　金：北京同仁堂股份有限公司企业自研项目(GF2014-3-01):益肾消肿丸质量标准研究;负责人:贾秀凌

摘　　要：目的:本研究旨在建立益肾消肿丸中乌头碱限量检查方法和五味子醇甲含量测定方法。方法:采用薄层色谱法对益肾消肿丸中乌头碱进行限量检查;运用高效液相色谱法测定五味子醇甲的含量。结果:通过方法学考察,建立了乌头碱限量查检方法和五味子醇甲的含量测定方法,与对照品色谱相应的位置上,乌头碱的检测限度为2.5μg,远低于乌头碱发生中毒反应的量,可用于益肾消肿丸中毒性成分乌头碱的限量控制;五味子醇甲的线性范围为2.92-95.36μg·m L^(-1),回归方程y=18.630x+2.556(r=1),平均回收率为:95.10%,RSD=1.55%(n=6)。结论:本研究建立的乌头碱、五味子醇甲检查和含量测定方法简便、准确,重复性好,适用于益肾消肿丸的质量控制。This study was aimed to establish an inspection method for the limited quantity of aconitine and the content determination of schisandrol in Yi-Shen Xiao-Zhong（YSXZ） pill. Thin layer chromatography（TLC） was used to inspect the limited quantity of aconitine in YSXZ pill. The content of schisandrol was determined by high-performance liquid chromatography（HPLC）. The results showed that the identification method of the limited quantity of aconitine and the content determination method of schisandrol were established. Compared to the correspondent position of the control chromatography, the limited quantity of aconitine was 2.5 μg, which was much lower than the dose of inducing toxic reaction. It can be used in the limited quantity control of aconitine for toxic reaction in YSXZ pill. The calibration curve of schisandrol was linear at 2.92-95.36 μg·m L-1. The regression equation was y = 18.630 x ＋ 2.556（r = 1）. The average recovery was 95.10% and RSD was 1.55%（n = 6）. It was concluded that the established method for the inspection and content determination of aconitine and schisandrol was simple, accurate and reproducible. It can be used in the quality control of YSXZ pill.

关 键 词：益肾消肿丸 乌头碱 五味子醇甲 高效液相色谱法 

分 类 号：R284[医药卫生—中药学]