一测多评法测定复方五仁醇胶囊中6种木脂素类成分  

Simultaneous determination of six lignanoids in Compound Wurenchun Capsules by QAMS

作　　者：缪应祥[1] 窦志华[1] 陈敏[1] 安莉萍[2] 

机构地区：[1]南通大学附属南通第三医院,江苏南通226006 [2]南京中医药大学,江苏南京210046

出　　处：《中成药》2014年第7期1439-1444,共6页Chinese Traditional Patent Medicine

基　　金：江苏省药学会-施贵宝医院药学科研项目(JS2012-04);南通市应用研究计划项目(K2008027)

摘　　要：目的建立一测多评法同时测定复方五仁醇胶囊(五味子、三七、柴胡、叶下珠)中6个木脂素类成分的量。方法以五味子醇甲为内参物,建立五味子醇乙、五味子酯甲、五味子甲素、五味子乙素和五味子丙素与内参物的相对校正因子。同时采用外标法测定,比较计算值与实测值的差异。结果在两个实验室的两种HPLC系统(Waters、Shimadzu)和两种色谱柱[Symmetry C18(4.6 mm×250 mm,5μm)和Lichrosphere C18(4.6 mm×250 mm,5μm)]对10批制剂中6个成分的相对校正因子测定的RSD均小于5%。结论所建立的方法表明具有良好的重现性。可用于复方五仁醇胶囊质量评价。AIM To develop an HPLC method for simultaneously determining six lignanoids in Compound Wurenchun Capsules（ Schisandrae chinensis Fructus,Notoginseng Radix et Rhizoma,Bupleuri Radix,Phyllantuus urinarial,CWC）. METHODS Schizandrol A was adopted as internal standard to determine the contents of schizandrol A,schizandrol B,schisantherin A,deoxyschizandrin,schizandrin B and schizandrin C in CWC. The latter relative correction factors（ RCF） to the schizandrol A were calculated and compared between the measured and the calculated values based on the external standard method. RESULTS The experimental data from ten batches of CWC showed that the effect of two HPLC columns [Symmetry C18（ 4.6 mm ×250 mm,5 μm） and Lichrosphere C18（ 4.6 mm ×250 mm,5 μm） ] and two apparatuses（ Waters and Shimadzu） in two laboratories on RCF were no more than 5%. CONCLUSION The developed method is repoducible,and can be used for quality control of CWC.

关 键 词：复方五仁醇胶囊 木脂素 高效液相色谱 

分 类 号：R927.2[医药卫生—药学]