护肝片中五味子含量测定方法的建立及不同厂家产品含量的比较

Establishment of quantitative determination of Wuweizi(Fructus Schisandrae) in Hugan Tablets and content comparison among products from different manufactures

目的建立护肝片中4种木脂素类有效成分的含量测定方法,并采用新方法比较不同厂家产品含量的差异。方法采用RP-HPLC法,色谱柱：Hypersil C18柱（250 mm×4.6 mm,5μm）;流动相：乙腈-水系统梯度洗脱;检测波长：250 nm;流速：1mL/min;进样量10μL。结果五味子醇甲、五味子酯甲、五味子甲素、五味子乙素的平均回收率依次为98.06%、98.28%、97.49%、99.82%,RSD依次为0.83%、1.80%、1.11%、0.83%。所收集的各厂家护肝片每片中五味子醇甲、五味子酯甲、五味子甲素、五味子乙素的含量依次为0.2128~0.6151 mg、0.0047~0.140 6 mg、0.0516~0.3050 mg、0.0913~0.3460 mg。结论本方法准确简便可行,可用于护肝片中五味子多指标成分的含量测定,且新方法测得不同厂家的产品质量差异显著。

Objective To establish a method for quantitative determination of 4 lignans constituents in Hugan Tablets,and compare the content difference among the products from different manufactures.Methods The RP-HPLC procedure was performed on the chromatographic column of Hypersil C18（250 mm×4.6 mm,5 μm）,and the mobile phase was acetonitrile-water in gradient elution program.The detection wavelength was 250 nm,flow velocity was 1 mL/min and the sample size was 10 μL.Results The average recovery of schizandrol A was 98.06%（RSD=0.83%）,schisantherin A,98.28%（RSD=1.80%）,deoxyschizandrin,97.49%（RSD=1.11%）,and γ-schisandrin,99.82%（RSD=0.83%）.In each piece of Hugan Tablets from different manufactures the content of schizandrol A was 0.212 8 mg-0.615 1 mg,schisantherin A,0.004 7 mg-0.140 6 mg,deoxyschizandrin,0.051 6 mg-0.305 0 mg,and γ-schisandrin,0.091 3 mg-0.346 0 mg.Conclusion The method was accurate and easy,which can be used in the quantitative determination of multiple constituents of Wuweizi（Fructus Schisandrae） in Hugan Tablets.The method finds out the significant difference among the products from different manufactures.