薛艳丽,娄朝晅,薛小琦,田广林
XUE Yanli,LOU Zhaoxuan,XUE Xiaoqi,TIAN Guanglin

• 1:河南科技大学第一附属医院药学部
• 2:河南科技大学法医学实验教学中心
• 3:遂成药业股份有限公司新药研发部

摘要(Abstract)：

目的 建立高效液相一标多测(high performance liquid chromatography-quantitative analysis of multi-components by single-marker, HPLC-QAMS)法同时测定参精止渴丸中人参皂苷Rg_1、人参皂苷Re、人参皂苷Rb_1、3′-羟基葛根素、葛根素、3′-甲氧基葛根素、五味子醇甲、五味子醇乙、五味子甲素及五味子乙素的含量。方法 采用Agilent Zorbax SB-C_(18)色谱柱(4.6 mm×250 mm, 5μm),流动相为乙腈(A)-体积分数0.1%磷酸溶液(B),梯度洗脱，流速为1.0 mL·min~(-1),柱温为30℃,检测波长分别为203 nm和250 nm;以葛根素为内参物，建立其他9种成分的相对校正因子，计算各成分含量。结果 10种成分分别在各自质量浓度范围内有较好的线性关系；平均加样回收率为96.98%～100.1%,RSD为0.6%～1.7%。一标多测法计算结果与外标法实测值无明显差异。结论 所建立的一标多测法结果准确，操作便捷，可作为参精止渴丸多指标成分质量控制方法。
Objective To develop an HPLC-QAMS method for the determination of ginsenoside Rg_1,ginsenoside Re, ginsenoside Rb_1,3′-hydroxy puerarin, puerarin, 3′-methoxy puerarin, schisandrin, schisandrol B,deoxyschizandrin and γ-schisandrin in Shenjing Zhike Pills.Methods The analysis was performed on Agilent Zorbax SB-C_(18)(4.6 mm×250 mm, 5 μm) column, the column temperature was set at 30 ℃.The mobile phase was composed of acetonitrile-0.1% phosphate acid in gradient elution manner at a flow rate of 1.0 mL·min~(-1).The detection wavelength were set at 203 nm and 250 nm.Using puerarin as an internal standard, the relative correction factors(RCF) of the other nine constituents were calculated, after which the content determination was made.Results Ten components have good linear relationship in a certain range, whose average recoveries were 96.98%-100.10%,RSDs were 0.6%-1.7%.There was no significant difference between the calculated by HPLC-QAMS method and measured values by external standard method(ESM).Conclusion The established HPLC-QAMS method has the advantages of accurate results and convenient operation, which can be used for the quality control method for the determination of multi-component index of Shenjing Zhike pills.

关键词(KeyWords)： 参精止渴丸;高效液相一标多测法;相对校正因子;多成分;含量
Shenjing Zhike Pills;HPLC-QAMS;relative correction factor;multicomponent;content

Abstract:

Keywords:

基金项目(Foundation):

作者(Author): 薛艳丽,娄朝晅,薛小琦,田广林
XUE Yanli,LOU Zhaoxuan,XUE Xiaoqi,TIAN Guanglin

DOI: 10.14066/j.cnki.cn21-1349/r.2021.0570

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