中国药品标准2024,Vol.25Issue(1) :48-54.DOI:10.19778/j.chp.2024.01.008

一测多评法测定莲芝消炎胶囊中4种二萜内酯

Simultaneous determination of four diterpene lactones in Lianzhi Xiaoyan capsules by QAMS

毕福钧 陆巧茵 林彤
中国药品标准2024,Vol.25Issue(1) :48-54.DOI:10.19778/j.chp.2024.01.008

一测多评法测定莲芝消炎胶囊中4种二萜内酯

Simultaneous determination of four diterpene lactones in Lianzhi Xiaoyan capsules by QAMS

毕福钧 1陆巧茵 2林彤1
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作者信息

  • 1. 广州市药品检验所,国家药品监督管理局中成药质量评价重点实验室,广州 510160
  • 2. 南方医科大学,广州 510515
  • 折叠

摘要

目的:建立一测多评法测定莲芝消炎胶囊中新穿心莲内酯等4种二萜内酯成分的含量.方法:色谱柱为Shimadzu Shim-pack C18(250 mm × 4.6 mm,5 μm);流动相乙腈-0.1%磷酸水溶液,梯度洗脱;流速1.0 mL·min-1;检测波长为203 nm.以穿心莲内酯为参照,计算其他3种二萜内酯成分的相对校正因子,并测定其含量.结果:4种二萜内酯成分在各自范围内线性关系良好(r≥0.999 9),平均加样回收率为100.0%~102.8%,RSD为1.1%~2.2%.一测多评法与外标法所得结果接近.结论:该方法快速准确,重复性好,可用于莲芝消炎胶囊的质量控制.

Abstract

Objective:To set up a multi-components by single maker(QAMS)method for determination of four diterpene lactones in Lianzhi Xiaoyan capsules.Methods:Shimadzu Shim-pack C18 column(250 mm ×4.6 mm,5μm)was adopted with 35 ℃.Acetonitrile-0.1%phosphoric acid aqueous solution as the mobile phase in gradient mode was used at flow rateof 1.0 mL·min-1.The detection wavelength was set at 203 nm.Andrographolide was used as reference to calculate the relative correction factors of the other three components.Results:The linear rela-tionships of four components were good(r ≥ 0.999 9)within their ranges,and their average recoveries were 100.0%-102.8%with RSDs 1.1%-2.2%.The results obtained by QAMS were close to those obtained by ex-ternal standard method.Conclusion:This rapid,precise and reproducible method can be used for the quality con-trol of Lianzhi Xiaoyan capsules.

关键词

莲芝消炎胶囊/穿心莲内酯/二萜内酯/校正因子/一测多评/外标法

Key words

Lianzhi Xiaoyan capsules/andrographolide/diterpene lactone/correction factor/QAMS/internal standard method

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基金项目

广州市科技计划项目(202201011705)

2021年广东省科技创新战略专项(20212210005)

出版年

2024
中国药品标准
国家药典委员会

中国药品标准

影响因子:0.372
ISSN:1009-3656
参考文献量15
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