首页|一测多评法测定莲芝消炎胶囊中4种二萜内酯

一测多评法测定莲芝消炎胶囊中4种二萜内酯

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

Lianzhi Xiaoyan capsulesandrographolidediterpene lactonecorrection factorQAMSinternal standard method

毕福钧、陆巧茵、林彤

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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

南方医科大学,广州 510515

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

广州市科技计划项目2021年广东省科技创新战略专项

20220101170520212210005

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
年,卷(期):2024.25(1)
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