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

作　　者：毕福钧[1] 陆巧茵 林彤[1] BI Fujun;LU Qiaoyin;LIN Tong(National Medical Products Administration Key Laboratory for Quality Evaluation of Traditional Chinese Medicine,Guangzhou Institute for Drug Control,Guangzhou 510160,China;Southern Medical University,Guangzhou 510160,China)

机构地区：[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

出　　处：《中国药品标准》2024年第1期48-54,共7页Drug Standards of China

基　　金：广州市科技计划项目(202201011705);2021年广东省科技创新战略专项(20212210005)。

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 C_(18)(250 mm×4.6 mm,5μm);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≥0.9999),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。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 C_(18) 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 rate of 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 relationships of four components were good(r≥0.9999)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 external standard method.Conclusion:This rapid,precise and reproducible method can be used for the quality control 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 

分 类 号：R921.2[医药卫生—药学]