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作 者:宋瑩 崔业波[1] 张大勇[1] 马晓静[1] SONG Ying;CUI Yebo;ZHANG Dayong;MA Xiaojing(Siping City Institute for Food and Drug Control,Jilin Siping 136000,China)
出 处:《中国医药导刊》2024年第3期260-263,共4页Chinese Journal of Medicinal Guide
摘 要:目的:建立舒肝和胃丸中α-香附酮和香附烯酮的高效液相色谱(HPLC-UV)含量测定法,为该制剂中醋香附含量的质量控制提供依据。方法:对舒肝和胃丸中α-香附酮和香附烯酮同时进行含量测定。采用Agilent ZORBAX SB-C18色谱柱(4.6 mm×250 mm,5μm),流动相为甲醇和水(65∶35),流速1.0 mL·min^(-1),检测波长254 nm,柱温30℃,进样量5μL。结果:采用该方法得到的舒肝和胃丸色谱图中,α-香附酮和香附烯酮色谱峰与相邻色谱峰分离效果较好,满足含量测定的要求;指标性成分α-香附酮、香附烯酮分别在0.08036~0.80360μg、0.2112~2.1120μg范围内线性关系良好,相关系数均为1.000;平均加标回收率分别为102.0%(RSD:1.6%,n=6),102.4%(RSD:2.0%,n=6);稳定性(24 h)、重复性、精密度良好。结论:本研究建立的α-香附酮和香附烯酮HPLC-UV含量测定方法简单、快捷、准确,可为舒肝和胃丸中醋香附含量的控制提供依据。Objective:To establish a content determination method of high performance liquid chromatography(HPLC-UV)forα-cyperone and cyperenone in shugan hewei pills,and to provide a basis for quality control of the content of vinegar-processed Cyperi Rhizoma in this preparation.Methods:The content ofα-cyperone and cyperenone in shugan hewei pills were determined simultaneously.The analysis was performed on a Agilent ZORBAX SB-C18 chromatography column(4.6 mm×250 mm,5μm),with mobile phase consisting of methanol and water(65∶35)at the flow rate of 1.0 mL·min^(-1).The detection wavelength was 254 nm.The column temperature was 30℃,and the injection volume was 5μL.Results:In the chromatogram of shugan hewei pills obtained by this method,α-cyperone and cyperenone have good separation effects from adjacent chromatographic peaks,meeting the requirements for content determination.The linear ranges of indicator componentsα-cyperone and cyperenone were 0.08036-0.80360μg and 0.2112-2.1120μg,respectively.The linear relationship within the range is good,and the correlation coefficients were all 1.000.The average spiked recovery rates were 102.0%(RSD:1.6%,n=6)and 102.4%(RSD:2.0%,n=6),respectively.The stability(24 h),repeatability and precision were compliance with requirements.Conclusion:The established method to determin the content ofα-cyperone and cyperenone by HPLC-UV is simple,fast and accurate,and can provide a basis for controlling the content of vinegar-processed Cyperi Rhizoma in shugan hewei pills.
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