中国中药杂志

2020, v.45(11) 2626-2633

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UPLC-MS/MS同时测定舒肝宁注射液在大鼠血浆中4种活性成分的含量及其药代动力学研究
Simultaneous determination of four components of Shuganning Injection in rat plasma by UPLC-MS/MS and its application to a pharmacokinetic study

康宁芳;李梅;胡贺佳;肖红琴;刘利琴;李银;李月婷;王爱民;王永林;张昀;何峰;巩仔鹏;
KANG Ning-fang;LI Mei;HU He-jia;XIAO Hong-qin;LIU Li-qin;LI Yin;LI Yue-ting;WANG Ai-min;WANG Yong-lin;ZHANG Yun;HE Feng;GONG Zi-peng;Provincial Key Laboratory of Pharmaceutics in Guizhou,State Key Laboratory of Functions and Applications of Medicinal Plants,Guizhou Provincial Engineering Research Center for the Development and Application of Ethnic Medicine and Traditional Chinese Medicine,School of Pharmacy,Guizhou Medical University;Guizhou Ruihe Pharmaceutical Co.,Ltd.;

摘要(Abstract):

该研究旨在揭示舒肝宁注射液在正常大鼠体内的药代动力学特征。实验采用超高液相色谱-电喷雾-串联质谱(UPLC-ESI-MS/MS)技术建立大鼠血浆样品中同时测定绿原酸、栀子苷、千层纸素A及黄芩苷4个活性成分的分析方法,并使用WinN onL in 6. 4软件中的非房室模型(NCA)进行药代动力学参数的拟合。经方法学验证,大鼠血浆样品中各成分的线性关系良好(r>0. 995),低、中、高剂量的血浆样品的提取回收率和基质效应在79. 14%~101. 4%。日内、日间精密度、准确度和稳定性均符合生物样品分析要求。药代动力学参数结果表明,绿原酸、栀子苷、千层纸素A在实验剂量下的半衰期(t_(1/2))没有发生显著性变化,药时曲线下面积(AUC_(0-t))与剂量成正比,提示3种成分在体内表现出线性动力学的特征,而黄芩苷表现出非线性动力学特征,且各成分在大鼠体内的滞留时间短。建立的UPLC-MS/MS定量分析方法快速、灵敏、准确,可用于大鼠血浆中绿原酸、栀子苷、千层纸素A以及黄芩苷的测定及舒肝宁注射液的药代动力学研究。
This study aims to reveal the pharmacokinetics of Shuganning Injection in normal rats. In this experiment,ultra-high performance liquid chromatography-electrospray-tandem mass spectrometry( UPLC-ESI-MS/MS) was used to establish an analytical method for simultaneous determination of chlorogenic acid,gardenioside,oroxylin A and baicalin in rat plasma. Then,the non-compartmental model( NCA) in Phoenix WinN onL in 6. 4 software was used to fit pharmacokinetic parameters. The methodological validation showed that the linear relationship of the components in rat plasma samples were good( r>0. 995). The recovery rate and matrix effect of plasma samples with low,middle and high concentration were 79. 14%-101. 4%. The intra-day and inter-day precision,accuracy and stability meet the requirements of biological sample analysis. The half-life( t1/2) of chlorogenic acid,gardenioside,oroxylin A did not change significantly and the area under blood concentration-time curve( AUC0-t) is proportional to the dose,which suggested that three components showed a linear kinetic characteristics,but baicalin showed nonlinear kinetic characteristics. Moreover,the retention time of each component in rats was short. The established UPLC-MS/MS quantitative analysis method is rapid,sensitive and accurate,which can be used for the determination of chlorogenic acid,gardenioside,oroxylin A and baicalin in rat plasma and pharmacokinetic study of Shuganning Injection.

关键词(KeyWords): 舒肝宁注射液;绿原酸;栀子苷;千层纸素A;黄芩苷;药代动力学
Shuganning Injection;chlorogenic acid;gardenioside;oroxylin A;baicalin;pharmacokinetics

Abstract:

Keywords:

基金项目(Foundation): 贵州省科技计划项目(黔科合[2016]支撑2850);; 贵州省民族药药效物质基础研究科技创新人才团队/贵州省高层次创新型人才培养(百层次)项目(黔科合平台人才[2016]5613/5677);; 中央引导地方科技专项项目(黔科中引地[2018]4006);; 贵阳市科研创新团队项目(筑科合同[2017]30-29号)

作者(Author): 康宁芳;李梅;胡贺佳;肖红琴;刘利琴;李银;李月婷;王爱民;王永林;张昀;何峰;巩仔鹏;
KANG Ning-fang;LI Mei;HU He-jia;XIAO Hong-qin;LIU Li-qin;LI Yin;LI Yue-ting;WANG Ai-min;WANG Yong-lin;ZHANG Yun;HE Feng;GONG Zi-peng;Provincial Key Laboratory of Pharmaceutics in Guizhou,State Key Laboratory of Functions and Applications of Medicinal Plants,Guizhou Provincial Engineering Research Center for the Development and Application of Ethnic Medicine and Traditional Chinese Medicine,School of Pharmacy,Guizhou Medical University;Guizhou Ruihe Pharmaceutical Co.,Ltd.;

Email:

DOI: 10.19540/j.cnki.cjcmm.20200323.201

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