摘要
目的 探讨采用超高效液相色谱-串联质谱(UPLC-MSMS)法检测分析冠心舒通胶囊中丹参素、咖啡酸、原儿茶醛、原儿茶酸、迷迭香酸、丹参酮Ⅰ、丹参酮ⅡA、隐丹参酮、丹酚酸A、丹酚酸B和熊果酸等药效成分的可行性.方法 选取多批次冠心舒通胶囊进行含量测定,采用UPLC-MSMS法分析检测,熊果酸以外的 10 种成分均为多反应监测(multiple reaction monitoring,MRM),熊果酸选择离子监测(selected ion monitor,SIR),采用多元数据处理软件SIMCA 14.0对测定结果进行主成分分析,并评价其质量.结果 在优化的色谱质谱条件下,丹参素、咖啡酸、原儿茶醛、原儿茶酸、迷迭香酸、丹参酮Ⅰ、丹参酮ⅡA、隐丹参酮、丹酚酸A、丹酚酸B和熊果酸分别在适当的质量浓度内呈良好线性关系(r≥0.9997);加样回收率 97%～100%.结论 采用 UPLC-MSMS 法检测分析冠心舒通胶囊中丹参素、咖啡酸、原儿茶醛、原儿茶酸、迷迭香酸、丹参酮Ⅰ、丹参酮ⅡA、隐丹参酮、丹酚酸A、丹酚酸B和熊果酸等药效成分不同批次药物质量稳定,且精密度均较高,能够从整体上综合评价药物质量,利于此药品的质量控制.
Abstract
Objective To explore the feasibility of determining the pharmacodynamic components of tanshinone Ⅰ,tanshinone ⅡA,cryptotanshinone,salvianolic acid A,salvianolic acid B and ursolic acid in Guanxinshutong capsule by ultra-high performance liquid chromatography-tandem mass spectrometry(UPLC-MSMS).Methods Multiple batches of Guanxin Shutong Capsules were selected for content determination.UPLC-MSMS method was used to analyze and detect 10 components other than ursolic acid.Multiple reaction monitoring(MRM),ursolic acid selected ion monitor(selected ion monitor,SIR),multivariate data processing software SIMCA14.0 was used to perform principal component analysis on the determination results and evaluate its quality.Results Under the optimized chromatographic mass spectrometry conditions,danshensu,caffeic acid,protocatechuic aldehyde,protocatechuic acid,rosmarinic acid,tanshinone Ⅰ,tanshinone ⅡA,cryptotanshinone,salvianolic acid A,salvianolic acid B and ursolic acid showed good linear relationships within appropriate mass concentrations(r≥0.9997).The recovery was 97％-100％.Conclusion UPLC-MSMS method was used to detect and analyze Danshensu,caffeic acid,protocatechuic aldehyde,protocatechuic acid,rosmarinic acid,tanshinone Ⅰ,tanshinone ⅡA,cryptotanshinone,salvianolic acid A,salvianolic acid B and ursolic acid in Guanxin Shutong Capsule.The quality of different batches of drugs is stable,and the detection stability and precision are high.It can comprehensively evaluate the quality of drugs as a whole,which is conducive to the quality control of this drug.
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