基于UPLC-Q/TOF-MS/MS技术对不同厂家妇康宝口服液的质量评价研究  

Study on the quality evaluation of Fukangbao oral liquid based on the technology of UPLC-Q-TOF-MS/MS

作　　者：郑新元 曲佳 陈博知 王静 张茉 周军 王杰 ZHENG Xin-yuan;QU Jia;CHEN Bo-zhi;WANG Jing;ZHANG Mo;ZHOU Jun;WANG Jie(Tianjin Institute for Drug and Control,Tainjin 300070,China;Tianjin Hongrentang Pharmaceutical Co.Ltd,Tainjin 300133,China;Waters Technologies(Beijing)Ltd.,Beijing 100025,China)

机构地区：[1]天津市药品检验研究院,天津300070 [2]天津宏仁堂药业有限公司,天津300133 [3]沃特世科技(北京)有限公司,北京100025

出　　处：《药物分析杂志》2021年第6期1100-1105,共6页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:对不同厂家妇康宝口服液的质量进行评价。方法:采用超高效液相色谱-电喷雾/四极杆飞行时间串联质谱(UPLC-Q/TOF-MS/MS)技术及主成分分析(PCA)方法,对5个厂家30批次妇康宝口服液的质量进行整体评价,对具有显著性差异的组分进行鉴定与归属,并采用HPLC法对样品中甘草酸铵和甘草苷含量进行了测定与比较。结果:PCA分析表明,厂家C的产品质量与其余4个厂家存在明显差异,发现了大量差异性组分,其中之一鉴定为甘草酸铵;HPLC测定结果表明,厂家C样品中甘草酸铵和甘草苷含量明显低于其他4个厂家。结论:本课题应用UPLC-Q/TOF-MS技术及PCA方法从化学成分的角度成功将5个不同厂家的妇康宝口服液进行了区分,并采用HPLC法对PCA结果进行了验证,为该产品质量标准的提高和完善提供依据。该方法为解决多组分复杂体系中成药的质量评价提供了新思路与新方法。Objective:To evaluate the quality of Fukangbao oral liquid from different manufacturers.Methods:The quality evaluation of Fukangbao oral liquid was carried out with 30 batches of products from 5 manufacturers based on the technology of UPLC-Q/TOF-MS and principal component analysis(PCA).Some components with significant difference were identified and assigned.The result of PCA analysis was verified by HPLC method.Results:It was revealed by the PCA analysis that the quality of products from manufacturer C was obviously different from that from the other four manufacturers.A large number of different components were found which verified among the five manufacturers,one of which was identified as ammonium glycyrrhizinate.The HPLC results showed that the quality of licorice root in products from manufacturer C was significantly lower than that from the other four manufacturers.The HPLC results were consistent with the PCA analysis.Conclusion:In this paper,the Fukangbao oral liquid from different manufacturers were distinguished clearly based on the technology of UPLC-Q/TOF-MS and PCA from the perspective of chemical composition.A lot of different components were found as well.It provides the basis for the improvement of the quality of Fukangbao oral liquid.This technology was helpful to solve the problem of quality evaluation of Chinese patent medicine with multi-component complex systems.

关 键 词：妇康宝口服液 超高效液相色谱串联四极杆飞行时间质谱 主成分分析 质量评价 比较分析 

分 类 号：R917[医药卫生—药物分析学]