一种快速分析聚山梨酯80组分的方法  

A method for rapid analysis of polysorbate 80 components

作　　者：周颖 赵恂 胡楠 王保成 袁耀佐 ZHOU Ying;ZHAO Xun;HU Nan;WANG Baocheng;YUAN Yaozuo(College of Pharmacy,Nanjing University of Chinese Medicine,Nanjing 210023;Jiangsu Institute for Food and Drug Control,Nanjing 210019;NMPA Key Laboratory for Impurity Profile of Chemical Drugs,Nanjing 210019;Agilent Technologies,Beijing 100102;Nanjing Well Pharmaceutical Co.,Ltd.,Nanjing 210009,China)

机构地区：[1]南京中医药大学药学院,南京210023 [2]江苏省食品药品监督检验研究院,南京210019 [3]国家药品监督管理局化学药品杂质谱研究重点实验室,南京210019 [4]安捷伦科技(中国)有限公司,北京100102 [5]南京威尔药业集团股份有限公司,南京210009

出　　处：《中国药科大学学报》2022年第2期192-199,共8页Journal of China Pharmaceutical University

摘　　要：由于聚山梨酯80的组分复杂,分析耗时耗力,亟需寻找一种能够快速分析聚山梨酯80组分的方法。本研究采用ExcipientProfiler药用辅料智能分析系统,通过UHPLC-HRMS对收集到的国内外3家企业共10批样品进行分析,同时利用扩展数据库对分析结果进行补充解析。分析结果显示,ExcipientProfiler软件能够快速识别质谱图中加合了Na^(+)的组分峰,得到样品的组分分布、组分数和聚合度信息,并利用系统聚类分析法证明能用其得到的组分数来区别注射级和普通级的样品。此外,通过手动搜索相关扩展数据库补充说明了样品中还含有其他脂肪酸酯类组分,以及根据质谱数据解析发现样品中存在聚氧乙烯山梨醇酐四油酸酯组分。实验结果表明,该方法虽然快速简便,但是后续需要添加四酯组分和其他脂肪酸酯类组分进一步完善ExcipientProfiler软件中信息,以便能更好地应用于聚山梨酯80的分析。Due to the complex components of polysorbate 80,analysis is time-consuming and labor-intensive,so there is an urgent need to find a method for rapid analysis of polysorbate 80 components.In this study,10 batches of samples collected from 3 domestic and foreign enterprises were analyzed by UHPLC-HRMS,with the being further results were analyzed by the ExcipientProfiler software and supplemented by the extended database.The results showed that the ExcipientProfiler software could quickly identify the[M+Na]^(+)peak in the mass spectrogram,and obtain the information of component distribution,the numbers of components and the degree of polymerization of the sample.Meanwhile,the numbers of components obtained by the ExcipientProfiler software could be used to distinguish the injection grade samples from the ordinary grade samples by systematic clustering analysis.In addition,it was found through further supplement that the sample contained other fatty acid ester components by manually searching the relevant extended database.The polyoxyethylene sorbitan tetraoleate components were found in the sample according to the analysis of mass spectrum data.Therefore,although this method is fast and simple,it is necessary to add polyoxyethylene sorbitan tetraoleate components and other fatty acid ester components to further supplement the information in the ExcipientProfiler software,so that it can be better used for the analysis of polysorbate 80.

关 键 词：聚山梨酯80 组分分析 ExcipientProfiler软件 数据库 聚类分析 

分 类 号：R917[医药卫生—药物分析学]