GC-MS和UPLC-QTOF-MS测定生物药用预充式注射笔中的可提取物  

Determination of Extractables in Pre-filled Injectable Pens for Biopharmaceuticals by GC-MS and UPLC-QTOF-MS

作　　者：鲁征 安皓月 杜振霞 LU Zheng;AN Haoyue;DU Zhenxia(College of Chemistry,Beijing University of Chemical Technology,Beijing 100029)

机构地区：[1]北京化工大学化学学院,北京100029

出　　处：《中国医药工业杂志》2024年第5期713-718,共6页Chinese Journal of Pharmaceuticals

基　　金：国家自然科学基金项目(21874006)。

摘　　要：采用超高效液相色谱串联四极杆飞行时间质谱(UPLC-QTOF-MS)和气相色谱串联四极杆质谱(GC-MS)技术,对3种生物药用预充式注射笔中的可提取物进行了非靶向筛查。基于注射笔的实际使用情况,在70 ℃、4 d的条件下,用4种提取剂对其进行组件整体提取。通过设置分析评估阈值(AET),并利用药品包装材料可提取物数据库结合人工谱库解析进行定性分析,最终共检出29种有机物,包括抗氧剂、增塑剂、润滑剂等成分。其中,使用普通卤化丁基活塞的注射笔检出27种物质,使用覆膜活塞的注射笔中检出4种可提取物。该研究所得的可提取物清单可以为开展后续的相容性研究提供数据参考。Non targeted screening of extractables in three biopharmaceutical pre-filled injection pens was conducted with ultra-high performance liquid chromatography tandem quadrupole time of flight mass spectrometry(UPLC-QTOF-MS)and gas chromatography tandem quadrupole mass spectrometry(GC-MS)techniques.Based on the actual use of the injection pens,the components were extracted as a whole using four extraction agents at 70℃for 4 d.By setting an analysis evaluation threshold(AET)and utilizing a database of extractables combined with manual spectral analysis,a total of 29 organic compounds were detected,including antioxidants,plasticizers,lubricants,and other components.Among them,27 substances were detected in injection pens with ordinary halogenated butyl rubber stoppers,and 4 extractables were detected in injection pens with coated rubber stoppers.The list of extractables obtained in this study can provide data references for subsequent compatibility studies.

关 键 词：UPLC-QTOF-MS GC-MS 药品包装材料 注射笔 可提取物 分析评估阈值 风险评估 

分 类 号：R917[医药卫生—药物分析学] TQ464.9[医药卫生—药学]