药用玻璃注射剂瓶的可提取物研究  

Analysis of extracts from pharmaceutical glass vials

作　　者：张芳芳 张凤兰 火静怡 ZHANG Fang-fang;ZHANG Feng-lan;HUO Jing-yi(Shanghai Food And Drug Packaging Material Control Center,Shanghai 201203,China)

机构地区：[1]上海市食品药品包装材料测试所,上海201203

出　　处：《药物分析杂志》2023年第9期1494-1499,共6页Chinese Journal of Pharmaceutical Analysis

基　　金：上海市科委科研计划项目(18DZ2292600);2021年上海市药监局课题项目(ZX-2021-03)。

摘　　要：目的:对药用玻璃注射剂瓶可提取物进行研究,并对不同元素提取情况进行差异性分析。方法:建立电感耦合等离子体发射光谱(ICP-OES)和电感耦合等离子体质谱(ICP-MS)法测定不同侵蚀条件下注射剂瓶中17种元素提取的测定方法,并进行不同提取介质下可提取物测定。结果:提取溶液、注射剂瓶生产厂家、生产工艺、玻璃类型等的不同会对测定结果产生显著影响。结论:需重点关注不同类型的药品、不同生产厂家、不同生产工艺、不同玻璃类型变更对注射剂质量安全的影响。Objective:To study the extracts of pharmaceutical glass vails and conduct differential analysis on the extracted elements.Methods:A method for the determination of 17 elements in glass vials under different erosion medium by inductively coupled plasma optical emission spectrometry(ICP-OES)and inductively coupled plasma mass spectrometry(ICP-MS)was established.The determination of extracts in different medium of glass vails was carried out.Results:The difference in extraction medium,glass vials manufacturer,production process,glass type,etc.has a significant impact on the measurement results.Conclusion:It is necessary to pay attention to the impact of different types of drugs,different manufacturers,different production processes,and different glass types on the quality and safety of injections.

关 键 词：玻璃 注射剂瓶 相容性 变更 可提取物 元素 

分 类 号：R917[医药卫生—药物分析学]