图尔荪托合提.托合提萨伊普,孙兆增,韩建勋,宋薇,魏海燕,肖进进.塑料药物包装材料可提取物全景分析方法概述[J].包装工程,2022,43(23):182-190.
TUERSUNTUOHETI Tuohetisayipu,SUN Zhao-zeng,HAN Jian-xun,SONG Wei,Wei，Hai-yan,XIAO Jin-jin.Overview of Comprehensive Analysis of Extractables from Plastic Pharmaceutical Packaging Materials[J].Packaging Engineering,2022,43(23):182-190. |
| 塑料药物包装材料可提取物全景分析方法概述 |
| Overview of Comprehensive Analysis of Extractables from Plastic Pharmaceutical Packaging Materials |
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| DOI：10.19554/j.cnki.1001-3563.2022.23.022 |
| 中文关键词: 塑料药物包材 包材相容性 可提取物 色谱质谱联用 |
| 英文关键词: plastic pharmaceutical packaging materials combability of packaging materials extractables combination of chromatography-mass spectrometry |
| 基金项目:科技服务品牌机构发展(20220467097);2022年度北京市博士后基金(2022–ZZ–053) |
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| 中文摘要: |
| 目的 对国内常用的塑料药物包材的挥发性、半挥发性、非挥发性物质及金属元素等提取物质的检测和分析方法进行总结，为塑料药物包材可提取物质全景分析和安全性评价提供参考。方法 通过检索国内外相关文献，对塑料药物包材中不同可提取物的分析方法进行总结和归纳。结果 目前，国内塑料药物包材日益更新，但可提取物的分析手段单一、检测分析方法不全面，缺乏相应的数据库。结论 药物包材的相容性研究在国内起步不久。针对目前存在的塑料包材可提取物的分析手段单一、不全面，缺乏相应的数据库等问题，现阶段亟需构建分辨率和灵敏度高、特异性强、筛查范围广的方法，对药物包材可提取物质进行全景分析，减少因包材安全性不良引起的医疗事故。 |
| 英文摘要: |
| The work aims to summarize the detection and analysis methods for the extractables, including volatile, semi-volatile, non-volatile substances and metal elements form plastic pharmaceutical packaging materials to provide reference for panoramic analysis and safety evaluation of the extractables of plastic pharmaceutical packaging materials. By searching the relevant publications at home and abroad, the analysis methods of different extractables in plastic pharmaceutical packaging materials were summarized. At present, plastic pharmaceutical packaging materials in our country are updated day by day, but the analysis method is fairly single to comprehensively analysis the extractables of plastic pharmaceutical packaging materials. Especially, the database about the extractables has not been established. The research on compatibility of pharmaceutical packaging materials has just started. In allusion to the aforementioned problems, it is urgent to build a method with high resolution, sensitivity, specificity and wide range of screening to have an overall analysis on the extractables of plastic pharmaceutical packaging materials and reduce medical safety issues caused by the plastic pharmaceutical packaging materials. |
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