| 应旭辉,张育乐,鲁梦霞,徐棋萍,金宏,刘雳.基于液质联用技术分析葡萄糖注射液包装材料浸出物[J].中国药品标准,2018,19(1):68-76 |
| 基于液质联用技术分析葡萄糖注射液包装材料浸出物 |
| LC-MS Based Methodology for Analysis of Leachables from Packaging Materials of Glucose Injection |
| 投稿时间：2017-10-13 修订日期：2018-02-08 |
| DOI： |
| 中文关键词: 葡萄糖注射液 包装材料 非PVC多层共挤输液袋 浸出物 烷醇酰胺 抗静电剂 |
| 英文关键词: glucose injection packaging materials non-PVC multi-layer co-extruded bags leachables alkanolamides antistatic agent |
| 基金项目:重大新药创制子项目《丹酚酸A临床研究及产业化开发》(2017ZX09301074-005) |
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| 中文摘要: |
| 目的：对市售非聚氯乙烯（non-PVC）多层共挤袋装5%葡萄糖注射液浸出物进行检测，研究烷醇酰胺类浸出物的迁移情况。方法：运用液相色谱-质谱联用技术鉴定葡萄糖注射液包装材料中烷醇酰胺类浸出物，并测定烷醇酰胺类浸出物在葡萄糖溶液和包装材料中的含量，对烷醇酰胺类浸出物的迁移率进行考察。结果：从6个厂家共12批葡萄糖注射液中初步鉴定出10个主要的烷醇酰胺类浸出物，不同厂家以及同一厂家不同批次间烷醇酰胺类浸出物总含量差异较大，在1.1 μg?mL-1到41.1 μg?mL-1之间，烷醇酰胺类浸出物迁移率大多在90%以上。结论：目前非PVC多层共挤袋装葡萄糖注射液包装材料烷醇酰胺类浸出物总含量差异较大，质量参差不齐，存在一定用药安全风险，应对葡萄糖注射液及其包装材料质量予以高度关注。 |
| 英文摘要: |
| Objective： To determin the alkanolamides leachables of commercially available 5% glucose injection within non-PVC multi-layer co-extruded bags and to inspect the migration of alkanolamides. Methods： The alkanolamides leachables from packaging materials of glucose injection were identified by liquid chromatography-mass spectrometry (LC-MS), and the contents of main alkanolamides in glucose solution and packaging materials were determined. The migration of main alkanolamides were investigated. Results： After preliminary identification, a total of 10 major alkanolamides leachables were detected in 12 batches of glucose injection from 6 manufacturers. The variability of alkanolamides content was relatively high in different manufacturers and different batches of the same manufacturers, ranging from 1.1 μg?mL-1 to 41.1 μg?mL-1. Most of the migration rate of alkanolamides were more than 90%. Conclution： The total content of the alkanolamides leachables of glucose injection within non-PVC multi-layer co-extruded bags is quite different and the quality is uneven. Hence, there is a certain safety risk using glucose injection in clinical, and the quality of glucose injection and its packaging materials should be paid more attention. |
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