化PVC医疗器械以防止增塑剂的迁移
Imen Dhifallah1, Daniel Claves1, Nicolas Batisse1
1Institut de Chimie de Clermont-Ferrand, Université Clermont Auvergne, 63178 Aubière, France.
International journal of pharmaceutics
|July 20, 2023
概括
化塑化聚乙烯 (PVC) 医疗器械形成了表面屏障,显著减少了塑化剂的迁移,并没有引起细胞毒性风险. 这种化学处理通过尽量减少医疗管道的有毒暴露来提高患者的安全性.
科学领域:
- 材料科学 材料科学 材料科学
- 生物医学工程 生物医学工程
- 聚合物化学 聚合物化学
背景情况:
- 医疗器械经常使用塑化聚乙烯 (PVC),可能会使塑化剂浸出到注入的溶液中.
- 浸的塑化剂可能会导致患者接触有毒物质,需要更安全的材料替代品.
- 目前的医疗器械材料需要增强的安全性,以减轻潜在的健康危害.
研究的目的:
- 研究表面化在减少PVC医疗器械中的可塑化剂迁移方面的有效性.
- 在化后对PVC医疗器械的物理化学变化进行表征.
- 评估化对修改设备的机械性能,光学清晰度和细胞毒性的影响.
主要方法:
- 使用纯分子的塑化PVC管状医疗器械的表面化.
- 通过光谱和显微技术进行物理化学表征,并进行拉伸试验.
- 使用气体染色学-质谱学 (GC-MS) 量化可塑化剂迁移.
- 根据ISO EN 10993-5标准进行细胞毒性评估.
主要成果:
- 在PVC医疗器械的内部表面成功形成共价碳- (C-F) 键.
- 化PVC设备的机械或光学性能没有显著的变化.
- 与原始设备相比,化设备的可塑化剂迁移显著减少.
- 来自化器械的迁移物中的三八三化物 (TOTM) 含量在24小时后低于量化极限.
- 化PVC对L929细胞没有表现出细胞毒性作用.
结论:
- 表面化是一种有效的方法,用于在塑化PVC医疗器械中创建屏障层.
- 这种处理显著抑制了可塑化剂的迁移,而不会损害材料的完整性或生物相容性.
- 化PVC医疗器械提供了更好的安全性,降低了患者的毒理风险.
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