Bourdeaux Daniel, Sautou-Miranda Valérie, Bagel-Boithias Sandrine, Boyer Anne, Chopineau Jean
Service Pharmacie, Hôpital Gabriel Montpied, Rue Montalembert, Place Henri Dunant BP69, 63003 Clermont-Ferrand Cedex, France.
J Pharm Biomed Anal. 2004 Apr 1;35(1):57-64. doi: 10.1016/j.jpba.2003.12.018.
Di(2-ethylhexyl)phthalate (DEHP), a plasticiser present in infusion equipment, is known to be harmful to human health. Various studies have shown that DEHP is released into drug solutions from polyvinyl chloride (PVC) infusion lines. New multi-layer tubing has therefore been marketed to overcome this problem. We assessed the inertness of this tubing when placed in contact with a solution of CELLTOP. Chromatographic assay of DEHP showed no significant difference in DEHP levels in the solution when placed in contact with PVC and with multi-layer tubing. Analysis by infrared spectrometry showed that DEHP was initially present in the polyethylene layer of the multi-layer tubing even before contact with the drug solution. Contact with the solution results in release of DEHP from the container into the contents. The substance responsible for this release is in fact an excipient of CELLTOP, polysorbate. This release of DEHP further proves to depend on parameters such as temperature, time of contact between solution and tubing, and the concentration of polysorbate in the infused drug solution.
邻苯二甲酸二（2-乙基己基）酯（DEHP）是输液设备中存在的一种增塑剂，已知对人体健康有害。各种研究表明，DEHP会从聚氯乙烯（PVC）输液管中释放到药液中。因此，新型多层管材已投放市场以解决这一问题。我们评估了这种管材与CELLTOP溶液接触时的惰性。DEHP的色谱分析表明，当与PVC和多层管材接触时，溶液中DEHP的水平没有显著差异。红外光谱分析表明，即使在与药液接触之前，DEHP最初就存在于多层管材的聚乙烯层中。与溶液接触会导致DEHP从容器中释放到内容物中。导致这种释放的物质实际上是CELLTOP的一种辅料聚山梨酯。DEHP的这种释放进一步证明取决于温度、溶液与管材的接触时间以及输液药液中聚山梨酯的浓度等参数。
