Croatian National Institute of Public Health, Environmental Health Service, Zagreb, Croatia.
J Appl Toxicol. 2013 Mar;33(3):214-9. doi: 10.1002/jat.1741. Epub 2011 Oct 28.
Di-(2-ethylhexyl) phthalate (DEHP) is a plasticizer widely used in the production of poly-(vinyl) chloride (PVC) materials. It is a reproductive and developmental toxicant in animals and a suspected endocrine modulator in humans. DEHP is not covalently bound within the PVC molecule, which is why migration into a suitable medium can be expected. Since application of infusion solutions is one of the most common medical treatments, the objective of this study was to determine the migration of phthalates from softened PVC storage bags into infusion solution in different time periods within one year from date of production using a gas chromatography-mass spectrometry method. The measured values of DEHP ranged between 0.22 and 14.00 µg l(-1) , but the unexpected presence of other phthalate esters was also detected. It was concluded that values obtained in infusion solutions match the reference data and represent a minor risk for the patient. The presence of other phthalate esters leads to the conclusion that the pharmacopeic requirement for polymer cleanness was not fully met. Since phthalate esters are among the most extensively used industrial chemicals and are widely distributed in the environment, special precautions and further monitoring should be conducted to minimize any possible health risks.
邻苯二甲酸二（2-乙基己基）酯（DEHP）是一种广泛用于聚氯乙烯（PVC）材料生产的增塑剂。它是一种动物生殖和发育毒物，也是人类疑似内分泌干扰物。DEHP 未与 PVC 分子共价结合，这就是为什么可以预期它会迁移到合适的介质中。由于输注溶液的应用是最常见的医疗治疗之一，因此本研究的目的是使用气相色谱-质谱法确定从生产之日起一年内不同时间点软化 PVC 储存袋中邻苯二甲酸酯向输注溶液中的迁移情况。DEHP 的测量值在 0.22 和 14.00 μg l(-1) 之间，但也检测到其他邻苯二甲酸酯的意外存在。得出的结论是，输注溶液中的值与参考数据相匹配，对患者的风险较小。其他邻苯二甲酸酯的存在表明药典对聚合物纯度的要求没有得到完全满足。由于邻苯二甲酸酯酯是用途最广泛的工业化学品之一，并且广泛分布在环境中，因此应采取特殊预防措施并进行进一步监测，以尽量减少任何可能的健康风险。
