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Study of endocrine disrupting compound release from different medical devices through an on-line SPE UHPLC-MS/MS method
Analytica Chimica Acta ( IF 5.7 ) Pub Date : 2018-12-01 , DOI: 10.1016/j.aca.2018.07.028
Fabio Gosetti , Bianca Bolfi , Elisa Robotti , Marcello Manfredi , Marco Binotti , Federica Ferrero , Gianni Bona , Emilio Marengo

The paper deals with the development of an online UHPLC-MS/MS method for the identification and determination of 25 Endocrine Disrupting Chemicals (EDCs) belonging to different chemical classes (perfluorochemicals, bisphenols, alkylphenols, phthalates, and parabens). The study regards the possible EDC migration from different medical devices of diverse materials used in the routine hospitals for blood sampling or for the parenteral nutrition therapies. In order to evaluate the release of EDCs, the equipment used for blood sampling (syringes, butterfly, cannula-needle, microcapillary tube) was put in contact with a physiological solution at a prefixed time. As regards the migration tests carried out on the medical devices used in the parenteral nutrition therapy (infusion tubes, venous catheters), the catheters were undergone to internal contact with parenteral solution and external contact with physiological one, whereas the infusion tubes were subjected only to internal migration test with parenteral solution. The results demonstrated the released of some ECDs (such as parabens at the concentration of few pg mL-1, diethylphthalate and dibutylphthlate at ng mL-1, level), when using physiological solution as the leaching agent. In addition, the presence of a PFOS structural isomer was found at 29.0 ng mL-1: this compound was released in part from the infusion tubes and mostly from the venous catheters, particularly from silicone ones. Using a more lipophilic solution, such as parenteral preparations, a greater amount of EDCs was released, among which also the diethylhexylphthalate that was quantified in all the investigated devices (without highlighting particular trends or migration from PVC devices), but its concentration remained always lower than imposed maximum threshold limit on medical device of 0.1% w/w. The releases from the infusion tubes of the same materials (polyethylene) from different manufacturers are very comparable, whereas the catheter of silicone releases greater amount of EDCs than that of polyurethane.

中文翻译:

通过在线 SPE UHPLC-MS/MS 方法研究不同医疗器械中内分泌干扰化合物的释放

本文介绍了一种在线 UHPLC-MS/MS 方法的开发,用于鉴定和测定属于不同化学类别(全氟化学品、双酚、烷基酚、邻苯二甲酸酯和对羟基苯甲酸酯)的 25 种内分泌干扰化学品 (EDC)。该研究考虑了 EDC 可能从常规医院用于血液采样或肠外营养治疗的不同材料的不同医疗设备中迁移。为了评估 EDC 的释放,将用于采血的设备(注射器、蝴蝶、套管针、微毛细管)在预定时间与生理溶液接触。关于对肠外营养治疗中使用的医疗器械(输液管、静脉导管)进行的迁移测试,导管进行了与肠胃外溶液的内部接触和与生理溶液的外部接触,而输液管仅进行了与肠胃外溶液的内部迁移测试。结果表明,当使用生理溶液作为浸出剂时,会释放一些 ECD(例如浓度为几 pg mL-1 的对羟基苯甲酸酯,邻苯二甲酸二乙酯和邻苯二甲酸二丁酯,浓度为 ng mL-1,水平)。此外,发现存在 29.0 ng mL-1 的全氟辛烷磺酸结构异构体:该化合物部分从输液管中释放,大部分从静脉导管中释放,特别是从硅胶导管中释放。使用更亲脂的溶液,如肠胃外制剂,释放出更多的 EDC,其中,邻苯二甲酸二乙基己酯也在所有研究的设备中进行了量化(没有突出特定趋势或来自 PVC 设备的迁移),但其浓度始终低于医疗器械规定的最大阈值 0.1% w/w。来自不同制造商的相同材料(聚乙烯)的输液管的释放量非常相似,而硅胶导管释放的 EDC 量比聚氨酯导管多。
更新日期:2018-12-01
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