Ito Rie, Seshimo Fumie, Miura Naoko, Kawaguchi Migaku, Saito Koichi, Nakazawa Hiroyuki
Department of Analytical Chemistry, Faculty of Pharmaceutical Sciences, Hoshi University, 2-4-41 Ebara, Shinagawa-ku, Tokyo 142-8501, Japan.
J Pharm Biomed Anal. 2005 Oct 4;39(5):1036-41. doi: 10.1016/j.jpba.2005.06.016. Epub 2005 Aug 2.
The risk assessment of di(2-ethylhexyl) phthalate (DEHP) that migrated from polyvinyl chloride (PVC) medical devices is an important issue for hospitalized patients. Many studies have been conducted to determine the level of DEHP migration. A recent report has indicated that DEHP in blood bags was hydrolyzed by esterase to mono(2-ethylhexyl) phthalate (MEHP). Therefore, a method for the simultaneous determination of DEHP and MEHP was developed. The migration of DEHP and MEHP from PVC tubing to drugs was examined. Although we detected MEHP in the drugs, we found no enzymatic activity involved in the migration process. Some reports have indicated that hydrolysis may have occurred during sterilization by autoclaving. However, we did not perform any heat treatment. It is speculated that the MEHP migrated directly from the PVC tubing. The simultaneous determination of DEHP and MEHP is required for risk assessment, as MEHP may be even more toxic than the parent compound.
从聚氯乙烯（PVC）医疗设备中迁移出来的邻苯二甲酸二（2-乙基己基）酯（DEHP）的风险评估，对于住院患者而言是一个重要问题。已经开展了许多研究来确定DEHP的迁移水平。最近一份报告指出，血袋中的DEHP被酯酶水解为邻苯二甲酸单（2-乙基己基）酯（MEHP）。因此，开发了一种同时测定DEHP和MEHP的方法。研究了DEHP和MEHP从PVC管材向药物中的迁移情况。尽管我们在药物中检测到了MEHP，但我们发现迁移过程中不存在酶活性。一些报告表明，在高压灭菌消毒过程中可能发生了水解。然而，我们并未进行任何热处理。据推测，MEHP是直接从PVC管材迁移过来的。由于MEHP的毒性可能比母体化合物更大，因此风险评估需要同时测定DEHP和MEHP。
