Risk assessment of di(2-ethylhexyl)phthalate released from PVC blood circuits during hemodialysis and pump-oxygenation therapy

被引:37
作者
Haishima, Y
Matsuda, R
Hayashi, Y
Hasegawa, C
Yagami, T
Tsuchiya, T
机构
[1] Natl Inst Hlth Sci, Div Med Devices, Setagaya Ku, Tokyo 1588501, Japan
[2] Natl Inst Hlth Sci, Div Foods, Setagaya Ku, Tokyo 1588501, Japan
[3] Natl Inst Hlth Sci, Div Safety Informat Drug Food & Chem, Setagaya Ku, Tokyo 1588501, Japan
关键词
DEHP; MEHP; hemodialysis; pump-oxygenator; PVC tubing; blood circuit;
D O I
10.1016/j.ijpharm.2004.01.009
中图分类号
R9 [药学];
学科分类号
1007 [药学];
摘要
This study deals with in vitro investigation of the release of di(2-ethylhexyl)phthalate (DEHP) during hemodialysis and pump-oxygenation therapy using medical grade PVC tubing. High resolution GC-MS analysis showed that the release of DEHP was time-dependently increased by circulation of bovine blood into a major system for the hemodialysis that is used in Japan, and the amount of DEHP released into the blood had reached 7.3 mg by 4 h of circulation. No significant difference was observed in the release patterns of DEHP under the conditions with and without fluid removal treatment during hemodialysis, indicating that the treatment seems not to be effective for eliminating DEHP from the blood through the hemodialysis membrane. Mono(2-ethylhexyl)phthalate (MEHP) analysis revealed that a small amount of DEHP (3-4%) was converted to MEHP by hydrolysis during the circulation of blood. A considerable amount of DEHP was also released from the PVC circuit mimicking the pump-oxygenation system, and 7.5-12.1 mg of DEHP had migrated into bovine blood from the circuit by 6 h. It was noticed, however, that the release was obviously suppressed by covalently coating the inner surface of the PVC tubing with heparin, though this effect was not observed with ionic bond type-heparin coating. Covalent bond type-heparin coating of PVC tubing seems to offer the advantage of decreasing the amount of DEHP exposure to patients during treatment using a PVC circuit. (C) 2004 Elsevier B.V. All rights reserved.
引用
收藏
页码:119 / 129
页数:11
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