Takatori Satoshi, Okamoto You, Kitagawa Yoko, Hori Shinjiro, Izumi Shun-Ichiro, Makino Tsunehisa, Nakazawa Hiroyuki
Division of Food Chemistry, Osaka Prefectural Institute of Public Health, 1-3-69 Nakamichi, Higashinari-ku, Osaka 537-0025, Japan.
Int J Pharm. 2008 Mar 20;352(1-2):139-45. doi: 10.1016/j.ijpharm.2007.10.020. Epub 2007 Oct 26.
The leaching of di(2-ethylhexyl)phthalate (DEHP) and mono(2-ethylhexyl)phthalate (MEHP) from medical products made of polyvinyl-chloride (PVC) to enteral nutrition (EN) for neonatal patients was determined in a simulated study. The study simulated a typical case of EN administration to a neonatal patient (body weight, 3 kg) in a neonatal care unit (temperature, 25 degrees C); the medical products used were an irrigator and catheter containing DEHP (9.1-31.8%, w/w) as a plasticizer. The worst-case daily exposures of the neonatal patient to DEHP and MEHP by the administration of EN were estimated to be 148 and 3.72 microg/(kg day), respectively, as assessed from the levels of these compounds leaching from the medical products to the EN. The use of DEHP-free medical products reduced the exposure of DEHP and MEHP to the minimum levels contained in the EN at preparation. A transition to DEHP-free medical products for neonatal patients would be effective in reducing the exposure of neonatal patients to DEHP via EN administration.
在一项模拟研究中,测定了聚氯乙烯(PVC)制成的医疗产品中邻苯二甲酸二(2-乙基己基)酯(DEHP)和邻苯二甲酸单(2-乙基己基)酯(MEHP)向新生儿患者肠内营养(EN)中的浸出情况。该研究模拟了新生儿护理病房(温度为25摄氏度)中对一名新生儿患者(体重3千克)进行肠内营养给药的典型案例;所使用的医疗产品是含有DEHP(9.1 - 31.8%,w/w)作为增塑剂的冲洗器和导管。根据这些化合物从医疗产品浸出到肠内营养中的水平评估,新生儿患者通过肠内营养给药每天接触DEHP和MEHP的最坏情况估计分别为148和3.72微克/(千克·天)。使用不含DEHP的医疗产品可将DEHP和MEHP的接触量降低至肠内营养制剂中所含的最低水平。向新生儿患者使用不含DEHP的医疗产品将有效减少新生儿患者通过肠内营养给药接触DEHP的情况。