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PVC一次性輸液器中DEHP和TOTM增塑劑溶出量對比

Comparison of DEHP and TOTM releasing from PVC disposable infusion set

作者: 黃元禮  王安琪  柯林楠  馮曉明  馬辰                          
單位:                                 中國醫(yī)學(xué)科學(xué)院北京協(xié)和醫(yī)學(xué)院藥物研究所(北京100050)            
關(guān)鍵詞:                               鄰苯二甲酸二乙基乙酯;偏苯三酸三辛酯;聚氯乙烯;一次性輸液器;溶出量              
分類號:
出版年·卷·期(頁碼):2015·34·2(161-166)
摘要:

目的  偏苯三酸三辛酯(trioctyl trimellitate, TOTM)被認(rèn)為是可替代鄰苯二甲酸二乙基乙酯[bis(2-ethylhexyl) phthalate, DEHP],提高醫(yī)用輸血輸液器中聚氯乙烯(polyvinyl chloride, PVC)管路使用安全性的新型醫(yī)用增塑劑。本實驗對比兩種增塑劑的溶出量,考察TOTM的安全性。方法 采用硝酸甘油、單硝酸異山梨酯兩種藥物及45%乙醇水模擬藥液,模擬臨床使用。藥液經(jīng)過輸液器后采用HPLC進(jìn)行測試,測量兩種藥物及模擬藥液中的TOTM和DEHP,考察采用上述兩種增塑劑的輸液器中增塑劑的溶出情況。結(jié)果 兩種藥物中均未檢出兩種增塑劑。在乙醇水模擬藥液中,檢出兩種增塑劑,且TOTM的溶出量較DEHP高。結(jié)論 模擬藥液評價增塑劑的溶出性能存在局限性,因此,需要醫(yī)療器械生產(chǎn)企業(yè)和醫(yī)療器械監(jiān)管機構(gòu)協(xié)同合作,模擬臨床實際使用進(jìn)行檢測,確保醫(yī)療器械的安全性。

Objective Trioctyl trimellitate(TOTM), a new plasticizer, is considered an alternative to bis(2-ethylhexyl) phthalate (DEHP) in order to improve the safety of polyvinyl chloride (PVC)-based medical infusion pipes. The release of the two plasticizers from medical infusion tubes is compared in this study for a safety analysis of TOTM. Methods To simulate clinical situation, nitroglycerin solution, isosorbidemononitrate solution and 45% ethanol aqueous solution were allowed to transfuse through both types of tubes, respectively, and were collected at multiple time points for a quantitative determination of the plasticizers content using HPLC. Results No plasticizer was found in the nitroglycerin or the isosorbidemononitrate solutions, whilst both TOTM and DEHP were detected in the ethanol water simulation solution, and the content of TOTM was higher than DEHP. Conclusions The simulation solution is insufficient to evaluate the safety of the plasticizer migration. Therefore, it calls for a closer collaboration between the medical device manufacturers and relevant regulatory bodies for the evaluations in mimicking clinical practices to guarantee the safety of infusion sets.

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