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对接触血液的聚氯乙烯医疗设备中释放的邻苯二甲酸二（2-乙基己基）酯的评估。

Evaluation of the Di(2-ethylhexyl)phthalate released from polyvinyl chloride medical devices that contact blood.

作者信息

Luo Hongyu, Sun Guangyu, Shi Yanping, Shen Yong, Xu Kai

机构信息

CFDA Jinan Quality Inspection Center for Medical Devices, 99 Tianluo Road H-T Industrial Development Zone, Jinan, 250000 China ; Shandong Provincial Key Laboratory of Biological Evaluation of Medical Device, 99 Tianluo Road H-T Industrial Development Zone, Jinan, 250000 China.

Shandong Hengxin Inspection Technology Development Center, 99 Tianluo Road H-T Industrial Development Zone, Jinan, 250000 China.

出版信息

Springerplus. 2014 Jan 29;3:58. doi: 10.1186/2193-1801-3-58. eCollection 2014.

DOI:10.1186/2193-1801-3-58
PMID:24516786
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3916584/
Abstract

Extraction methods that simulate those used in the clinic are recommended for obtaining extraction solutions. For polyvinyl chloride (PVC) medical devices that have contact with human blood, an alternative medium (ethanol/water mixture) is suggested as an extraction screening vehicle to evaluate the di(2-ethylhexyl)phthalate (DEHP) released. A test comparing the extraction ability between the alternative medium and whole blood from three healthy volunteers has been conducted. An experimental method is provided outlining the chemical analysis of the DEHP released from medical devices made with polyvinyl chloride (PVC). Gas chromatography-mass spectrometry (GC-MS) in the selective ion monitoring (SIM) mode was used to analyze and quantify the extracted DEHP. The linear range of the SIM method was 0.1-200 μg/mL, and the recoveries were 89.6-101.5% and 91.0-98.9% when using the ethanol/water mixture and whole blood as the extraction media, respectively. The validated method demonstrates that it is suitable for the determination of the DEHP released from PVC medical devices that have contact with blood. The results from the determination of the DEHP released will be compared with the limits derived from toxicological data for the parenteral exposure route and certain population groups, and the results will be used in the risk assessment of medical devices.

摘要

建议采用模拟临床使用的提取方法来获取提取液。对于与人体血液接触的聚氯乙烯（PVC）医疗设备，建议使用替代介质（乙醇/水混合物）作为提取筛选载体，以评估释放的邻苯二甲酸二（2-乙基己基）酯（DEHP）。已进行了一项比较替代介质与三名健康志愿者全血提取能力的测试。提供了一种实验方法，概述了对由聚氯乙烯（PVC）制成的医疗设备释放的DEHP的化学分析。采用选择性离子监测（SIM）模式的气相色谱-质谱联用（GC-MS）对提取的DEHP进行分析和定量。SIM方法的线性范围为0.1-200μg/mL，当分别使用乙醇/水混合物和全血作为提取介质时，回收率分别为89.6-101.5%和91.0-98.9%。经过验证的方法表明，它适用于测定与血液接触的PVC医疗设备释放的DEHP。所测定的DEHP释放结果将与从肠胃外暴露途径和特定人群组的毒理学数据得出的限值进行比较，结果将用于医疗设备的风险评估。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1112/3916584/819a107338ea/40064_2013_799_Fig7_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1112/3916584/f3a9f79b04d0/40064_2013_799_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1112/3916584/2585a7ee39a6/40064_2013_799_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1112/3916584/7c945ab3b29b/40064_2013_799_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1112/3916584/5ea7e5d17bd0/40064_2013_799_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1112/3916584/c4a4824458b0/40064_2013_799_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1112/3916584/f3d313d165a2/40064_2013_799_Fig6_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1112/3916584/819a107338ea/40064_2013_799_Fig7_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1112/3916584/f3a9f79b04d0/40064_2013_799_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1112/3916584/2585a7ee39a6/40064_2013_799_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1112/3916584/7c945ab3b29b/40064_2013_799_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1112/3916584/5ea7e5d17bd0/40064_2013_799_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1112/3916584/c4a4824458b0/40064_2013_799_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1112/3916584/f3d313d165a2/40064_2013_799_Fig6_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1112/3916584/819a107338ea/40064_2013_799_Fig7_HTML.jpg

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