应用GC/TEA法测定天然胶乳橡胶避孕套中可迁移亚硝胺  

Application of GC/TEA in detection of nitrosamines migration from natural rubber latex condoms

作　　者：宁丽峰[1] 果吉尔锑[1] 原思渊 郭颖志[1] 周越[1] 

机构地区：[1]国家人口计生委科学技术研究所,国家人口计生委药具质量监测中心,北京100081 [2]国家人口计生委药具管理中心

出　　处：《中国计划生育学杂志》2014年第1期33-37,共5页Chinese Journal of Family Planning

摘　　要：目的：验证国际标准ISO29941（（天然胶乳橡胶避孕套中可迁移亚硝胺的测定》中步骤B的方法“利用气相色谱／热能分析仪（GC／TEA）测定天然胶乳橡胶避孕套中可迁移亚硝胺含量”在我国的适用度。方法：抽样选取我国市场上销售的10个厂家20个批次的天然胶乳橡胶避孕套，根据国际标准ISO29941方法中的步骤B，将避孕套在水中浸提10min后，用二氯甲烷萃取，再经干燥和浓缩后利用GC／TEA检测从避孕套中迁移出的亚硝胺含量，内标法定量。结果：在检测的20批避孕套中，共6种亚硝胺被检出，迁移量分别为：N-亚硝基二甲胺，1．4～10．2ng／g，检出率55％；N-亚硝基二乙胺，1．3～6．7ng／g，检出率80％；N-亚硝基二丁胺，O．8～6．9ng／g，检出率20％；N-亚硝基哌啶，5．7ng／g，检出率5％；N-亚硝基吡咯烷，2．3ng／g，检出率5％；N-亚硝胺甲乙胺，2．5～9．7ng／g，检出率65％。总亚硝胺迁移量为4．6～18．2ng／g。结论：本方法简便、快速、准确，可以满足天然胶乳橡胶避孕套中可迁移亚硝胺的测定要求。Objective： To detect nitrosamines migration from natural rubber latex condoms using GC/TEA, so as to validate procedure B of International Standard ISO 29941 ; Condoms -- Determination of nitrosamines migrating from natural rubber latex condoms. Methods.. Twenty batches of natural rubber latex condoms from 10 different manufacturers were sampled. According to the procedure B of ISO 29941, samples were treated with water for 10 mins, ex tracted by dichlormethane, and detected nitrosamines migration with GC/TEA. Results.. Six nitrosamines were found from 20 batches of natural rubber latex condoms, including N--nitrosodimethylamine （NDMA）, N--nitrosodiethylamine （NDEA）, N-- nitrosodibutylamine （NDBA）, N -- nitrosopiperidine （NPIP）, N-- nitrosopyrrotidine （ NPYR）, N--nitroso--methyl--ethylamine （NMEA）. The migration levels varied in 1.4--10.2 ng/g of NDMA with 55 % of the detection rate, 1.3--6.7 ng/g of NDEA with 80% of the detection rate, 0.8--6.9 ng/g of NDBA with 20% of the detection rate, 5.7 ng/g of NPIP with 50//00 of the detection rate, 2.3 ng/g of NPYR with 5% of the detection rate, and 2.5--9.7 ng/g of NMEA with 65 % of the detection rate. Total nitrosamines varied from 4.6 to 18.2 ng/g. Conclusion： This method is simple, fast, accurate, and can be used routinely for the determination of nitrosamines migration from natural rubber latex condoms.

关 键 词：避孕套 N-亚硝胺 气相色谱 热能分析仪 迁移量 

分 类 号：R169.41[医药卫生—公共卫生与预防医学]