气相色谱/热能分析仪法测定橡胶避孕套中可迁移亚硝胺的方法验证  

Method validation on detection of migrating nitrosamines from natural rubber latex condoms

作　　者：周越[1] 果吉尔锑[1] 郭颖志[1] 郑玉梅[1] 宁丽峰[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

出　　处：《中国卫生检验杂志》2014年第6期791-793,799,共4页Chinese Journal of Health Laboratory Technology

摘　　要：目的验证国际标准ISO 29941《天然胶乳橡胶避孕套中可迁移亚硝胺的测定》中的步骤A方法,利用气相色谱/热能分析仪测定天然胶乳橡胶避孕套中可迁移亚硝胺含量。方法抽样选取中国市场上销售的8个厂家17个批次的橡胶避孕套,根据国际标准ISO 29941方法中的步骤A,将避孕套在水中浸提10 min后,经硅藻土分离,二氯甲烷萃取,再经干燥和浓缩后利用气相色谱/热能分析仪检测从避孕套中迁移出的亚硝胺含量。结果在检测的17批避孕套中,共7种亚硝胺被检出,迁移量分别为:NDMA,0.9 ng/g^4.7 ng/g,检出率41.2%;NDEA,2.4 ng/g^37.2 ng/g,检出率88.2%;NDBA,5.1 ng/g^8.2 ng/g,检出率17.6%;NPIP,1.3 ng/g^4.6 ng/g,检出率11.8%;NPYR,0.8 ng/g^2.8 ng/g,检出率11.8%;NMOR,1.6 ng/g,检出率5.9%;NMEA,3.3 ng/g^21.4 ng/g,检出率88.2%。总亚硝胺迁移量为7.0 ng/g^52.3 ng/g。结论本方法简便、快速、准确,可以满足橡胶避孕套中可迁移亚硝胺的测定要求。Objective To validate the procedure A of ISO 29941 ＂Determination of migrating nitrosamines from natural rubber latex condoms＂ using GC/TEA. Methods Seventeen batches of natural rubber latex condoms from 8 different manufacturers were sampled to detect the migrating nitrosamines content according to the procedure A of ISO 29941. The samples were diges- ted in water for 10 rain, then separated by diatomaceous earth, extracted by dichlormethane, dried and concentrated for detec- tion of nitrosamines migration using GC/TEA. Results Seven kinds of nitrosamincs were found from the 17 batches of natural rubber latex condoms, including N - nitrosodimethylamine （ NDMA）, N - nitrosodiethylamine （ NDEA）, N - nitrosodibutyl- amine （NDBA） , N - nitrosopiperidine （ NPIP）, N - nitrosopyrrolidine （ NPYR）, N - nitorosmorpholine （ NMOR）, N - nitroso - methyl - ethylamine （NMEA）. The migration level of NDMA was 0.9 ng/g -4.7 ng/g, and the detection rate was 41.2% ; That of NDEA was 2.4 ng/g - 37.2 ng/g, with detection rate of 88.2% ; That of NDBA was 5.1 ng/g - 8.2 ng/g, with detec- tion rate of 17.6% ; That of NPIP was 1.3 ng/g -4.6 ng/g, with detection rate of 11.8% ; That of NPYR was 0.8 ng/g - 2.8 ng/g, with detection rate of 11.8% ; That of NMOR was 1.6 ng/g, with detection rate of 5.9% ; That of NMEA was 3.3 ng/g - 21.4 ng/g, with detection rate of 88.2%. Total migration quantity of nitrosamines varied from 7.0 ng/g to 52.3 ng/g. Conclusion This method is simple, fast, accurate, and it can be used for 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：O657.71[理学—分析化学]