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目的:用《ISO/CD 29941委员会草案》的标准方法对中国10种市售天然避孕套中致癌物亚硝胺的迁移量进行检测分析,为制定乳胶避孕套中亚硝胺迁移量的国家标准检测方法提供了可靠的依据。方法:从中国市场上随机购买了10种天然乳胶避孕套,用《ISO/CD 29941委员会草案》标准方法,将避孕套在水中浸提10 min后,用二氯甲烷萃取,再经干燥和浓缩后利用气相色谱法-热能分析仪检测从乳胶避孕套中迁移出的亚硝胺含量。结果:二甲基亚硝胺(NDMA)、二乙基亚硝胺(NDEA)和二丁基亚硝胺(NDBA)被检出。在10 min之内,从10种天然乳胶避孕套中NDMA的迁移量为0~18.74μg/kg,NDEA的迁移量为1.53~14.69μg/kg,NDBA的迁移量为0~39.54μg/kg,总亚硝胺迁移量为9.87~50.52μg/kg。仅有一种样品符合93/11/EEC的亚硝胺限量标准。结论:我国市售天然乳胶避孕套中亚硝胺迁移量较高,建议制定乳胶避孕套中亚硝胺迁移量检测的国家标准方法及迁移量的限量标准。
OBJECTIVE: To detect and analyze the migration of carcinogenic nitrosamines in 10 kinds of commercially available natural condoms in China according to the standard method of “ISO / CD 29941 Committee Draft”. In order to develop a national standard for the migration of nitrosamines in latex condoms Detection methods provide a reliable basis. Methods: Ten natural latex condoms were randomly purchased from the Chinese market. The condoms were leached in water for 10 min using the standard method of “ISO / CD 29941 Commission Draft”, extracted with dichloromethane, and then dried and concentrated After the use of gas chromatography - thermal analyzer to detect the migration from the latex condom nitrosamine content. Results: NDMA, NDEA and NDBA were detected. Within 10 min, the migration of NDMA from 10 kinds of natural latex condoms was 0 ~ 18.74μg / kg, the migration of NDEA was 1.53 ~ 14.69μg / kg, the migration of NDBA was 0 ~ 39.54μg / kg, Total nitrosamines migration of 9.87 ~ 50.52μg / kg. Only one sample meets the nitrosamine limit of 93/11 / EEC. CONCLUSION: The migration of nitrosamines in natural latex condoms marketed in our country is relatively high. It is suggested that a national standard method for detecting the migration of nitrosamines in latex condoms and a limited standard for migration should be formulated.