聚乙烯输卵管节育栓的生物学实验研究  

Biological Study of Polyethylene Oviduct Contraceptive Plug

作　　者：李素春[1] 冯苗[1] 唐运革[1] 俞顺明[2] 程少霞[1] 许伟琴[3] 

机构地区：[1]广东省计划生育科学技术研究所,广州510600 [2]上海市计划生育科学研究所,上海200032 [3]国家食品药品监督管理局上海市医疗器械质量监督检验中心,上海200070

出　　处：《生殖与避孕》2013年第9期643-646,共4页Reproduction and Contraception

基　　金：广东省科技厅科技计划项目(2009B030803044);广东省人口和计划生育委员会科研项目重大项目(2009103)

摘　　要：目的:检测聚乙烯输卵管节育栓的生物学性能。方法:对聚乙烯输卵管节育栓进行细胞毒性实验、阴道刺激实验、迟发型超敏实验、植入实验及遗传毒性试验(Ames试验)。结果:聚乙烯输卵管节育栓的细胞毒性试验显示细胞相对增殖度为1级;阴道刺激指数为0;迟发型超敏反应等级为0级;输卵管栓植入3个月后,植入的局部反应无明显异常;输卵管栓遗传毒性Ames试验检测结果为阴性。结论:聚乙烯输卵管节育栓各项生物学性能指标符合节育栓注册标准,具有可靠的生物安全性。Objective： To test the biological properties of polyethylene oviduct contraceptive plug. Methods： Cytotoxicity test, vaginal irritation test, delayed-type hypersensitivity test, implantation test and genotoxicity Ames test were performed for polyethylene oviduct contraceptive plug. Results： Biological tests of polyethylene oviduct contraceptive plug showed that cell relative growth rate in cytotoxicity test was grade l, and vaginal irritation index was 0, and delayed-type hypersensitivity test was grade 0. There was no abnormal reaction in the implanted location at 3 months after the implantation. Ames test was negative. Conclusion： Biological properties of polyethylene oviduct contraceptive plug meet the registered criteria, and polyethylene oviduct contraceptive plug shows reliable biosecurity.

关 键 词：聚乙烯 输卵管 节育栓 生物性能 

分 类 号：R169.41[医药卫生—公共卫生与预防医学]