具药天然胶乳橡胶避孕套的细胞毒性试验  

Experiment on the Cytotoxicity of Medicated latex rubber condom

作　　者：王昕[1] 施燕平[1] 朱雪涛[1] 郝树彬[1] 

机构地区：[1]国家食品药品监督管理局济南医疗器械产品质量监督检验中心,济南250013

出　　处：《齐鲁药事》2005年第11期677-678,共2页qilu pharmaceutical affairs

摘　　要：目的研究具药天然胶乳橡胶避孕套的细胞毒性。方法遵照ISO10993医疗器械生物学评价国际标准的试验原则,采用国际标准的试验方法,在此基础上进一步定量化,更精确的反应了产品的细胞毒性。结果及结论具药天然胶乳橡胶避孕套在浸提液浓度大于1.5cm2.ml-1时具有重度细胞毒性。在浸提液浓度小于等于1cm2.ml-1时具有极轻的细胞毒性反应。Objective Study the cytotoxicity of medicated latex rubber condom. Methods According to the experimental principle of international biological appraising standard （ISO10993） on medical apparatus ,and adopting the experimental method on the study of medicated condom ,and its composite container in the US, the study is quantitative and can response cytotoxicity accurately. Results and conclusion When the extracted fluid concentration was greater than 1.5cm^2·ml^-1, the medicated condom had severe cytotoxicity. When the extracted fluid concentration was smaller than 1cm^2·ml^-1, the medicated condom had litte cytotoxicity.

关 键 词：具药天然胶乳橡胶避孕套 细胞毒性 浸提液 

分 类 号：R927.11[医药卫生—药学]