关于不同中和剂对天然橡胶胶乳避孕套微生物限度检查影响的研究与分析  

About the Effect of Different Neutralizers on Natural Rubber Latex Condoms Research and Analysis on the Influence of Microbial Limit Test

作　　者：朱彩霞 梁霞霞 周飞 牟玥 胡亚平 陈丽华 张泉州 ZHU Cai-xia;LINAG Xia-xia;ZHOU Fei;MU Yue;HU Ya-ping;CHEN Li-hua;ZHANG Quan-zhou(Gansu Medical Device Inspection and Testing Institute,Gansu Lanzhou 730300;Qingyang City Ecological Environment Protection Bureau,Gansu Qingyang 745000)

机构地区：[1]甘肃省医疗器械检验检测所,甘肃兰州730300 [2]庆阳市生态环境保护局,甘肃庆阳745000

出　　处：《中国医疗器械信息》2023年第9期13-15,37,共4页China Medical Device Information

基　　金：甘肃省药品科研项目(项目名称:避孕套微生物限度检查方法适用性的建立及应用,项目编号:2021GSMPA003)。

摘　　要：采用平皿计数法进行微生物回收试验,探究不同中和剂用量以及同一中和剂用量下不同添加剂对天然橡胶胶乳避孕套微生物限度检查实验结果的影响。结果显示,仅用含0.3%的卵磷脂或3%的聚山梨酯-80的供试液无法对5株验证菌完全中和,而含0.3%卵磷脂和3%聚山梨酯-80的供试液对5株验证菌中和效果显著,回收率在50%~200%;其次,研究发现,避孕套中的添加剂成分玻尿酸对铜绿假单胞菌和真菌的生长有干扰作用,原材料天然橡胶胶乳对白色念珠菌的生长有干扰,而二甲基硅油对5株验证菌的干扰较小。In this study,the plate counting method was used to carry out the microbial recovery test to explore the effect of different neutralizer dosage and different additives under the same neutralizer dosage on the microbial limit test results of natural rubber latex condoms.The results showed that only the test solution containing 0.3%lecithin or 3%polysorbate-80 could not completely neutralize the 5 validation bacteria,while the test solution containing 0.3%lecithin and 3%polysorbate-80 had a significant neutralization effect on the 5 validation bacteria,with a recovery rate between 50%and 200%;Secondly,the study found that hyaluronic acid,an additive component in condoms,interferes with the growth of Pseudomonas aeruginosa and fungi,while natural rubber latex,the raw material,interferes with the growth of Candida albicans,while dimethyl silicone oil has less interference with the 5 strains of validation bacteria.

关 键 词：天然橡胶胶乳避孕套 微生物限度检查 计数方法 中和剂 回收率 

分 类 号：R446.5[医药卫生—诊断学]