摘要
按照《中国药典》2015版四部有关微生物限度检查法的规定,对天然胶乳橡胶避孕套进行微生物限度方法适用性检查,发现不同厂家的避孕套对需氧菌有不同的抑菌作用,需氧菌总数采用1:20(含2%聚山梨酯-80)供试液平皿法检验,大肠菌群、铜绿假单胞菌、金黄色葡萄球菌、溶血性链球菌控制菌检查采用常规方法检验。
In accordance with the 2015 edition Chinese Pharmacopoeia four on the microbial limit test of the law, of microbial limit test method is suitable for the natural latex rubber condoms, condoms have found different manufacturers of different bacteriostasis effect on aerobic bacteria, aerobic bacteria by 1:20(polysorbate-80 containing 2%) test solution method of Petri dish test. Coliform bacteria, Pseudomonas aeruginosa, Staphylococcus aureus, Streptococcus control bacteria examination by routine method test.
作者
张明君
朱毅忠
任艳艳
ZHANG Ming-jun;ZHU Yi-zhong;REN Yan-yan(Laboratory of Pharmacology and Microbiology, Xinjiang Uygur Autonomous Region for Food and Drug Inspection Institute (Xinjiang Urumqi 830004)
出处
《中国医疗器械信息》
2018年第9期14-15,46,共3页
China Medical Device Information
关键词
避孕套
微生物限度
方法适用性检查
condoms
microbial limit
method applicability examination