聚丙烯药用滴眼剂瓶无菌检查法的研究  

Study on sterility test method of polypropylene medicinal eye drops

作　　者：周燕丽[1] ZHOU Yan-li(First People's Hospital of Yuhang District,Hangzhou,Zhejiang 311100,China)

机构地区：[1]杭州市余杭区第一人民医院,浙江杭州311100

出　　处：《中国卫生检验杂志》2021年第14期1711-1714,共4页Chinese Journal of Health Laboratory Technology

摘　　要：目的建立聚丙烯药用滴眼剂瓶无菌检查方法。方法洗脱液为0.9%无菌氯化钠溶液,取样量参照《中国药典》四部通则<1101>医疗器械,瓶身中加入标示容量的0.9%无菌氯化钠溶液,旋紧外盖振摇30 s,合并提取液后采用薄膜过滤法检查;内盖采用直接接种法检查。结果无菌检查前处理研究中低浓度人工污染的枯草芽胞杆菌、大肠埃希菌、金黄色葡萄球菌、黑曲霉和白色念珠菌的回收率均符合《中国药典》要求;方法适用性实验中试验菌生长均良好。结论本法取样量和样品前处理方法科学有效,适用于聚丙烯药用滴眼剂瓶的无菌检查。Objective To establish a sterility test method for polypropylene medicinal eye drops.Methods The 0.9%sterile sodium chloride solution was used as eluent.According to the sampling amount of medical devices in the aseptic test method in the four general rules of Chinese Pharmacopoeia<1101>,0.9%sterile sodium chloride solution with marked capacity was added into the bottle body,the outer cover was pressed and shaking for 30 seconds,and the combined extract was examined by membrane filtration method.The inner cap was examined by direct inoculation.Results The eluting recovery rates of Bacillus subtilis,Escherichia coli,Staphylococcus aureus,Aspergillus Niger and Candida albicans in the study of pre-treatment for sterility test were in line with the requirements of Chinese Pharmacopoeia.The growth of the tested bacteria was good.Conclusion This method is scientific and effective in sample quantity and sample pretreatment.It is suitable for sterility test of polypropylene medicinal eye drops.

关 键 词：聚丙烯滴眼剂瓶 直接接种法 薄膜过滤法 无菌检查 

分 类 号：R446[医药卫生—诊断学]