乙二胺四乙酸钠铁口服液微生物限度检查方法验证  

Validation of Microbial Limit Test for Ferric Sodium Edetate Oral Solution

作　　者：于桂兰[1] 杨建春[1] 阚淑月[1] 王春艳[1] 张琦[1] 

机构地区：[1]唐山市妇幼保健院,河北唐山063000

出　　处：《中国药师》2008年第6期633-635,共3页China Pharmacist

基　　金：2005年河北省科学技术研究与发展第一批指导计划立项课题(编号05276413)

摘　　要：目的:建立乙二胺四乙酸钠铁口服液的微生物限度检查法。方法:通过加菌回收的方法对不同批次产品进行验证。对照菌株为金黄色葡萄球菌,大肠埃希菌,枯草芽孢杆菌,白色念珠菌,黑曲霉。结果:常规法对照用阳性菌金黄色葡萄球菌、大肠埃希菌、枯草芽孢杆菌、白色念珠菌回收率<70%,薄膜过滤法回收率均>80%。结论:薄膜过滤法可有效去除乙二胺四乙酸钠铁口服液的抑菌活性。用该法进行微生物限度检查,可行性强,能达到检测目的。Objective： To establish the microbial limit test method for ferric sodium edetate oral solution. Method： The validation was tested by microbial recovery from different batches samples. The control microorganisms were added to samples including Staphylococcus aureus, Escherichia coli, Bacillus subtilis, Candida albicans, Aspergillus niger. Result： Two testing methods had different percentage recovery. By commonly method ,theratios of Staphylococcus aureus, Escherichia coli, Bacillus subtilis, Candida albicans and Aspergillus niger were 〈 70%. By filtration membrane, all the ratios were 〉 80%. Conclusion： The filtration membrane can effectively remove the bacteriostasis activeness of ferric sodium edetate oral solution, the method is simple, feasible and accurate.

关 键 词：乙二胺四乙酸钠铁口服液 微生物限度检查 验证 

分 类 号：R927.111[医药卫生—药学]