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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 a microbial limit test of sodium edetate sodium oral liquid. Methods: Different batches of products were verified by the way of adding bacteria. The control strains Staphylococcus aureus, Escherichia coli, Bacillus subtilis, Candida albicans, Aspergillus niger. Results: The recovery rates of Staphylococcus aureus, Escherichia coli, Bacillus subtilis and Candida albicans were less than 70% for the positive control bacteria and 80% for the membrane filtration method. Conclusion: The membrane filtration method can effectively remove the antibacterial activity of sodium edetate oral liquid. With the method of microbial limit test, feasibility, to achieve the test purpose.