快立洁手消毒凝胶的微生物限度检查方法学验证

Validation of method for microbial limit test of fast vertical liquid hand disinfectant gel

目的建立快立洁手消毒凝胶的微生物限度检查方法。方法采用薄膜过滤法,按照《中国药典》2010年版二部有关微生物限度检查法的相关要求进行快立洁手消毒凝胶的微生物限度检查方法验证。方法学验证试验以枯草芽孢杆菌、金黄色葡萄球菌、大肠杆菌、白色念珠菌、黑曲霉为试验菌,铜绿假单胞菌和金黄色葡萄球菌为控制菌。验证试验进行3次独立的平行试验,并分别计算各试验菌每次试验的回收率。结果细菌、真菌和酵母菌计数方法验证试验中,试验菌的回收率、控制菌检查结果均符合要求。结论薄膜过滤法有效可行,可用于快立洁手消毒凝胶的微生物限度检查。

Objective To establish a method for microbial limit test of fast vertical liquid hand disinfectant gel.Methods The membrane filtration method,in accordance with the Chinese Pharmacopoeia 2010 Edition（ part two） relevant requirements of microbial limit test method for validation of microbial limit test for fast vertical liquid hand disinfectant gel. Bacillus subtilis,Staphylococcus aureus,Escherichia coli,Candida a lbicans,Aspergillus niger were taken as test bacteria,Pseudomonas aeruginosa and Staphylococcus aureus were taken as control bacteria. Verification test was carried out in parallel test for 3 independent,recoveries and every trail rate were calculated. Results In bacteria,molds and yeasts count method validation test,recovery test strain rate,the control bacteria test results met the requirements. Conclusion The membrane filtration method was feasible and effective,which could be used for microbial limit test of fast vertical liquid hand disinfectant gel.