聚维酮碘溶液微生物限度检查方法验证

Validation on Method of Microbial Limit Test of Povidone Iodine Solution

目的:建立聚维酮碘溶液微生物限度检查方法。方法:采用平皿法(Ⅰ)、培养基稀释法(Ⅱ)、薄膜过滤法(Ⅲ)以及硫代硫酸钠中和并薄膜过滤法(Ⅳ),对聚维酮碘溶液进行微生物限度检查方法学验证研究。结果:各试验菌回收率Ⅰ法和Ⅱ法几乎为0,Ⅲ法均低于70%,Ⅳ法均大于85%;Ⅱ法和Ⅲ法检测控制菌生长均不正常,Ⅳ法控制菌生长正常。结论:对聚维酮碘溶液进行微生物限度检查采用Ⅳ法较好。

OBJECTIVE： To establish a microbial limit test method for povidone iodine solution. METHODS： Validation on methodology of the microbial limit test of povidone iodine solution was performed using plating method （ Ⅰ ）, culture agent dilution method （ Ⅱ ）, membrane - filter procedure method （Ⅲ） and sodium thiosulfate neutralization in combination with membrane - filter procedure method （ Ⅳ）. RESULTS： The recovery rates of all of the test organisms in method Ⅰ and method Ⅱ approached zero, less than 70% in method Ⅲ but above 85% in method Ⅳ . The growth of the control bacteria was abnormal in method Ⅱ and method Ⅲ, but normal in method Ⅳ . CONCLUSION： It is advisable to adopt the method Ⅳ for microbial limit test of povidone iodine solution.