两种方法验证隐形眼镜护理液的抑菌性能  

COMPARISON ON TWO WAYS TO VALIDATE ANTIMICROBIAL EFFICACY OF THE CONTACT LENS CARE SOLUTION

作　　者：方菁嶷[1] 徐琳[2] 邹婷[2] 李新寅[2] 

机构地区：[1]苏州大学医学部,江苏苏州215123 [2]苏州大学卫生与环境技术研究所

出　　处：《中国消毒学杂志》2014年第7期680-682,共3页Chinese Journal of Disinfection

摘　　要：目的观察一种隐形眼镜护理液抑菌性能及其使用持续时间。方法采用ISO 14730-2000和USP 35<51>规定的两种方法,对该隐形眼镜护理液的抑菌性能进行观察,比较ISO和USP两种方法试验结果的差异性。结果按照USP 35<51>方法,该隐形眼镜护理液在启用后第7、14和28 d,各试验菌减少量均符合要求。按照ISO14730:2000方法,该隐形眼镜护理液在启用后第14 d,各试验菌减少量均符合要求,第28 d各试验菌减少量均不符合ISO要求。结论应根据产品用途、有效期、预期的抑菌发生速度及维持时间建立合理的试验方案。Objective To observe the antimicrobial efficacy and its duration of one kind of contact lens care solution. Methods The methods of ISO 14730 - 2000 and USP 35 〈 51 〉 were used to validate the antimicrobial efficacy and compare the difference between the results of the solution. Result According to the method of USP 35 〈 51 〉 , the count at the 7^th day, 14^th day and 28^th day all met the criteria. According to the method of ISO 14730 -2000, the count at the 14^th day met the criteria and not of the 28^th day＇s count. Conclusion The usage, expireation date, and the expectant antimicrobial speed and the duration of the antimicrobial efficacy help to make a reasonable test protocol.

关 键 词：隐形眼镜 护理液 抑菌性能 验证方法 国际标准 

分 类 号：R187.3[医药卫生—流行病学]