荧光素钠滴眼液微生物限度检查的验证  

Validation of microbial limit tests of sodium fluorescein ophthalmic solution

作　　者：张锦兴[1] 李运景[1] 李卓亚[1] 

机构地区：[1]中山市人民医院,528403

出　　处：《中国现代药物应用》2014年第2期7-8,共2页Chinese Journal of Modern Drug Application

摘　　要：目的建立荧光素钠滴眼液的微生物限度检查方法。方法测定荧光素钠滴眼液对大肠埃希菌等5种试验菌的回收率,通过观察回收率来确定适宜的检验方法,以及控制菌(大肠埃希菌)的检查方法进行验证。结果用常规法检查本品的细菌数霉菌数及酵母菌数,其试验菌回收率达到70%以上;用常规法检查本品的大肠埃希菌,其试验组呈阳性反应。结论荧光素钠滴眼液无明显抑菌作用,可直接取样用常规法进行细菌数霉菌及酵母菌和控制菌大肠埃希菌检查。Objective To establish a method of microbial limit test for sodium fluorescein ophthalmic solution. Methods According to the People＇ s Republic of China pharmacopoeia 2010 edition, the recovery rates of 5 tested strains treated by sodium fluorescein ophthalmic solution were determined by commonm ethod, and the test method of the control bacteria was verified. Results Sodium fluorescein ophthalmic solution has no obvious bacteriostasis. Conclusion The common method of the microbial limit tests can be used for sodium flu- orescein ophthalmic solution by direct sampling.

关 键 词：荧光素钠滴眼液 微生物限度检查 方法学验证 

分 类 号：R927[医药卫生—药学]