3种滴耳液微生物限度检查方法验证  

Validation of microbial limit test method of 3 kinds of ear drops

作　　者：傅昌芳[1] 唐丽琴[1] 

机构地区：[1]安徽省立医院药剂科,安徽合肥230001

出　　处：《安徽医药》2009年第5期569-570,共2页Anhui Medical and Pharmaceutical Journal

摘　　要：目的建立本院3种滴耳液(硼酸滴耳液,水杨酸滴耳液,碳酸氢钠滴耳液)微生物限度检查方法。方法按2005年版《中国药典》二部附录微生物限度检查法中细菌、霉菌及酵母菌计数方法和控制菌检查法进行验证。结果平皿法测定碳酸氢钠滴耳液5个试验菌的回收率均高于70%;平皿法测定硼酸滴耳液的枯草牙孢杆菌和水杨酸滴耳液的白色念珠菌的回收率均低于70%,采用培养基稀释法可消除其抑菌活性,其它4菌回收率均高于70%。结论碳酸氢钠滴耳液可采用平皿法进行微生物限度检查;硼酸滴耳液和水杨酸滴耳液可采用培养基稀释法进行微生物限度检查。Aim To establish a method for the microbial limit tests of three hospital preparations ： boric acid ear drops, salicylic acid ear drops and sodium bicarborate ear drops. Methods A validation on the microbial limit test method was conducted in accordance with the counting method of bacteria, mycetes and yeasts and the control bacteria test method stated in the Appendix of China Pharmacopoeia （2005 edition）. Results The recovery rates of five representative bacteria of sodium bicarborate ear drops determined by plate count method were more than 70%. That of bacillus subtilis of boric acid ear drops and that of candida albicans of salicylic acid ear drops determined by this method were less than 70%. Culture medium-diluting method can eliminate the antiblastic effects. The recovery rates in the rest were above 70%. Conclusion The microbial limit tests of boric acid ear drops can be determined by plate count method. That of salicylic acid ear drops and salicylic acid ear drops can be determined by culture medium diluting method.

关 键 词：微生物限度 硼酸滴耳液 水杨酸滴耳液 碳酸氢钠滴耳液 方法学验证 

分 类 号：R927[医药卫生—药学]