3种滴耳液微生物限度检查法的验证  

Validation of microbial limit tests for 3 ear drops

作　　者：胡玥珊[1] 孙国祥[2] 

机构地区：[1]中国医科大学附属第一医院药学部,沈阳110001 [2]沈阳药科大学药学院,沈阳110016

出　　处：《中南药学》2013年第12期928-931,共4页Central South Pharmacy

摘　　要：目的建立3种滴耳液的微生物限度检查方法。方法按2010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。结果常规法测定碳酸氢钠滴耳液和硼酸滴耳液的回收率>70%;采用培养基稀释法可消除氯霉素氢化可的松滴耳液的抑菌活性,使其回收率符合要求。结论建立了3种滴耳液的微生物限度检查方法,可有效控制其质量。Objective To establish the microbial limit tests for 3 ear drops with antibacterial ingredients. Methods Common methods in Chinese Pharmacopoeia （edition 2010） were used to cultivate media dilution, with recovery rate of the bacteria in the comparison experiment. Results The recovery rates of 5 representative bacteria in the sodium bicarbonate ear drops and boric acid ear drops determined by plate count method were more than 70%. Culture medium-diluting methods eliminated the antiblastic effect of chloramphenicol and hydrocortisone ear drops. Conclusion The microbial limit tests for the quality control of 3 ear drops have been established.

关 键 词：微生物限度 方法验证 碳酸氢钠滴耳液 硼酸滴耳液 氯霉素氢化可的松滴耳液 

分 类 号：R927.11[医药卫生—药学]