聚山梨酯80在微生物限度检查中的应用  

Application of Polysorbate 80 in Microbial Limit Test

作　　者：廖祥茹[1] 陈晨[1] 李旸[1] 陈鹰[1] 

机构地区：[1]广州军区武汉总医院药剂科,武汉430070

出　　处：《中国药师》2014年第10期1776-1777,共2页China Pharmacist

摘　　要：目的:对有抑菌性或非水溶性的药品提供适宜的供试液制备方法,建立方便有效的微生物限度检查方法。方法:应用聚山梨酯80的中和、乳化、增溶及保护微生物等作用,对本院配制的11种制剂进行供试液的制备及微生物限度检查验证。结果:加菌回收率及控制菌检查结果符合《中国药典》的要求。结论:聚山梨酯80可用于上述药品微生物限度检查时供试液的制备。Objective：To provide appropriate test liquid preparation methods for antibacterial or water-insoluble drugs, and estab-lish a convenient and effective method for microbial limit test. Methods：Using function of polysorbate 80 as neutralization, emulsifica-tion, solubilization and microbial protection, We carried out the liquid preparations were prepared and microbial limit test validation was carried out for 11 kinds of hospital drugs. Results：The bacteria recovery rate and the control bacteria test were in accordance with the requirement of pharmacopoeia. Conclusion：Polysorbate 80 can be used in the microbial limit test of the drugs.

关 键 词：聚山梨酯80 微生物限度检查法 供试液 

分 类 号：R927.11[医药卫生—药学]