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.
出处
《中国药师》
CAS
2014年第10期1776-1777,共2页
China Pharmacist