硫酸新霉素凝胶微生物限度检查方法的适用性试验  

Operational test of methodology on the microbial limit test for neomycin sulphate gel

作　　者：唐菱[1] 侯晓军[1] 周剑 车坷科 支世君 

机构地区：[1]重庆市中医院药剂科,重庆400021 [2]重庆市食品药品检验检测研究院,重庆401121 [3]重庆市人民医院,重庆400014

出　　处：《中国抗生素杂志》2016年第9期680-683,共4页Chinese Journal of Antibiotics

基　　金：重庆市卫生计生委学科研项目(No.2015MSXM067)

摘　　要：目的建立硫酸新霉素凝胶的微生物限度检查法，并对检查方法进行验证。方法利用硫酸镁能与凝胶中的卡波姆结合形成镁盐沉淀达到絮凝的原理，用10％硫酸镁溶液10mL与硫酸新霉素凝胶10g混匀，加0．9％无菌氯化钠溶液80mL，静置，取上清液1mL，加0．9％无菌氯化钠溶液100mL稀释后过膜，用900mLpH7．0无菌氯化钠-蛋白胨缓冲液分9次冲洗滤膜，每次100mL。结果各试验菌的计数回收比值均在0．5～2．0，控制菌生长良好，符合《中国药典》2015年版规定。结论该方法有效可行，可用于硫酸新霉素凝胶的微生物限度检查。Objective To establish a microbial limit test method of neomycin sulfate gel, and carry out the verification of methodology. Methods Add MgSO4 into neomycin sulphate gel to produce the precipitate and destroy the gel. 10mL of 10% MgSO4 solution and 10g of neomycin sulphate gel were mixed together and then added 0.9% NaC1 solution to 100mL. 100mL of the solution （lmL upper solution diluted with sterile 0.9% NaC1 solution） can be filtered by membrane and then wash the filter membrane 9 times with 900mL pH7.0 NaCl-peptone buffer. Results Recoveries of trial bacteria were between 0.5 to 2.0, and controlled bacteria grew well. The method could pass the validation test of Chinese Pharmacopoeia 2015 version. Conclusion It was proved that the method was reliable, and it can be used in microbial limit test of neomycin sulphate gel.

关 键 词：硫酸新霉素凝胶 微生物限度 适用性试验 薄膜过滤 

分 类 号：R978.1[医药卫生—药品]