奥美拉唑原料药微生物限度检查法的方法学验证  

Methodological validation of microbial limit test for omeprazole active pharmaceutical ingredient

作　　者：王琪 黄臻辉 WANG Qi;HUANG Zhenhui(the First Biochemical Pharmaceutical Co.,Ltd.,Shanghai Pharmaceutical Group,Shanghai 200240,China)

机构地区：[1]上海上药第一生化药业有限公司,上海200240

出　　处：《上海医药》2022年第19期74-78,共5页Shanghai Medical & Pharmaceutical Journal

摘　　要：目的:建立选取适宜的奥美拉唑稀释剂后进行微生物限度检查的方法。方法:先用平皿法确认奥美拉唑是否具有抑菌性,再根据平皿法结果建立薄膜法去除奥美拉唑抑菌性的可行性。结果:奥美拉唑对铜绿假单胞菌和白色假丝酵母有一定的抑菌性,0.1 mol/L的无菌NaOH溶液可作为其稀释剂,薄膜过滤可去除其抑菌性。结论:薄膜法适用于奥美拉唑原料药的微生物限度检查。Objective:To establish a method for microbial limit test after selecting suitable omeprazole diluent.Methods:Firstly,the bacteriostatic activity of omeprazole against Pseudomonas aeruginosa and Candida albicans was confirmed by plate method,and then the feasibility of removing bacteriostatic activity of omeprazole by film method was established based on the results of plate method.Results:Sterile NaOH solution(0.1 mol/L) could be used as its diluent and its bacteriostatic activity could be removed by film method.Conclusion:Film method is suitable for microbial limit test of omeprazole active pharmaceutical ingredient(API).

关 键 词：奥美拉唑 微生物限度 标准菌株 平皿法 薄膜法 

分 类 号：R975.2[医药卫生—药品] R927.11[医药卫生—药学]