法莫替丁氯化钠注射液的无菌检查方法验证试验  

Confirmatory Experiment of Sterility Test Method for Famotidine Sodium Chlorid e Injection

作　　者：王沁馨 

机构地区：[1]重庆市药品检验所,重庆401121

出　　处：《中国药业》2008年第18期35-36,共2页China Pharmaceuticals

摘　　要：目的建立法莫替丁氯化钠注射液的无菌检查方法。方法按2005年版《中国药典(二部)》附录无菌检查法项下薄膜过滤法进行检查。结果样品对生孢梭菌有一定抑菌作用。结论对样品进行无菌检查时,至少需用0.1%无菌蛋白胨水溶液300mL,方可消除其抑菌作用。Objective To establish a method of sterility test for famotidine sodium chloride injection. Methods The membrane filtration method of sterility test in the appendix of Chinese Pharmacopoeia（2005 edition） was used. Results Through the methodological verification, famotidine sodium chloride injection had certain bacteriostatic action to Clostridium sporogenes. Conclusion When performing sterile test for famotidine sodium chloride injection, eliminating its bacteriostatic effect needs at least 300 mL of 0. 1% sterile peptone solution.

关 键 词：法莫替丁氯化钠注射液 无菌检查 薄膜过滤法 方法验证 

分 类 号：R927.12[医药卫生—药学] R975.6