3种局麻药无菌检查方法验证  

Studies on Test for Sterility of Three Kinds of Local Anesthetics

作　　者：刘全芳[1] 郑绍忠[2] 

机构地区：[1]福建省龙岩市第二医院药剂科,龙岩364000 [2]中国人民解放军第175医院(厦门大学附属东南医院)制剂科,漳州363000

出　　处：《海峡药学》2015年第11期36-39,共4页Strait Pharmaceutical Journal

摘　　要：目的建立盐酸利多卡因注射液、盐酸普鲁卡因注射液、盐酸丁卡因注射液的无菌检查方法。方法根据《中国药典》2010版收载的无菌检查方法进行验证试验,采用直接接种法、薄膜过滤法对3种局麻药进行无菌检查方法研究。结果盐酸利多卡因注射液、盐酸普鲁卡因注射液采用直接接种法时无抑菌作用,盐酸丁卡因注射液用直接接种法时对金黄色葡萄球菌、大肠埃希菌、枯草芽孢杆菌有明显的抑菌作用,而采用薄膜过滤法,每张滤膜用氯化钠注射液300m L分3次冲洗,可消除样品的抑菌活性。结论盐酸利多卡因注射液、盐酸普鲁卡因注射液可采用直接接种法进行无菌检查,盐酸丁卡因注射液可采用薄膜过滤法并用300m L氯化钠注射液作为冲洗液进行无菌检查,方法可行,结果可靠。OBJECTIVE To establish the sterility test of Lidocaine hydrochloride, Procaine hydrochloride and Tetracaine hydroehloride injection. METHODS According to ＂Chinese Pharmacopoeia＂ 2010 edition collection to verify the sterility test method to research the sterility test by direct inoculation method and membrane filtration sterility test. RESULTS Lidocaine hydrochloride and Procaine hydrochloride injection with direct inoculation method without bacteriostasis. Tetracaine hydrochloride injection has obvious bacteriostasis on staphylococcus aureus, esche- richia coli, bacillus subtilis with direct inoculation method, but antibacterial activity could be eliminated by membrane filtration method with Sterile sodium chloride injection 300mL washed three times. CONCLUSION Lidocaine hydrochloride and procaine hydrochloride injection can use direct inoculation method for sterility test, and Tetracaine hydrochloride injection can use membrane filtration method with 0.9% Sterile sodium chloride injection 300mL as blunt lotion for sterility test. Methods are feasible, and results are reliable.

关 键 词：盐酸利多卡因注射液 盐酸普鲁卡因注射液 盐酸丁卡因注射液 无菌检查 方法验证 

分 类 号：R969.4[医药卫生—药理学]