注射用头孢曲松钠无菌检查方法研究

摘要

Objective To establish a method of sterility test of ceftriaxone sodium for injection.Methods The method was based on the verification of sterility test of Chinese Pharmacopoeia (2010 edition) and the membrane-filter method was used.Ten samples were dissolved in 8 ml sodium chloride solution (0.9％) with each transferred thoroughly to 400 ml sodium chloride solution (0.9％),then filtered through three layer membranes.Each filter was washed with 400 ml 0.1％ peptone solution.The positive control bacteria was Escherichia coli.Results The result of verification test showed that the sample and negative control tubes had no growth of microorganism and the test and all of positive control tubes revealed growth of microorganism.It illustrated that the sample had no antimicrobial activity in this sample quantity and test condition.Conclusion The sterility test method is simple and feasible,which can be used in the sterility test of ceftriaxone sodium for injection.%目的 完善注射用头孢曲松钠无菌检查方法标准.方法 根据《中国药典》2010年版无菌检查法验证实验的要求,采用薄膜过滤法.将10支供试品,每瓶加8ml的0.9％无菌氯化钠溶液溶解,将其转移至约400 ml的0.9％无菌氯化钠溶液中混匀作为供试品液,供试品按薄膜过滤法,用3只滤筒过滤,400 ml/筒的0.1％蛋白胨水溶液冲洗,每筒加青霉素酶1 ml.阳性对照菌为大肠埃希菌.结果 供试品、空白对照(主要为冲洗液或者青霉素酶)均无菌生长,供试品阳性菌与阳性对照菌比较均生长良好.结论 该方法简单、可行,可作为注射用头孢曲松钠常规无菌检查方法.