注射用亚胺培南西司他丁钠无菌检查法的优化及标准化

Optimization and standardization of the sterility test method of imipenem and cilastation sodium for injection

目的对注射用亚胺培南西司他丁钠的无菌检查方法进行优化及确认。方法依据《中国药典》2020版四部通则1101无菌检查法,对供试液、敏感菌、冲洗量和中和剂等可能的影响因素进行了探讨,并在供试液配制,滤膜,冲洗量及冲洗次数、中和剂及其使用量、阳性对照菌等方面对注射用亚胺培南西司他丁钠的无菌检查方法进行优化。结果选取4个厂家样品对注射用亚胺培南西司他丁钠的无菌检查方法进行确认,6株阳性试验菌在规定时间内都生长良好。结论该方法能有效去除注射用亚胺培南西司他丁钠的抑菌性,具有操作简便,高效可靠等优点,适用于注射用亚胺培南西司他丁钠上市抽验样品和批出厂产品的无菌检查。

Objective To improve and confirm the sterility test method of imipenem and cilastation sodium for injection.Methods According to the sterility test method in general rule 1101 of Chinese Pharmacopoeia(2020 Edition),The factors that might influence such as the test solution,sensitive bacteria,flushing amount and neutralizer,etc were explored,and the sterility test method of imipenem and cilastation sodium for injection was optimized in the aspects of test solution preparation,filter membrane,flushing amount and flushing times,neutralizer and its use amount,positive control bacteria,etc.Results The samples of four manufacturers were selected to confirm the sterility test method of imipenem and cilastation sodium for injection,Six positive test bacteria grew well within the specified time.Conclusion The optimized and standardized method can effectively eliminate bacteriostasis of mipenem and cilastation sodium for injection,and has the advantages of simple operation,high efficiency and reliability,it is suitable for the sterility test of imipenem and cilastation sodium for injection for market sampling and batch products.