中国药典2015版无菌检查法与美、欧、日药典的差异分析与讨论_潘友文.pdfVIP

中国药典2015 版无菌检查法与美、欧、日药典的差异分析与讨论 潘友文 （罗氏/基因泰克，美国南旧金山，94080） 2016 年07 月29 日 摘要目的： 分析中国药典2015 版无菌检查法与美、欧、日药典无菌检查法的之间的差异性，为评 价不同药典中无菌检查法的等效性提供参考。方法： 对无菌检查法的主要实验步骤和参数进行一对 一比较，对有差异的步骤和参数进行科学论证和评价。结果：中国药典 2015 版无菌检查法与美、欧、 日药典无菌检查法的主要参数和步骤是一致的，但中国药典无菌检查法还需要做阳性对照和厌氧需 氧菌的额外培养。并且，中国药典用大肠埃希菌代替美、欧、日药典中的铜绿假单胞菌参与无菌检 查法的适用性试验。结论：各药典的无菌检查法是等效的。在不影响方法等效性的前提下，中国药 典2015 版无菌检查法在阳性对照和培养方法上还可以进一步简化。 关键词:无菌检查法；中国药典；美国药典；欧洲药典；日本药典 Gap Assessment and Discussion on Sterility Tests in Chinese Pharmacopoeia 2015, United States Pharmacopoeia, European Pharmacopoeia, and Japanese Pharmacopoeia Youwen Pan (Genentech, a Member of Roche, South San Francisco, USA 94080) Abstract Objective：Gap assessment and discussion on the sterility test methods in Chinese Pharmacopoeia 2015 edition (CP2015), United States Pharmacopoeia (USP), European Pharmacopoeia (EP), and Japanese Pharmacopoeia (JP). Method ：The test procedures and key parameters in the sterility test methods in different pharmacopoeia were compared step by step and the differences were identified. The identified differences are scientifically evaluated for their impact to the equivalence of the methods. Result ：The sterility test method in CP2015 is largely harmonized with that in USP, EP and JP except for a few differences. Positive control and extra incubation bacteria are required in CP2015 only, and Escherichia coli is used in method suitability test in CP2015 while Pseudomonas aeruginosa is used in USP/EP/JP. Conclusion：The Sterility Test Methods in CP2015, USP, EP, and JP are equivalent. The method in CP2015 could be simplified more without compromising the validity, accuracy and reliability of the method. Key words： sterility test；Chinese Pharmacopoeia 2015；United States Pharmacopoeia ；European Pharmacopoeia ；Japanese Pharmacopoeia