摘要
目的针对不同剂型细胞因子类制品建立适宜的无菌检查方法。方法依据《中国药典》2005年版三部要求,将细胞因子类制品按照不同的品种和剂型,分别采取直接接种法和薄膜过滤法进行无菌检查。结果与结论细胞因子类制品不同的品种和剂型可以采用不同的无菌检查法,并对新建立的无菌检查法进行方法学验证。
Objective To establish appropriate methods of sterile test for different varieties and formulations of cytokines.Methods Direct inoculation method and membrane filtration method were used in according to varieties and formulations of cytokines by requests of ChP 2005,volume Ⅲ,respectively.Results and Conclusion Different varieties and formulations of cytokines could apply dissimilar methods in sterile test.Methodology validations were performed for these new established tests.
出处
《中国药事》
CAS
2010年第6期600-601,607,共3页
Chinese Pharmaceutical Affairs
关键词
细胞因子
无菌检查
薄膜过滤
cytokines
sterile test
membrane filtration
