| 细胞因子类制品的无菌检查法 |
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| 引用本文： | 丁有学,毕华,刘兰. 细胞因子类制品的无菌检查法[J]. 中国药事, 2010, 24(6): 600-601,607 |
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| 作者姓名： | 丁有学 毕华 刘兰 |
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| 作者单位： | 中国药品生物制品检定所,北京,100050 |
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| 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。
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| 关 键 词： | 细胞因子 无菌检查 薄膜过滤 |
Sterile Tests for Cytokines Bioproducts |
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| Ding Youxue,Bi Hua,Liu Lan. Sterile Tests for Cytokines Bioproducts[J]. Chinese Pharmaceutical Affairs, 2010, 24(6): 600-601,607 |
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| Authors: | Ding Youxue Bi Hua Liu Lan |
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| Affiliation: | (National Institute for the control of Pharmaceutical and Biological Products,Beijing 100050) |
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| Abstract: | 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. |
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| Keywords: | cytokines sterile test membrane filtration |
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