| 动物源性生物制品病毒灭活/去除工艺的验证 |
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| 引用本文： | 巩薇,付瑞,王吉,卫礼,肖镜,贺争鸣. 动物源性生物制品病毒灭活/去除工艺的验证[J]. 中国生物制品学杂志, 2007, 20(12): 920-923 |
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| 作者姓名： | 巩薇 付瑞 王吉 卫礼 肖镜 贺争鸣 |
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| 作者单位： | 中国药品生物制品检定所动标室,北京100050 |
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| 摘 要： | 目的对动物源性生物制品病毒灭活/去除工艺进行验证。方法针对不同动物源性制品,选择相关的指示病毒,对4个厂家不同的病毒灭活/去除工艺进行效果验证。结果各工艺均可灭活/去除指示病毒4Logs以上,均为有效的灭活/去除病毒工艺。结论4个厂家的灭活/去除病毒工艺均可保证制品的安全性。
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| 关 键 词： | 动物源性 生物制品 病毒灭活/去除 验证 |
| 文章编号： | 1004-5503（2007）12-920-04 |
| 收稿时间： | 2007-05-24 |
| 修稿时间： | 2007-03-27 |
Verification of Inactivation/Removal Procedure of Viruses in Biologics of Animal Origins |
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| GONG Wei, FU Rui, WANG Ji, et al. Verification of Inactivation/Removal Procedure of Viruses in Biologics of Animal Origins[J]. Chinese Journal of Bilogicals, 2007, 20(12): 920-923 |
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| Authors: | GONG Wei FU Rui WANG Ji et al |
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| Abstract: | Objective To verify the inactivation/removal procedure of viruses in biologics of animal origin.Methods Verify the efficiencies of low pH incubation,S/D method,nano-membrane filtration and resin column adsorption in inactivation/removal of viruses in biologics of animal origins,using murine hepatitis virus(MHV),infectious ectromelia virus(Ect),vesicular stomatitis virus(VSV)and Theller murine encephalomyelitis virus(TMEV)as indicators.Results By using the four inactivation/removal procedures,the titers of all indicator viruses decreased by more than 4 log CCID50/0.1 ml.Conclusion All the above-mentioned four inactivation/removal procedures ensured the safety of biologics of animal origins. |
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| Keywords: | Animal origin Biologics Virus inactivation/removal Verification |
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