| 人凝血因子Ⅷ血液制品中的病毒灭活与验证 |
| 投稿时间：2013-03-05 修订日期：2013-06-19 点此下载全文 |
| 引用本文：闫晨,熊可强,王文姬,李玲.人凝血因子Ⅷ血液制品中的病毒灭活与验证[J].药学实践杂志,2014,32(3):199~202 |
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| 中文摘要:目的 研究人凝血因子Ⅷ制备过程中S/D病毒灭活法和80℃、72 h干热灭活法的病毒灭活工艺的灭活效果。方法 经过S/D法及80℃、72 h干热法双重处理灭活病毒,并通过加入指示病毒(PRV、Sindbis、HIV、EMCV、PPV)验证病毒灭活效果。结果 上述工艺可有效灭活脂包膜和非脂包膜病毒。最终制品中TNBP残余量小于1/10万(10 ppm)、吐温-80(Tween-80)残余量小于1/万(100 ppm),符合安全标准,人凝血因子Ⅷ的生物活性及其他各项指标未发现明显变化。结论 可以作为人凝血因子Ⅷ实验过程中的病毒灭活方法。 |
| 中文关键词:人凝血因子Ⅷ 病毒灭活 S/D处理 干热处理 |
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| Inactivation and validation of virus in blood products of human coagulation factor Ⅷ |
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| Abstract:Objective To study effect of virus inactivation/removal treated by solvent/detergent method and dry heating at 80℃, 72 h for inactivation in human coagulation factor Ⅷ.Methods Human coagulation factor Ⅷ extracted from healthy human plasma were treated by solvent/detergent method and dry heating at 80℃, 72 h for inactivation. The virus inactivation effect was validated by adding the indicator virus ( PRV, Sindbis, HIV, EMCV, PPV).Results The methods could effectively inactivate lipid-enveloped and non lipid-enveloped viruses which could be used for virus inactivation/removal during human coagulation factor Ⅷ experiments, the residual amount of TNBP in production was less than one percent ten thousand(10 ppm), the residual Tween-80 concentration was less than one percent hundred thousand(100 ppm),which all met the safety standards. Conclusion and no significant change was observed in the activation and other indicators of human coagulation factor Ⅷ. |
| keywords:human coagulation factor Ⅷ virus inactivation solvent/detergent treatment dry heating |
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