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人凝血因子Ⅷ血液制品中的病毒灭活与验证

闫晨,  熊可强,  王文姬,  李玲

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文章导航 > 药学实践与服务  > 2014 >  32(3): 199-202
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]. 药学实践与服务, 2014, 32(3): 199-202. doi: 10.3969/j.issn.1006-0111.2014.03.009
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]. 药学实践与服务, 2014, 32(3): 199-202. doi: 10.3969/j.issn.1006-0111.2014.03.009
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YAN Chen, XIONG Keqiang, WANG Wenji, LI Ling. Inactivation and validation of virus in blood products of human coagulation factor Ⅷ[J]. Journal of Pharmaceutical Practice and Service, 2014, 32(3): 199-202. doi: 10.3969/j.issn.1006-0111.2014.03.009
Citation: YAN Chen, XIONG Keqiang, WANG Wenji, LI Ling. Inactivation and validation of virus in blood products of human coagulation factor Ⅷ[J]. Journal of Pharmaceutical Practice and Service, 2014, 32(3): 199-202. doi: 10.3969/j.issn.1006-0111.2014.03.009
shu

人凝血因子Ⅷ血液制品中的病毒灭活与验证

doi: 10.3969/j.issn.1006-0111.2014.03.009
  • 1.

    上海新兴医药股份有限公司, 上海 200135

  • 2.

    上海卡乐康包衣技术有限公司, 上海 201206

Inactivation and validation of virus in blood products of human coagulation factor Ⅷ

  • 1.

    Shanghai Xinxing Medical Company Limited, Shanghai 200135, China

  • 2.

    Shanghai Colorcon Coating Technology Limited, Shanghai 201206, China

  • 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。
    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.
  • [1] 刘隽湘. 输血疗法与血液制剂[M].北京: 人民卫生出版社, 1996: 214-215.
    [2] Brackmann HH, Oldenburg J, Eis-Hubinger AM, et al. Hepatitis A virus infection among the hemophiliapopulation at the Bonn Hemophilia Center[J]. Vox Sang,1994, 67(S1): 3-8.
    [3] Mannucci PM, Gdovin S, Gringeri A, et al. Transmission of hepatitis A to patients with hemophilia by factor Ⅷ concentrates treated with organic solvent and detergent to inactivate viruses. The Italian Collaborative Group[J].Ann Intern Med,1994, 120(1): 1-7.
    [4] Lawlor E, Johnson Z, Thornton L, et al. Investigation of an outbreak of hepatitis A in Irish haemophilia A patients[J].Vox Sang 1994,67(S1): 18-20.
    [5] Soucie JM, Robertson BH, Bell BP, et al. Hepatitis A virus infections associated with clotting factor concentrate in the United States[J].Transfusion,1998, 38(6): 573-579.
    [6] Aguilar FC, Lucia CJF, Ferrer TJ, et al. Parvovirus B19 infection in patients with congenital blood coagulation disorders[J].Med Clin,1997, 108(17): 641-646.
    [7] Santagostino E, Mannucci PM, Gringeri A, et al. Transmission of parvovirus B19 by coagulation factor concentrates exposed to 100 degrees C heat after lyophilization[J].Transfusion,1997, 37(5): 517-522.
    [8] Lefrere JJ, Mariotti M, Thauvin M. B19 parvovirus DNA in solvent/detergent-treated anti-haemophilia concentrates[J].Lancet,1994, 343(8891): 211-212.
    [9] Azzi A, Ciappi S, Zakvrzewska K, et al. Human parvovirus B19 infection in hemophiliacs first infused with two high-purity, virally attenuated factor Ⅷ concentrates[J]. Am J Hematol,1992, 39: 228-230.
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  • 收稿日期:  2013-03-05
  • 修回日期:  2013-06-19

人凝血因子Ⅷ血液制品中的病毒灭活与验证

doi: 10.3969/j.issn.1006-0111.2014.03.009
  • 1. 上海新兴医药股份有限公司, 上海 200135
  • 2. 上海卡乐康包衣技术有限公司, 上海 201206
  • 收稿日期: 2013-03-05
  • 修回日期: 2013-06-19

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。

English Abstract

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]. 药学实践与服务, 2014, 32(3): 199-202. doi: 10.3969/j.issn.1006-0111.2014.03.009
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]. 药学实践与服务, 2014, 32(3): 199-202. doi: 10.3969/j.issn.1006-0111.2014.03.009
shu
YAN Chen, XIONG Keqiang, WANG Wenji, LI Ling. Inactivation and validation of virus in blood products of human coagulation factor Ⅷ[J]. Journal of Pharmaceutical Practice and Service, 2014, 32(3): 199-202. doi: 10.3969/j.issn.1006-0111.2014.03.009
Citation: YAN Chen, XIONG Keqiang, WANG Wenji, LI Ling. Inactivation and validation of virus in blood products of human coagulation factor Ⅷ[J]. Journal of Pharmaceutical Practice and Service, 2014, 32(3): 199-202. doi: 10.3969/j.issn.1006-0111.2014.03.009
shu

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