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在人静脉注射免疫球蛋白制剂生产过程中通过液体加热使细小病毒B19失活。

Inactivation of parvovirus B19 by liquid heating incorporated in the manufacturing process of human intravenous immunoglobulin preparations.

作者信息

Yunoki Mikihiro, Urayama Takeru, Tsujikawa Muneo, Sasaki Yoshie, Abe Shunichi, Takechi Kazuo, Ikuta Kazuyoshi

机构信息

Hirakata Laboratory, Research and Development Division, Benesis Corporation, Osaka, Japan.

出版信息

Br J Haematol. 2005 Feb;128(3):401-4. doi: 10.1111/j.1365-2141.2004.05309.x.

Abstract

Several reports have suggested the possible transmission of human parvovirus B19 (B19) through the administration of plasma derivatives that had undergone virus inactivation by various types of heat treatment. However, none of the reports evaluated and discussed the inactivation of B19 by the heat treatment that is implemented in the individual manufacturing processes of such products. The present study evaluated the ability to inactivate B19 of liquid-heat treatment at 60 degrees C for 10 h that was incorporated in the manufacturing process of intravenous human immunoglobulin preparations. The results showed that B19 was rapidly inactivated under the conditions used for the liquid-heat treatment.

摘要

几份报告表明,人细小病毒B19(B19)可能通过使用经过各种热处理进行病毒灭活的血浆衍生物传播。然而,这些报告均未评估和讨论在此类产品的个体生产过程中实施的热处理对B19的灭活情况。本研究评估了静脉用人免疫球蛋白制剂生产过程中采用的60℃液体热处理10小时对B19的灭活能力。结果表明,在液体热处理所用条件下,B19迅速被灭活。

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