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静脉注射用人免疫球蛋白中的中和病毒抗体

[Neutralizing virus antibodies in human immunoglobulins for intravenous use].

作者信息

Weeke-Lüttmann M, Schmidt I, Fenyves A, von Wangenheim G, Fischer L

出版信息

Immun Infekt. 1984 Aug;12(4):201-7.

PMID:6090309
Abstract

Neutralizing antibodies against measles, poliomyelitis, rubella, herpes simplex, influenza and vaccinia viruses were measured in batches of a representative selection of human immunoglobulins for intravenous use licensed in the Federal Republic of Germany. Rubella antibodies were also examined by haemagglutination-inhibition tests. Where available, reference preparations were used, and antibody levels expressed in I. U. All preparations contained significant amounts of the examined antibodies, with relatively low variation from one batch to the other. In most cases activity data specified by the manufacturers could be confirmed. However, differences between the various preparations were sometimes important, some of them relating mainly to individual antibodies, others more or less to the whole range. Some striking findings are emphasized with consideration of manufacturing and control problems.

摘要

对在德意志联邦共和国获得许可的一批有代表性的静脉用人免疫球蛋白制剂,检测了其针对麻疹、脊髓灰质炎、风疹、单纯疱疹、流感和牛痘病毒的中和抗体。风疹抗体也通过血凝抑制试验进行检测。如有可用的参考制剂,则使用参考制剂,并以国际单位(I.U.)表示抗体水平。所有制剂均含有大量检测抗体,批次间差异相对较小。在大多数情况下,制造商规定的活性数据能够得到证实。然而,不同制剂之间的差异有时很显著,其中一些主要与个别抗体有关,另一些或多或少与整个抗体范围有关。考虑到生产和控制问题,强调了一些显著的发现。

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