Skvaril F, Gardi A
Institute for Clinical and Experimental Cancer Research, University of Berne, Switzerland.
Pediatr Infect Dis J. 1988 May;7(5 Suppl):S43-8.
Today almost all IgG preparations for intravenous use (IVIG) fulfill the basic requirements for a preparation given intravenously (sterility, pyrogenicity, antibody content but also anticomplementary activity, etc.). However, there are still marked differences among such preparations caused by the method of preparation: (1) Enzymatically treated IVIGs (by pepsin and plasmin) have a shorter biologic half-time and a disturbed IgG subclass composition; (2) in chemically treated IVIGs (beta-propiolactone, reduced or sulfonated IgGs) the IgG3 subclass is lacking and some of the Fc-related functions are altered; and (3) the IVIGs purified by anion exchangers are poor in the IgG4 subclass. The three main preparations sold in the United States (Gamimune N, Gammagard and Sandoglobulin) belong to the nonmodified preparations and, with the exception of the IgG subclass representation, show similar Fab- and Fc-related properties (antibody content, interaction with Fc receptors on monocytes, phagocytosis-promoting activity, etc.) In none of these preparations, an elevated level of undesired contaminants (prekallikrein activator, irregular anti-erythrocyte antibodies) are found.
如今，几乎所有静脉注射用免疫球蛋白制剂（IVIG）都满足静脉给药制剂的基本要求（无菌性、无热原性、抗体含量以及抗补体活性等）。然而，由于制备方法的不同，这些制剂之间仍存在显著差异：（1）经酶处理的IVIG（用胃蛋白酶和纤溶酶）生物半衰期较短，IgG亚类组成紊乱；（2）经化学处理的IVIG（β-丙内酯、还原或磺化IgG）缺乏IgG3亚类，一些与Fc相关的功能发生改变；（3）通过阴离子交换剂纯化的IVIG中IgG4亚类含量较低。在美国销售的三种主要制剂（Gamimune N、Gammagard和Sandoglobulin）属于未修饰制剂，除了IgG亚类表现外，显示出相似的Fab和Fc相关特性（抗体含量、与单核细胞上Fc受体的相互作用、促进吞噬活性等）。在这些制剂中均未发现不期望的污染物（前激肽释放酶激活剂、不规则抗红细胞抗体）水平升高。
