Immunoglobulin preparations are one of the promising drugs for Alzheimer's disease (AD). Anti-β-amyloid (Aβ) oligomers antibodies in immunoglobulin preparations are considered to be critical for the therapeutic effect against Alzheimer's disease. However, the antibodies content in immunoglobulin preparations varies greatly. In order to determine which factor contributes to the difference of the antibodies content, the content of anti-Aβ oligomers antibodies in multiple batches of immunoglobulin preparations from two manufacturers were measured by enzyme-linked immunosorbent assay. The results showed that no significant difference was found in the antibodies content among different bathes of normal immunoglobulin preparations prepared by the same process from the same manufacturer, whereas significant difference was found in the antibodies content between normal immunoglobulin preparations prepared by ethanol fractionation and those by chromatography process from the same manufacturer. In addition, significant variation existed in the antibodies content between normal immunoglobulin preparations and specific immunoglobulin preparations that are produced by plasma pool of immunized donors. Based on analysis of these results, the preparation process and raw plasma could be the main contributing factors affecting the content of anti-Aβ oligomers antibodies in immunoglobulin preparations. This finding might help to develop AD-specific immunoglobulin preparation containing higher content of anti-Aβ oligomers antibodies.

免疫球蛋白制剂是治疗阿尔茨海默氏病（AD）的有前途的药物之一。免疫球蛋白制剂中的抗β-淀粉样蛋白（Aβ）寡聚体抗体被认为对抵抗阿尔茨海默氏病的治疗至关重要。但是，免疫球蛋白制剂中的抗体含量差异很大。为了确定哪个因素导致抗体含量的差异，通过酶联免疫吸附测定法测量了来自两个制造商的多批免疫球蛋白制剂中抗Aβ寡聚体抗体的含量。结果表明，在同一制造商以相同方法制备的正常免疫球蛋白制剂的不同浴液中，抗体含量没有明显差异，而通过乙醇分级分离制备的正常免疫球蛋白制剂与同一制造商的色谱方法制备的抗体之间的抗体含量存在显着差异。另外，在正常免疫球蛋白制剂和由免疫供体血浆池产生的特异性免疫球蛋白制剂之间，抗体含量存在显着差异。基于对这些结果的分析，制备过程和原始血浆可能是影响免疫球蛋白制剂中抗Aβ寡聚体抗体含量的主要因素。该发现可能有助于开发包含更高含量的抗Aβ低聚物抗体的AD特异性免疫球蛋白制剂。