Ye Shengliang, Zeng Renyong, Jiang Peng, Hou Mingxia, Liu Fengjuan, Wang Zongkui, Du Xi, Yuan Jing, Chen Yunhua, Cao Haijun, Ma Li, Li Changqing
Institute of Blood Transfusion, Chinese Academy of Medical Sciences, 26 Huacai Road, Longtan Industry Park, Chenghua District, Chengdu, 610052, China.
Guizhou Taibang Biological Products Co. Ltd., 156 Daqian Road, Huaxi District, Guiyang, 550025, China.
J Pharm Biomed Anal. 2017 May 10;138:277-282. doi: 10.1016/j.jpba.2017.02.024. Epub 2017 Feb 17.
Intravenous immunoglobulin (IVIg) preparations are being investigated as a potential agent for treatment or prevention of Alzheimer's disease (AD). Antibodies towards soluble β-amyloid (Aβ) contained in IVIg were considered to be the major component contributing to the beneficial effect of the preparations in pilot studies. This study compared the antibody concentrations against Aβ in Octagam IVIg (Octapharma) and 9 IVIg preparations from different Chinese manufacturers by ELISA, using Aβ40 monomer, Aβ40 soluble oligomers, Aβ42 monomer and Aβ42 soluble oligomers as the antigens. The results showed that each preparation contained different antibody levels against the four Aβ forms. The median values of the four antibody concentrations in Chinese IVIg preparations were 16.53, 8.47, 24.36 and 33.25μg/mL, which were remarkably higher than that in Octagam IVIg (1.66, 2.07, 4.61 and 4.64μg/mL). Moreover, the anti-Aβ42 oligomer antibody levels in almost all IVIg preparations were higher than the anti-Aβ42 monomer antibody, and the concentrations of anti-Aβ42 antibodies in most of the IVIg preparations were significantly higher than that of anti-Aβ40 antibodies. These findings will contribute to an increased understanding of the uniqueness of Chinese IVIg preparations, and could provide support for a trial of a Chinese IVIg product in AD patients.
静脉注射免疫球蛋白(IVIg)制剂正在作为治疗或预防阿尔茨海默病(AD)的潜在药物进行研究。在前期研究中,IVIg中针对可溶性β淀粉样蛋白(Aβ)的抗体被认为是该制剂产生有益作用的主要成分。本研究采用酶联免疫吸附测定法(ELISA),以Aβ40单体、Aβ40可溶性寡聚体、Aβ42单体和Aβ42可溶性寡聚体作为抗原,比较了Octagam IVIg(奥克太珐玛公司)和9种不同中国制造商生产的IVIg制剂中抗Aβ抗体的浓度。结果显示,每种制剂针对四种Aβ形式的抗体水平各不相同。中国IVIg制剂中四种抗体浓度的中位数分别为16.53、8.47、24.36和33.25μg/mL,显著高于Octagam IVIg中的浓度(分别为1.66、2.07、4.61和4.64μg/mL)。此外,几乎所有IVIg制剂中抗Aβ42寡聚体的抗体水平均高于抗Aβ42单体抗体,且大多数IVIg制剂中抗Aβ42抗体的浓度显著高于抗Aβ40抗体。这些发现将有助于加深对中国IVIg制剂独特性的理解,并可为在中国AD患者中试用国产IVIg产品提供支持。