Tanaka K, Sawatani E, Shigueoka E M, Campos T C, Nakao H C, Dias G A, Fujita R K, Arashiro F
Divisão de Produção e Desenvolvimento Industrial, Fundação Pró-Sangue Hemocentro de São Paulo, SP, Brasil.
Braz J Med Biol Res. 1998 Nov;31(11):1375-81. doi: 10.1590/s0100-879x1998001100002.
Immunoglobulin G (IgG) of excellent quality for intravenous use was obtained from the cryosupernatant of human plasma by a chromatographic method based on a mixture of ion-exchange, DEAE-Sepharose FF and arginine Sepharose 4B affinity chromatography and a final purification step by Sephacryl S-300 HR gel filtration. The yield of 10 experimental batches produced was 3.5 g IgG per liter of plasma. A solvent/detergent combination of 1% Tri (n-butyl) phosphate and 1% Triton X-100 was used to inactivate lipid-coated viruses. Analysis of the final product (5% liquid IgG) based on the mean for 10 batches showed 94% monomers, 5.5% dimers and 0.5% polymers and aggregates. Anticomplementary activity was 0.3 CH50/mg IgG and prekallikrein activator levels were less than 5 IU/ml. Stability at 37 degrees C for 30 days in the liquid state was satisfactory. IgG was stored in flasks (2.5 g/flask) at 4 to 8 degrees C. All the characteristics of the product were consistent with the requirements of the 1997 Pharmacopée Européenne.
通过基于离子交换、DEAE-琼脂糖凝胶FF和精氨酸琼脂糖4B亲和色谱混合物的色谱方法，以及Sephacryl S-300 HR凝胶过滤的最终纯化步骤，从人血浆的冷冻上清液中获得了质量优异的静脉注射用免疫球蛋白G（IgG）。所生产的10个实验批次的产量为每升血浆3.5克IgG。使用1%磷酸三（正丁基）酯和1% Triton X-100的溶剂/洗涤剂组合来灭活脂质包膜病毒。基于10个批次的平均值对最终产品（5%液体IgG）的分析显示，94%为单体，5.5%为二聚体，0.5%为聚合物和聚集体。抗补体活性为0.3 CH50/mg IgG，前激肽释放酶激活剂水平低于5 IU/ml。在37℃下液态保存30天的稳定性良好。IgG以2.5克/瓶的规格储存在4至8℃的烧瓶中。该产品的所有特性均符合1997年《欧洲药典》的要求。
