公开(公告)号：US20150250879A1

公开(公告)日：2015-09-10

申请号：US14431498

申请日：2013-09-26

申请人： OCTAPHARMA AG

发明人： Andrea Heger ,  Tor-Einar Svae ,  Juergen Roemisch ,  Alfred Zoechling

IPC分类号： A61K47/18 ,  C07K16/18 ,  G01N33/49

CPC分类号： A61K47/183 ,  A61K39/39591 ,  C07K16/00 ,  C07K16/18 ,  G01N33/49 ,  G01N33/80

摘要： A non-hemolytic acidic composition comprising an immunoglobulin selected from immunoglobulin A, immunoglobulin G or immunoglobulin M at a pH value in the range of 4.65 to 5.7 comprising one or more excipients selected from amino acids, sugars and sugar alcohols in a concentration range of 100-350 mmol/l, in particular 200-350 mmol/l, characterized in that it displays an optical density (OD) in the range of 0.14 to −0.1 when the OD is determined in a spectrophotometer at 414 nm at a film thickness of 0.825 mm; and its use in an assay for determination of the hemolytic potential of intravenously applied pharmaceuticals and compositions and preparations displaying a reduced potential of hemolysis when being applied intravenously.

摘要翻译： 一种非溶血酸性组合物，其包含选自免疫球蛋白A，免疫球蛋白G或免疫球蛋白M的免疫球蛋白，其pH值在4.65至5.7范围内，包含一种或多种选自浓度范围为100的氨基酸，糖和糖醇的赋形剂 -350mmol / l，特别是200-350mmol / l，其特征在于当在分光光度计中在414nm处测定OD时，它的光密度（OD）在0.14至-0.1的范围内，膜厚度 0.825毫米; 并且其用于测定静脉内施用的药物和组合物和制剂的溶血潜力的测定法，其在静脉内施用时显示出降低的溶血潜力。