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性状供静脉注射用的人体免疫球蛋白(IGH)制品为未变性的IgG的无菌的冷冻干燥制品,其中含的人体白蛋白和果糖为稳定剂。IgG亚型的分布状态与存在于正常人体血浆中的IgG相类似。它含IgG_169%;IgG_223%;IgG_36%和IgG_42%;人体血浆中各亚型的参比值分别是:65%、23%、8%和4%。本品用冷乙醇沉集的血浆部份制得,且未因化学的或酶的影响而发生变性。本品为免疫球蛋白制品,系干燥块状物,
Characterization Human immunoglobulin (IGH) preparations for intravenous injection are sterile lyophilized preparations of undenatured IgG containing human albumin and fructose as stabilizers. The distribution of IgG subtypes is similar to that found in normal human plasma. It contains IgG_l69%; IgG_223%; IgG_36% and IgG_42%; the reference values for each subtype in human plasma are: 65%, 23%, 8% and 4%, respectively. This product is made of cold ethanol precipitation of the plasma part of the system, and not due to chemical or enzymatic degeneration. This product is immunoglobulin products, the Department of dry lumps,