| 摘要 |
PURPOSE: To produce intravenously administrable polyclonal immunoglobulin preparation containing IgM in high concentration, showing low anticomplement activities, stable in an aqueous solution and especially useful for treatment and prophylaxis of bacterial infections. CONSTITUTION: An immunoglobulin-containing fraction of human, animal or bacterial provenance is treated with an anion exchanger to bind the IgM, further eluted with a saline or pH gradient. The elute is ultra-filtrated to condense the elute, further gel-filtrated, and treated withβ-propiolactone and PEG 400 before or after an anion exchange chromatography or gel-filtration, and optionally heated to provide an intravenously administrable polyclonal immunoglobulin preparation (i) containing at least 50wt.% IgM based on the momental total content of immunoglobulin, (ii) showing low anticomplement activities, (iii) stable in an aqueous solution and (iv) including no virus.
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