| abstract |
Disclosed are a cytomegalovirus human immunoglobulin for intravenous injection and a preparation method therefor. The cytomegalovirus human immunoglobulin for intravenous injection according to the present invention has a specific activity of no less than 2.5 PEI-U/mg, an anti-CMV titer of no less than 100 PEI-U/ml, a purity of more than 98.2%, and a protein content of 51 to 55 mg/ml. In the present invention, octanoic acid precipitation and the anion exchange chromatography are adopted instead of a partial ethanol precipitation step in the traditional cryogenic ethanol process, and a process of inactivating virus with octanoic acid and removing virus with a nano-membrane is adopted. |