The invention discloses a
human cytomegalovirus immunoglobulin for intravenous injection and a preparation method thereof, and aims to improve the purity, yield and safety of the product. In the invention, the
specific activity of the
human cytomegalovirus immunoglobulin for intravenous injection is not less than 2.5 PEI-U / mg, the anti-CMV
titer is not less than 100 PEI-U / ml, the purity is greater than 98.2%, and the
protein content is 51-55 mg / ml.
Caprylic acid precipitation and
anion exchange chromatography are used instead of the partial
ethanol precipitation step in the traditional low-temperature
ethanol method, thereby keeping IgG in the supernate all the time so as to keep the IgG activity; and processes of
caprylic acid virus inactivation and nano film
virus removal are used, thereby effectively ensuring the safety of the product. Researches show that the preparation method disclosed by the invention improves the purity, yield and safety of the product, saves the energy and reduces the production cost.