abstract |
The present invention relates to a method for fractionating plasma proteins for preparing, inter alia, immune serum globulin and albumin. The method is characterized by the following steps: A. REMOVING BLOOD CORPUSCLES AND CELL FRAGMENTS FROM THE PLASMA IN THE BLOOD; B. PRECIPITATING THE GLOBULINS IN THE PLASMA WITH POLYETHYLENE GLYCOL IN A CONCENTRATION OF 10 TO 15 % BY WEIGHT AND AT A PH of 6.5 to 8.0, preferably 7.0; C. CENTRIFUGING OUT ALL OF THE PRECIPITATE AND POSSIBLY EXTRACTING ALBUMIN OUT OF THE REMAINING SOLUTION; D. DISSOLVING THE PRECIPITATE AT PH 5.8 in 0.05 sodium acetateacetic acid buffer and centrifuging out undissolved fibrinogen and IgM; e. adsorbing the globulins on a cation exchanger, preferably carboxy methyl dextran, pH 5.8, and eluting with 0.2 sodium chloride in 0.05 phosphate buffer at pH 7.5 to 8.0, preferably 7.8; F. PRECIPITATING WITH POLYETHYLENE GLYCOL AT PH 6.5 to 8.0, preferably 7.0, centrifuging and dissolving the precipitate in 0.2 M phosphate buffer at pH 6.6; g. adsorbing all the globulins excluding IgG on an anion exchanger, preferably diethyl aminoethyl dextran, pH 6.6; h. cooling the IgG solution to -0.3*C and precipitating IgG with ethanol in a 25 % by volume concentration at -5* to -10*C, preferably -7*C; i. separating the precipitate, suspending and washing with 25 % by volume ethanol at pH 7.0 at -5* to -10*C, preferably -7*C, and then renewed centrifuging; J. DISSOLVING IN GLYCINE AND STERILE-FILTERING; K. FREEZE-DRYING AND PREPARING A 16 TO 16.5 % IgG solution in 0.3 glycine for injection. |