| 摘要 |
The preparation method of immunoglobulin preparations on the base of IgG+IgA and IgG+IgM for intramuscular administration from blood mixed immunoglobulin preparation on the base of IgG+IgA+IgM. Protein solution containing IgG+IgA+IgM with protein concentration from 5 to 100 g per one litre, optimally from 20 to 50 g per one litre, is precipitated by 6 to 10 volume percent of ethanol related to the total volume of the reaction mixture, with the final temperature from -5 to -12 degrees C; the sediment undergoes mixing or stabilization under the above mentioned conditions for 5 to 12 hours and the suspension is separated into the precipitate rich in IgG+IgM and supernatant rich in IgG+IgA by subsequent centrifugation, while protein concentration of both the solutions is adjusted to 20 to 50 g per one litre and sodium chloride is added to final concentration of 3 to 9 g per one litre. Before final lyophilisation, the solutions are stabilized by adding glucose, maltose or other sugars, the pH value is adjusted to 6.4 to 7.4. If need be, both the solutions undergo further processing, e.g. by means of gel, ion exchange, or affinity chromatography, they are sterilised for example by means of filtration, dispensed and lyophilized.
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