FIELD: pharmaceutical industry, in particular method for production of immunoglobulin drug.
SUBSTANCE: target drug is prepared by blood plasma fractionating to produce fibrin, albumin, beta-globulin and lipids by multiple treatment with ethanol, sodium chloride and chloroform. After beta-globulin and lipid centrifugation target product-containing centrifugate is filtered under certain conditions and cooled. To immunoglobulin precipitation polyethylene glycol in sodium chloride solution is added into filtrate at certain rate and temperature. Further mixture in agitated, centrifugated, immunoglobulin-containing precipitate is separated, dissolved in injection water under certain conditions; glycine is added to obtained solution up to certain finished concentration, pH is adjusted up to certain value, and product is filtered with simultaneous sterilization.
EFFECT: target product of improved quality.
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Authors
Dates
2005-05-27—Published
2004-04-30—Filed