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STABILIZATION OF BIOLOGICAL AND PHARMACEUTICAL PRODUCT DURING THERMAL INACTIVATION OF VIRUS AND BACTERIA CONTAMINANT

机译:热灭活病毒和细菌污染物过程中生物和医药产品的稳定化

摘要

PROBLEM TO BE SOLVED: To stabilize a biological and pharmaceutical product before inactivation of a pollutant of the biological and pharmaceutical product by a virus and/or a bacterium, etc., and to protect its activity during the inactivation treatment. SOLUTION: A biological and pharmaceutical product containing a king selected from antithrombin III, 1 -antitrypsin, IgG and prothrombin is mixed into an aqueous solution containing at least one kind of primary stabilizer selected from sugars or sugar alcohols and at least one kind of secondary stabilizer selected from neutral salts before inactivating a pollutant of the product. The aqueous solution is adjusted to pH5-10 and subjected to a pathogen inactivation treatment. After the treatment, the primary stabilizer and the secondary stabilizer are arbitrarily removed from the aqueous solution.
机译:要解决的问题:在通过病毒和/或细菌等使生物和医药产品的污染物灭活之前,稳定生物和医药产品,并在灭活处理过程中保护其活性。解决方案:将包含选自抗凝血酶III,1-抗胰蛋白酶,IgG和凝血酶原的国王的生物和医药产品混合到含有至少一种选自糖或糖醇的一级稳定剂和至少一种二级稳定剂的水溶液中灭活产品污染物前从中性盐中选择。将水溶液调节至pH5-10并进行病原体灭活处理。处理后,从水溶液中任意除去第一稳定剂和第二稳定剂。

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