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METHOD OF IGG + IGA AND IGG + IGM-BASE IMMUNOGLOBULIN PREPARATIONS FOR INTRAMUSCULAR ADMINISTRATION FROM BLOOD MIXED IMMUNOGLOBULIN IGG + IGA + IGM-BASE PREPARATION
METHOD OF IGG + IGA AND IGG + IGM-BASE IMMUNOGLOBULIN PREPARATIONS FOR INTRAMUSCULAR ADMINISTRATION FROM BLOOD MIXED IMMUNOGLOBULIN IGG + IGA + IGM-BASE PREPARATION
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机译：从血液混合免疫球蛋白IGG + IGA + IGM基制备中进行肌内给药的IGG + IGA和IGG + IGM基免疫球蛋白制备方法
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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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机译：基于IgG + IgA + IgM的血液混合免疫球蛋白制剂的肌内给药的基于IgG + IgA和IgG + IgM的免疫球蛋白制剂的制备方法。含有IgG + IgA + IgM的蛋白溶液，其蛋白浓度为每升5至100 g，最理想的是每升20至50 g，相对于反应混合物的总体积而言，乙醇的体积百分比为6至10％，最终温度为-5至-12摄氏度;沉淀物在上述条件下混合或稳定5至12小时，然后通过离心将悬浮液分离成富含IgG + IgM的沉淀物和富含IgG + IgA的上清液，同时将两种溶液的蛋白质浓度调节至每升20至50克，氯化钠的最终浓度为每升3至9克。在最终冻干之前，通过添加葡萄糖，麦芽糖或其他糖来稳定溶液，将pH值调节至6.4至7.4。如果需要，两种溶液都经过进一步处理，例如通过凝胶，离子交换或亲和色谱法，例如通过过滤将它们灭菌，分配和冻干。
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