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CHROMATOGRAPHIC METHOD FOR ISOLATING AND PURIFYING HIGH-PURITY RECOMBINATION HUMAN SERUM ALBUMIN

机译:层析纯化高纯度重组人血清白蛋白的方法

摘要

Disclosed is a chromatographic method for isolating and purifying high-purity recombined human serum albumin, comprising: conducting cation-exchange chromatography on recombined human serum albumin, and adding alcohol to a buffer solution to remove endotoxin, so as to obtain a primary product I; under binding conditions, conducting anion/hydrophobic composite resin exchange chromatography on the primary product I to obtain an intermediate product II; conducting hydrophobic chromatography on the intermediate product II to obtain the target product, the purified high-purity recombined human serum albumin. The purity of the recombined human serum albumin obtained by isolating and purifying with the chromatographic method of the present invention is greater than 99.9999%, and the content of the endotoxin meets the criteria stipulated by Chinese pharmacopoeia.
机译:本发明公开了一种分离纯化纯化高纯度重组人血清白蛋白的色谱方法,包括:对重组人血清白蛋白进行阳离子交换层析,并向缓冲液中加入乙醇去除内毒素,得到初级产物I。在结合条件下,对初级产物I进行阴离子/疏水复合树脂交换层析,得到中间体II。在中间产物II上进行疏水层析,得到目标产物,即纯化的高纯度重组人血清白蛋白。通过本发明的色谱方法分离纯化得到的重组人血清白蛋白的纯度大于99.9999%,内毒素含量符合中国药典规定的标准。

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