METHOD FOR PREPARING HIGHLY PURE DOXORUBICIN
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United States of America Patent
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Oct 22, 2015
app pub date -
Oct 25, 2013
filing date -
Nov 21, 2012
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Abstract
The present invention relates to a method for preparing highly pure doxorubicin. The method comprises the following steps: (1) chromatographing a prepurified doxorubicin solution by using macroporous resin, pre-washing the chromatographed system by using an acidic low concentration aqueous organic solvent, and performing elution by using an acidic high concentration aqueous organic solvent; (2) performing chromatographic separation on eluted components by using a preparative column, so that a highly pure doxorubicin component can be obtained, and the doxorubicin can, if needed, be separated from the aqueous solution by using conventional concentration and crystallization methods in the prior art. The present invention has the advantages such as simplicity, high yield, low cost, and less environmental pollution. The content of the prepared doxorubicin is greater than 99.5%, the content of each impurity is controlled to be lower than 0.10%, and the USP and EP standards are met.
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