Preparation method of nadroparin calcium

Abstract

The invention discloses a preparation method of nadroparin calcium, and belongs to the technical field of biological medicines. By optimizing the key steps of degradation, reduction, ion exchange, oxidation and the like of heparin sodium and combining specific anion exchange resin, the yield and purity of the product are remarkably improved. The method comprises the following steps: mixing heparin sodium with purified water, and degrading by adjusting the pH value and adding sodium nitrite; continuously reacting by using sodium hydroxide and sodium borohydride, and collecting a precipitate through sterilization treatment and ethanol precipitation. Then, the precipitate reacts with anion exchange resin in purified water, and after washing and precipitation, oxidation reaction is carried out; and finally, filtering, dehydrating and drying to obtain nadroparin calcium. Compared with the prior art, the preparation method disclosed by the invention has the advantages of higher yield and purity, more concentrated molecular weight distribution, higher proportion of effective components and obviously reduced proportion of micromolecular and macromolecular impurities, thereby improving the quality and curative effect of the product.

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