Method for reducing organic residue in heparin sodium by using vacuum drying method

Abstract

The invention discloses a method for reducing organic residue in heparin sodium by using a vacuum drying method. The method comprises the following steps: firstly adding ethanol precipitate wet solid obtained through sterilization in a heparin sodium crude product refining process into ethanol with concentration of more than 99 percent to perform dewatering treatment; then repeatedly performing dewatering treatment for 1-4 times on the treated precipitate with the ethanol with concentration of more than 97 percent; next performing vacuum drying on the precipitate for more than 60 hours under the conditions of 30-70 DEG C and relative vacuum degree of smaller than or equal to 0.08 MPa below zero to obtain a heparin sodium refined product, wherein the temperature does not exceed 40 DEG C in 12 hours before vacuum drying and then is gradually increased, and meanwhile a drying agent is replaced. According to the prepared heparin sodium refined product, the ethanol content is lower than 0.5 percent (namely 5,000ppm) on the basis that the quality of the heparin sodium is guaranteed. The method has the advantages of low energy consumption, low cost, high stability and the like.

Description

Technical field [0001] The invention belongs to the production field of heparin sodium, and specifically relates to a method for reducing organic residues in the refining process of crude heparin sodium. Background technique [0002] Heparin sodium is a biochemical drug extracted from pig small intestinal mucosa. It is an irreplaceable, life-saving, and unstoppable drug of choice during surgery. Since it was used clinically in the 1940s, its application range has been expanding. Especially since the 1990s, the product is mainly used to prevent thrombosis and treat cardiovascular diseases, blood diseases, uremia, etc. Western countries have begun to study the prevention and treatment effects of heparin sodium on cancer, and its new uses continue to increase. [0003] Since the 1970s, my country's heparin sodium production process has been continuously improved, and it has become the country with the largest heparin sodium output in the world. More than 70% of heparin sodium produc...

AI Technical Summary

Problems solved by technology

[0004] The purpose of the present invention is to provide a method for reducing organic residues in heparin sodium by vacuum drying, aiming at the problem that the organic residues of heparin sodium refined products obtained by the existing refining process exceed the standard.