Production process of nadroparin calcium with low ethanol residue

Abstract

The invention discloses a production process of nadroparin calcium with low ethanol residue. The process comprises the following steps of: performing cracking, reduction, ultrafiltration and concentration on heparin sodium which is taken as a raw material to obtain a solution of the nadroparin calcium, and then regulating the concentration of the solution of the nadroparin calcium, the using quantity of anhydrous ethanol during an alcohol precipitation process, the using quantity of the anhydrous ethanol during a pulping process and the temperature during vacuum drying so as to finally obtain a finished product of the nadroparin calcium. According to the production process of the nadroparin calcium with the low ethanol residue, disclosed by the invention, the problem of the ethanol residue during the production process of the nadroparin calcium is solved, the ethanol residue in the nadroparin calcium is not more than 0.5% and in line with the requirements of European Pharmacopoeia EP7.0, the use of freeze-drying equipment is avoided, and the production process has the advantages of low price of the equipment, low operation energy consumption, convenience in maintenance, small floor area, easiness in production amplification, low production cost, stable process and the like.

Description

technical field

[0001] The invention belongs to the production field of nadroparin calcium, in particular to a production process of nadroparin calcium with low ethanol residue. Background technique

[0002] Heparin is a sulfated glycosaminoglycan extracted from mammalian tissues (eg, intestinal mucosa, lung, liver). In 1916, Mclean first discovered this substance in the liver of dogs while studying blood clotting problems, and named it "heparin". Heparin is a mixture of mucopolysaccharide sulfates, with molecular weight ranging from 3kd to 30kd. The molecular structure is extremely complex and cannot be synthesized artificially for a long time. Currently, only heparin derived from porcine intestinal mucosa can be used for clinical treatment.

[0003] Heparin series drugs are mainly used for the prevention and treatment of acute coronary syndrome, the prevention and treatment of ischemic cerebral thrombosis, the prevention and treatment of postoperative anticoagulation and...