FIELD: chemistry.
SUBSTANCE: invention relates to a method of producing nadroparin calcium. Method involves dissolving sodium heparin in water, adding acetic acid to pH 3.0-3.5. Then heparin is depolymerised with sodium nitrite in weight ratio of sodium nitrite and sodium heparin of 1:30. Solution pH is increased to 10.0-10.5, sodium borohydride is added in amount of 1.67% of the weight of sodium heparin and mixed. Then hydrogen peroxide is added and mixed. Hydrogen peroxide is decomposed with hydrochloric acid at pH 3.5-4.0 and pH of the solution is adjusted to 7.0-7.5. Obtained mixture is purified by ultrafiltration on a membrane with a molecular weight exclusion limit of 1 kDa, diafiltration of obtained solution on membrane with molecular weight exclusion limit of 1 kDa relative to calcium chloride solution, sterilizing filtration of the solution and sending the sterile solution for lyophilization.
EFFECT: invention increases output of nadroparin calcium, reduces the number of steps and does not use a solvent ethanol.
2 cl, 2 dwg, 1 tbl, 3 ex
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RU2512768C1 |
Authors
Dates
2025-03-31—Published
2024-09-20—Filed