Preparation and purification process of nadroparin calcium

Abstract

The invention relates to a preparation and purification process for nadroparin calcium. The process comprises the following steps: depolymerization; reduction; recrystallization; chromatography; and filtration. According to the invention, the process can effectively extract a fragment with a narrow molecular weight distribution range; nadroparin calcium is obtained through improvement of a preparation process for low-molecular-weight heparin calcium, an out-dated solvent fractional precipitation method is changed, conditions for anion exchange chromatography are optimized, and the fragment both meeting requirements for molecular weight of LMWH in China and according with molecular weight distribution of nadroparin calcium are obtained through gradient?elution.

Description

technical field

[0001] The invention relates to a preparation and purification process of nadroparin calcium. Background technique

[0002] Low-molecular-weight heparin (LMWH) is a kind of oligosaccharide mixture with lower molecular weight obtained from unfractionated heparin as the starting material after fractionation or degradation. It has anti-Xa activity and can inhibit the formation of thrombus and arteriovenous thrombosis in vivo and in vitro, but it does not affect platelet aggregation and the combination of fibrinogen and platelets. Nadroparin calcium belongs to a kind of low-molecular-weight heparin, and it has been widely used clinically at home and abroad as a first-line anticoagulant drug. The coagulation and fibrinolytic systems have little effect. When antithrombotic effect occurs, bleeding is less likely. At present, it is mainly used for the prevention and treatment of deep venous thrombosis and pulmonary embolism, hemodialysis anticoagulation, unstable ...

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