A kind of production method of nadroparin calcium

Abstract

The invention discloses a production method of nadroparin calcium and belongs to the field of biomedicine. According to the method, crude heparin sodium is taken as raw material. Basing on enzymolysis and improved nitrite degradation method, nadroparin calcium high-quality product with particular average molecular weight (3800 to 5000Da) is prepared by enzymolysis, oxidative decolorization, ultrafiltration and impurity removal, ethanol precipitation and impurity removal, degradation, reduction, ultraviolet radiation, oxidation, Calcium replacement, nanofiltration, Ultrafiltration and refining, freeze-drying and other steps. The method provided by the invention has advantages of simple preparation technology, high bioavailability of the product, long half life in vivo, small hemorrhagic tendency and the like.

Description

technical field

[0001] The invention relates to the field of biomedicine, in particular to a method for producing Nadroparin calcium (Nadroparin). Background technique

[0002] Heparin (unfractionated heparin) is a highly sulfated glycosaminoglycan that has anticoagulant effects both in vivo and in vitro. However, unfractionated heparin has defects such as low bioavailability, large side effects, and frequent administration, and its replacement product, low-molecular-weight heparin such as nadroparin calcium, not only has better antithrombotic effect than unfractionated heparin, but also has high bioavailability, long half-life in vivo, Small bleeding tendency and other advantages. The anticoagulant activity of heparin is divided into two categories: antithrombotic activity (FXa) and anticoagulant (FIIa) activity. In the process of antithrombosis, both anti-FXa activity and anti-FIIa activity are necessary. The measuring standard of FXa / FIIa is expressed by the value of an...

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