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Abstract

The process makes an oligosaccharide fraction from commerically available heparin solutions containing from 1 to 10 % heparin. This oligosaccharide fraction has antithrombotic activity, bioavailability, almost no toxic effects as well as a comparatively lower hemorrhagic risk and a reduction in bleeding time and a molecular weight range of less than 5000 D. This process includes the steps of ultrafiltering an aqueous starting solution of the heparin through a membrane of 3,000 D nominal molecular weight cut-off to form a rejected ultrafiltered heparin solution so that the oligosaccharide fraction does not contain molecular fragments too short for binding with antithrombin and thrombin; performing a phase partitioning of the rejected ultrafiltered heparin solution with aqueous saline solution and dichloromethane and making a heparin-quaternary ammonium complex so as to form a dichloromethane phase and a saline phase so that fractions of a predetermined anionicity and specificity are excluded from the product, adding benzyl chloride to the dichloromethane phase to benzylate and after that adding benzyltrimethylammonium hydroxide to the dichloromethane phase to form a depolymerized heparin fraction in the dichlormethane phase and subsequently isolating the oligosaccharide fraction by steps including phase partitioning to form other saline phases, debenzylating, adding sodium hydroxide to the other saline phases and subsequently lyophilizing and dialyzing. The oligosaccharide fraction formed by this process with the above-mentioned properties is also a part of the invention.

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First Claim