Process for preparing high purity sodium heparin by purification of crude sodium heparin

Abstract

This invention is purification method of raw heparin sodium. The product high-quality heparin sodium could be used for injection. The procedure is as followings: we use raw heparin sodium as material and purify to get high-quality heparin sodium with ion-exchange chromatography, kalium hypermanganicum oxidization, ultrafiltration and organic solvent fractional precipitation in the order we describe here. The ion-exchange chromatography helps remove most of foreign substance and ultrafiltration remove manganese ions, heavy metal ions and pigments. We choose NaCl solution as washing liquid to make sure the separation of heparin sodium and other foreign substances. This invention is advantageous in low cost, stable quality, high yieldness, and the apposite molecular and weight range. It's also approximate for alarge scale production.

Description

technical field [0001] The invention relates to a method for separating and purifying crude heparin sodium into high-purity low-molecular-weight heparin sodium for injection. Background technique [0002] Heparin sodium has been used clinically as an anticoagulant drug for 60 years. In the early years, heparin sodium was isolated from dog liver, hence the name "heparin". Later, it was found that the content of heparin in bovine lung was higher. After World War II, heparin was extracted from intestinal mucosa. Since the 1980s, low-molecular-weight heparin for the treatment and prevention of thrombosis has been developed by chemically modifying heparin sodium molecules. At present, the top four pharmaceutical companies in the world have low molecular weight heparin products. In 2005, the global sales of heparin products exceeded 4 billion US dollars. [0003] At present, tens of thousands of people across the country are engaged in the production of crude products of small...

AI Technical Summary

Problems solved by technology

This traditional process has long production