Sulodexide production method

Abstract

The invention discloses a sulodexide production method and belongs to the technical field of bio-pharmaceuticals. The sulodexide production method comprises the following steps: using a heparin byproduct as a raw material, and performing oxidization to obtain an intermediate crude product heparin solution; adding acetate into the intermediate crude product heparin solution, and separating by ultra-filtration to obtain a rapid movement heparin crude product and a dermatan sulfate crude product; then respectively refining a rapid movement heparin crude product and a dermatan sulfate crude product; performing refinement on the rapid movement heparin crude product and the dermatan sulfate crude product; finally mixing and dissolving precipitates obtained by refining, filtering, collecting a filtrate, and carrying out freeze-drying processing to obtain a sulodexide raw material. The method has the advantages that product purity and stability are improved; as the byproduct produced during the production of heparin is used as the raw material, the production cost is reduced, required production equipment is simple, and production conditions are easy to control.

Description

technical field [0001] The invention belongs to the technical field of biopharmaceuticals, and in particular relates to a production method of sulodexide. Background technique [0002] Sulodexide, trade name "Vessel Due F", was first developed by Alfa Wassermann Pharmaceuticals in Italy as a low-molecular-weight heparin drug, which belongs to the same class of glycosaminoglycans as heparin drug. Heparan sulfate and dermatan sulfate, both contained in the drug, work synergistically, giving the drug a different profile than heparin. Compared with heparin, sulodexide has stronger antithrombotic effect and less possibility of causing bleeding. Sulodexide can be taken orally, especially making it suitable for long-term antithrombotic treatment. Sulodexide exerts its pharmacological effects through anticoagulation, fibrinolysis, hemorrheology, antiproliferation and membrane permeability maintenance, which makes sulodexide can be used to prevent and treat thrombotic diseases; A...

AI Technical Summary

Problems solved by technology

[0003] The international and domestic preparation methods of sulodexide are relatively simple, and the products produced are often not pure enough, the internal structure is greatly damaged, the qualified rate of structure confirmation is low, or the process is often difficult to simply mix fast-moving heparin and dermatan sulfate. control, making it difficult for the final product to meet higher requirements

Instead, the use of duodenum with a small content as raw material often causes problems such as high raw material prices, relatively large production equipment, and difficult control of the production environment. The most important thing is that the produced products have a low pass rate and insufficient purity. This just makes the injection medicine that makes has certain risk during use