Method for directly producing low-molecular weight heparin sodium through heparin sodium crude product

Abstract

The invention relates to a method for directly producing low-molecular weight heparin sodium through a heparin sodium crude product, and the method comprises the following steps of: (1) dissolving the heparin sodium crude product into a heparin sodium crude product solution by using a sodium chloride solution, regulating the pH value of the heparin sodium crude product solution to 5.0-10.0 by using hydrochloric acid or a sodium hydroxide solution, centrifugalizing by using a high-speed centrifuge to remove undissolved substances, depositing liquid obtained through centrifugalization by using ethanol, standing the deposited liquid at low temperature, collecting a sediment A, diluting the sediment A by using purified water, adding hydrogen peroxide for oxidation after the sediment A is completely dissolved, filtering, adding the ethanol for deposition, and standing to obtain a sediment B; and (2) taking out the sediment B as the intermediate of the heparin sodium crude product, adding the purified water for dissolution, stirring, adding sodium nitrite to degrade heparin sodium at the same time, adding sodium borohydride to reduce the heparin sodium, intercepting large molecules by using an ultrafilter after the reduction is finished, adding the ethanol to ultrafiltrate for deposition, dewatering by using the ethanol, and drying to obtain the low-molecular weight heparin sodium.

Description

technical field [0001] The invention relates to a preparation method of low-molecular-weight heparin sodium, in particular to a method for directly producing low-molecular-weight heparin sodium from crude heparin sodium. Background technique [0002] Heparin is a sulfated glycosaminoglycan compound widely present in animal organs and tissues (such as small intestinal mucosa, lung, etc.), which has anticoagulant, anti-inflammatory, anti-allergic, anti-viral, anti-cancer, and hypolipidemic properties. a biological function. Low molecular weight heparin is obtained by physical, chemical or enzymatic depolymerization of unfractionated heparin. Its molecular weight ranges from 3000 to 8000, and it has better antithrombotic activity than heparin. High, long half-life, predictable anticoagulant effect and no need for laboratory monitoring, the current clinical indications continue to expand. After decades of development, the research of low molecular weight heparin has made great...

AI Technical Summary

Problems solved by technology

[0003] At present, the production of low molecular weight heparin (including low molecular weight heparin sodium and low molecular weight heparin calcium) all use high-quality heparin sodium as the starting material. The content of substances (such as dermatan sulfate) is very low to ensure that the molecular weight of low-molecular-weight heparin meets the standard requirements. Because macromolecular substances such as dermatan sulfate need to be removed during the production of high-quality heparin sodium, this process often loses 3-5 % or even more potency, resulting in an increase in raw material costs

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