Technology for preparing enoxaparin sodium by membrane separation

Abstract

The invention discloses a technology for preparing enoxaparin sodium by membrane separation. The technology is characterized in that the enoxaparin sodium is sequentially subjected to treatments such as quaternary ammonium salt salinization, benzyl esterification and alkalinity degradation so as to realize beta-degradation, oxidation decoloration and filtration edulcoration, and filter liquor is subjected to ultrafiltration treatment to obtain an enoxaparin sodium product which can meet average molecular weight and molecular weight distribution range. According to the technology disclosed by the invention, membranes with different hole diameters are used for realizing ultrafiltration so as to control molecular weight and molecular weight distribution of a control product, and the enoxaparin sodium product with high purity and high activity is prepared; hydrogen peroxide oxidation decoloration and activated carbon filtration edulcoration are adopted, the impurities in a reaction system are effectively removed, and the product chromaticity is remarkably improved; the weight-average molecular weight of the prepared enoxaparin sodium is 3800-5000, the size and distribution range of molecular weight are ideal, the measured anti-FXa resistant / anti-FII a specific value is greater than 3.3, the main factor anti-FII a activity for causing a bleeding danger is greatly reduced, the anti-FXa activity for playing an embolism resisting action is relatively improved, and the validity and security advantages of the product are obvious.

Description

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AI Technical Summary

Benefits of technology

This patented technique allows for controlled preparing highly pure or active ingredients from large amounts of crude drug called Heparan Sulfate Na (HSNa). By controllably adjusting certain parameters like size, pores, temperature, pressure, time, etc., this can be used to create various types of compounds that have unique properties such as reducing blood clotting activity without causing excessive bleeding when administered intravacularly. These techniques help make drugs more effective at treating diseases caused by blockages within body vessels.

Problems solved by technology

Technics: Current methods for producing low molecule size heparinate or enoxaporodilane involve complicated processes involving multiple stages like crystallization, purification, drying, lyophillizing, etc., leading to increased costs associated therewith.

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