Novel method for separating and preparing technical raw materials by multi-grade resin

Abstract

The present invention relates to a process method for separating and purifying iodixanol by using a macroporous adsorption resin material, comprising dissolving and synthesizing raw materials of iodixanol in water, using a PIPO-02 macroporous resin column to adsorb, separate and purify, and adopting a non-linear chromatography method, Pressurized continuous chromatography, ethanol segmental elution, and the separation material is activated and recycled. The technological process is simple, the cost is low, the benefit is high, environmental protection, the column can be activated and regenerated on-line, and it is suitable for industrial production of iodixanol products for injection. Compared with C-18 separation material, PIPO-02 macroporous adsorption resin has obvious advantages, the cost is only about 20% of C-18 reversed-phase silica gel, the adsorption capacity is about 2.5 times that of C-18 separation material, and a nonlinear layer is used Analytical method, maximum production of 98% iodixanol for injection products, has obvious advantages.

Description

technical field [0001] The patent of the present invention relates to a process for separating and purifying iodixanol using a macroporous resin adsorption resin material, and belongs to the field of extraction, separation and purification of synthetic raw materials. The macroporous adsorption resin PIPO-00 was used for separation and purification, and the advanced asymmetric chromatography concept was adopted, with single-column loading and multi-column segmented high-pressure elution. Background technique [0002] Iodixanol is a contrast agent for injection, which is suitable for intracone angiography, cardiovascular and cerebrovascular angiography, and intravenous urography. Its principle of action is to combine iodine to absorb X-rays in blood vessels or tissues to produce image display. There are many by-products in the raw materials for synthesizing iodixanol, and the purity of generally synthesized iodixanol is about 40%, which cannot meet the purity requirement ...

AI Technical Summary

Problems solved by technology

There are many by-products in the raw materials for synthesizing iodixanol, and the purity of generally synthesized iodixanol is about 40%, which cannot meet the purity requirement of more than 97% for injections

Iodixanol is water-soluble, and normal phase silica gel cannot be separated and purified. Reversed phase silica gel C-18 can be used for separation and purification, but the cost is high. Generally, C-18 material is 5,000-8,000 yuan per kilogram, which is used for industrial production of iodixanol Alcohol has high cost, weak adsorption capacity, and low production efficiency.