Method for separating and purifying iodixanol injection raw materials by macroporous resin

Abstract

The invention relates to a method for separating and purifying iodixanol injection raw materials by macroporous resin. The method comprises the following steps: dissolving and synthetizing the iodixanol raw materials with water, carrying out adsorption separation and purification with PIPO-02 macroporous resin, adopting a non-linear chromatography method to perform pressing continuous chromatography, carrying out segmentation elution with ethanol, activating and recycling parting materials. The process flow is simple, the cost is low, the efficiency is high, the environment is protected, posts can be subjected to on-line activation and recycle, and the method is suitable for producing iodixanol products for injection industrially. PIPO-02 macroporous resin has remarkable advantages as compared with C-18 separating material, the cost of PIPO-02 macroporous resin is only about 20% of C-18 reverse phase silica gel, the adsorption capacity of PIPO-02 macroporous resin is about 2.5 times of C-18 separating material, the non-linear chromatography method is adopted to produce 98% iodixanol products for injection to the maximum limit, and the 98% iodixanol products have 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 is used for separation and purification, and the advanced asymmetric chromatography concept is 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 cause 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 of more ...

AI Technical Summary

Problems solved by technology

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

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 5000-8000 yuan per kilogram, and it is used for industrial production of iodixanol. Alcohol has high cost, weak adsorption capacity, and low production efficiency.