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

A resin separation and process technology, applied in the field of extraction, separation and purification of synthetic raw materials, can solve problems such as low production efficiency, weak adsorption capacity, and inability to satisfy injections.

Inactive Publication Date: 2017-09-26
JIANGSU WANLI BIOTECH CO LTD
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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 puri

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment approach 1

[0014] 1. 20-40 times aqueous solution ultrasonically dissolves the synthetic iodixanol raw material; first use 1000 kg to dissolve 100 kg of the synthetic raw material iodixanol, and add the remaining water during the dissolution process. 1000 kg to 3000 kg of water is completely dissolve.

[0015] 2. Use a nonlinear method to load the sample;

[0016] Load as much dissolved iodixanol liquid onto the first 500LPIPO-02 column as possible until iodixanol is observed to overflow the end of the first column.

[0017] 3. Single-column loading, multi-column segmented high-pressure elution;

[0018] Connect the second 500LPIPO-02 column, use 5000-7500L volume of 3%-5% ethanol to elute the front-end impurities, and use the second column to absorb the front-end impurities. After the second 200LPIPO-02 column is connected to the front impurities, that is The first PIPO-02 column, when there is no former impurity, separate the two columns, connect the first column with the third 300LP...

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PUM

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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 ...

Claims

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Application Information

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IPC IPC(8): C07C231/24C07C237/46B01D15/08
CPCC07C231/24B01D15/08
Inventor 蒋铁平冯爱军刘春捷
Owner JIANGSU WANLI BIOTECH CO LTD
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