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

An iodixanol, separation and purification technology is applied in the field of extraction, separation and purification of synthetic raw materials, and can solve the problems of low production efficiency, weak adsorption capacity, and inability to satisfy injections.

Inactive Publication Date: 2013-01-16
PI & PI BIOTECH
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  • Abstract
  • Description
  • Claims
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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...

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment approach 1

[0015] 1. 20-40 times aqueous solution ultrasonically dissolved to synthesize iodixanol raw materials;

[0016] First use 1000 kg to dissolve 100 kg of synthetic raw material iodixanol, and add the remaining 1000 kg to 3000 kg of water during the dissolution process to completely dissolve under ultrasonic conditions.

[0017] 2. Use a nonlinear method to load the sample;

[0018] As much as possible, upload the dissolved iodixanol liquid onto the first 500LPIPO-02 column until it is found that iodixanol overflows from the end of the first column.

[0019] 3. Single-column loading, multi-column segmented high-pressure elution;

[0020] Connect the second 500LPIPO-02 column, use 5000-7500L volume of 3%-5% ethanol to elute the front-end impurities, use the second column to absorb the front-end impurities, after the second 200LPIPO-02 column is connected to the front-end impurities, that is The first PIPO-02 column, when there is no former impurity, separate the two columns, con...

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PUM

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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 ...

Claims

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Application Information

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IPC IPC(8): C07C237/46C07C231/24B01D15/08B01D15/42
Inventor 袁晓周东斌高俊飞樊路子
Owner PI & PI BIOTECH
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