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Process for purifying ioversol

A technology for ioversol and ethanol, applied in the field of purifying ioversol, can solve the problems of troublesome water-soluble evaporation, large amount of solvent consumption, low final yield and the like, and can shorten the refining period, improve the product yield, and control the production. cost effect

Active Publication Date: 2012-04-25
JIANGSU HENGRUI MEDICINE CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This method consumes a large amount of solvent, and it is troublesome to dissolve and evaporate to dryness. The final yield is low, and the requirements for moisture control are relatively high. , refinement failed

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0015] Add 10 g of ioversol crude product (purity 92.9%, moisture 1.13%) to the reaction flask, add 200 mL of absolute ethanol, heat to reflux under rapid stirring, the reaction solution gradually becomes clear, and after dissolving, evaporate the ethanol under normal pressure. When the volume is 80 mL, add a little seed crystal, start to crystallize, reflux and stir for crystallization for 2 hours, cool down to 50°C and stir for 3 hours, more crystals precipitate, filter while hot, wash twice with a small amount of ethanol, drain, and dry to obtain Iover 8.1 g of primary refined alcohol, with a purity of 98.1%, and a yield of 81.0%.

[0016] Add 8.0 g of ioversol primary refined product (98.1% purity, 1.47% moisture content) into the reaction flask, add 120 mL of ethanol, and heat to reflux under rapid stirring. When 24 mL of ethanol is evaporated, add a little seed crystal, reflux, stir and crystallize for 2 hours, cool down to 50°C and stir for 3 hours, more crystals are pr...

Embodiment 2

[0018] Ioversol crude product (purity 92.9%, moisture content 1.56%) 10g joins in the reaction bottle, adds ethanol 200mL, heats to reflux under rapid stirring, and reaction solution is clarified gradually, after dissolving clear, evaporate ethanol, when steaming out 60mL ethanol, Add the seed crystal, the seed crystal dissolves immediately, until 80mL is evaporated, add the seed crystal, and start to crystallize, after reflux for 2 hours, cool down to 50°C and stir for 3 hours, more solids are precipitated, filter while hot, wash twice with a small amount of ethanol, pump Drying and drying yielded 8.6 g of refined ioversol with a purity of 98.5% and a yield of 86.0%.

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Abstract

The invention relates to a method for purifying ioversol that is x-ray nonionic contrast agent. The method adopts ethanol as recrystallization solvent to recrystallize ioversol crude-product, and the content of the obtained ioversol pure-product is more than 98.5 percent. The method is simple, easy to operate, economical and practical, and suitable for large-scale industrial production.

Description

technical field [0001] The present invention relates to a method for purifying ioversol, which is widely used as an X-ray non-ionic contrast agent. Background technique [0002] So far, ioversol has been widely used as a safe x-ray non-ionic contrast agent, and has the characteristics of good water solubility, low osmotic pressure and relatively stable chemical properties. It is an ideal contrast agent widely used in angiography. Venography, arthrography, urography, chest and cervical spine angiography, gastrointestinal examination, etc. However, ioversol is used as a drug for intravascular injection, and its purity requirements are relatively high. Therefore, it is very necessary to study the method of effectively purifying ioversol. [0003] Crude ioversol contains some non-ionic impurities, mainly 5-amino-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-1,3-benzenedi Formamide; 5-[[N-(2-hydroxyethyl)carbamoyl]methoxy]-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-triiodo -1,3-Phenyl...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07C237/46C07C231/24A61K49/04
Inventor 孙飘扬谭友建陈永江
Owner JIANGSU HENGRUI MEDICINE CO LTD
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