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Method for preparing high-purity calcobutrol

A high-purity technology of calcobutrol is applied in the field of preparing high-purity calcibutrol, which can solve the problems of being unfavorable for scale-up production, high operating cost, unfriendly to the environment, etc., so as to improve stability and bioavailability, improve Purity, Environmentally Friendly Effects

Active Publication Date: 2020-04-21
CHEN STONE GUANGZHOU CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

This operation cost is high, the operation is cumbersome, it is not conducive to large-scale production, and a large amount of resin and ammonia water are used, which is very unfriendly to the environment

Method used

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  • Method for preparing high-purity calcobutrol
  • Method for preparing high-purity calcobutrol
  • Method for preparing high-purity calcobutrol

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Embodiment Construction

[0044] The method for preparing high-purity calcobutrol calcium will be described in detail below by way of examples.

[0045] The first step, the neutralization reaction

[0046] At 10~30 ℃, add 2Kg water and 1Kg butanol (formula 2) to the reaction kettle, after stirring and dissolving, add 300g sodium hydroxide, measure the pH of the system is greater than 14, heat under reflux for 1 hour, drop 25Kg ethanol , after maintaining reflux for 1 hour, cooling and aging, the moisture content is 6%, filtered, the filter cake is washed with an appropriate amount of absolute ethanol or 95% ethanol, and dried to obtain 1.05Kg of butanol sodium salt of formula 3.

[0047] compound of formula 3 1 H-NMR as figure 1 shown. compound of formula 3 13 C-NMR as figure 2 shown.

[0048] 1 H-NMR (MeOD): δ 1.50-2.40 (m), 2.50-3.50 (m), 3.50-4.00 (m).

[0049] 13 C-NMR (MeOD): δ 45.86, 47.1-48.1 (m), 58.65, 58.71, 59.34, 60.16, 63.83, 70.14, 178.09, 178.24, 178.40.

[0050] The second st...

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Abstract

The invention discloses a method for preparing high-purity calcobutrol. The method comprises the following steps: (1) preparing an alkali metal salt of butrol by taking butrol as a starting material,and (2) reacting the alkali metal salt of the butrol with a calcium source to obtain the calcobutrol. The invention also provides a crystal form of calcobutrol. In an X-ray powder diffraction pattern,a 2 theta angle is used for representation, and characteristic diffraction peaks exist at the positions of 8.448 degrees, 8.970 degrees, 9.329 degrees, 9.711 degrees, 11.428 degrees, 12.309 degrees,13.744 degrees, 14.443 degrees, 15.715 degrees and 16.953 degrees. The preparation method provided by the invention can be used for obtaining high-purity calcobutrol.

Description

technical field [0001] The present application relates to a method for preparing high-purity combutrol calcium. Background technique [0002] In the field of gadolinium-containing contrast agents, gadobutrol is sold commercially around the world under the tradenames Galoxian or Gadavist. Gadobutrol is a non-ionic coordination compound composed of gadolinium and macrocyclic ligand dihydroxy-hydroxy-methyl-propyl-tetraazacyclododecane-triacetic acid (butanol), which is a novel The gadolinium-containing contrast agent is approved for contrast-enhanced magnetic resonance imaging (CE-MRI) diagnosis of multiple sites in the human body, including the brain, spinal cord, blood vessels, liver and kidneys. Gadobutrol contains a high concentration of ionic T1-relaxation potency, which gives it excellent image quality. [0003] It is known that calcium complex is used as an additive in most gadolinium-containing contrast agent preparations (gadobutrol-containing), and the excess calci...

Claims

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Application Information

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IPC IPC(8): C07D257/02
CPCC07B2200/13C07D257/02
Inventor 周磊谭俊荣赖英杰梁龙杨永年
Owner CHEN STONE GUANGZHOU CO LTD
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