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Fine purification method for iohexol

A technology of iohexol and purification, applied in the field of drug purification, can solve problems such as adverse reactions, achieve pollution-free costs, reduce environmental pressure and costs, and achieve high yields

Inactive Publication Date: 2018-02-23
SUZHOU NANOMICRO TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

As mentioned earlier, the presence of impurities in iohexol can cause serious adverse reactions, so it is necessary to do further research on the fine purification process of iohexol

Method used

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  • Fine purification method for iohexol

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Effect test

Embodiment 1

[0034] 4.4 g of crude iohexol (98.68% purity) was dissolved in 10 ml of deionized water, stirred to dissolve, filtered through a filter membrane with a pore size of 0.45 μm, and the filtrate was collected for later use. A chromatographic column of 15 × 310mm was used, and UniBPC60 polymer microspheres (produced by Suzhou Nawei Technology Co., Ltd.) were used as the packing material of the chromatographic column, and the packing volume was 55m1. The column was equilibrated with deionized water before loading the sample, and then eluted with deionized water. The solution of the target peak was collected in sections, and the component solutions meeting the requirements were summarized. After high-performance liquid chromatography analysis, the purity of iohexol in the eluent was above 99.5%, and the yield was 93%. The sum of the peak areas of each impurity in iohexol is less than 0.6% of the total peak area, the peak area of ​​other individual impurities except O-alkyl compound i...

Embodiment 2

[0036] Take 42g of crude iohexol (98.68% purity) and dissolve it in 130ml of deionized water, stir to dissolve, filter with a filter membrane with a pore size of 0.45 μm, and collect the filtrate for later use. A DAC50 chromatographic column with a column height of 20 cm was used, and UniBPC60 polymer microspheres (produced by Suzhou Nanwei Technology Co., Ltd.) were used as the chromatography column filler, and the column volume was 392 ml. The column was equilibrated with deionized water before loading the sample, and then eluted with deionized water. The solution of the target peak was collected in sections, and the component solutions meeting the requirements were summarized. After high-performance liquid chromatography analysis, the purity of iohexol in the eluent was above 99.7%, and the yield was 90%. The sum of the peak areas of each impurity in iohexol is less than 0.6% of the total peak area, the peak area of ​​other individual impurities except O-alkyl compound impu...

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Abstract

The invention provides a fine purification method for iohexol. Crude iohexol is dissolved and filtered; the filtered iohexol solution is loaded into a chromatographic column of high-molecular polymermicrospheres containing hydrophilic and lipophic functional groups for chromatography; water is adopted as a mobile phase to elute the iohexol solution; iohexol solutions of target peaks are collectedstage by stage, and component solutions which meet requirement are gathered, so that a finely purified iohexol solution is obtained. Iohexol which is finely purified by the method disclosed by the invention is high in purity and yield and stable; moreover, operation is simple and convenient, conditions are mild, and high temperature is not needed; since the used stationary phase can be recycled and the used mobile phase is water, environmental protection pressure and cost are greatly reduced; and the fine purification method for iohexol is suitable for large-scale application.

Description

technical field [0001] The invention relates to the field of medicine purification, in particular to a method for purifying iohexol. Background technique [0002] Iohexol (Iohexol) 5-[acetyl(2,3-dihydroxypropyl)amino]-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-triiodo -1,3-phthalamide is a raw material of water-soluble, non-ionic X-CT contrast agent. Iohexol was launched by the Norwegian Nycomyn Company in the 1980s, and the trade name is Omnipaque. This contrast agent is usually injected into the vein before CT contrast diagnosis, and is used for angiography, urinary system, spinal cord and hip joint, and lymphatic system contrast. It has the advantages of low contrast density, low toxicity, and good tolerance. It is currently the best One of the most common contrast agents, developed countries have completely replaced ionic contrast agents with it. With many advantages such as high safety, high contrast, low osmotic pressure and low human toxicity, iohexol has become the best-...

Claims

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Application Information

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IPC IPC(8): C07C237/46C07C231/24G01N30/02
CPCC07C231/24G01N30/02G01N2030/027C07C237/46
Inventor 江必旺毕士峰邹胜
Owner SUZHOU NANOMICRO TECH CO LTD
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