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Purification method of iodixanol

A technology of iodixanol and purification method, which is applied in the field of purification of iodixanol, can solve problems such as separation and purification methods that are rarely reported, and achieve the effect of simple and convenient purification method, high purification yield and high yield

Active Publication Date: 2020-07-24
SUZHOU NANOMICRO TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] At present, most of the reports on iodixanol in domestic and foreign patents and documents are synthesis method patents, and there are few reports on separation and purification methods

Method used

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  • Purification method of iodixanol
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  • Purification method of iodixanol

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] The crude extract of iodixanol with a purity of 84.56% was taken and dissolved in pure water, and the concentration of iodixanol in the solution was 30 mg / mL. After the solution was clarified, it was filtered through a filter membrane with a pore size of 0.45 μm, and the filtrate was collected for later use.

[0038] A chromatographic column of 4.6 × 250 mm was used, and uniform particle size reversed-phase silica gel C18 microspheres (produced by Suzhou Nanowell Technology Co., Ltd.) were used as the column packing, and the column volume was 4.2 mL. Perform pre-column pretreatment on the chromatographic column, first remove impurities with 90% ethanol, then equilibrate with 4% ethanol-water solution, and then use 4% ethanol-water solution as mobile phase for isocratic elution, and one column for the peak After volume, change to 8% ethanol-water solution for isocratic elution, and the flow rate is controlled at 1.0 mL / min.

[0039] Collect the solution of the target pe...

Embodiment 2

[0044]The crude extract of iodixanol with a purity of 82.33% was taken and dissolved in pure water, and the concentration of iodixanol in the solution was 30 mg / mL. After the solution was clarified, it was filtered through a filter membrane with a pore size of 0.45 μm, and the filtrate was collected for later use.

[0045] A chromatographic column of 4.6 × 250 mm was used, and uniform particle size reversed-phase silica gel C18 microspheres (produced by Suzhou Nanowell Technology Co., Ltd.) were used as the column packing, and the column volume was 4.2 mL. Perform pre-column pretreatment on the chromatographic column, first remove impurities with 90% ethanol, then equilibrate with 4% ethanol-water solution, then use 4% ethanol-water solution as the mobile phase for isocratic elution, and the peak is one column volume Afterwards, 8% ethanol-water solution was used for isocratic elution, and the flow rate was controlled at 1.0 mL / min.

[0046] Collect the solution of the target...

Embodiment 3

[0049] The crude extract of iodixanol with a purity of 84.19% was taken and dissolved in pure water, and the concentration of iodixanol in the solution was 30 mg / mL. After the solution was clarified, it was filtered through a filter membrane with a pore size of 0.45 μm, and the filtrate was collected for later use.

[0050] A chromatographic column of 4.6 × 250 mm was used, and uniform particle size reversed-phase silica gel C18 microspheres (produced by Suzhou Nanowell Technology Co., Ltd.) were used as the column packing, and the column volume was 4.2 mL. Perform pre-column pretreatment on the chromatographic column, first remove impurities with 90% ethanol, then equilibrate with 4% ethanol-water solution, then use 4% ethanol-water solution as the mobile phase for isocratic elution, and the peak is one column volume Afterwards, 8% ethanol-water solution was used for isocratic elution, and the flow rate was controlled at 1.0 mL / min.

[0051] Collect the solution of the targe...

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Abstract

The invention provides a purification method of iodixanol. The purification method of iodixanol comprises the following steps: (1) dissolving and filtering a crude extract of iodxanol; (2) loading a sample of an iodixanol solution filtered in the step (1) into a chromatographic column filled with homogeneous reversed-phase silica gel for chromatography, and eluting the iodixanol solution by adopting a mobile phase; and (3) collecting the ioxanol solution with the target peak value in sections, and gathering the component solutions meeting the requirements to obtain the purified ioxanol. According to the purification method of iodixanol, homogeneous reverse-phase silica gel is used as a stationary phase, and with one-step chromatography purification, the main single impurity of the ioxanolcan be less than 0.1%, the remaining single impurity can be less than 0.05%, the purity can be more than 95%, the yield can be more than 88%, and the purification yield is high and stable. The purification method is simple and convenient, can be used for large-scale production, and can substantially reduce the production cost.

Description

technical field [0001] The invention relates to the technical field of medicine purification, in particular to a method for purifying iodixanol. Background technique [0002] Iodixanol, an X-ray contrast agent. Cardiovascular angiography, cerebral angiography (conventional and i.a.DSA), peripheral arteriography (conventional and i.a.DSA), abdominal angiography (i.a.DSA), urography, venography and CT-enhanced examination in adults. The structural formula is as follows: [0003] [0004] At present, most of the reports on iodixanol in domestic and foreign patents and documents are synthesis method patents, and there are few reports on separation and purification methods. [0005] CN1273574A discloses a method for crystallizing iodixanol by using methanol / isopropanol / water. The crystallization is carried out under high heat energy, especially when high pressure and temperature exceed the boiling point of the solution. The conditions are harsh and the requirements for produ...

Claims

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Application Information

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IPC IPC(8): C07C231/24C07C237/46
CPCC07C231/24C07C237/46B01D15/08B01D15/42
Inventor 江必旺王希吴永跃陈强强
Owner SUZHOU NANOMICRO TECH CO LTD
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