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Refinement method of ceftriaxone sodium crude product

A technology of ceftriaxone sodium and a refining method, which is applied in the field of chemical pharmacy, can solve problems affecting the quality of ceftriaxone sodium, instability of ceftriaxone sodium, and high color grade of the product, so as to achieve improved safety and effectiveness and low price , The effect that the solvent is easy to get

Active Publication Date: 2014-09-10
LIVZON PHARM GRP INC +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Ceftriaxone sodium is prone to degradation reactions during the crystallization process, mainly because ceftriaxone sodium is unstable in pure water systems and is easily oxidized and degraded to produce degradation products, which cause high color grades of products and directly affect the quality of ceftriaxone sodium

Method used

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  • Refinement method of ceftriaxone sodium crude product
  • Refinement method of ceftriaxone sodium crude product

Examples

Experimental program
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Effect test

Embodiment 1

[0024] The refining method of ceftriaxone sodium, the steps are as follows:

[0025] (1) Weigh 50 g of ceftriaxone sodium crude product and 0.5 g of 3,4-difluorobenzonitrile, add 100 ml of dichloromethane, 40 ml of ethanol and 10 ml of water for injection, stir for 30 min at room temperature, add 1 g of activated carbon for decolorization 20min.

[0026] (2) The above solution is filtered through nitrogen pressure, and activated carbon and other impurities are removed by a microporous membrane. Then use the same proportion of mixed solvents to wash the suction filter flask, wash the filter cake, and transfer them to the crystallizer together.

[0027] (3) When the solution in the crystallizer reaches the crystallization temperature, start to drop fresh acetone, and after the acetone has been added dropwise, add sterile grade ceftriaxone sodium crystal seeds, and crystallize for 4 hours.

[0028] (4) Vacuum suction filtration is performed after dissolution and crystallization...

Embodiment 2

[0040] The refining method of ceftriaxone sodium, the steps are as follows:

[0041] (1) Weigh 50 g of ceftriaxone sodium crude product and 0.5 g of 3,4-difluorobenzonitrile, add 100 ml of dichloromethane, 50 ml of ethanol and 10 ml of water for injection, stir for 30 min at room temperature, add 1 g of activated carbon for decolorization 20min.

[0042] (2) The above solution is filtered through nitrogen pressure, and activated carbon and other impurities are removed by a microporous membrane. Then use the same proportion of mixed solvents to wash the suction filter flask, wash the filter cake, and transfer them to the crystallizer together.

[0043] (3) When the solution in the crystallizer reached the crystallization temperature, start to drop fresh acetone, after the acetone was added dropwise, add sterile grade ceftriaxone sodium crystal seeds, and crystallize for 5 hours.

[0044] (4) Vacuum suction filtration is performed after dissolution and crystallization, the fil...

Embodiment 3

[0046] The refining method of ceftriaxone sodium, the steps are as follows:

[0047] (1) Weigh 50 g of ceftriaxone sodium crude product and 0.5 g of 3,4-difluorobenzonitrile, add 100 ml of dichloromethane, 40 ml of ethanol and 20 ml of water for injection, stir for 30 min at room temperature, add 1 g of activated carbon for decolorization 20min.

[0048] (2) The above solution is filtered through nitrogen pressure, and activated carbon and other impurities are removed by a microporous membrane. Then use the same proportion of mixed solvents to wash the suction filter flask, wash the filter cake, and transfer them to the crystallizer together.

[0049] (3) When the solution in the crystallizer reached the crystallization temperature, start to drop fresh acetone, after the acetone was added dropwise, add sterile grade ceftriaxone sodium crystal seeds, and crystallize for 5 hours.

[0050] (4) Vacuum suction filtration is performed after dissolution and crystallization, the fil...

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Abstract

The invention provides a refinement method of a ceftriaxone sodium crude product. Ceftriaxone sodium can be easily subjected to degradation reaction in the crystallization process; and the ceftriaxone sodium is not stable and can be easily subjected to oxidative degradation to generate a degradation product mainly in a pure water system, thereby causing high color grade of the product and directly influencing the quality of the ceftriaxone sodium. The refinement method provided by the invention can lower the degradation of the ceftriaxone sodium in the crystallization process.

Description

technical field [0001] The invention relates to the field of chemical pharmacy, in particular to a method for refining crude crystalline ceftriaxone sodium, which is used for preparing the refined ceftriaxone sodium. Background technique [0002] Molecular formula of ceftriaxone sodium: C 18 h 17 N 8 NaO 7 S 3 , the structural formula is as follows: [0003] [0004] The chemical name of ceftriaxone sodium is (6R,7R)-3-[[(1,2,5,6-tetrahydro-2-methyl-5,6-dioxo-1,2,4-triazine -3-yl)thio]methyl]-7-[[(2-amino-4-thiazolyl)methoxyiminoacetyl]amino]-8-oxo-5-thia-1-aza Sodium bicyclo[4.2.0]oct-2-ene-2-carboxylate. It is white or off-white crystalline powder, odorless and tasteless, hygroscopic, easily soluble in water, slightly soluble in methanol, almost insoluble in chloroform or ether. [0005] Ceftriaxone sodium was developed by Swiss Hoffmann-LaRoche Company and first launched in Switzerland in 1982. Belonging to the third generation of cephalosporin antibiotics, it...

Claims

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Application Information

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IPC IPC(8): C07D501/36C07D501/12
CPCC07D501/12C07D501/36
Inventor 孔祥生徐晓王锐陶德胜
Owner LIVZON PHARM GRP INC
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