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Method for refining cefamandole nafate, cefamandole nafate and application thereof

A technology of cefamandole sodium and its refining method, which is applied in the processing of cefamandole sodium, the refining of cefamandole sodium, the application in the preparation of antibacterial drugs, and the field of sterile composition powder injection, which can solve the problem of stability Poor, poor solubility, deep color and other problems, to achieve the effect of reducing the generation of degradation products and other impurities, good solubility, and good clarity of the solution

Active Publication Date: 2013-05-01
HAIKOU PHARMA FACTORY +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Therefore, the object of the present invention is to overcome the defects that existing cefamandole sodium preparations have many impurities, dark color, poor solubility and poor stability, and a kind of refining method of cefamandole sodium is provided, by which The dissolution rate of the cefamandole sodium refined by the method is fast, the product color meets the quality requirements, and the product quality is high and the stability is good. Meanwhile, the present invention also provides the cefamandole sodium prepared according to the refining method, containing the The sterile composition powder injection of cefamandole sodium, and the application of the cefamandole sodium in the preparation of antibacterial drugs

Method used

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  • Method for refining cefamandole nafate, cefamandole nafate and application thereof
  • Method for refining cefamandole nafate, cefamandole nafate and application thereof
  • Method for refining cefamandole nafate, cefamandole nafate and application thereof

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Embodiment 1

[0034] This embodiment is used to illustrate the refining method of cefamandole sodium of the present invention.

[0035] (1) Prepare 3L of mixed solvent with methanol and ethyl acetate at a volume ratio of 1:5, stir evenly, and set aside.

[0036] (2) Take 500 g of crude cefamandole sodium at room temperature, dissolve it in 2 L of water for injection, stir until all the solids are dissolved, add dropwise 10% aqueous sodium acetate to adjust the pH to 6.5, and obtain a crude solution.

[0037] (3) Add the above mixed solvent into the crude product solution, stir while adding, keep the reaction temperature at 20-25°C during the dropping process, and the dropping rate is 0.25L / min, and a white solid is found to precipitate from the solution. After the dropwise addition, continue to add 1L of ethyl acetate dropwise to obtain a suspension.

[0038] (4) Cool the obtained suspension to 3-5°C, let the crystal grow for 24 hours, filter under reduced pressure, and dry in vacuum at 40...

Embodiment 2

[0041] This embodiment is used to illustrate the refining method of cefamandole sodium of the present invention.

[0042] (1) Prepare 3L of mixed solvent with methanol and ethyl acetate at a volume ratio of 1:10, stir evenly, and set aside.

[0043] (2) Take 500 g of crude cefamandole sodium at room temperature, dissolve it in 2 L of water for injection, stir until all the solids are dissolved, add dropwise 10% aqueous sodium acetate to adjust the pH to 6.5, and obtain a crude solution.

[0044] (3) Add the above mixed solvent into the crude product solution, stir while adding, keep the reaction temperature at 20-25°C during the dropping process, and the dropping rate is 0.25L / min, and a white solid is found to precipitate from the solution. After the dropwise addition, continue to add 1L of ethyl acetate dropwise to obtain a suspension.

[0045] (4) Cool the resulting suspension to 3-5°C, let it grow for 24 hours, filter under reduced pressure, and dry it in vacuum at 40°C t...

Embodiment 3

[0048] This embodiment is used to illustrate the refining method of cefamandole sodium of the present invention.

[0049] (1) Prepare 3L of mixed solvent with ethanol and ethyl acetate at a volume ratio of 1:5, stir well, and set aside.

[0050] (2) Take 500 g of crude cefamandole sodium at room temperature, dissolve it in 2 L of water for injection, stir until all the solids are dissolved, add dropwise 10% aqueous sodium acetate to adjust the pH to 6.5, and obtain a crude solution.

[0051] (3) Add the above mixed solvent into the crude product solution, stir while adding, keep the reaction temperature at 20-25°C during the dropping process, and the dropping rate is 0.25L / min, and a white solid is found to precipitate from the solution. After the dropwise addition, continue to add 1L of ethyl acetate dropwise to obtain a suspension.

[0052] (4) Cool the resulting suspension to 3-5°C, let it grow for 24 hours, filter under reduced pressure, and dry it in vacuum at 40°C to ob...

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Abstract

The invention provides a method for refining cefamandole nafate, which comprises the following steps: (1) mixing lower alcohol and acetone or mixing lower alcohol and ethyl acetate to obtain a mixed solvent, wherein the volume ratio of the lower alcohol to the acetone or that of the lower alcohol to the ethyl acetate is (1-2) : (5-10); (2) dissolving the crude cefamandole nafate in a stirring manner into water for injection, and adjusting pH to 6-8 to obtain a crude solution; (3) when stirring, dropwise adding the mixed solvent into the crude solution, and then, dropwise adding ethyl acetate or acetone with the volume 30-40% of that of the mixed solvent, so as to obtain a suspension; and (4) cooling the suspension to 3-5 DEG C, standing for devitrification for 12-36 hours, vacuum filtration and drying to obtain refined cefamandole nafate. The invention further provides cefamandole nafate produced according to the refined method, sterile composition powder-injection preparation containing the cefamandole nafate, and application of the cefamandole nafate in preparing antibacterial agents.

Description

technical field [0001] The present invention relates to a kind of processing method of cefamandole sodium, be specifically related to a kind of refining method of cefamandole sodium, and the cefamandole sodium obtained according to the refining method, containing the cefamandole sodium without Bacteria composition powder injection, and the application of the cefamandole sodium in the preparation of antibacterial drugs. Background technique [0002] Cefamandol (Cefamandol, CMD) is the second generation of cephalosporin antibiotics. It was first successfully developed by E. Lilly Company in the United States in 1972. It was launched in Canada as MONDOL in 1978 and used clinically. It was the first in China to be successfully developed by Shanghai New Pioneer Pharmaceutical Co., Ltd. in 1979, and it was exclusively marketed in 1987. Its chemical name is: 7-D-(2-formyloxyphenylacetamide)-3[(1-methyl-1H-tetrazol-5yl)mercaptomethyl]-3 cephem-4-carboxylate sodium Salt. Molecular...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D501/36C07D501/12A61K31/546A61K9/14A61P31/04
Inventor 曾祎华张志兰沙莹
Owner HAIKOU PHARMA FACTORY
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