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Method for purifying cefepime hydrochloride

A technology of cefepime hydrochloride and purification method, applied in the direction of organic chemistry, etc., can solve the problems of large equipment investment, complicated operation, high operation and maintenance cost, and achieve uniform particle size, simplified operation steps, and good fluidity.

Active Publication Date: 2019-05-31
NORTH CHINA PHARMA HEBEI HUAMIN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This method requires the use of an activated carbon filter system, which requires large equipment investment, complicated operation, and high equipment operation and maintenance costs.

Method used

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  • Method for purifying cefepime hydrochloride
  • Method for purifying cefepime hydrochloride
  • Method for purifying cefepime hydrochloride

Examples

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preparation example Construction

[0028] The preparation method comprises the following steps:

[0029] A. dissolving the cefepime hydrochloride crude product in a mixed solution of water and an organic solvent, stirring and dissolving at 20 to 30° C. to obtain a cefepime hydrochloride crude product solution;

[0030] The ratio of the volume in milliliters of the mixed solution of water and the organic solvent to the mass of the cefepime hydrochloride crude product in grams is 2.5 to 4.5:1; the volume ratio of water and the organic solvent in the mixed solution of the water and the organic solvent is 1:1.5 to 2.5, The organic solvent is any one or a combination of acetone, acetonitrile or N,N-dimethylformamide;

[0031] B. adjust the pH of the cefepime hydrochloride crude product solution to 4.0~5.0;

[0032] The solution used to adjust the pH is any one of dipropylamine, diethylamine or triethylamine;

[0033] C. Add a dispersant, adjust the pH to 0.8-1.0 with hydrochloric acid solution at a temperature of ...

Embodiment 1

[0039] The invention discloses a method for purifying cefepime hydrochloride. The crude product of cefepime hydrochloride is used as a raw material, the pH of the solution solution of the crude product of cefepime hydrochloride is adjusted, a dispersant is added, and cefepime hydrochloride is obtained after isoelectric point crystallization.

[0040] The preparation method comprises the following steps:

[0041] A. Get 20g of cefepime hydrochloride crude product, add in the mixed solution of 20mL purified water and 30mL acetonitrile, control temperature 30 ℃, stir until dissolving clear, obtain cefepime hydrochloride crude product solution;

[0042] B. adding diethylamine to adjust the pH of the cefepime hydrochloride crude product solution to 5.0;

[0043] C. Add 100mL of a mixture of ethyl acetate and acetone with a volume ratio of 1:1.5, under temperature control at 25°C, add hydrochloric acid solution dropwise to adjust the pH to 0.8, and grow crystals at 20°C for 0.5h;

...

Embodiment 2～3

[0047] Embodiments 2-3 have the same production process steps as Embodiment 1, the difference is the selection of process parameters, as shown in Table 1 below.

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Abstract

The invention discloses a method for purifying cefeprime hydrochloride and belongs to the field of chemical pharmaceutical. The method includes: taking a coarse product of the cefeprime hydrochlorideas a raw material; adjusting the pH value of solving liquid of the coarse product of the cefeprime hydrochloride and adding a dispersing agent to obtain the cefeprime hydrochloride after crystallization of isoelectric points. The purity of the cefeprime hydrochloride can be improved, and the prepared cefeprime hydrochloride has the advantages of low color level, uniform particle size and good fluidity.

Description

technical field [0001] The invention relates to a purification method of a compound, in particular to a purification method of β-lactam antibiotics, and belongs to the field of chemical pharmacy. Background technique [0002] The chemical name of cefepime hydrochloride is 1-[[(6R,7R)-7-[(2Z)-(2-aminothiazol-4-yl)-2-(methoxyimino)acetamido]-2-carboxy -8-Oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl]-1-methylpyrrolidinium monohydrochloride monohydrate, It is white to slightly yellow powder or crystalline powder, easily soluble in water or methanol, slightly soluble in ethanol, insoluble in ether, and its structural formula is as follows: [0003] [0004] Cefepime hydrochloride has effects on both Gram-positive and Gram-negative bacteria. At present, it is mainly used clinically for various infections caused by sensitive bacteria. The purification methods of cefepime hydrochloride mainly include activated carbon adsorption, chromatographic column separation, crystall...

Claims

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Application Information

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IPC IPC(8): C07D501/46C07D501/12
Inventor 任峰贾全田洪年刘树斌魏宝军贺娇
Owner NORTH CHINA PHARMA HEBEI HUAMIN PHARMA
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