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Purification method of cefepime dihydrochloride

A technology of cefepime hydrochloride and purification method, applied in the direction of organic chemistry, etc., to achieve the effects of good stability, high content, and improved efficiency

Active Publication Date: 2019-05-21
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 is only applicable to the purification of cefepime hydrochloride crude product, not applicable to the process of preparing cefepime hydrochloride with cefepime hydrochloride arginine as raw material

Method used

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  • Purification method of cefepime dihydrochloride
  • Purification method of cefepime dihydrochloride
  • Purification method of cefepime dihydrochloride

Examples

Experimental program
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Effect test

preparation example Construction

[0032] The preparation method includes the following steps:

[0033] A. Dissolve cefepime hydrochloride arginine with water, control the temperature at 20-25°C, adjust the pH to 4.0-6.0 with any of hydrochloric acid, phosphoric acid or sulfuric acid solution, stir and dissolve to obtain cefepime hydrochloride arginine solution ;

[0034] The ratio of the number of milliliters of water added to the mass grams of cefepime hydrochloride arginine is 2~5:1;

[0035] B. Add a complexing agent to the cefepime hydrochloride arginine dissolving solution, filter to remove the precipitate to obtain a filtrate, and wash the complex with water to obtain a washing solution;

[0036] The complexing agent is sodium dodecyl benzene sulfonate or dodecyl benzene sulfonic acid, and the molar ratio of the complexing agent to cefepime in cefepime hydrochloride arginine is 1.05~1.10:1;

[0037] C. Combine the filtrate and the washing liquid, add a decolorizing agent, the decolorizing temperature is 10-20 ℃, ...

Embodiment 1

[0045] A method for purifying cefepime hydrochloride, using cefepime hydrochloride arginine hydrochloride that does not meet the quality index of cefepime hydrochloride for injection in the 2015 Chinese Pharmacopoeia as a raw material, and adding cefepime hydrochloride arginine hydrochloride dissolving solution After the complexing agent is decolorized, a dispersing agent and a crystallization agent are added to the decolorizing solution for crystallization to obtain cefepime hydrochloride.

[0046] The preparation method includes the following steps:

[0047] A. Add 60mL of water to 20g of cefepime hydrochloride arginine (containing 12.6g of cefepime), adjust the pH to 4.0 with 18% hydrochloric acid solution, control the stirring temperature to 20°C, stir and dissolve until it is clear to obtain cefepime hydrochloride Pyromoxime arginine dissolving solution;

[0048] B. Add 9.0 g of dodecylbenzene sulfonic acid to the raw material solution, react for 2 hours, filter to remove the c...

Embodiment 2～3

[0054] The production process steps in Examples 2 to 3 are the same as those in Example 1, except for the selection of process parameters, as shown in Table 1 below.

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Abstract

The invention discloses a purification method of cefepime dihydrochloride, and belongs to the field of chemical pharmacy. The method comprises the following steps: cefepime dihydrochloride arginine istaken as a raw material, a complexing agent is added in the dissolving solution of the cefepime dihydrochloride arginine for decoloration; and a dispersant and a crystallization agent are added intothe decolorated solution for crystallization, so as to finally obtain the cefepime dihydrochloride. The purification method can enable the cefepime dihydrochloride arginine which does not meet the quality standard to be fully recycled, therefore the prepared cefepime dihydrochloride has the advantages of high content, less impurities and high stability; and the preparation method is simple, energy-saving and environmental-friendly, thereby being suitable for large-scale industrial production.

Description

Technical field [0001] The invention relates to a method for purifying compounds, in particular to a method for purifying beta-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-carboxyl -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, and insoluble in ether. Its structural formula is as follows: [0003] [0004] The purification methods of cefepime hydrochloride mainly include activated carbon adsorption, chromatographic column separation, crystallization, etc. Patent document CN201610314754.3 describes a method for preparing cefepime hydrochloride suitable for industrial production, wherein the purification of cefepime hydrochloride u...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D501/04C07D501/12C07D501/46
Inventor 贾全田洪年任峰刘树斌魏宝军贺娇
Owner NORTH CHINA PHARMA HEBEI HUAMIN PHARMA
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