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A kind of purification method of cefepime hydrochloride

A technology of cefepime hydrochloride and purification method, applied in the direction of organic chemistry, etc., to achieve the effect of saving production cost, ensuring stability and good stability

Active Publication Date: 2020-11-10
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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  • A kind of purification method of cefepime hydrochloride
  • A kind of purification method of cefepime hydrochloride
  • A kind of purification method of cefepime hydrochloride

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preparation example Construction

[0032] The preparation method comprises the following steps:

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

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

[0035] B. add complexing agent in cefepime hydrochloride arginine dissolving solution, filter and remove precipitate, obtain filtrate, wash complex compound with water, obtain washing solution;

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

[0037] C. Combine the filtrate and washing liquid, add decolorizing agent, the decolorizing temperature is 10-20°C, decolorize for 0...

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 edition of the Chinese Pharmacopoeia as a raw material, adding cefepime hydrochloride arginine hydrochloride solution The complexing agent is used for decolorization, and then a dispersant and a crystallization agent are added to the decolorization solution for crystallization to obtain cefepime hydrochloride.

[0046] The preparation method comprises the following steps:

[0047] A. Add 60mL of water to dissolve in 20g cefepime hydrochloride arginine (containing cefepime 12.6g), adjust the pH to 4.0 with 18% hydrochloric acid solution, control the stirring temperature to be 20°C, stir and dissolve until dissolved to get cephalosporin hydrochloride Pyroxime arginine solution;

[0048] B. Add 9.0 g of dodecylbenzenesulfonic acid to the raw material solution, react for 2 hours, remove t...

Embodiment 2～3

[0054] 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 cefepime hydrochloride, belonging to the field of chemical pharmacy, using cefepime hydrochloride arginine as a raw material, adding a complexing agent to a solution of cefepime hydrochloride arginine, decolorizing, and then adding Adding a dispersant and a crystallizer to the decolorizing solution for crystallization to obtain cefepime hydrochloride; the invention can fully recycle cefepime hydrochloride arginine that does not meet the quality standards, and the prepared cefepime hydrochloride has a content of It has the advantages of high concentration, less impurities and good stability, simple preparation method, energy saving and environmental protection, and is suitable for large-scale industrial production.

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] The purification methods of cefepime hydrochloride mainly include activated carbon adsorption, chromatographic column separation, crystallization, etc. Patent document CN201610314754.3 records a preparation method of cefepime hydrochloride suitable for industrial production, wherein the purification of cefepime hydro...

Claims

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Application Information

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Patent Type & Authority Patents(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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