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Stable cefuroxime sodium and preparation method thereof

A technology of cefuroxime sodium and cefuroxime acid, applied in the field of medicine, can solve the problems of unsatisfactory stability and color of cefuroxime sodium, unsatisfactory dissolution effect of cefuroxime, large amount of water and acetone, etc., and achieve residual solvent The effect of reducing production cost and reducing dosage

Inactive Publication Date: 2019-11-22
SHANGHAI LONGXIANG BIO MEDICINE DEV CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But common problem at present is that the cefuroxime sodium stability (mainly color aspect) that makes is unsatisfactory
In addition, the organic solvents in the prior art are all selected acetone, and the dissolving effect of single acetone on cefuroxime is still unsatisfactory, and what have just add cosolvent isopropanol, acetonitrile, but still unsatisfactory, the consumption of water and acetone is big, and total solvent amount And the large amount of water makes post-processing difficult and costly

Method used

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  • Stable cefuroxime sodium and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] Dissolve 10.0g of cefuroxime acid in a mixed solution of 10ml of water and 100ml of acetone, stir until it is clear, add 0.5g of activated carbon and stir for 30 minutes, filter to remove the carbon, and wash the activated carbon with a mixture of acetone and water; % Sodium lactate and 50ml ethanol solution, add activated carbon and stir and filter; add the sodium lactate solution dropwise to the above-mentioned furocinic acid combined solution, stir after the addition, and precipitate solids, then add 100ml acetone dropwise and continue stirring for 60 minutes; filter and collect , Wash the crystals and vacuum dry at 35°C to obtain 10.10 g of stable cefuroxime sodium, with a yield of 95.9%.

[0040] The calculation method of the yield is: yield (%) = experimentally obtained cefuroxime sodium mass / theoretical cefuroxime sodium mass. Specifically, the molecular weight of cefuroxime acid is 424.39, the molecular weight of cefuroxime sodium is 446.37, and the theoretical mas...

Embodiment 2

[0042] Dissolve 10.0g of cefuroxime acid in a mixed solution of 10ml of water and 100ml of acetone, stir until it is clear, add the aqueous solution, add 0.5g of activated carbon and stir for 30 minutes, filter and remove the carbon, wash the activated carbon with a mixture of acetone and water, and combine The filtrate and the charcoal washing liquid, the temperature is controlled at 30℃, 3.0g 60% sodium lactate and 1.2g sodium acetate mixture solvent 30ml methanol and added to the above-mentioned furocic acid combined solution, after the addition, stir, stir for 30 minutes, and then add dropwise 100ml of acetone, continue to stir for 60 minutes; filter, collect, wash the crystals, and vacuum dry at 35°C to obtain 9.9g of stable cefuroxime sodium with a yield of 94.1%.

Embodiment 3

[0044] Dissolve 10.0g of cefuroxime acid in a mixed solution of 100ml of acetone and 100ml of methanol, stir until it is clear, add 0.5g of activated carbon and stir for 30 minutes, filter to remove the carbon, wash the carbon with an appropriate amount of methanol and acetone mixed solution, combine the filtrate and the carbon wash Add 6.0g of 60% sodium lactate to the combined solution of furocylic acid, add 6.0g of 60% sodium lactate to the combined solution of furoconic acid, add 50ml of acetone dropwise, and continue to stir for 60 minutes; filter, collect and wash the crystals. After vacuum drying at 35°C, 10.45 g of stable cefuroxime sodium was obtained with a yield of 99.3%.

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Abstract

The invention belongs to the technical field of medicines, and relates to a preparation method of the stable cefuroxime sodium. The preparation method comprises the following steps of S1, dissolving the cefuroxime acid in a solvent to obtain a solution A; S2, dissolving a salt-forming agent in a solvent to obtain a solution B; S3, mixing the solution A and the solution B, and stirring to precipitate the crystals; S4, continuing to add a poor solvent into the crystallization system in S3, and further precipitating the crystals; and S5, collecting the crystals, washing and drying to obtain the cefuroxime sodium. The preparation method has the advantages of extremely few residual solvents, good product color and luster, good stability and high yield, reduces the consumption of water and totalsolvents, is beneficial to production, reduces the production cost, and ensures that the obtained cefuroxime sodium has the better stability.

Description

Technical field [0001] The invention belongs to the technical field of medicine, and relates to a stable cefuroximesodium (Cefuroximesodium), namely (6R, 7R)-7-[[2-furanyl(cis-methoxyimino)acetyl]amino]- The preparation method of 3-carbamoyloxymethyl cef-3-en-4-carboxylate sodium. Background technique [0002] Cefuroxime sodium is a second-generation efficient, safe, and broad-spectrum semi-synthetic cephalosporin. Since Glaxo was developed and marketed in the UK in 1975, it is a good medicine that is not metabolized by the liver in the body but excreted in the urine through the kidneys in its original form due to its excellent curative effect on most of the infections caused by β-lactamase-producing bacteria. Kinetics and safety are currently widely used in clinical applications, especially for the treatment of Gram-negative bacteria infections. Cefuroxime sodium is a national essential drug, and it is also one of the eight cephalosporin species that are not restricted for use...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D501/34C07D501/04C07D501/12A61P31/04A61K31/546
CPCA61P31/04C07B2200/13C07D501/04C07D501/12C07D501/34
Inventor 熊毅杨洪朱延亮
Owner SHANGHAI LONGXIANG BIO MEDICINE DEV CO LTD