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Cefuroxime sodium crystal compound and preparation method thereof

A crystalline compound, the technology of cefuroxime sodium, applied in the field of medicine, can solve problems such as poor stability, and achieve the effects of good stability, high yield and good fluidity

Inactive Publication Date: 2018-01-16
ZHEJIANG YONGNING PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] For the deficiencies in the prior art, the object of the present invention is to provide a kind of cefuroxime sodium crystalline form compound and preparation method thereof, the cefuroxime sodium product color refined by this technology meets quality requirements, product purity is high, good stability, The dissolution speed is fast and the packaging is easy, which can solve the problems of poor stability of ordinary solvent crystallization and avoid a series of follow-up product quality problems caused by it, providing a safety guarantee for the clinical application of cefuroxime sodium

Method used

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  • Cefuroxime sodium crystal compound and preparation method thereof
  • Cefuroxime sodium crystal compound and preparation method thereof
  • Cefuroxime sodium crystal compound and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0024] In a 5000mL flask, dissolve 446g (1mol) of crude cefuroxime sodium in 800mL of water, add 2000ml of acetone at 25°C, place the flask in an ultrasonic generator, control the temperature at 15°C, turn on the ultrasonic seeding for 30min, and The frequency is 50KHz, then stir for 30min, then slowly add 1000mL acetone to the flask, control the temperature at 10°C for crystallization for 2h, filter, wash the filter cake twice with 500mL of acetone, vacuum dry the material at 20°C for 30min, then rise to 45°C Cefuroxime sodium was dried under vacuum for 3 hours to obtain 431 g of the crystalline compound of cefuroxime sodium, with a yield of 96.7%.

Embodiment 2

[0026] In a 5000mL flask, dissolve 446g (1mol) of crude cefuroxime sodium in 800mL of methanol, add 2000ml of acetone at 25°C, place the flask in an ultrasonic generator, control the temperature at 15°C, and turn on the ultrasonic seeding for 30min. The ultrasonic frequency is 50KHz, then stir for 30min, then slowly add 1000mL acetone to the flask, control the temperature at 10°C for crystallization for 2h, filter, wash the filter cake twice with 500mL of acetone, vacuum dry the material at 20°C for 30min, and then rise to After vacuum drying at 45°C for 3 hours, 44.6 g of the crystalline compound of cefuroxime sodium was obtained, with a yield of 10%.

Embodiment 3

[0028] In a 5000mL flask, dissolve 446g (1mol) of crude cefuroxime sodium in 800mL of water, add 2000ml of ethanol at 25°C, place the flask in an ultrasonic generator, control the temperature at 15°C, turn on ultrasonic seeding for 30min, and The frequency is 50KHz, then stir for 30min, then slowly add 1000mL ethanol to the flask, control the temperature at 10°C for crystallization for 2h, filter, wash the filter cake twice with 500mL ethanol each, vacuum dry the material at 20°C for 30min, then rise to 45°C Cefuroxime sodium was dried under vacuum for 3 hours to obtain 138 g of the crystal form compound of cefuroxime sodium, with a yield of 31%.

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Abstract

The invention relates to the field of medicines, and relates to a new crystal form of cefuroxime sodium, and a preparation method thereof. The preparation method of the cefuroxime sodium crystal formsample comprises the following steps: dissolving crude cefuroxime sodiumin water, adding an organic solvent for crystallization into the above obtained organic phase, crystallizing the cefuroxime sodium under an ultrasonic condition, and filtering the obtained crystals to obtain the cefuroxime sodium. Ultrasonic waves have a strong orientation effect, has a ripple effect needed by the enhancementof the formation of critical crystal nuclei, can accelerate the crystallization process, allows the crystal nuclei to be fast produced, and can prevent coalescence during the growth of the crystals, to the cefuroxime sodium crystal form sample has the advantages of high purity, good stability, good fluidity, and suitableness for being sub-packaged. The method has the advantages of high yield in the production process, simplicity, easiness in control, low preparation cost, and good safety and reliability.

Description

technical field [0001] The invention relates to the field of medicine, and mainly relates to a new crystal form of cefuroxime sodium and a preparation method thereof. Background technique [0002] Cefuroxime sodium, also known as (6R,7R)-7-[2-furyl(methoxyimino)acetamido]3-carbamoyloxymethyl-8-oxo-5-thia-1- Azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid sodium salt. Its structural formula is: [0003] [0004] This product is white, off-white or light yellow powder or crystalline powder; odorless, bitter taste; hygroscopic. This product is soluble in water, slightly soluble in methanol, insoluble in ethanol or chloroform. [0005] This product is a second-generation cephalosporin antibiotic. The antibacterial activity against Gram-positive cocci is similar to or slightly worse than that of the first-generation cephalosporins, but it is quite stable against β-lactamases produced by Staphylococci and Gram-negative bacilli. Methicillin-resistant Staphylococcus, Enterococc...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D501/34C07D501/12
Inventor 叶天健陈鑫陈识峰蔡翔金彬书
Owner ZHEJIANG YONGNING PHARMA
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