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Novel industrial crystallizing technology for cefuroxime sodium

A technology for cefuroxime sodium and industrial crystallization, applied in the field of medicine, can solve the problems of dark color and many impurities in cefuroxime sodium, and achieve the effects of high separation efficiency, short crystallization time, and no residual solvent toxicity

Active Publication Date: 2015-10-07
HAINAN LINGKANG PHARMA CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] The purpose of the present invention is to solve the problems of existing cefuroxime sodium with many impurities and dark color, aiming at simplifying the process and improving efficiency, and providing a method and equipment for crystallizing cefuroxime sodium that can be industrialized. Through the technology and equipment The color of the refined cefuroxime sodium product meets the quality requirements, and the product has high quality, good stability and fast dissolution rate

Method used

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  • Novel industrial crystallizing technology for cefuroxime sodium
  • Novel industrial crystallizing technology for cefuroxime sodium
  • Novel industrial crystallizing technology for cefuroxime sodium

Examples

Experimental program
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Effect test

Embodiment 1

[0044] (1) Take by weighing 5.43 kg of cefuroxime sodium crude product with a purity of 93.4% and place it in the extraction tank, add 50 kg of a mixed solvent of 50% ethanol water, control the temperature at 40° C., and stir to dissolve it;

[0045] (2) Pump in CO with a high-pressure liquid pump 2 Fluid to 15Mpa, stir, and maintain the pressure and temperature for 5 minutes, turn off the high pressure pump;

[0046] (3) Place crystal seeds in the crystallization pool, raise the height of the extraction pool to 30cm, open the quick interface of the two pools, let the liquid in the extraction pool enter the crystallization pool, and close the quick interface;

[0047] (4) Regulate the pressure in the crystallization tank to be 0.5Mpa, the temperature is 20°C, and keep this temperature and pressure for 20 minutes;

[0048] (5) After the system was cooled down and the pressure was released, it was dried under reduced pressure to obtain 4.52 kg of high-purity cefuroxime sodium c...

Embodiment 2

[0051] (1) Take 5.66 kg of cefuroxime sodium crude product with a purity of 93.4% and place it in the extraction tank, add 60 kg of a mixed solvent of 80% ethanol water, control the temperature at 60° C., and stir to dissolve it;

[0052] (2) Pump in CO with a high-pressure liquid pump 2 Fluid to 40Mpa, stir, and maintain the pressure and temperature for 20 minutes, turn off the high pressure pump;

[0053] (3) Place crystal seeds in the crystallization pool, raise the height of the extraction pool to 30cm, open the quick interface of the two pools, let the liquid in the extraction pool enter the crystallization pool, and close the quick interface;

[0054] (4) Adjust the pressure in the crystallization tank to be 5Mpa, the temperature is 30°C, and keep this temperature and pressure for 40 minutes;

[0055] (5) After the system was cooled down and the pressure was relieved, it was dried under reduced pressure to obtain 4.66 kg of high-purity cefuroxime sodium crystalline prod...

Embodiment 3

[0058] (1) Take by weighing 6.97 kg of the crude product of cefuroxime sodium with a purity of 93.4% and place it in the extraction tank, add 70 kg of mixed solvent of 70% ethanol and water, control the temperature at 50° C., and stir to dissolve it;

[0059] (2) Pump in CO with a high-pressure liquid pump 2 Fluid to 30Mpa, stir, and maintain the pressure and temperature for 10 minutes, turn off the high pressure pump;

[0060] (3) Place crystal seeds in the crystallization pool, raise the height of the extraction pool to 30cm, open the quick interface of the two pools, let the liquid in the extraction pool enter the crystallization pool, and close the quick interface;

[0061] (4) Regulate the pressure in the crystallization tank to be 1Mpa, the temperature is 25°C, and keep this temperature and pressure for 30 minutes;

[0062] (5) After the system cools down and the pressure is released, dry under reduced pressure to obtain 5.65 kg of high-purity cefuroxime sodium crystall...

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Abstract

The invention discloses novel industrial crystallizing technology for cefuroxime sodium. Recrystallizing of cefuroxime sodium is realized by adopting a mode combining supercritical fluid extraction technology with conventional crystallizing technology. In a crystallizing system, the processes of extracting, adsorbing, crystallizing and drying are completed under specific temperature and pressure conditions and under joint action of supercritical fluid, solvent, an extraction pool and a crystallization pool to realize recrystallizing of cefuroxime sodium. The novel industrial crystallizing technology is high in separation efficiency and few in impurity, and quality of cefuroxime sodium is improved greatly.

Description

technical field [0001] The invention relates to a novel industrial crystallization technology of cefuroxime sodium, which belongs to the technical field of medicine. Background technique [0002] Cefuroxime sodium, English name Cefuroxime Sodium, also known as cefuroxime, cefuroxime, Chinese nickname: (6R, 7R)-7-[2-furyl (methoxyimino) acetamido]-3-aminomethyl Sodium acyloxymethyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate. Molecular weight: 446.36. Molecular formula: C 16 h 15 N 4 NaO 8 S, chemical structural formula: [0003] [0004] Cefuroxime sodium is white, off-white or light yellow powder or crystalline powder; odorless, bitter taste; hygroscopic. This product is easily soluble in water, slightly soluble in methanol, insoluble in ethanol or chloroform, in the solution containing 10mg per 1ml, the specific rotation is +55° to +65°; it is determined by spectrophotometry at 274nm Absorbance was measured at a wavelength of 10000 Å, and the absorpt...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D501/34C07D501/12A61K9/14
CPCA61K9/0019A61K9/14C07D501/12C07D501/34C07B2200/13Y02P20/54B01D9/0054B01D11/0411B01D2009/0095
Inventor 陶灵刚
Owner HAINAN LINGKANG PHARMA CO LTD
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