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Novel industrial crystallization technology for cefamandole nafate

A technology of cefamandole sodium and industrial crystallization, which is applied in the field of medicine, can solve the problems of cefamandole sodium with many impurities, poor solubility, poor stability, etc., and achieve no solvent residual toxicity, short crystallization time, and high crystallization efficiency Effect

Active Publication Date: 2015-09-09
HAINAN LINGKANG PHARMA CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The purpose of the present invention is to solve the problems that existing cefamandole sodium has many impurities, deep color, poor solubility and poor stability, aims at simplifying the process and improving efficiency, and provides a kind of cefamandole sodium crystallization technology available for industrialization And equipment, the color of cefamandole sodium product refined by this technology and equipment meets the quality requirements, the product has high quality, good stability, and fast dissolution speed

Method used

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  • Novel industrial crystallization technology for cefamandole nafate
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  • Novel industrial crystallization technology for cefamandole nafate

Examples

Experimental program
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Effect test

Embodiment 1

[0045](1) taking by weighing 4.01kg of cefamandole sodium crude product with a purity of 83.51% is placed in the extraction tank, adding 40kg of mixed solvent of 65% acetone water, controlling the temperature at 45°C, and stirring to make it dissolve;

[0046] (2) Pump in CO with a high-pressure liquid pump 2 Fluid to 10Mpa, stir, and maintain the pressure and temperature for 5 minutes, turn off the high pressure pump;

[0047] (3) Place crystal seeds in the crystallization pool, raise the height of the extraction pool to 25cm, open the quick interface of the two pools, make the liquid in the extraction pool enter the crystallization pool, and close the quick interface;

[0048] (4) Regulate the pressure in the crystallization tank to be 0.5Mpa, the temperature is 20°C, and keep this temperature and pressure for 30 minutes;

[0049] (5) After cooling down the system, after depressurization, dry under reduced pressure to obtain 3.02 kg of high-purity cefamandole sodium crystal...

Embodiment 2

[0052] (1) taking by weighing 5.64kg of cefamandole sodium crude product with a purity of 83.51% is placed in the extraction tank, adding 60kg of mixed solvent of 90% acetone water, controlling temperature at 65°C, and stirring to dissolve it;

[0053] (2) Pump in CO with a high-pressure liquid pump 2 Fluid to 30Mpa, stir, and maintain the pressure and temperature for 15 minutes, turn off the high pressure pump;

[0054] (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;

[0055] (4) Regulate the pressure in the crystallization tank to be 5Mpa, the temperature is 30°C, and keep this temperature and pressure for 10 minutes;

[0056] (5) After the system cools down, after decompression, dry under reduced pressure to obtain 4.53 kg of high-purity cefamandole sodium crystalline product, a...

Embodiment 3

[0059] (1) taking by weighing purity is that 83.51% cefamandole sodium crude product 4.86kg is placed in the extraction tank, adds the mixed solvent 50kg of 80% acetone water, controls temperature 50 ℃, stirs and makes it dissolve;

[0060] (2) Pump in CO with a high-pressure liquid pump 2 Fluid to 20Mpa, stir, and maintain the pressure and temperature for 10 minutes, turn off the high pressure pump;

[0061] (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;

[0062] (4) Adjust the pressure in the crystallization tank to be 3Mpa, the temperature is 25°C, and keep this temperature and pressure for 20 minutes;

[0063] (5) After cooling down the system, after depressurization, dry under reduced pressure to obtain 3.77 kg of high-purity cefamandole sodium crystalline product, and obtain...

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Abstract

The invention discloses a novel industrial crystallization technology for cefamandole nafate. Recrystallization of the cefamandole nafate is realized through combination of a supercritical fluid extraction technology and a traditional crystallization technology. In a whole crystallization system, extraction, adsorption, crystallization and drying processes are finished under the coaction of a supercritical fluid, a solvent, an extraction pool and a crystallization pool under specific temperature and pressure conditions, and recrystallization of the cefamandole nafate is realized. According to the method, the separation efficiency is high, the product purity is high, few impurities exist, and the preparation product quality is greatly improved.

Description

technical field [0001] The invention relates to a novel industrial crystallization technology of cefamandole sodium, which belongs to the technical field of medicine. Background technique [0002] Cefamandole sodium (Cefamadole Nafate) is a second-generation semi-synthetic cephalosporin antibiotic developed by Eli Lilly and Company in 1972. It is easily soluble in water, slightly soluble in methanol, and insoluble in ethanol or ether. Cefamandole sodium was used clinically in 1978. The trade name is Mandol, and the chemical name is 7-D-(2-formyloxyphenylacetamide)-3-[(1-methyl-1H-tetrazol-5 base ) Thiomethyl]-3-cephem-4-carboxylic acid sodium salt, molecular weight 512.5, structural formula: [0003] [0004] Cefamandole sodium enters the human body and is rapidly hydrolyzed into cefamandole. The antibacterial activity of cefamandole is 5 to 10 times that of cefamandole sodium. Cefamandole sodium has both the advantages of first-generation and third-generation cephalos...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D501/36C07D501/12
CPCC07D501/12C07D501/36Y02P20/54
Inventor 陶灵刚
Owner HAINAN LINGKANG PHARMA CO LTD
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