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Cefamandole nafate compound entity used for children and preparation thereof

A technology of cefamandole sodium and compound, which is applied in the field of cefamandole sodium compound entity and its preparation for children, can solve the problems of low purification efficiency and increase the difficulty of separation, and achieves improved extraction efficiency, less impurities, The effect of improving solubility

Inactive Publication Date: 2015-10-28
ZHEJIANG CHANGDIAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Though this method can improve the purity of cefamandole sodium, for this highly polar compound of cefamandole sodium, the purification efficiency of this neutral resin of Hp-20 resin is not high, and in the process of adjusting the pH value It will also bring new negative ion impurities, increasing the difficulty of separation

Method used

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  • Cefamandole nafate compound entity used for children and preparation thereof
  • Cefamandole nafate compound entity used for children and preparation thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] (1) take by weighing 100g of cefamandole sodium crude product, add 1000ml of water to dissolve, add sodium bicarbonate solution to adjust pH to 6.5-7.5, add 10g activated carbon, stir and decolorize, filter;

[0025] (2) Add 10ml of ethyl acetate to the above-mentioned filtrate under stirring, transfer to a 1000ml pressure-resistant container, ensure that it is full and remove air bubbles, seal the container, shake, and take out after freezing at -18°C for 8 hours;

[0026] (3) Liquid-solid separation, after the ice melts, transfer to a crystallizing tank, add 5000ml of ethanol dropwise for about 30 minutes, stir at a slow speed for 30 minutes, continue to grow crystals for 1 hour, suction filtration, wash with ethanol, vacuum dry, and aseptically separate The finished product of cefamandole sodium is obtained. Maximum single miscellaneous 0.23%, total miscellaneous 0.52%.

Embodiment 2

[0028] (1) take by weighing 100g of cefamandole sodium crude product, add 1000ml of water to dissolve, add sodium bicarbonate solution to adjust pH to 6.5-7.5, add 10g activated carbon, stir and decolorize, filter;

[0029] (2) Add 7ml of chloroform to the above-mentioned filtrate under stirring, transfer to a 1000ml pressure-resistant container, ensure that it is full and remove air bubbles, seal the container, shake, and take out after freezing at -18°C for 8 hours;

[0030] (3) Liquid-solid separation, after the ice melts, transfer to a crystallizing tank, add 5000ml of ethanol dropwise for about 30 minutes, stir at a slow speed for 30 minutes, continue to grow crystals for 1 hour, suction filtration, wash with ethanol, vacuum dry, and aseptically separate The finished product of cefamandole sodium is obtained. Maximum single miscellaneous 0.39%, total miscellaneous 0.59%.

Embodiment 3

[0032] (1) take by weighing 100g of cefamandole sodium crude product, add 1000ml of water to dissolve, add sodium bicarbonate solution to adjust pH to 6.5-7.5, add 10g activated carbon, stir and decolorize, filter;

[0033] (2) Add 10ml of ether to the above-mentioned filtrate under stirring, transfer it to a 1000ml pressure-resistant container, ensure that it is full and remove air bubbles, seal the container, shake, and take out after refrigerating at -18°C under temperature control for 3 hours;

[0034] (3) Remove the organic phase, after the ice melts, transfer to a crystallizing tank, add 5000 ml of ethanol dropwise for about 30 minutes, stir at a slow speed for 30 minutes, continue to grow crystals for 1 hour, filter with suction, wash with ethanol, vacuum dry, and aseptically separate The finished product of cefamandole sodium is obtained. The largest single miscellaneous 0.27%, the total miscellaneous 0.54%.

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Abstract

The invention provides a cefamandole nafate compound entity used for children. The structural formula is as shown in specifications. The cefamandole nafate compound entity is prepared through the following steps that step1, a cefamandole nafate crude product is dissolved in water, sodium hydrogen carbonate is added, pH is adjusted to 6.5-7.5, active carbon stirring and discoloring are performed, and then filtering is performed; step2, an extracting agent is added into filtrate, and then the filtrate is transferred into a pressure-resistant container in a filling mode and taken out after being defoamed and frozen in a temperature control mode; step3, an organic phase is removed, after a solid is melted, ethyl alcohol is dripped, and then slow stirring, crystal growing, filtration washing and vacuum drying are performed to obtain the cefamandole nafate finished product. The cefamandole nafate prepared through the method has the advantages of having few impurities, being high in purity and the like compared with a traditional technology.

Description

technical field [0001] The invention relates to a compound entity of cefamandole sodium for children and a preparation thereof, belonging to the field of medicinal chemistry. Background technique [0002] Cefamandole sodium, chemical name: 7-D-(2-formyloxyphenylacetamide)-3-[(1-methyl-1H-tetrazol-5-yl)thiomethyl]-8- Oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate sodium salt, Chinese alias: mendoli, cefdrozole. [0003] It is a second-generation cephalosporin, in addition to having the same effect as cefazolin, it also has antibacterial effect on some gram-negative bacteria. The antibacterial spectrum is similar to that of cefotaxime, and it is not as good as cefotaxime against Gram-positive cocci. The main feature of this product is that it has a strong effect on gram-negative bacteria, which is better than cefazolin. It has a strong effect on anaerobic Clostridium, meningococcus, Neisseria gonorrhoeae, Escherichia coli, pneumonia bacillus, influenza bacillus and i...

Claims

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Application Information

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IPC IPC(8): C07D501/36C07D501/12A61K9/19
CPCA61K9/0019A61K9/19C07D501/12C07D501/36
Inventor 陈宇东厉达中
Owner ZHEJIANG CHANGDIAN PHARMA
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