Children ceftizoxime sodium compound entity and preparation thereof

A technology for ceftizoxime sodium and ceftizoxime, which is applied in the field of cefizoxime sodium compound entities and their preparations for children, can solve the problems of complicated operation, low purity, poor stability of aqueous solution, etc., and achieves reduction of impurity content and improvement of extraction. Efficiency, the effect of improving solubility

Inactive Publication Date: 2015-11-11
ZHEJIANG CHANGDIAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Ceftizoxime sodium powder for injection has been widely used in clinical practice, and is one of the most widely used antibiotic drugs at present. The purity is not high, the clarity after dissolution is poor, the stability in aqueous solution is poor, and the side effects are large, etc.
Therefore, it has seriously affected the clinical application safety of ceftizoxime sodium
[0005] Chinese patent CN101348492 discloses a method for preparing high-purity ceftizoxime sodium. Ceftizoxime sodium is converted into ceftizoxime acid in water, and the crude product of ceftizoxime acid is obtained by extraction with an organic reagent. The solvent in the phase is dissolved by adding a lower alcohol, and the product is extracted by adding alkali. The organic extraction effect of this method is limited, and an alumina chromatography column is used, and a large amount of eluent is used, which has high cost, pollutes the environment, and is complicated to operate. Suitable for industrial production

Method used

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  • Children ceftizoxime sodium compound entity and preparation thereof
  • Children ceftizoxime sodium compound entity and preparation thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] (1) Weigh 100 g of ceftizoxime sodium crude product, add 1000 ml of water, heat up to 30 ° C until completely dissolved, add 10 g of activated carbon, stir for decolorization, and filter;

[0024] (2) Add 10ml of ethyl acetate to the above filtrate under stirring, transfer it to a 1000ml pressure-resistant container, make sure it is full and the air bubbles are removed, seal the container, oscillate, freeze at -18°C for 8 hours, and then take it out;

[0025] (3) Liquid-solid separation, after the ice melts, transfer to a crystallization tank, add 5000ml of ethanol dropwise for about 1 hour, stir at a slow speed for 30 minutes, continue to grow crystals for 1 hour, filter with suction, wash with ethanol, dry in vacuum, and pack aseptically, Obtain the ceftizoxime sodium finished product. The maximum impurity is 0.13%, and the total impurity is 0.23%.

Embodiment 2

[0027] (1) Weigh 100 g of ceftizoxime sodium crude product, add 1000 ml of water, heat up to 30 ° C until completely dissolved, add 10 g of activated carbon, stir for decolorization, and filter;

[0028] (2) Add 10ml of chloroform to the above filtrate under stirring, transfer it to a 1000ml pressure-resistant container, make sure it is full and the air bubbles are removed, seal the container, oscillate, freeze at -18°C for 8 hours, and then take it out;

[0029] (3) Liquid-solid separation, after the ice melts, transfer to a crystallization tank, add 5000ml of ethanol dropwise at 5°C for about 1 hour, stir at a slow speed for 30 minutes, continue to grow crystals for 1 hour, filter with suction, wash with ethanol, vacuum dry, and aseptic Subpackage to obtain the finished product of ceftizoxime sodium. Maximum single impurity 0.19%, total impurity 0.29%.

Embodiment 3

[0031] (1) Weigh 100 g of ceftizoxime sodium crude product, add 1000 ml of water, heat up to 30 ° C until completely dissolved, add 10 g of activated carbon, stir for decolorization, and filter;

[0032] (2) Add 5ml of ethyl acetate and 5ml of chloroform mixed solvent to the above filtrate under stirring, transfer it to a 1000ml pressure-resistant container, make sure it is full and the air bubbles are removed, seal the container, oscillate, freeze at -18°C for 3 hours, and then take it out;

[0033] (3) Remove the organic phase, transfer to the crystallization tank after the ice melts, add 5000ml of ethanol dropwise at 5°C for about 1 hour, stir at a slow speed for 30 minutes, continue to grow crystals for 1 hour, filter with suction, wash with ethanol, dry in vacuum, and aseptic Subpackage to obtain the finished product of ceftizoxime sodium. The maximum simple impurity is 0.17%, and the total impurity is 0.24%.

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Abstract

The present invention provides a children ceftizoxime sodium compound entity, which has the following structural formula. The preparation steps comprise: (1) dissolving a ceftizoxime sodium crude product in water, carrying out stirring decolorizing with active carbon, and filtering; (2) adding an extraction agent to the filtrate, transferring and filling into a pressure-resistant container, removing gas bubbles, carrying out temperature control freezing, and taking out; and (3) removing the organic phase, adding ethanol in a dropwise manner after the solid melts, stirring at a slow speed, growing the crystal, carrying out filtering washing, and carrying out vacuum drying to obtain the ceftizoxime sodium finished product. According to the present invention, the ceftizoxime sodium prepared by the method has advantages of less impurity, high purity and the like of the ceftizoxime sodium prepared by the conventional process.

Description

technical field [0001] The invention relates to a ceftizoxime sodium compound entity and preparation thereof for children, belonging to the field of medicinal chemistry. Background technique [0002] Ceftizoxime sodium, chemical name: (6R,7R)-7-[(Z)-2-(2-amino-4-thiazolyl)-2-methoxyiminoacetamido]-8-oxo -5-thia-1-aminoheterobicyclo[4.2.0]oct-2-ene-2-carboxylic acid sodium salt, Chinese aliases: demethioxime cephalosporin, cefotaxime, ampulcillin, Security speed. [0003] This product is a semi-synthetic third-generation cephalosporin with a broad antibacterial spectrum, similar to cefotaxime. It has a moderate antibacterial effect on some Gram-positive bacteria and a strong effect on Gram-negative bacteria. The antibacterial spectrum includes: Staphylococcus aureus, Streptococcus, Pneumococcus, Haemophilus influenzae, Streptococcus pneumoniae, Escherichia coli, Klebsiella, Proteus and Enterobacteriaceae etc. Some Gram-negative bacteria resistant to first-generation cepha...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D501/20C07D501/12A61K9/19
CPCC07D501/20A61K9/0019A61K9/19C07D501/12
Inventor 陈宇东厉达中
Owner ZHEJIANG CHANGDIAN PHARMA
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