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Child-type medicinal composition with ceftizoxime sodium and low-sodium carrier

A technology of cefizoxime sodium and composition, applied in the field of medicinal chemistry, can solve the problems of limited organic extraction effect, complicated operation, polluted environment, etc., and achieve the effects of improving clinical application quality, improving extraction efficiency and reducing impurity content

Inactive Publication Date: 2015-09-23
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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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] (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;

[0038] (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;

[0039] (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

[0041] (1) Weigh 100g of ceftizoxime crude product, add 1000ml of water, heat up to 30°C until completely dissolved, add 10g of activated carbon, stir for decolorization, and filter;

[0042] (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;

[0043] (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 acid.

[0044] (4) Add 400ml of ethanol, 60ml of water and 80g of ceftizoxime acid into the crystallizer, stir at a temperature of 25°C until dissolved, add 100ml of 0.2g / ml anhydrous sodium acetat...

Embodiment 3

[0046] (1) Weigh 100g of ceftizoxime crude product, add 1000ml of water, heat up to 30°C until completely dissolved, add 10g of activated carbon, stir for decolorization, and filter;

[0047] (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;

[0048] (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 acid.

[0049] (4) Add 400ml of ethanol, 60ml of water and 80g of ceftizoxime acid into the crystallizer, stir at a temperature of 25°C until dissolved, a...

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Abstract

The invention relates to a child-type medicinal composition with ceftizoxime sodium, i.e. a medicinal combined preparation with ceftizoxime sodium and low-sodium carrier infusion fluid, especially combined application package comprising the ceftizoxime sodium and the low-sodium infusion carrier fluid. The low-sodium carrier infusion fluid comprises glucose and sodium chloride injection fluid (15-200:1) and glucose and sodium-chloride potassium-chloride injection fluid (15-200:10-1) and the like. The child-type medicinal composition has the advantages that compared with the compatible and mixing use of the ceftizoxime sodium and the low-sodium carrier infusion fluid, the clinical application steps are simplified, the clinical risks caused by incapability of metabolizing excessive sodium in blood since the kidney of a child is not matured are reduced and the clinical application quality and safety of child administration are improved.

Description

technical field [0001] The invention relates to a pharmaceutical composition of children's type ceftizoxime sodium and a low-sodium carrier, 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 firs...

Claims

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Application Information

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IPC IPC(8): A61K47/26A61K47/02A61K9/08A61K31/546A61P31/04C07D501/20C07D501/12
Inventor 陈宇东厉达中
Owner ZHEJIANG CHANGDIAN PHARMA
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