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Children cefodizime sodium compound entity and preparation thereof

A technology of cefodizime sodium and compound, which is applied in the field of cefodizime sodium compound entity and its preparation for children, can solve the problems of unsatisfactory material index, increase the risk of preparation use, etc., so as to improve the safety of the drug, improve the Product stability and the effect of improving extraction efficiency

Inactive Publication Date: 2015-10-07
ZHEJIANG CHANGDIAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although this method controls the water content in the product well, the applicant found during the research process that the relevant substance indicators of this method are not ideal, which increases the risk of using the preparation

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

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

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

[0025] (3) Remove the organic phase. After the ice melts, control the temperature at 10-15°C, slowly add 3000ml of ethanol dropwise for about 1 hour under the protection of nitrogen, cool down to 0-5°C and continue growing crystals for 1h, filter with suction, and wash with ethanol for 40 ℃ vacuum drying.

Embodiment 2

[0027] (1) Weigh 200 g of the crude product of cefodizime sodium, 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 under stirring, transfer to a 1000ml pressure-resistant container, make sure it is full and the air bubbles are removed, seal the container, oscillate, and freeze at -18°C for 3 hours before taking it out;

[0029] (3) Remove the organic phase. After the ice melts, control the temperature at 10-15°C, slowly add 3000ml of ethanol dropwise for about 1 hour under the protection of nitrogen, cool down to 0-5°C and continue growing crystals for 1h, filter with suction, and wash with ethanol for 40 ℃ vacuum drying.

Embodiment 3

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

[0032] (2) Add 7ml of ethyl acetate under stirring, transfer to a 1000ml pressure-resistant container, make sure it is full and air bubbles are removed, seal the container, oscillate, freeze at -18°C for 8 hours, and then take it out;

[0033] (3) Remove the organic phase. After the ice melts, control the temperature at 10-15°C, slowly add 3000ml of ethanol dropwise for about 1 hour under the protection of nitrogen, cool down to 0-5°C and continue growing crystals for 1h, filter with suction, and wash with ethanol for 40 ℃ vacuum drying.

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PUM

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Abstract

The present invention provides a children cefodizime sodium compound entity, which has the following structural formula. The preparation method comprises: (1) dissolving a cefodizime sodium crude product in water, adding active carbon, carrying out stirring decolorization, and filtering; (2) adding an extractant under stirring, transferring and filling into a pressure resistance container, removing air bubbles, carrying out sealed oscillation, carrying out temperature control freezing, and taking out; and (3) removing the organic phase, controlling the temperature of the filtrate at 10-15 DEG C for 60 min under the protection of nitrogen gas after the solid melts, slowly adding ethanol in a dropwise manner to the filtrate, cooling to a temperature of 0-5 DEG C, growing the grain, filtering, washing, and carrying out 30 DEG C vacuum drying. The cefodizime sodium prepared through the preparation method of the present invention has characteristics of uniform particle size distribution, less impurities, and good stability.

Description

technical field [0001] The invention relates to a compound entity of cefodizime sodium for children and a preparation thereof, belonging to the field of medicinal chemistry. Background technique [0002] Cefodizime, original product name: Modi, chemical name: (6R,7R)-7-[(2-amino-4-thiazolyl)(methoxyimino)acetamido]-3-[[(5 -Carboxymethyl-4-methyl-2-thiazolyl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid disodium salt. It is a semi-synthetic third-generation cephalosporin broad-spectrum antibacterial drug, which has antibacterial activity against Gram-positive bacteria and negative bacteria, is stable to β-lactamase, and is extremely stable to cephalosporinase and penicillinase. Clinically, it is mainly used for pneumonia, bronchitis, pharyngitis, tonsillitis, pyelonephritis, urinary tract infection, gonococcal urethritis, cholecystitis, cholangitis, gynecological infection, sepsis and Otitis media etc. [0003] What affect the quality of cefodiz...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D501/36C07D501/12A61K31/546A61K9/14
CPCA61K9/14A61K31/546C07D501/12C07D501/36
Inventor 陈宇东厉达中
Owner ZHEJIANG CHANGDIAN PHARMA
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