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Children cefuroxime sodium compound entity and preparation thereof

The technology of cefuroxime sodium and compound is applied in the field of cefuroxime sodium compound entity and its preparation for children, and can solve the problems of poor stability of cefuroxime sodium, occurrence of degradation products, easy discoloration of appearance, etc., and achieves good clarity, Improve solubility and stability

Inactive Publication Date: 2015-09-16
ZHEJIANG CHANGDIAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] However, the prepared cefuroxime sodium still exhibits poor stability, and is unstable to heat, acidic environment, and alkaline environment. It is manifested in problems such as easy discoloration in appearance, reduced content, and occurrence of degradation products. The reason may be that the raw material cephalosporin Part of the impurity in furoctanoic acid cannot be removed by crystallization

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] (1) Weigh 100 g of cefuroxime 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;

[0026] (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;

[0027] (3) Remove the organic phase, transfer to the crystallization tank after the ice melts, add 5000ml of acetone dropwise for about 1 hour at 5°C, stir at a slow speed for 30 minutes, continue to grow crystals for 1 hour, filter with suction, wash with acetone, dry in vacuum, and aseptic Subpackage to obtain the cefuroxime finished product.

[0028] (4) Add 400ml of acetone, 60ml of water and 80g of cefuroxime acid into the crystallizer, stir at a temperature of 25°C until dissolved, add 100ml of 0.2g / ml anhydrous sodium acet...

Embodiment 2

[0030] (1) Weigh 100 g of cefuroxime 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;

[0031] (2) Add 10ml of chloroform to the above filtrate under stirring, transfer it to a 1000ml pressure-resistant container, ensure that it is full and remove air bubbles, seal the container, oscillate, freeze at -18°C for 3 hours, and then take it out;

[0032] (3) Remove the organic phase, transfer to the crystallization tank after the ice melts, add 5000ml of acetone dropwise for about 1 hour at 5°C, stir at a slow speed for 30 minutes, continue to grow crystals for 1 hour, filter with suction, wash with acetone, dry in vacuum, and aseptic Subpackage to obtain the cefuroxime finished product.

[0033] (4) Add 400ml of acetone, 60ml of water and 80g of cefuroxime acid into the crystallizer, stir at a temperature of 25°C until dissolved, add 100ml of 0.2g / ml anhydrous sodium acetate ethano...

Embodiment 3

[0035] (1) Weigh 100 g of cefuroxime 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;

[0036] (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;

[0037] (3) Remove the organic phase, transfer to the crystallization tank after the ice melts, add 5000ml of acetone dropwise for about 1 hour at 5°C, stir at a slow speed for 30 minutes, continue to grow crystals for 1 hour, filter with suction, wash with acetone, dry in vacuum, and aseptic Subpackage to obtain the cefuroxime finished product.

[0038] (4) Add 400ml of acetone, 60ml of water and 80g of cefuroxime acid into the crystallizer, stir at a temperature of 25°C until dissolved, add 100...

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Abstract

The present invention provides a children cefuroxime sodium compound entity, which has the following structural formula. The preparation method comprises: (1) dissolving a cefuroxime sodium crude product in water, adding active carbon, carrying out stirring decolorization, and filtering; (2) adding an extractant to the filtrate, transferring and filling into a pressure resistance container, removing air bubbles, carrying out temperature control freezing, and taking out; (3) carrying out liquid-solid separation, adding acetone in a dropwise manner after the solid melts, stirring at a slow speed, growing the grain, filtering, washing, and carrying out vacuum drying; and (4) adding acetone, water and the obtained cefuroxime acid to a crystallizer, stirring until achieving a dissolved state, adding a sodium liquid in a dropwise manner, continuously stirring, growing the grain, carrying out suction filtration washing, and carrying out vacuum drying to obtain the cefuroxime sodium finished product. The powder used for injection and prepared from the children cefuroxime sodium compound of the present invention has advantages of good clarity (no white point phenomenon), good stability, low impurity and the like.

Description

technical field [0001] The invention relates to a cefuroxime sodium compound entity and preparation thereof for children, belonging to the field of medicinal chemistry. Background technique [0002] The alias of cefuroxime is cefuroxime, and the original trade name is Xilixin, Chinnate Tablet. This product is a second-generation cephalosporin for injection. It is stable against the broad-spectrum β-lactamase produced by negative bacilli, and its anti-negative bacillus effect is stronger than that of the first generation. [0003] The antibacterial activity against Gram-positive cocci is similar to or slightly worse than that of the first-generation cephalosporins, but it is quite stable against β-lactamase produced by Staphylococcus and Gram-negative bacilli. Methicillin-resistant Staphylococcus, Enterococcus and Listeria are drug-resistant, and other positive cocci (including anaerobic cocci) are sensitive to this product. The antibacterial activity against Staphylococcu...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D501/34C07D501/12A61K31/546A61K9/14A61P31/04
CPCA61K9/14A61K31/546C07D501/12C07D501/34
Inventor 陈宇东厉达中
Owner ZHEJIANG CHANGDIAN PHARMA
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