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Juvenile Cefamandole Nafate and low-sodium carrier pharmaceutical composition

A technology of cefamandole sodium and its composition, which is applied in antibacterial drugs, organic chemistry, etc., can solve the problems of low purification efficiency and increased separation difficulty, so as to improve extraction efficiency, improve clinical application quality, and improve solubility Effect

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

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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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] (1) Take cefamandole sodium crude product 100g, add water 1000ml to dissolve, add sodium bicarbonate solution to adjust pH to 6.5-7.5, add 10g gac, stir and decolorize, filter;

[0039] (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;

[0040] (3) Liquid-solid separation, after the ice melts, transfer to a crystallization 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, filter with suction, wash with ethanol, vacuum dry, and aseptically separate Pack, obtain cefamandole sodium finished product. The maximum impurity is 0.23%, and the total impurity is 0.52%.

Embodiment 2

[0042] (1) Take cefamandole sodium crude product 100g, add water 1000ml to dissolve, add sodium bicarbonate solution to adjust pH to 6.5-7.5, add 10g gac, stir and decolorize, filter;

[0043] (2) Add 7ml 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;

[0044] (3) Liquid-solid separation, after the ice melts, transfer to a crystallization 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, filter with suction, wash with ethanol, vacuum dry, and aseptically separate Pack, obtain cefamandole sodium finished product. The maximum simple impurity is 0.39%, and the total impurity is 0.59%.

Embodiment 3

[0046] (1) Take cefamandole sodium crude product 100g, add water 1000ml to dissolve, add sodium bicarbonate solution to adjust pH to 6.5-7.5, add 10g gac, stir and decolorize, filter;

[0047] (2) Add 10ml of diethyl ether 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, oscillate, freeze at -18°C for 3 hours, and then take it out;

[0048] (3) Remove the organic phase. After the ice melts, transfer it to a crystallization 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, filter with suction, wash with ethanol, dry in vacuum, and aseptically separate Pack, obtain cefamandole sodium finished product. The largest single impurity is 0.27%, and the total impurity is 0.54%.

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Abstract

The invention relates to a juvenile Cefamandole Nafate pharmaceutical composition, namely a pharmaceutical composite preparation of Cefamandole Nafate and low-sodium carrier infusion, in particular to a composite application package, comprising Cefamandole Nafate for injection and low-sodium carrier infusion. The low-sodium carrier infusion comprises glucose and sodium chloride injection ((15-200):1), glucose, sodium chloride and potassium chloride ((15-200):1:(0-1)) and the like. Compared with compatible mixed use of the Cefamandole Nafate and the low-sodium carrier infusion, the pharmaceutical composition has the advantages that clinical application step is simplified, clinical risks caused by a child with underdeveloped kidneys being unable to metabolize extra sodium in blood are decreased, and clinical application of medication for children is better in quality and safety.

Description

technical field [0001] The invention relates to a pharmaceutical composition of children's type cefamandole sodium and a low-sodium carrier, 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-carboxylic acid sodium salt, Chinese aliases: Mandoli, Cefuroxime. [0003] It is a second-generation cephalosporin. In addition to having the same effect as cefazolin, it also has antibacterial effects on some Gram-negative bacteria. The antibacterial spectrum is similar to that of cefotaxime, but 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, Klebsiella pneumoniae, i...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/546A61P31/04C07D501/36C07D501/12
Inventor 陈宇东厉达中
Owner ZHEJIANG CHANGDIAN PHARMA
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