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Cefpiramide sodium powder composition and preparation method thereof

A technology of cefpiramide and composition, applied in the field of cephalosporin drug powder injection composition, can solve the problems of high corrosion of equipment, slow dissolution speed, environmental pollution, etc., achieve fast dissolution speed, improved dissolution performance, and convenient clinical use Effect

Active Publication Date: 2011-12-21
SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The cefpiramide sodium crude drug prepared by this method is then prepared into cefpiramide sodium for injection, which has a slow dissolution rate in water, and can be mixed with toxic organic solvents in the product, which is unfavorable for injecting into the human body, and will be difficult to obtain during crystallization. A large amount of organic solvents are used in the process, which pollutes the environment and is highly corrosive to equipment

Method used

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  • Cefpiramide sodium powder composition and preparation method thereof
  • Cefpiramide sodium powder composition and preparation method thereof
  • Cefpiramide sodium powder composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] 2.5g cefpiramide is dissolved in the mixed solvent (the volume ratio of dimethylformamide and absolute ethanol is 10: 1) of the dimethylformamide of 5ml and dehydrated alcohol, first with speed be 1.5 ℃ / min Reduce the cefpiramide solution to 5°C at a speed of 0.5°C / min, then drop the cefpiramide solution to -5°C at a speed of 0.5°C / min, and stand at -5°C for 2 hours to obtain white crystals, filter, and filter cake After washing with acetone for 3 times and vacuum drying for 2 hours, cefpiramide crystals were obtained. After testing, the content of dimethylformamide in the obtained cefpiramide crystals was lower than 0.075%. Carry out X-ray powder diffraction to gained cefpiramide crystal (see figure 1 ), the diffraction peaks are displayed at the diffraction angles of 7.27°, 10.0°, 11.55°, 12.01°, 15.67°, 17.65°, 19.23°, 22.50°, 22.84°.

Embodiment 2

[0021] 2.5g cefpiramide is dissolved in the mixed solvent (the volume ratio of dimethylformamide and absolute ethanol is 12: 1) of the dimethylformamide of 5ml and dehydrated alcohol, first with speed be 1.0 ℃ / min Reduce the cefpiramide solution to 10°C at a speed of 0.7°C / min, then drop the cefpiramide solution to -10°C at a speed of 0.7°C / min, and stand at -10°C for 2 hours to obtain white crystals, filter, and filter cake After washing with acetone for 3 times and vacuum drying for 2 hours, cefpiramide crystals were obtained. After testing, the content of dimethylformamide in the obtained cefpiramide crystals was lower than 0.075%. The obtained cefpiramide crystals were analyzed by X-ray powder diffraction and hydrogen nuclear magnetic resonance, and the results were consistent with the obtained cefpiramide crystals in Example 1.

Embodiment 3

[0023] 2.5g cefpiramide is dissolved in the mixed solvent (the volume ratio of dimethylformamide and absolute ethanol is 15: 1) of the dimethylformamide of 5ml and dehydrated alcohol, first with speed be 1.2 ℃ / min Reduce the cefpiramide solution to 5°C at a speed of 0.5°C / min, then drop the cefpiramide solution to -7°C at a speed of 0.5°C / min, and stand at -7°C for 1 hour to obtain white crystals, filter, and filter cake After washing with acetone for 3 times and vacuum drying for 1 hour, cefpiramide crystals were obtained. After testing, the content of dimethylformamide in the obtained cefpiramide crystals was lower than 0.075%. The obtained cefpiramide crystals were analyzed by X-ray powder diffraction and hydrogen nuclear magnetic resonance, and the results were consistent with the obtained cefpiramide crystals in Example 1.

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Abstract

The invention relates to a cefpiramide sodium powder injection composition which contains cefpiramide crystals and anhydrous sodium carbonate, wherein the mass ratio of the cefpiramide crystals to the anhydrous sodium carbonate is (1:0.17)-(1:0.2); and in the X-ray powder diffraction, the main peaks of the cefpiramide crystals are displayed at the diffraction angles of 7.25 degrees + / -0.1 degree,10.04 degrees+ / -0.1 degree, 11.51 degrees+ / -0.1 degree, 12.04 degrees+ / -0.1 degree, 15.67 degrees+ / -0.1 degree, 17.65 degrees+ / -0.1 degree, 19.28 degrees+ / -0.1 degree, 22.52 degrees+ / -0.1 degree and 22.84 degrees+ / -0.1 degree. According to the invention, the water solubility of the cefpiramide crystals is improved to certain extent; when the cefpiramide crystals together with the anhydrous sodiumcarbonate are prepared into sterile powder injection, the amount of anhydrous sodium carbonate is greatly reduced, and the dissolution speed of the powder injection is high, that is to say, the powder injection can be completely dissolved in a short time, thereby being convenient for clinical use.

Description

technical field [0001] The invention relates to a cephalosporin drug powder composition, in particular to a cefpiramide powder composition and a preparation method for the powder injection. Background technique [0002] Cefpiramide Sodium (Cefpiramide Sodium) is a semi-synthetic third-generation cephalosporin antibiotic, which has the characteristics of broad antibacterial spectrum, strong antibacterial activity and stability to lactamase. It is effective against many Gram-positive cocci, including Staphylococcus and Enterococcus, and is also effective against Gram-negative bacilli and anaerobic bacteria. Among them, it has good antibacterial activity against Pseudomonas aeruginosa. Cefpiramide sodium is used for pneumonia caused by sensitive Gram-negative and positive bacteria such as Escherichia coli, Proteus, Klebsiella pneumoniae, Pseudomonas aeruginosa, influenza bacillus, pneumococcus, Staphylococcus aureus, acute bronchitis, Acute exacerbation of chronic bronchitis, ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D501/36C07D501/12A61K31/546A61K9/14A61P31/04
Inventor 李明杰李强贺成志
Owner SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD
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