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Antibacterial drug-cefamandole nafate composition

A technology for cefamandole sodium and an antibacterial drug, applied in the field of medicine, can solve the problems of structural damage, great harm to patients, unfavorable stability, etc., and achieves the effects of low content of insoluble particles, simple preparation method, and suitability for clinical application

Inactive Publication Date: 2015-10-28
QINGDAO LANSHENGYANG PHARMA & BIOTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] Cefamandole sodium is a broad-spectrum antibiotic that is effective against various diseases caused by gram-negative bacteria and gram-positive bacteria. It is widely used in clinical practice, but the structure of cefamandole sodium contains unstable The β-lactam ring is prone to hydrolysis and rearrangement reactions, leading to structural damage and loss of antibacterial activity, and some degradation products may cause allergic reactions, so the stability of this type of antibiotics in infusion solutions should attract extensive attention
At the same time, because its basic structure is the same as that of many semi-synthetic β-lactam antibiotics on the market, it will also form a high molecular weight polymer, which will also cause immediate allergic reactions in clinical use, which is extremely harmful to patients
At the same time, cefamandole sodium is very easy to attract moisture, which has a very adverse effect on its stability.

Method used

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  • Antibacterial drug-cefamandole nafate composition
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  • Antibacterial drug-cefamandole nafate composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Example 1: Preparation of Cefamandole Sodium Crystals

[0023] The cefamandole sodium crude product saturated methanol solution of preparation 30 ℃, then add the mixed solvent that volume is 5 times of isobutanol and sherwood oil of saturated methanol solution volume, the volume ratio of described isobutanol, sherwood oil is 2: 1.5. After stirring evenly, stir while cooling down. The cooling rate is 5°C / hour, and the stirring speed is 130 rpm. At the same time, add ether whose volume is 4 times the volume of the mixed solvent, stop stirring after cooling down to 0°C, and let stand to raise crystallized for 3 hours, filtered, and dried under reduced pressure to obtain cefamandole sodium crystalline compound.

[0024] The X-ray powder diffraction figure obtained by the cefamandole sodium crystal prepared using Cu-Kα ray measurement is as follows figure 1 Shown, its purity as determined by high performance liquid chromatography is 99.9%.

Embodiment 2

[0025] Example 2: The preparation method of cefamandole sodium composition, step is as follows:

[0026] The composition comprises: 1 part by weight of cefamandole sodium crystal prepared by the invention, and 0.001 part by weight of arginine.

[0027] The preparation method is:

[0028] (1) Weigh cefamandole sodium crystals and arginine in proportion and mix them thoroughly;

[0029] (2) Dispense into sterilized vials and stopper them.

Embodiment 3

[0030] Example 3: The preparation method of cefamandole sodium composition, step is as follows:

[0031] The composition comprises: 1 part by weight of cefamandole sodium crystal prepared by the present invention, and 0.002 part by weight of arginine.

[0032] The preparation method is:

[0033] (1) Weigh cefamandole sodium crystals and arginine in proportion and mix them thoroughly;

[0034] (2) Dispense into sterilized vials and stopper them.

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PUM

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Abstract

The invention relates to an antibacterial drug-a cefamandole nafate composition, and belongs to the technical field of medicine. The composition is composed of cefamandole nafate and arginine, the cefamandole nafate is a crystal, and an X-ray powder diffraction pattern obtained by measuring with a Cu-K alpha ray is shown as figure 1. The antibacterial drug cefamandole nafate composition is different from a crystal structure of the prior art, and it is surprised to find that the crystal composition is high in purity, good in fluidity and stability, low in polymer content, not prone to absorbing moisture and safe and reliable in clinical application through experimental verification; a powder injection prepared by utilizing the novel crystal composition is good in stability, good in stability after being combined with solvent, extremely low in insoluble particle content, and very suitable for clinical application.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to an antibacterial drug cefamandole sodium composition. Background technique [0002] Cefamandole sodium is a broad-spectrum antibiotic that is effective against various diseases caused by gram-negative bacteria and gram-positive bacteria. It is widely used in clinical practice, but the structure of cefamandole sodium contains unstable The β-lactam ring of β-lactam is prone to hydrolysis and rearrangement reactions, resulting in structural damage and loss of antibacterial activity. Some degradation products may cause allergic reactions. Therefore, the stability of this type of antibiotic in infusion solutions should attract extensive attention. At the same time, because its basic structure is the same as that of many semi-synthetic β-lactam lactam antibiotics on the market, it will also form high molecular polymers, which will also cause immediate allergic reactions in clinical use,...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/546C07D501/36C07D501/12A61P31/04A61K31/198
Inventor 刘学键
Owner QINGDAO LANSHENGYANG PHARMA & BIOTECH CO LTD
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