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Cefamandole nafate composition for the treatment of infectious diseases

A technology of cefamandole sodium and infectious diseases, which is applied in the field of medicine, can solve the problems of structural damage, unfavorable stability, and great harm to patients, and achieve the effects of low content of insoluble particles, suitable for clinical application, and simple preparation methods

Inactive Publication Date: 2015-11-18
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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  • Cefamandole nafate composition for the treatment of infectious diseases
  • Cefamandole nafate composition for the treatment of infectious diseases
  • Cefamandole nafate composition for the treatment of infectious diseases

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Example 1: Preparation of Cefamandole Sodium Crystals

[0027] (1) Grinding the crude product of cefamandole sodium, passing through a 60-mesh sieve, then adding it to deionized water whose volume is 6 times the weight of cefamandole sodium, and stirring at 130 rpm for 10 minutes;

[0028] (2) Add methanol whose volume is 4 times the weight of cefamandole sodium under stirring at 90 rpm, and raise the temperature to 30°C at the same time;

[0029] (3) After the solution is added, let it stand for 3 hours, and add dropwise a mixed solution of ethanol and chloroform whose volume is 8 times the weight of cefamandole sodium at 0°C under stirring at 150 rpm, and a mixture of ethanol and chloroform The volume ratio is 3:1, and the uniform dropwise addition is completed within 2 hours;

[0030] (4) After the dropwise addition, cool down to -5°C, continue to stir at a stirring rate of 80 rpm for 2 h, let stand for 1 h to precipitate crystals, filter, wash, and dry in vacuo t...

Embodiment 2

[0032] Example 2: Preparation of cefamandole sodium composition

[0033] The composition comprises: 1 part by weight of the cefamandole sodium crystal prepared by the present invention, and 0.001 part by weight of anhydrous sodium carbonate.

[0034] The preparation method is:

[0035] (1) Weigh cefamandole sodium crystals and anhydrous sodium carbonate in proportion and mix them thoroughly;

[0036] (2) Dispense into sterilized vials and stopper them.

Embodiment 3

[0037] Example 3: Preparation of cefamandole sodium composition

[0038] The composition comprises: 1 part by weight of the cefamandole sodium crystal prepared by the present invention, and 0.0015 part by weight of anhydrous sodium carbonate.

[0039] The preparation method is:

[0040] (1) Weigh cefamandole sodium crystals and anhydrous sodium carbonate in proportion and mix them thoroughly;

[0041] (2) Dispense into sterilized vials and stopper them.

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PUM

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Abstract

The present invention discloses a cefamandole nafate composition for the treatment of infectious diseases and belongs to the technical field of medicine. The composition comprises cefamandole nafate and anhydrous sodium carbonate; the cefamandole nafate is a novel crystalline form compound; and an X-ray powder diffraction pattern obtained by Cu-K alpha radiation measurement is shown as a figure 1. The cefamandole nafate novel crystalline form provided by the invention differs from the crystal structure in the prior art; experiment verification is pleasantly surprised to find that the novelcrystalline compound has high purity, good liquidity, good stability, low polymer content and no hygroscopicity, and is safe and reliable for clinical applications; powder prepared from the novel crystalline form compound has good stability, good compatibility stability with the solvent and very low content of insoluble particles, and is very suitable for clinical application.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a cefamandole sodium composition for treating infectious diseases. 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 ...

Claims

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Application Information

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IPC IPC(8): A61K31/546A61P31/04C07D501/36C07D501/12A61K9/19
Inventor 王贵宾
Owner QINGDAO LANSHENGYANG PHARMA & BIOTECH CO LTD
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