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Medicine cefamandole nafate composition for treating bacterial infection

A technology of cefamandole sodium and spamandole sodium, which is applied in the field of medicine, can solve problems such as structural damage, unfavorable stability, and great harm to patients, achieve low insoluble particle content, be suitable for clinical application, and have a simple preparation method Effect

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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  • Medicine cefamandole nafate composition for treating bacterial infection
  • Medicine cefamandole nafate composition for treating bacterial infection
  • Medicine cefamandole nafate composition for treating bacterial infection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Example 1: Preparation of Cefamandole Sodium Crystals

[0028] (1) Get cefamandole sodium crude drug, add deionized water, the volume consumption of deionized water is 9 times of the quality of cefamandole sodium;

[0029] (2) Stir until completely dissolved, and adjust the pH to 6-9;

[0030] (3) Add activated carbon for decolorization and filter to obtain a clear solution;

[0031] (4) Move the clarified solution into a pressure vessel, add dropwise 45% isopropanol aqueous solution at 0°C under the condition that the pressure in the pressure vessel is controlled at 1.5Mpa and stirred, the stirring speed is controlled at 25rmp, and the isopropanol aqueous solution The volume dosage is 3 times the volume of deionized water;

[0032] (5) Release the pressure after the dropwise addition, cool the solution to -5°C at a rate of 4°C / min, let it stand for 3.5 hours, filter, wash with ether, and dry under reduced pressure to obtain cefamandole sodium crystals.

[0033] Th...

Embodiment 2

[0034] Example 2: Preparation of cefamandole sodium composition

[0035] The composition comprises: 1 part by weight of cefamandole sodium crystal prepared by the present invention, and 0.003 part by weight of sodium dihydrogen phosphate.

[0036] The preparation method is:

[0037] (1) Weigh cefamandole sodium crystals and sodium dihydrogen phosphate in proportion, and mix them thoroughly;

[0038] (2) Dispense into sterilized vials and stopper them.

Embodiment 3

[0039] Example 3: Preparation of cefamandole sodium composition

[0040] The composition comprises: 1 part by weight of cefamandole sodium crystal prepared by the present invention, and 0.004 part by weight of sodium dihydrogen phosphate.

[0041] The preparation method is:

[0042] (1) Weigh cefamandole sodium crystals and sodium dihydrogen phosphate in proportion, and mix them thoroughly;

[0043] (2) Dispense into sterilized vials and stopper them.

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Abstract

The invention relates to a cefamandole nafate medicine composition for treating bacterial infection and belongs to the technical field of medicines. The composition is composed of cefamandole nafate and sodium dihydrogen phosphate; cefamandole nafate is a crystal and an X-ray powder diffraction pattern obtained through measurement of Cu-K(alpha) ray is shown in the graph I. The novel crystal form of cefamandole provided by the invention is different from the crystal form structure in the prior art, through experimental verification, the fact that the novel crystal form compound is high in purity, good in mobility and stability, low in polymer content, low in hygroscopicity, and safe and reliable during clinical application is found, powder-injection prepared from the novel crystal form compound is good in stability, good in stability after being combined with a solvent, and extremely low in content of insoluble particles and is particularly suitable for being applied clinically.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a cefamandole sodium composition for treating bacterial infection. 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): A61K31/546A61P31/04C07D501/36C07D501/12
Inventor 邢继华
Owner QINGDAO LANSHENGYANG PHARMA & BIOTECH CO LTD
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