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Medicine ceftezole sodium composition for curing infectious diseases

A technology of ceftezole sodium and infectious diseases, which is applied in the field of ceftezole sodium compositions for the treatment of infectious diseases, can solve problems such as structural damage, great harm to patients, and unfavorable stability, and achieve low content of insoluble particles, The preparation method is simple and the effect suitable for clinical application

Inactive Publication Date: 2015-11-18
QINGDAO HUAZHICAO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The structure of ceftezole sodium contains an unstable β-lactam ring, which is prone to hydrolysis and rearrangement reactions, resulting in the destruction of the structure and the loss of antibacterial activity. Some degradation products may cause allergic reactions, so this type of antibiotics in the infusion The stability of the
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, ceftezole sodium is very easy to attract moisture, which has a very adverse effect on its stability.

Method used

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  • Medicine ceftezole sodium composition for curing infectious diseases
  • Medicine ceftezole sodium composition for curing infectious diseases
  • Medicine ceftezole sodium composition for curing infectious diseases

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Example 1: Preparation of Ceftezole Sodium Crystals

[0027] (1) Grind the crude product of ceftezole sodium, pass it through a 60-mesh sieve, then add it into deionized water whose volume is 6 times the weight of ceftezole sodium, and stir at 130 rpm for 10 minutes;

[0028] (2) Add methanol with a volume 4 times the weight of ceftezole 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 ceftezole sodium at 0°C under stirring at 150 rpm, and the volume of ethanol and chloroform The ratio is 3:1, and the uniform dropwise addition is completed within 2 hours;

[0030] (4) After the dropwise addition, the temperature was lowered to -5°C, and the stirring rate was continued at 80 rpm for 2 h, and the crystals were precipitated after standing for 1 h, filtered, washed, and va...

Embodiment 2

[0032] Example 2: Preparation of Ceftezole Sodium Composition

[0033] The composition comprises: 1 part by weight of ceftezole 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 ceftezole 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 Ceftezole Sodium Composition

[0038] The composition comprises: 1 part by weight of ceftezole 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 ceftezole 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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Abstract

The invention discloses a medicine ceftezole sodium composition for curing infectious diseases, belonging to the technical field of medicines. The composition is prepared from ceftezole sodium and anhydrous sodium carbonate; the ceftezole sodium is a crystal, and an X-ray powder diffraction pattern obtained by Cu-Kalpha ray measurement is shown as picture 1. The new crystal form of the ceftezole sodium provided by the invention is different from crystal form structures in the prior art, by means of experimental verification, the new crystal form compound is surprisedly found to be high in purity, good in mobility and stability, low in polymer content, free of hygroscopicity and safe and reliable in clinic application, and a powder-injection prepared by using the new crystal form compound is good in stability, good in stability after being matched with a solvent, extremely low in insoluble particle content and very suitable for clinic application.

Description

technical field [0001] The invention belongs to the technical field of medicines, and relates to a ceftezole sodium composition for treating infectious diseases. Background technique [0002] Ceftezole sodium is the first-generation cephalosporin for injection, developed by Fujisawa Company in Japan, and first listed in Japan, South Korea, Italy and other countries. The structure of ceftezole sodium contains an unstable β-lactam ring, which is prone to hydrolysis and rearrangement reactions, resulting in the destruction of the structure and the loss of antibacterial activity. Some degradation products may cause allergic reactions, so this type of antibiotics in the infusion The stability should be paid attention to widely. 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, which is ext...

Claims

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Application Information

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IPC IPC(8): A61K31/546A61K9/14A61P31/04C07D501/36C07D501/12
Inventor 刘学键
Owner QINGDAO HUAZHICAO PHARMA CO LTD
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