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Anti-infective drug ceftezole sodium composition

A technology of ceftazole sodium and a composition is applied in the field of an anti-infective drug ceftazole sodium composition, which can solve the problems of structural damage, great harm to patients, unfavorable stability and the like, and achieves low content of insoluble particles, simple preparation method, Effects suitable for clinical application

Inactive Publication Date: 2015-12-02
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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  • Anti-infective drug ceftezole sodium composition
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  • Anti-infective drug ceftezole sodium composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Example 1: Preparation of Ceftezole Sodium Crystals

[0024] Get ceftezole sodium crude drug, add 30 ℃ volumes in the mixed solvent A of water, acetone, N-methylacetamide that is 8 times of the weight of ceftezole sodium, water, acetone, N-methylacetamide volume ratio Be 4:1:0.5, obtain solution; Apply the constant magnetic field that magnetic field intensity is 1.5T then on the horizontal direction of the liquid surface of gained solution, and drop volume is ceftezole sodium in the solution under the condition of this constant magnetic field Mixed solvent B of methanol, isobutanol, and ether with 10 times the weight, the volume ratio of methanol, isobutanol, and ether is 2:3:4; after the dropwise addition, cool down to 0°C, let stand for 3 hours, filter, and wash , vacuum-dried to obtain the ceftezole sodium crystals.

[0025] The X-ray powder diffraction figure that the prepared ceftezole sodium crystal uses Cu-Kα ray measurement to obtain is as follows figure 1 S...

Embodiment 2

[0026] Example 2: Preparation of Ceftezole Sodium Composition

[0027] The composition comprises: 1 part by weight of ceftezole sodium crystal prepared by the present invention, and 0.04 part by weight of sodium chloride.

[0028] The preparation method is:

[0029] (1) Weigh ceftezole sodium crystals and sodium chloride in proportion and mix them thoroughly;

[0030] (2) Dispense into sterilized vials and stopper them.

Embodiment 3

[0031] Example 3: Preparation of Ceftezole Sodium Composition

[0032] The composition comprises: 1 part by weight of ceftezole sodium crystal prepared by the present invention, and 0.05 part by weight of sodium chloride.

[0033] The preparation method is:

[0034] (1) Weigh ceftezole sodium crystals and sodium chloride in proportion and mix them thoroughly;

[0035] (2) Dispense into sterilized vials and stopper them.

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PUM

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Abstract

The invention discloses an anti-infective drug ceftezole sodium composition, which belongs to the field of medical technology, and comprises ceftezole sodium and sodium chloride, wherein the ceftezole sodium is crystals, and an X-ray powder diffraction diagram which is obtained by using Cu-Ka rays to measure is shown in a picture 1. A novel crystal of the ceftezole sodium is different form an existing crystal structure, the anti-infective drug ceftezole sodium composition is high in purity through experimental verification, is excellent in mobility, excellent in stability, low in polymer content, not easy to wet and reliable in clinical application. Power injections which are prepared through the anti-infective drug ceftezole sodium composition is excellent in stability, excellent in stability after being combined with solvent, extremely low in content of insoluble particles, and is extremely suitable for clinical application.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to an anti-infection drug ceftezole sodium composition. 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 extremely harmfu...

Claims

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Application Information

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