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Anti-infective medicinal cefazedone sodium sterile composition

A technology of cefazedone sodium and its composition, which is applied in the field of anti-infective drug cefazedone sodium composition, can solve the problems of affecting the safety of the drug, high content of related substances, high content of substances, etc., and achieve improved stability and good fluidity , good safety effect

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

Although the stability of the obtained cefazedone sodium powder injection of the present invention is relatively good, the content of related substances is still relatively high, and needs to be further reduced.
[0006] Patent CN101584671A discloses a cefzidone sodium powder injection, which is prepared by crushing and bottling the single main drug cefzidone sodium. The content is high, and the change is obvious after long-term storage, which affects the safety of the drug

Method used

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  • Anti-infective medicinal cefazedone sodium sterile composition
  • Anti-infective medicinal cefazedone sodium sterile composition
  • Anti-infective medicinal cefazedone sodium sterile composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Example 1: Preparation of Cefoxizone Sodium Crystals

[0028] (1) Take cefazedone sodium raw material and add it to deionized water, the volume of deionized water used is 3 times the mass of cefazedone sodium;

[0029] (2) Stir until completely dissolved, and adjust the pH to 6-7;

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

[0031] (4) Move the clarified solution into the pressure vessel, add dropwise the acetone solution at 10°C under the condition of controlling the pressure in the pressure vessel at 1.5Mpa and stirring, the stirring speed is controlled at 30rmp, and the volume of the acetone solution is deionized water 5 times the volume of

[0032] (5) Release the pressure after the dropwise addition, cool the solution to -5°C at a rate of 5°C / min, let it stand for 2 hours, filter, wash with ether, and dry under reduced pressure to obtain crystals of cefazedone sodium.

[0033] The X-ray powder diffraction patter...

Embodiment 2

[0034] Example 2: Preparation of Cefazedone Sodium Composition

[0035] The composition comprises: 1 part by weight of cefazedone sodium crystal prepared by the present invention, and 0.1 part by weight of sodium chloride.

[0036] The preparation method is:

[0037] (1) Weigh cefazedone sodium crystals and sodium chloride in proportion and mix them thoroughly;

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

Embodiment 3

[0039] Example 3: Preparation of Cefazedone Sodium Composition

[0040] The composition comprises: 1 part by weight of cefazedone sodium crystal prepared by the present invention, and 0.2 part by weight of sodium chloride.

[0041] The preparation method is:

[0042] (1) Weigh cefazedone sodium crystals and sodium chloride in proportion and mix them thoroughly;

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

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Abstract

The invention discloses an anti-infective medicinal cefazedone sodium composition, and belongs to the technical field of medicines. The composition consists of cefazedone sodium and sodium chloride; the cefazedone sodium is crystals; an X-ray powder diffraction pattern obtained by measuring the crystals by using Cu-K alpha rays is shown as figure 1; the main particle size of the crystals of the cefazedone sodium is 150 to 180 mu m, and the distribution width is 135 to 195 mu m. The new crystal form of the cefazedone sodium provided by the invention is different from the crystal form structure in the prior art; through experimental verification, people surprisingly find that powder-injection prepared by utilizing the new crystal form compound is high in mobility compared with the prior art; moreover, the content of impurities and the content of water are effectively reduced; the product is high in safety and high in stability.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to an anti-infection medicine cefazedone sodium composition. Background technique [0002] Infectious diseases are a common and frequently-occurring disease in clinical practice. According to the World Health Organization (WHO) report, the number of deaths from infectious diseases is as high as 33.3% of the total number of deaths from various causes. Cephalosporins are the most widely used first-line drugs in clinical practice. In recent years, due to the abuse of antibiotics, many "super bacteria" have emerged, and the problem of bacterial drug resistance has become increasingly serious. The "Administrative Measures for the Clinical Application of Antibacterial Drugs" officially implemented by the state restricts the clinical application of the third-generation and fourth-generation cephalosporins with strong alternatives. Therefore, there is an urgent need for clinically effecti...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/546A61K9/14A61P31/04C07D501/36
Inventor 刘学键
Owner QINGDAO HUAZHICAO PHARMA CO LTD
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