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Pharmaceutical composition for treating infectious diseases and preparation thereof

A technology for infectious diseases and compositions, which is applied in the field of compositions of cefazedone sodium for injection, can solve the problems of high content of related substances, affecting drug safety, high content of substances, etc., and achieves improved stability, good fluidity, good safety effect

Inactive Publication Date: 2015-08-12
苗怡文
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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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  • Pharmaceutical composition for treating infectious diseases and preparation thereof
  • Pharmaceutical composition for treating infectious diseases and preparation thereof
  • Pharmaceutical composition for treating infectious diseases and preparation thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Example 1: Preparation of Cefoxizone Sodium Crystals

[0026] Prepare 30 DEG C of cefazedone sodium crude product saturated aqueous solution, then add the mixed solvent of n-butanol, acetone and sherwood oil of saturated solution volume 30%, the volume ratio of the mixed solvent of described n-butanol, acetone and sherwood oil is 4:8:12, after stirring evenly, stir while cooling down, the cooling rate is 5-10°C / hour, and the stirring speed is 100-110 rpm After ℃, the stirring was stopped, and the crystals were left to grow for 3 hours, filtered, and dried under reduced pressure at 35 ℃ for 6 hours to obtain cefazedone sodium crystals.

[0027] The X-ray powder diffraction pattern obtained by the cefazedone sodium crystal prepared using Cu-Kα ray measurement is as follows figure 1 As shown, the main particle size of the cefazedone sodium crystal is 40-50 μm, and the distribution width is 25-65 μm through scanning electron microscope observation and particle size analy...

Embodiment 2

[0028] Example 2: Preparation of Cefazedone Sodium Composition

[0029] The composition comprises: 1 part by weight of cefazedone sodium crystal prepared by the present invention, and 0.3 part by weight of anhydrous sodium carbonate.

[0030] The preparation method is:

[0031] (1) Weigh cefazedone sodium crystals and anhydrous sodium carbonate in proportion, and mix them thoroughly;

[0032] (2) Dispense into sterilized vials and stopper them.

Embodiment 3

[0033] Example 3: Preparation of Cefazedone Sodium Composition

[0034] The composition comprises: 1 part by weight of the cefazedone sodium crystal prepared by the present invention, and 0.5 part by weight of anhydrous sodium carbonate.

[0035] The preparation method is:

[0036] (1) Weigh cefazedone sodium crystals and anhydrous sodium carbonate in proportion, and mix them thoroughly;

[0037] (2) Dispense into sterilized vials and stopper them.

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Abstract

The invention relates to a pharmaceutical composition for treating infectious diseases and a preparation thereof, specifically to a composition of cefazedone sodium for injection. The composition comprises cefazedone sodium and anhydrous sodium carbonate, wherein the cefazedone sodium is a crystal, and in the X-ray powder diffraction pattern of the crystal measured by using Cu-K alpha rays, cefazedone sodium has characteristic peaks at diffraction angles 6.5 DEG, 8.2 DEG, 9.5 DEG, 16.4 DEG, 17.0 DEG, 19.2 DEG, 23.1 DEG, 23.9 DEG, 26.0 DEG, 27.4 DEG, 29.8 DEG, and 32.1 DEG. According to verification results of test, it is found out that compared with prior art, a powder injection prepared from the compound with the novel crystal form has good fluidity, effectively reduced impurity and moisture contents, good security and high stability.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a pharmaceutical composition for treating infectious diseases and a preparation thereof, in particular to a composition of cefazedone sodium for injection. 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 c...

Claims

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Application Information

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IPC IPC(8): A61K31/546A61K9/14A61P31/04C07D501/36C07D501/12
Inventor 王玉美
Owner 苗怡文
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