Cefoxitin sodium compound-containing pharmaceutical composition

A technology of cefoxitin sodium and compounds, which is applied in the field of pharmaceutical compounds, can solve the problems affecting the quality of medicines, poor stability of cefoxitin sodium raw materials, large changes in color grade and content, etc., and the method is simple and feasible, and has excellent thermal stability The effect of sex and content is small

Active Publication Date: 2013-02-27
罗诚
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] However, the cefoxitin sodium bulk drug has always had the disadvantages of poor stability, especially its color level and content vary greatly, and it has strong hygroscopicity, which affects the quality of the drug.

Method used

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  • Cefoxitin sodium compound-containing pharmaceutical composition
  • Cefoxitin sodium compound-containing pharmaceutical composition
  • Cefoxitin sodium compound-containing pharmaceutical composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] [Example 1] Preparation of Cefoxitin Sodium Compound Crystal

[0046] 1) adding the crude product of cefoxitin sodium into a mixed solvent of n-butanol and tetrahydrofuran, stirring and dissolving to obtain a solution of cefoxitin sodium in n-butanol and tetrahydrofuran;

[0047] 2) Add diethyl ether dropwise to the n-butanol and tetrahydrofuran solution of cefoxitin sodium obtained in step 1) under an ultrasonic field until crystallization occurs;

[0048] 3) Turn off the ultrasonic field, cool down, let stand, filter, wash the filter cake with ethanol, and dry to obtain the cefoxitin sodium compound crystal.

[0049] The particle diameter of the cefoxitin sodium compound crystal of gained is 105 μ m, and this crystal uses Cu-Kα ray to measure, and the X-ray powder diffraction figure that obtains is as follows figure 1 As shown, its X-ray powder diffraction pattern represented by 2θ±0.2° diffraction angle is at 3.50°, 4.00°, 4.25°, 5.50°, 7.00°, 8.75°, 9.00°, 12.00°, ...

preparation Embodiment 1

[0056] [Preparation Example 1] Cefoxitin Sodium Powder Injection

[0057] Dispensing 80 g of cefoxitin sodium compound crystals and 20 g of mannitol into 1000 bottles under aseptic conditions to obtain cefoxitin sodium powder injection.

preparation Embodiment 2

[0058] [Preparation Example 2] Cefoxitin Sodium Powder Injection

[0059] 120 g of cefoxitin sodium compound crystals and 10 g of mannitol are aseptically packed into 1000 bottles to obtain the product.

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Abstract

The invention relates to a pefoxitin sodium compound-containing pharmaceutical composition. The pefoxitin sodium compound is crystal and has X-ray diffraction pattern shown by figure 1. A preparation method of the pharmaceutical composition comprises the steps of: 1) adding mixed solvent of n-butyl alcohol and tetrahydrofuran with 55-85 DEG C into pefoxitin sodium crude product, and stirring for dissolving to obtain the n-butyl alcohol and tetrahydrofuran solution of the pefoxitin sodium; 2) dripping diethyl ether into the n-butyl alcohol and tetrahydrofuran solution of the pefoxitin sodium obtained in the step 1) under the ultrasonic field until the crystal is separated out; and 3) closing the ultrasonic field, cooling, standing still, filtering, washing a filter cake by ethanol, and drying to obtain the pefoxitin sodium compound crystal. The pefoxitin sodium compound crystal has better stability and basically does not absorb moisture.

Description

technical field [0001] The invention belongs to the field of pharmaceutical compounds, in particular to a pharmaceutical composition containing cefoxitin sodium compound. Background technique [0002] Cefoxitin sodium is a cephamycin antibiotic, which is produced by Streptomyces Iactamdurans. It is a new class of antibiotics produced by semi-synthesis. Its mother nucleus is similar to cephalosporins. , and the antibacterial properties are also similar, and are also customarily included in the second-generation cephalosporins. Cefoxitin acts antibacterially by binding to one or more penicillin-binding proteins (PBPs), inhibiting cell wall biosynthesis in actively dividing cells of bacteria. Cefoxitin sodium is effective against Gram-negative bacteria Haemophilus influenzae, Klebsiella, Escherichia coli, Morganella morganii, Mirabilis proteus, Providencia rettgeri and Neisseria gonorrhoeae. Strong antibacterial effect. [0003] Cefoxitin sodium is especially suitable for pr...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D501/57C07D501/12A61K31/546A61P31/04
Inventor 罗诚
Owner 罗诚
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