A kind of cefoperazone sodium tazobactam sodium pharmaceutical composition

A technology of tazobactam sodium and cefoperazone sodium, which is applied in the field of medicine, can solve the problems of poor stability, high content of related substances, uncontrollable quality and other problems of cefoperazone sodium and tazobactam sodium pharmaceutical composition, so as to improve drug safety and reduce related substances , quality controllable effect

Active Publication Date: 2011-12-14
江西璟瑞药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0008] None of the above patents can solve the problems of poor stability, high content of related substances and uncontrollable quality of cefoperazone sodium and tazobactam sodium pharmaceutical composition

Method used

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  • A kind of cefoperazone sodium tazobactam sodium pharmaceutical composition
  • A kind of cefoperazone sodium tazobactam sodium pharmaceutical composition
  • A kind of cefoperazone sodium tazobactam sodium pharmaceutical composition

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] The preparation method of the tazobactam sodium provided by the present invention is as follows: N, N-dimethylformamide and acetone are formulated into a mixed solvent with a volume ratio of 3:1, 100 g of the tazobactam sodium bulk drug is taken, and N , 850ml of mixed solvent of N-dimethylformamide and acetone, stirred until completely dissolved, and adjusted the pH of the solution to 5.5 with acetic acid. The solution was flowed through a 0.5T DC magnetic field at a speed of 10m / s, and the direction of the magnetic field was perpendicular to the flow direction of the solution. After the solution has undergone a magnetic treatment, add activated carbon to decolorize, filter to obtain a clear solution, add 5100ml cyclohexane to the clear solution, filter to obtain a filter cake, wash the filter cake with acetone, and then dry it under reduced pressure for 4 hours to obtain a white microcrystalline powder. The yield is 90.5%, and the purity is 99.85% by high-performance...

Embodiment 2

[0044] The preparation method of the tazobactam sodium provided by the invention is as follows: N, N-dimethylformamide and acetone are formulated into a mixed solvent with a volume ratio of 1:1, and 100 g of the tazobactam sodium bulk drug is taken, and N , 1050ml of a mixed solvent of N-dimethylformamide and acetone, stirred until completely dissolved, and adjusted the pH of the solution to 5.0 with acetic acid. The solution was flowed through a 0.5T DC magnetic field at a speed of 7m / s, and the direction of the magnetic field was perpendicular to the flow direction of the solution. After the solution is magnetically treated once, add activated carbon for decolorization, filter, and then filter with a 0.22 μm ultrafiltration membrane to obtain a clear solution, add 4200ml cyclohexane to the clear solution, filter to obtain a filter cake, wash the filter cake with acetone, and then Dry under reduced pressure for 2 hours to obtain white microcrystalline powder. The yield was 8...

Embodiment 3

[0048] The preparation method of the tazobactam sodium provided by the present invention is: N,N-dimethylformamide and acetone are formulated into a mixed solvent with a volume ratio of 2:1, take 100g of the tazobactam sodium bulk drug, add N , N-dimethylformamide and acetone mixed solvent 900ml, stirred until completely dissolved, the pH of the solution was adjusted to 5.3 with acetic acid. The solution was flowed through a 0.5 T DC magnetic field at a speed of 15 m / s, and the direction of the magnetic field was perpendicular to the direction of solution flow. After the solution has undergone a magnetic treatment, add activated carbon to decolorize, filter to obtain a clear solution, add 5100ml cyclohexane to the clear solution, filter to obtain a filter cake, wash the filter cake with acetone, and then dry it under reduced pressure for 2 to 4 hours, namely A white microcrystalline powder was obtained. The yield was 89.1%, and the purity was 99.87% by high-performance liquid...

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Abstract

The invention relates to a medicinal composition of cefoperazone sodium and tazobactam sodium. The medicinal composition comprises the following components in part by weight: 4 to 8 parts of cefoperazone sodium and 1 part of tazobactam sodium, wherein the tazobactam sodium is measured by a powder X-ray diffraction measuring method, and characteristic diffraction peaks are shown at the positions of 6.9 degrees, 10.5 degrees, 11.4 degrees, 16.6 degrees, 19.2 degrees, 22.7 degrees, 27.0 degrees, 29.7 degrees and 33.5 degrees in an X-ray powder diffraction map expressed by a diffraction angle of between 2 theta+/-0.2 degree. The medicinal composition has the advantages of high stability, low relevant substance content, controllable quality and the like, and the administration safety of patients is improved. The invention also relates to a method for preparing the tazobactam sodium with the technical characteristics of the characteristic diffraction peaks.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a cefoperazone sodium tazobactam sodium pharmaceutical composition. Background technique [0002] Cefoperazone sodium is a representative of the third-generation cephalosporins. It exerts antibacterial effects by inhibiting the synthesis of bacterial cell walls. It belongs to lactam antibiotics. Compared with other third-generation cephalosporins, it has a broad antibacterial spectrum and strong antibacterial effect. It has the advantages of low toxicity, good curative effect, and less allergic reaction, so it has been widely used clinically since it was launched. Tazobactam sodium has no antibacterial activity against other bacteria except Neisseriaceae and Acinetobacter, but tazobactam is effective against most important β-lactamases produced by β-lactam antibiotic-resistant strains Has an irreversible inhibitory effect. Tazobactam can prevent drug-resistant bact...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/546A61K31/431A61P31/04
Inventor 周晓东夏智红
Owner 江西璟瑞药业有限公司
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