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Drug composition of cefoperazone sodium and tazobactam sodium and preparation method thereof

A technology of cefoperazone sodium and tazobactam sodium, which is applied in the field of medicine, can solve problems such as the increase of polymer impurity content, the decrease of drug active ingredient content, and the impact on product stability, effectiveness, and safety, achieving good stability, The effect of reducing the content of impurities

Inactive Publication Date: 2013-08-07
四川省惠达药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] However, due to the hygroscopicity of cefoperazone sodium, it will cause changes in physical and chemical properties such as agglomeration, decreased fluidity, deliquescence, and crystal form changes after moisture absorption, thereby affecting internal quality such as product stability, effectiveness, and safety.
And because cefoperazone sodium is a weak acid and strong base salt, the mother nucleus in the chemical structure contains an unstable β-lactam ring, which is easily hydrolyzed and degraded; in the storage process, degradation and polymerization often occur because of thermal instability, thereby Leading to a decrease in the content of active ingredients in the drug and an increase in the content of polymer impurities

Method used

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  • Drug composition of cefoperazone sodium and tazobactam sodium and preparation method thereof
  • Drug composition of cefoperazone sodium and tazobactam sodium and preparation method thereof
  • Drug composition of cefoperazone sodium and tazobactam sodium and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] [Example 1] Preparation of Cefoperazone Sodium Compound

[0044] 1) Dissolve 12kg of crude cefoperazone sodium in 10L of water to obtain a 1.2kg / L aqueous solution of cefoperazone sodium;

[0045] 2) Add activated carbon to the cefoperazone sodium aqueous solution in step 1) (the amount of activated carbon is 0.3% g / ml of the volume of the cefoperazone sodium aqueous solution), stir, suction filter, and take the filtrate;

[0046]3) Add 50L of organic solvent A to the filtrate of step 2) at a stirring speed of 50r / min (the flow rate of organic solvent A is 13L / min) to form a turbid solution, wherein the organic solvent A is methanol A mixed solvent composed of tetrahydrofuran and tetrahydrofuran at a volume ratio of 2:1;

[0047] 4) After adjusting the stirring speed to 15r / min, add 300L of organic solvent B to the turbid solution in step 3) (the flow rate of organic solvent B is 12L / min). It is a mixed solvent composed of isobutyl methyl ketone and dimethyl formamide...

Embodiment 2

[0050] [embodiment 2] the preparation of cefoperazone sodium compound

[0051] 1) Dissolve 26kg of crude cefoperazone sodium in 10L of water to obtain a 2.6kg / L aqueous solution of cefoperazone sodium;

[0052] 2) Add activated carbon to the cefoperazone sodium aqueous solution in step 1) (the amount of activated carbon is 0.3% g / ml of the volume of the cefoperazone sodium aqueous solution), stir, suction filter, and take the filtrate;

[0053] 3) Add 100L of organic solvent A to the filtrate of step 2) at a stirring speed of 60r / min (the flow rate of organic solvent A is 20L / min) to form a turbid solution, wherein the organic solvent A is methanol A mixed solvent composed of tetrahydrofuran and tetrahydrofuran at a volume ratio of 5:1;

[0054] 4) After adjusting the stirring speed to 25r / min, add 200L of organic solvent B to the turbid solution in step 3) (the flow rate of organic solvent B is 6L / min). It is a mixed solvent composed of isobutyl methyl ketone and dimethyl f...

Embodiment 3

[0057] [embodiment 3] the preparation of cefoperazone sodium compound

[0058] 1) Dissolve 20kg of crude cefoperazone sodium in 10L of water to obtain a 2.0kg / L aqueous solution of cefoperazone sodium;

[0059] 2) Add activated carbon to the cefoperazone sodium aqueous solution in step 1) (the amount of activated carbon is 0.3% g / ml of the volume of the cefoperazone sodium aqueous solution), stir, suction filter, and take the filtrate;

[0060] 3) Add 80L of organic solvent A to the filtrate of step 2) at a stirring speed of 55r / min (the flow rate of organic solvent A is 15L / min) to form a turbid solution, wherein the organic solvent A is methanol A mixed solvent composed of tetrahydrofuran and tetrahydrofuran at a volume ratio of 3.5:1;

[0061] 4) After adjusting the stirring speed to 20r / min, add 100L of organic solvent B to the turbid solution in step 3) (the flow rate of organic solvent B is 8L / min). It is a mixed solvent composed of isobutyl methyl ketone and dimethyl ...

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Abstract

The invention belongs to the technical field of medicines and in particular relates to a drug composition of cefoperazone sodium and tazobactam sodium and a preparation method thereof. The drug composition is sterile powder injection. The mass ratio of cefoperazone sodium to tazobactam sodium in the drug composition is (4-8):1, wherein cefoperazone sodium is shown in a drawing 1, an X-ray powder diffraction pattern obtained by powder X-ray diffractometry and the chemical structural formula of cefoperazone sodium is shown in the formula (I) in the specification. Compared with the prior art, the cefoperazone sodium compound used in the drug composition has lower hygroscopicity and good thermal stability, thus improving the stability of the drug composition of cefoperazone sodium and tazobactam sodium and reducing the impurity content.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a pharmaceutical composition of cefoperazone sodium and tazobactam sodium and a preparation method thereof. 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. Ta...

Claims

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Application Information

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IPC IPC(8): A61K31/546C07D501/36C07D501/12A61P31/04A61K31/431
Inventor 闫晓晔
Owner 四川省惠达药业有限公司
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