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Cefuroxime and tazobactam pharmaceutical composition

A technology of cefuroxime and tazobactam, which is applied to the active ingredients of heterocyclic compounds, antibacterial drugs, pharmaceutical formulations, etc., can solve problems such as poor clarity, incomplete dissolution, and static electricity, and achieve good solubility, The effect of fast dissolution

Inactive Publication Date: 2013-04-24
卓远清
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] A pharmaceutical composition composed of cefuroxime or its salt and tazobactam or its salt is a two-component sterile powder drug for injection, because the two main drug raw materials have special physical characteristics: such as intermolecular force , particle size, fluidity, charge, etc., are found in industrial production. When subpackaging, problems such as fluidity and static electricity are likely to affect the subpackaging of drugs and the labeled content of each component in the final product; the prepared Products often have slow dissolution rate, poor clarity, incomplete dissolution, partial sticking to the wall and other dissolution phenomena, which affect the quality of the product

Method used

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  • Cefuroxime and tazobactam pharmaceutical composition
  • Cefuroxime and tazobactam pharmaceutical composition
  • Cefuroxime and tazobactam pharmaceutical composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Example 1 Screening of Cefuroxime Sodium and Tazobactam Sodium with Different Particle Sizes

[0035] Take 1000 g of cefuroxime sodium and pass through 65 mesh sieve, 80 mesh sieve, 100 mesh sieve, 120 mesh sieve, 140 mesh sieve and 150 mesh sieve in sequence, respectively take the part that can pass through 65 mesh sieve and cannot pass through 80 mesh sieve (i.e. The powder within the particle size range of 180 μm to 250 μm is called “Fuxin A”), and the part that can pass through the 80 mesh sieve and cannot pass through the 100 mesh sieve (that is, the powder within the particle size range of 150 μm to 180 μm is called “Fuxin B” ), which can pass through a 100-mesh sieve and cannot pass through a 120-mesh sieve (that is, the powder within the particle size range of 125 μm to 150 μm is called “Fuxin C”), and can pass through a 120-mesh sieve and cannot pass through a 140-mesh sieve (that is, 106 μm The powder within the particle size range of 90 μm to 125 μm is called...

Embodiment 2

[0038] Embodiment 2 cefuroxime sodium and tazobactam sodium pharmaceutical composition

[0039] Tazobactam ("Bactan D" and "Bactam E") with different particle sizes screened in Example 1, and tazobactam with different particle sizes ("Fuxin A", "Fuxin B", "Fuxin C", "Fuxin D", "Fuxin E" and "Fuxin F"), respectively accurately weigh 0.66 g of each cefuroxime sodium and 0.33 g of each tazobactam sodium (weight ratio 2: 1), respectively packed in 10mL antibiotic glass, add 7mL distilled water, observe the dissolution effect and measure the dissolution time, the results are as follows:

[0040]

[0041] Note: In the above table, " / " in the dissolution phenomenon column means no sticking to the wall and small lumps.

[0042] From the results in the above table, it can be found that when “Bactan D” and “Bactan E” are repacked with cefuroxime sodium of different particle sizes, due to poor fluidity, it is difficult to repackage and it is difficult to ensure that the products are ...

Embodiment 3

[0043] Example 3 Pharmaceutical composition of cefuroxime sodium and tazobactam sodium

[0044] According to the experimental results of Example 1, "Bactan A", "Bactan B" and "Bactan C" were further selected and cefuroxime sodium with different particle sizes were subpackaged, and the subpackaging conditions were observed and the dissolution effect was determined. Tazobactam sodium ("Bactan A", "Bactan B" and "Bactam C") with different particle diameters screened in Example 1, and cefuroxime sodium with different particle diameters ("Fuxin A" , "Fuxin B", "Fuxin C", "Fuxin D", "Fuxin E" and "Fuxin F"), respectively accurately weigh 0.66g of cefuroxime sodium with each particle size and other Zobactam sodium 0.33g (weight ratio 2:1), cefuroxime sodium 0.75g of each particle size and tazobactam sodium 0.25g (weight ratio 3:1), cefuroxime sodium of each particle size 0.8 g and each particle size tazobactam sodium 0.2g (weight ratio 4:1), each particle size cefuroxime sodium 0.88...

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Abstract

The invention provides a cefuroxime and tazobactam pharmaceutical composition which comprises cefuroxime or salt powder of the cefuroxime, and tazobactam and salt powder of the tazobactam, wherein the cefuroxime or salt powder of the cefuroxime has the particle size of 106-250mu m, and the tazobactam and salt powder of the tazobactam has the particle size of more than 150mu m. The cefuroxime and tazobactam pharmaceutical composition has good solubility and dissolution rate, so that the product quality is effectively guaranteed, and the pharmaceutical composition has significance for medicament safety and effectiveness.

Description

technical field [0001] The invention relates to a pharmaceutical composition composed of cefuroxime or its salt and tazobactam or its salt. Background technique [0002] Cefuroxime (CXM) is a second-generation cephalosporin. As a broad-spectrum bactericidal antibiotic, it has strong antibacterial effect on Gram-positive bacteria and most Gram-negative bacteria. , Low nephrotoxicity. With the widespread clinical use of cefuroxime, some strains that were originally sensitive to cefuroxime developed resistance to cefuroxime, making its antibacterial effect decline. Studies have found that the main mechanism of bacterial resistance to cephalosporins is to produce specific β-lactamase to decompose the drug. [0003] In order to overcome the drug resistance caused by β-lactamase-producing bacteria to cefuroxime, an anti-β-lactamase antibiotic pharmaceutical composition composed of cefuroxime and tazobactam has been developed, for example, in Chinese patent document CN1513457A d...

Claims

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Application Information

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IPC IPC(8): A61K31/546A61K9/14A61P31/04A61K31/431
Inventor 蔡燕霞
Owner 卓远清