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Beta-lactamase antibiotic drug composition

A lactamase antibiotic and composition technology, which is applied in the field of pharmaceutical compositions composed of cefuroxime or its salt and sulbactam or its salt, can solve the problem of cefuroxime content deviation from the product label, poor content uniformity, Difficult to mix evenly etc.

Inactive Publication Date: 2013-03-20
SHENZHEN SALUBRIS PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] A pharmaceutical composition composed of cefuroxime or its salt and sulbactam or its salt is a two-component sterile powder drug for injection, because the two main drug raw materials each have special physical characteristics: such as intermolecular forces, Particle size, fluidity, charge, etc., are difficult to mix evenly in industrial production, which often leads to a large deviation of the content of cefuroxime or its salt and sulbactam or its salt from the product label, and the content uniformity is poor

Method used

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  • Beta-lactamase antibiotic drug composition
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  • Beta-lactamase antibiotic drug composition

Examples

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Embodiment 1

[0031] Embodiment 1 cefuroxime sodium and sulbactam sodium pharmaceutical composition

[0032] Pass the cefuroxime sodium raw material through a 24-mesh sieve, take the part that can pass through the 24-mesh sieve and then pass through the 80-mesh sieve, take the part that fails to pass through the 80-mesh sieve, weigh 80g, and weigh 40g of the sulbactam sodium raw material, put it into Mix in a mixer for 20 minutes, randomly select 6 points of the final mixed powder, carry out content determination (calculated as cefuroxime and sulbactam), calculate RSD% value, and investigate content uniformity.

Embodiment 2

[0033] Embodiment 2 cefuroxime sodium and sulbactam sodium pharmaceutical composition

[0034] Pass the cefuroxime sodium raw material through an 80 mesh sieve, take the part that can completely pass through the 80 mesh sieve and then pass through a 150 mesh sieve, take the part that fails to pass through the 150 mesh sieve, weigh 80g, and weigh 40g of the sulbactam sodium raw material, put it into Mix in a mixer for 20 minutes, randomly select 6 points of the final mixed powder, carry out content determination (calculated as cefuroxime and sulbactam), calculate RSD% value, and investigate content uniformity.

[0035] For the pharmaceutical composition of 80 g of cefuroxime sodium and 40 g of sulbactam sodium, the powder with a particle diameter of 80-150 mesh accounts for more than 96% of the total amount of the pharmaceutical composition.

Embodiment 3

[0036] Embodiment 3 cefuroxime sodium and sulbactam sodium pharmaceutical composition

[0037] Pass the cefuroxime sodium raw material through a 150-mesh sieve, take the part that can completely pass through the 150-mesh sieve, weigh 80g, and weigh 40g of the sulbactam sodium raw material, put it in a mixer and mix for 20 minutes, and randomly take 6 final mixed powders point, carry out content determination (based on cefuroxime and sulbactam), calculate the RSD% value, and examine the content uniformity.

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Abstract

The present invention provides a beta-lactamase antibiotic drug composition, which comprises cefuroxime or salt powder thereof, and sulbactam or salt powder thereof, wherein a particle size of the cefuroxime or the salt powder thereof is 80-150 mesh. According to the drug composition, a good content uniformity is provided, drug quality is ensured, and important significances are provided for medication safety and effectiveness.

Description

technical field [0001] The invention relates to a β-lactamase antibiotic pharmaceutical composition, in particular to a pharmaceutical composition composed of cefuroxime or its salt and sulbactam 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 drugs. [0003] In order to overcome the drug resistance caused by β-lactamase-producing bacteria to cefuroxime, an anti-β-lactamase antibiotic compound preparation composed of cefuroxime and sulbactam has been devel...

Claims

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Application Information

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IPC IPC(8): A61K31/546A61K31/43A61P31/04
Inventor 蔡燕霞
Owner SHENZHEN SALUBRIS PHARMA
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