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Cefbuperazone pharmaceutical composition and preparation method thereof

A technology of cefbuperazone and cefbuperazone acid, which is applied in the field of cephalosporin antibiotic pharmaceutical composition and its preparation, can solve the problems of uneven mixing and easy layering of the cefbuperazone pharmaceutical composition, and achieve good fluidity and dissolution fast effect

Inactive Publication Date: 2014-02-19
SHENZHEN SALUBRIS PHARMA CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The object of the present invention is to provide a kind of cefbuperazone pharmaceutical composition, is made up of the cefbuperazone acid in the specific particle diameter range and aseptic auxiliary agent, and the cefbuperazone pharmaceutical composition of the present invention has solved the problem of cephalosporin in the prior art. The problem of uneven mixing of the irazone pharmaceutical composition and easy stratification during storage and transportation, the obtained cefbuperazone pharmaceutical composition has a fast dissolution rate and good fluidity, and the product obtained by subpackaging complies with the pharmacopoeia about the difference in powder injection bottle weight and clarification of the solution degree and other index requirements

Method used

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  • Cefbuperazone pharmaceutical composition and preparation method thereof
  • Cefbuperazone pharmaceutical composition and preparation method thereof
  • Cefbuperazone pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Preparation of Cefrazone Acid Granules

[0025] Get 4 kilograms of cefbuperazone acid crystals, after being pulverized by a pulverizer, first pass through a 60-mesh sieve, and the resulting product is placed on a 70-mesh sieve and vibrated until no particles are sieved out to obtain cefbuperazone with a particle size range of 224 to 280 μm acid granules.

Embodiment 2

[0027] Preparation of L-arginine particles

[0028] Take 1 kg of L-arginine, pulverize it in a jet mill for 15 minutes, measure the particle size, and obtain L-arginine particles with a particle size ranging from 20 to 50 μm.

Embodiment 3

[0030] In this example, the aseptic co-solvent was screened based on the water-soluble time, clarity, and gas production of the aseptic co-solvent and the cefbuperazone acid composition. The method adopted is: add 1g of the composition (0.8g of cephrazone acid + 0.2g of auxiliary agent) to 50ml of water, and shake slightly. The results are shown in Table 1.

[0031] Table 1. Dissolving situation of cefbuperazone pharmaceutical composition

[0032] Sterile Auxiliary Clarity Gas production Sodium carbonate clarify gas production sodium bicarbonate clarify gas production L-Arginine clarify no gas

[0033] It can be seen from the data in the above table that sodium carbonate and sodium bicarbonate have the disadvantage of producing a large amount of gas, which will cause an increase in the internal pressure of the bottle when used, so L-arginine that does not produce gas is selected as an auxiliary agent.

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Abstract

A cefbuperazone pharmaceutical composition has the advantages of high uniformity, strong anti-layering performance, fast dissolving rate and good fluidity. A product obtained by packaging is accord with pharmacopeia index requirements about powder injection bottle weight difference, solution clarity and the like.

Description

technical field [0001] The present invention relates to a cephalosporin antibiotic pharmaceutical composition and a preparation method thereof, more specifically, the present invention relates to a cephbuperazone pharmaceutical composition for injection and a preparation method thereof. Background technique [0002] Cefbuperazone (Cefbuperazone, CAS 76610-84-9), also known as cephbuperazone acid, is a third-generation cephalosporin antibiotic developed by Toyama Chemical Industry Pharmaceutical Co., Ltd. in Japan in the 1970s and listed in 1985. Its antibacterial The effect is similar to that of cefmetazole, especially for Escherichia coli, Klebsiella, Citrobacter, Enterobacter, Serratia and indole-positive Proteus; β-lactamase is extremely stable and has a strong antibacterial effect on β-lactamase-producing bacteria. Cefbuperazone sodium (Cefbuperazone Sodium Salt, CAS 76648-01-6) is the sodium salt of cefbuperazone acid. The dosage form is cefbuperazone sodium powder in...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/14A61K31/546A61K47/18A61P31/04
Inventor 杨睿华怀杰
Owner SHENZHEN SALUBRIS PHARMA CO LTD
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