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Cefoperazone sodium and tazobactam sodium medicinal composition for injection and preparation method thereof

A technology of cefoperazone sodium and tazobactam sodium, which is applied in the field of medicine, can solve the problems of prolonging the production cycle, taking a long time, increasing costs, etc., and achieve the effects of stable product quality, improved product quality, and avoiding degradation

Active Publication Date: 2015-05-06
CHENGDU EASTON BIOPHARMACEUTICALS CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

As we all know, it takes a lot of time to crush and sieve materials, the production cycle is greatly extended, the relative humidity is controlled in a low range, and the requirements for the production workshop environment are further increased, thereby increasing costs.

Method used

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  • Cefoperazone sodium and tazobactam sodium medicinal composition for injection and preparation method thereof
  • Cefoperazone sodium and tazobactam sodium medicinal composition for injection and preparation method thereof
  • Cefoperazone sodium and tazobactam sodium medicinal composition for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Example 1 Cefoperazone Sodium and Tazobactam Sodium for Injection (in 1000 pieces, unit: g)

[0037] cefoperazone sodium

[0038] Preparation process: Inject 500ml of water for injection into the liquid mixing tank, cool down to lower the temperature below 20°C, add 2g of polyethylene glycol 15-hydroxystearate, stir until dissolved, then add 200g of cefoperazone sodium and 50g of tazoba Stir the sodium tannin until dissolved; adjust the pH to 6.01 with 1% meglumine solution, add water for injection lower than 20°C to the full amount, fine filter with a 0.22 μm microporous membrane until clear, and conduct semi-finished product inspection; Sealed in a vial, freeze-dried; crimped, sealed, and packaged.

Embodiment 2

[0039] Example 2 Cefoperazone Sodium and Tazobactam Sodium for Injection (in 1000 pieces, unit: g)

[0040] cefoperazone sodium

[0041] Preparation process: Inject 500ml of water for injection into the liquid mixing tank, cool down to lower the temperature below 20°C, add 4g of polyethylene glycol 15-hydroxystearate, stir until dissolved, then add 200g of cefoperazone sodium and 50g of tazoba Stir sodium tannin until dissolved; use 1% meglumine solution to adjust the pH to 6.25, then add water for injection lower than 20°C to the full amount, fine filter with a 0.22 μm microporous membrane until clear, and conduct semi-finished product inspection; Sealed in a vial, freeze-dried; crimped, sealed, and packaged.

Embodiment 3

[0042] Example 3 Cefoperazone Sodium and Tazobactam Sodium for Injection (in 1000 pieces, unit: g)

[0043] cefoperazone sodium

[0044] Preparation process: Inject 500ml of water for injection into the liquid mixing tank, cool down to lower the temperature below 20°C, add 10g of polyethylene glycol 15-hydroxystearate, stir until dissolved, then add 200g of cefoperazone sodium and 50g of tazoba Stir sodium tannin until dissolved; use 1% meglumine solution to adjust the pH to 6.93, then add water for injection lower than 20°C to the full amount, fine filter with a 0.22 μm microporous membrane until clear, and conduct semi-finished product inspection; Sealed in a vial, freeze-dried; crimped, sealed, and packaged.

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Abstract

The invention relates to a cefoperazone sodium and tazobactam sodium medicinal composition for injection and a preparation method thereof. The cefoperazone sodium and tazobactam sodium medicinal composition for injection, prepared by adopting the prescription and the process, is stable in quality and quick in re-solution, and can be stable for a long time in the placement process, so that the product stability is greatly improved; the product has high physiological tolerance, painless administration can be realized even the medicinal composition is high in concentration, no hemolysis or irritation happens, and the safety is better.

Description

technical field [0001] The invention relates to a pharmaceutical composition for injection and a preparation process thereof, in particular to a pharmaceutical composition of cefoperazone sodium tazobactam sodium for injection and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Cefoperazone Sodium and Tazobactam Sodium for Injection is a compound preparation composed of cefoperazone sodium and tazobactam sodium in a certain proportion. Most of the currently marketed products are produced by aseptic subpackaging, but this process has very high requirements on the sterility of raw materials, so passing them through the sterilizing and filtering process in the freeze-drying process can reduce the requirements on the asepticity of raw materials. [0003] The Chinese patent application number 201110260244.X discloses a preparation method of cefoperazone sodium and tazobactam sodium composition for injection. The patent imp...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/546A61P31/04A61K31/431
Inventor 王颖
Owner CHENGDU EASTON BIOPHARMACEUTICALS CO LTD
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