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Aztreonam compound, as well as preparation method and pharmaceutical composition thereof

An aztreonam and compound technology, applied in the field of medicine, can solve problems such as product pollution, achieve the effects of less impurity content, high safety performance, and improved drug safety

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

However, the resulting product is susceptible to contamination by organic solvents

Method used

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  • Aztreonam compound, as well as preparation method and pharmaceutical composition thereof
  • Aztreonam compound, as well as preparation method and pharmaceutical composition thereof
  • Aztreonam compound, as well as preparation method and pharmaceutical composition thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0055] Preparation of aztreonam compound:

[0056] Dissolve 50 g of aztreonam crude drug completely in 150 ml of mixed solvent of dimethyl sulfoxide / acetone, the volume ratio of dimethyl sulfoxide to acetone is 5:1, and adjust the pH value of the liquid with triethylamine or acetic acid to 4.0, then add activated carbon, stir and adsorb for 30 minutes, filter for decarbonization and sterilization, add activated carbon in an amount of 0.2% g / ml of the total volume of the medicinal solution, and obtain a clear solution, move the clear solution into a pressure vessel, and put it in the pressure vessel Under the conditions of pressure of 1Mpa and temperature of the clear solution in the pressure vessel at 65°C, slowly add ethanol and stir, the volume ratio of ethanol to mixed solvent is 5:1, and the stirring speed is 27rpm when adding ethanol dropwise, resulting in a white precipitate. Filter, wash twice with ethanol and deionized water successively, and dry under reduced pressure...

Embodiment 2

[0059] Preparation of aztreonam compound:

[0060] Dissolve 50 g of aztreonam crude drug completely in 250 ml of a mixed solvent of dimethyl sulfoxide / acetone, the volume ratio of dimethyl sulfoxide to acetone is 7:1, and adjust the pH value of the liquid with triethylamine or acetic acid to 5.0, then add activated carbon, stir and adsorb for 30min, filter for decarburization and sterilization, add activated carbon in an amount of 0.3% g / ml of the total volume of the medicinal solution, and obtain a clear solution, move the clear solution into a pressure vessel, and The pressure is 1Mpa, the temperature of the clear solution in the pressure vessel is 75°C, slowly add ethanol and stir, the volume ratio of ethanol to mixed solvent is 8:1, and the stirring speed is 28rpm when ethanol is added dropwise, and a white precipitate is produced. Filter, wash twice with ethanol and deionized water successively, and dry under reduced pressure to obtain white microcrystalline powder. Yiel...

Embodiment 3

[0063] Aztreonam sterile powder injection

[0064] Weigh 100 g of aztreonam and 50 g of arginine prepared in Example 1 under aseptic conditions, place them in a solid powder mixer and mix them uniformly, and transfer the obtained raw materials to a sterile preparation workshop for precise metering and packaging. Each bottle contains ammonia Qunan 1.0g, stoppered and capped, the finished product is packaged for storage and sent for inspection.

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PUM

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Abstract

The invention provides an aztreonam compound. The structural formula of the aztreonam compound is as shown in the specification, and an X-ray powder diffraction spectrum of the aztreonam compound, which is obtained by using Cu-K alpha rays to measure, is as shown in Figure 1. The invention further provides a preparation method of the aztreonam compound and a pharmaceutical composition containing the aztreonam compound. The formulations of an aztreonam medicament are of sterile powder for injection and freeze-dried powder for injection. Compared with the prior art, the aztreonam compound and the pharmaceutical composition thereof, provided by the invention, have the advantages of better stability in storage and flowability, and can greatly improve the medication safety of patients.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to an aztreonam compound, a preparation method of the aztreonam compound and a pharmaceutical composition containing the aztreonam compound. Background technique [0002] Aztreonam (Aztreonam) is an antibacterial drug developed by Bristol-Myers Squibb Company in the United States. It was listed in Italy in 1984. It is the first monocyclic β-lactam antibiotic used in clinical practice. It has a strong effect on Gram-negative bacilli. Antibacterial activity, stable against β-lactamase. In recent years, with the widespread application of antibacterial drugs, the proportion of Gram-negative bacilli infection has increased significantly, and the drug-resistant strains have also increased significantly, making the clinical efficacy of cephalosporin antibiotics far worse than before. However, because of its unique structure, aztreonam makes bacteria sensitive to it, so it is ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D417/12A61K31/427
Inventor 闫晓晔梁宏平
Owner 四川省惠达药业有限公司
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