Aztreonam composition freeze-dried powder for injection

Abstract

The invention provides an aztreonam composition freeze-dried powder for injection, relating to the technical field of drugs and drug preparation. The aztreonam composition freeze-dried powder comprises the following raw material components in parts by weight: 9.47-11.58 parts of aztreonam, 4.74-5.79 parts of chitosan nanoparticles and 75.79-92.63 parts of water for injection. The aztreonam composition freeze-dried powder has the advantages: (1) a composition composed of aztreonam and chitosan nanoparticles according to the proportion of 1:0.5 not only can be used for improving the solubility of aztreonam in water, but also can be used for shortening the dissolving time of aztreonam so as to be beneficial for clinical application; (2) the composition can be used for remarkably enhancing the antibacterial effect of aztreonam and can be used for clinically reducing the dosage and adverse reaction of aztreonam, and an in-vitro experiment proves that 0.2g of aztreonam containing the chitosan nanoparticles has the same antibacterial effect with 0.4g of aztreonam not containing the chitosan nanoparticles; (3) the chitosan nanoparticles can be used as a freeze-dried skeleton agent of the freeze-dried powder for injection to replace arginine, so that the activation effect of arginine to human bodies is eliminated.

Description

Technical field: [0001] The invention relates to the technical field of medicine and medicine manufacture, in particular to a freeze-dried powder injection of aztreonam composition for injection. Background technique: [0002] Aztreonam is a synthetic monocyclic β-lactam antibiotic. Its antibacterial mechanism is that it can quickly pass through the outer membrane wall of Gram-negative aerobic cells, and has a high affinity for penicillin-binding protein 3 (PBP-3). By acting on PBP-3, it inhibits the synthesis of bacterial cell walls, resulting in Cell lysis and death. Aztreonam has a high degree of antibacterial activity against most aerobic Gram-negative bacteria, including Escherichia coli, Klebsiella pneumoniae and Oxitoella, Bacillus aerogenes, Bacillus cloacae, Serratia, Enterobacteriaceae such as Citrobacter and Shigella, as well as influenza bacilli, Neisseria gonorrhoeae, Neisseria meningitidis, etc., also have good antibacterial effects on Pseudomonas aeruginosa....

AI Technical Summary

Problems solved by technology

[0005] However, there are deficiencies in the above methods; first, aztreonam and arginine are aseptically subpackaged after mixing, and the two are difficult to mix evenly, and the shock in the subpackaging process, storage, and transportation process easily cause the two to stratify. Inhomogeneous mixing, resulting in inconsistent stability from bottle to bottle

Secondly, after aztreonam and arginine are used to form a salt, the method of recrystallization has the disadvantage of using lossy and toxic organic solvents, which is not environmentally friendly

Third, when used together with arginine, the amount of use is relatively large, and the side effects are also relatively large

[0007] Chitosan nanoparticles are microparticles with a particle size of less than 100nm. As a drug carrier, they have sustained-release and targeting effects, but there is no clinically available pharmaceutical dosage form containing chitosan nanoparticles.

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