Aztreonam for injection and production method thereof

Abstract

The invention discloses a new aztreonam for injection and a production method thereof. The aztreonam for injection consists of beta crystal form aztreonam and L-arginine, and the weight ratio of the beta crystal form aztreonam to the L-arginine is 1:0.74-1:0.86, wherein the components of aztreonam and L-arginine both need to be ground with the granularity respectively capable of passing a medicinal sieve ranging from 80 meshes to 120 meshes, preferentially a medicinal sieve of 100 meshes. The aztreonam for injection has the advantage of ensuring the crystal form of the aztreonam for injectionsame as that of raw materials, as well as the advantages of accurate rate of two ingredients and subpackage dosage, small subpackage difference among every bottle, uniform mixing, no delamination of two ingredients in production, transportation and storage, and the like. Simultaneously, the invention reduces the impurities of ring-opening aztreonam to some extent.

Description

technical field [0001] The invention relates to pharmaceutical preparation technology, and more specifically relates to aztreonam for injection with uniform mixing, accurate dosage and low content of open-ring aztreonam impurities and a production method thereof. Background technique [0002] Aztreonam is a novel β-lactam antibiotic of monobactams. In 1978, it was first discovered in the culture solution of the soil bacterium Chromobacterium violaceum in New Jersey, USA, and it has now been synthesized. It was first developed by Bristol-Myers Squibb in the United States and first launched in Italy in 1984. It is the first monocyclic β-lactam antibiotic for clinical use. Aztreonam is a bacterial fungicide. It can quickly pass through the outer membrane wall of Gram-negative aerobic bacteria, 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, leading to cell lysis and death . [0003] Azt...

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Problems solved by technology

In addition, the vibration during storage, transportation, and subpackaging can easily lead to the separation of the two components, uneven mixing, and aztreonam and L-arginine cannot be fully contacted and protected, resulting in the solubility of aztreonam between each bottle , dissolution rate, stability, etc.

[0013] The 3rd, adopt the method of recrystallization after aztreonam and arginine are salified, and its advantage is that can guarantee two kinds of components packing dosage, ratio, stability, shortcoming is to use and loss poisonous organic solvent, not only to Potentially harmful effects on the body and not friendly to the environment

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