Anti-infective medicine of cefamandole nafate composition

Abstract

The invention discloses an anti-infective medicine of a cefamandole nafate composition, and belongs to the technical field of medicine. The composition comprises components including cefamandole nafate and sodium chloride; the cefamandole nafate is crystals; an X-ray powder diffraction pattern obtained through Cu-K alpha ray measurement is shown as figure 1. The novel crystal form of the cefamandole nafate provided by the invention is different from the crystal form structure in the prior art. Through experimental verification, users pleasantly and surprisedly find that the purity of a novel crystal form compound is high; the flowability is good; the stability is good; the polymer content is low; hygroscopicity is avoided; the clinical application is safe and reliable. Powder injections prepared from the novel crystal form compound have the advantages that the stability is good; the stability after the matching with solvents is good; the insoluble particulate content is extremely low; the powder injections are very suitable for clinical application.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to an anti-infection drug cefamandole sodium composition. Background technique [0002] Cefamandole sodium is a broad-spectrum antibiotic that is effective against various diseases caused by gram-negative bacteria and gram-positive bacteria. It is widely used in clinical practice, but the structure of cefamandole sodium contains unstable The β-lactam ring of β-lactam is prone to hydrolysis and rearrangement reactions, resulting in structural damage and loss of antibacterial activity. Some degradation products may cause allergic reactions. Therefore, the stability of this type of antibiotic in infusion solutions should attract extensive attention. At the same time, because its basic structure is the same as that of many semi-synthetic β-lactam lactam antibiotics on the market, it will also form high molecular polymers, which will also cause immediate allergic reactions in clinical use...

AI Technical Summary

Problems solved by technology

[0002] Cefamandole sodium is a broad-spectrum antibiotic that is effective against various diseases caused by gram-negative bacteria and gram-positive bacteria. It is widely used in clinical practice, but the structure of cefamandole sodium contains unstable The β-lactam ring is prone to hydrolysis and rearrangement reactions, leading to structural damage and loss of antibacterial activity, and some degradation products may cause allergic reactions, so the stability of this type of antibiotics in infusion solutions should attract extensive attention

At the same time, because its basic structure is the same as that of many semi-synthetic β-lactam antibiotics on the market, it will also form a high molecular weight polymer, which will also cause immediate allergic reactions in clinical use, which is extremely harmful to patients

At the same time, cefamandole sodium is very easy to attract moisture, which has a very adverse effect on its stability.

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