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Clinically used to treat severe infections. Cefepime hydrochloride precipitate sodium salt under weak acidic conditions, effectively avoiding the problem of decomposition and color deepening under alkaline conditions of cefepime, and improve product quality.
Uses of Cefepime Hydrochloride.
Cefepime hydrochloride is a sterile mixture made of cefepime hydrochloride and an appropriate amount of L-arginine. It is a white to light yellow powder, almost odorless and moisture-inducing. In vitro tests showed that this product has effects on both gram-positive and Gram-negative bacteria. This product has low affinity for β-lactamase encoded by bacterial chromosomes, can highly tolerate the hydrolysis of most β-lactamases, and can quickly penetrate into the cells of gram-negative bacteria. In bacterial cells, the target molecule is penicillin-binding protein (PBP).
preparation of Cefepime Hydrochloride.
At room temperature (15 ~ 25℃), 171g sodium isocrylate (1.03mol) was dissolved in 900mL water and 200mL acetone, and 300g cefepime sulfate (0.52mol, weight according to anhydrous matter) was added in batches under effective agitation to form a slurry system with good fluidity. After 10 minutes, add 1600mL of acetone and appropriate amount of activated carbon and stir for 30 minutes. Centrifuge or filter to separate solids. Wash the filter cake with 500mL of acetone-water 2∶1(v/v) mixture and combine the filtrate. Stir and add 18% HCl to the filtrate to pH1.0 ~ 1.5. Then add 8L of acetone within an hour. The system was then cooled to 5 ~ 10℃ and continued to stir for 1 hour. Strain. Filter cake washed with acetone, vacuum drying at 40℃, about 270g of white crystalline powder. Purity 99.7%, water content 3.8% (K-F method), acetone residue 0.25%. The product is cefepime hydrochloride monohydrate, or cefepime hydrochloride. All quality indicators meet the requirements of the United States Pharmacopeia.
Product Methods of Cefepime Hydrochloride.
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