Method for preparing kitasamycin tartrate injection

Abstract

The present invention solves the difficult problem of microlide medicine kitasamycin tartrate in unstable structure, and provides preparation process of kitasamycin tartrate injection. The kitasamycin tartrate injection consists of kitasamycin tartrate or kitasamycin as main medicine component, solvent for injection, pH stabilizer, chemical structure stabilizer, metal ion complexing agent, isosmotic regulator and other auxiliary components. The kitasamycin tartrate injection has high stability, high safety and effectiveness, simplified clinical use and other advantages.

Description

technical field

[0001] The invention relates to a preparation method of macrolide drug kitasamycin tartrate injection. Background technique

[0002] Kitasamycin (kitasamycin) is the first generation of macrolides - 16-membered ring macrolides. The mechanism of action and antibacterial spectrum are similar to erythromycin, but it has strong antibacterial effect on Gram-positive bacteria, and has effects on staphylococcus, hemolytic streptococcus, pneumococcus, diphtheria bacillus, tetanus bacillus, anthrax bacillus, etc. . It also has antibacterial effect on Gram-negative bacteria such as Neisseria gonorrhoeae and Bacillus pertussis. Some erythromycin-resistant Staphylococcus aureus are still sensitive to kitasamycin, and they are also quite active against Leptospira, Rickettsia, and Mycoplasma.

[0003] At present, the kitasamycins that are marketed at home and abroad are all kitasamycin tartrate powder injections, and their pH value is 3.0 to 5.0. composition of the mix...