Daptomycin freeze-dried powder injection for injection and production process thereof

Abstract

The invention discloses a daptomycin freeze-dried powder for injection, which comprises the following components in parts by mass: 70-100 parts of daptomycin, 5-15 parts of an organic solvent and thebalance of water for injection, totaling 1000 parts. By adding a small amount of the organic solvent, the product is high in stability, uniform in appearance and short in redissolution time.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a daptomycin freeze-dried powder for injection. Background technique [0002] Daptomycin is a ring lipopeptide antibiotic with a new structure extracted from the fermentation broth of Streptomyces (S. Not only does it have a novel chemical structure, but its mode of action is also different from any approved antibiotic: it disrupts the transport of amino acids by the cell membrane, thereby hindering the biosynthesis of peptidoglycan in the bacterial cell wall, changing the properties of the plasma membrane, It can destroy the function of bacterial cell membrane in many ways, and quickly kill Gram-positive bacteria. In addition to its ability to act on most clinically relevant Gram-positive bacteria, daptomycin is more important for isolates that have shown resistance to methicillin, vancomycin, and linezolid in vitro. Potent activity, this property has very important clinical ...

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Problems solved by technology

This patent increases the stability of product content by adding buffer salts and stabilizers, and does not examine other key quality attributes of injection products, nor does it solve the problem of stratification of liquid medicine during the freeze-drying process

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