Netilmicin sulfate injection and preparation method thereof

Abstract

The invention relates to a netilmicin sulfate injection and a preparation method thereof. The netilmicin sulfate injection is characterized in that: every 1,000 ml of injection contains 50,000,000 units of netilmicin sulfate, 0.5-2g of an antioxidant and 0.1-1g of a complexing agent, and the pH value of the netilmicin sulfate injection is 5.3-5.7. A preparation process of the netilmicin sulfate injection comprises the following steps of: cooling an appropriate amount of water for injection to below 30 DEG C under the condition that the air cleanliness is in a hundred level; introducing nitrogen to remove oxygen; adding a prescription dose of the antioxidant and the complexing agent into the water for injection for completely dissolving; adding a prescription dose of the netilmicin sulfate into a solution; stirring for completely dissolving; adsorbing with 0.05-0.2 percent (g / ml) needle active carbon; primarily filtering with one set of 1mum filter for removing carbon; adjusting the pH to 5.3-5.7 with a sodium citrate solution; stirring uniformly; fixing the volume to a full dose by using the water for injection; finely filtering with one set of 0.22 / 0.22mum polypropylene foldable filter core filter and two sets of 0.22 / 0.22mum polyether sulfone microporous membrane filter core filters for removing bacteria; embedding under a hundred-level condition (introducing nitrogen in the entire process); assisting in sterilizing at the temperature of 100 DEG C; and performing lamp inspection and packaging. Due to the adoption of a scientific formula and process, the stability of the netilmicin sulfate injection is ensured; and due to the adoption of a sterile assistant sterilization preparation method, the sterile guarantee level of a medicament is raised.

Description

Technical field: [0001] The invention relates to the technical field of medicine, and relates to a semi-synthetic aminoglycoside broad-spectrum antibiotic netilmicin sulfate injection and a preparation method thereof. Background technique: [0002] The mechanism of action of netilmicin sulfate injection is to bind to the 30S subunit of bacterial ribosomes and inhibit the synthesis of bacterial proteins. Indicated for the treatment of serious infections caused by sensitive Gram-negative bacilli such as Pseudomonas aeruginosa, Proteus (indole positive and negative), Escherichia coli, Klebsiella, Enterobacter, Serratia Neonatal sepsis, septicemia, central nervous system infection (including meningitis), urinary tract infection, respiratory tract infection, gastrointestinal tract infection, peritonitis, biliary tract infection, skin or Bone infection, otitis media, sinusitis, soft tissue infection, listeriosis, etc. The combination of this product and β-lactams can often obtai...

AI Technical Summary

Problems solved by technology

Therefore, there are currently existing dosage forms: small-volume injections and large-volume injections. Conventional production methods (sterilized at 100°C) can no longer fully guarantee the sterility requirements, especially large-volume injections are more risky; freeze-dried powder injections, although the sterility guarantee can reach 10 -3 Level, but there are disadvantages such as complex preparation process, high cost, and reconstitution for clinical use