Tobramycin sulfate injection and process for preparing same

Abstract

The invention provides a tobramycin sulfate injection and a process for preparing the tobramycin sulfate injection. Every 10,000ml of the tobramycin sulfate injection contains the following raw materials: 400g of tobramycin, 25-38g of sodium bisulfite, 0.8-1.2g of EDTA-2Na (ethylenediaminetetraacetic acid and disodium) and the balance of water for injection. The process comprises the following steps of: adding the water for injection into a proportioning tank, wherein the amount of the added water for injection is 80% of total amount of the raw materials; introducing CO2 into the water for injection for 10-20 minutes until the water for injection is saturated; adding tobramycin into the proportioning tank; adding 25% (volume concentration) sulfuric acid into the proportioning tank; stirring to dissolve the tobramycin; adding the sodium bisulfite and solution of the EDTA-2Na dissolved with the water for injection into the proportioning tank; keeping the pH value of a solution at 4.7-5.1; adding the water for injection until the total amount of the solution reaches the preparation amount; stirring the solution uniformly; introducing CO2 into the solution; filtering the solution with a folded filtering element until the solution is clear; filling the solution into an ampoule, and sealing the ampoule, wherein N2 is introduced into the ampoule in the process of filling the solution. The steps are carried out in the aseptic preoaration condition. The process provided by the invention has the advantage that the SAL (sterility assurance level) of the sterilized tobramycin sulfate injection can be not more than 10<-3>.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to tobramycin sulfate injection and its preparation process. Background technique [0002] Tobramycin Sulfate Injection belongs to aminoglycoside antibiotics, the main ingredient is tobramycin. This product is an aminoglycoside antibiotic. The antibacterial spectrum is similar to that of gentamicin, against Escherichia coli, Bacillus aerogenes, Klebsiella, Proteus mirabilis, some indole-positive Proteus, Pseudomonas aeruginosa, some Neisseria, some Gram-negative bacteria such as Serratia aeruginosa and Shigella have antibacterial effects; the antibacterial effect of this product on Pseudomonas aeruginosa is 3 to 5 times stronger than that of gentamicin, and Pseudomonas aeruginosa that is moderately sensitive to gentamicin Monascus is highly sensitive to this product. Among Gram-positive bacteria, Staphylococcus aureus (including lactamase-producing strains) is sensitive to this ...

AI Technical Summary

Problems solved by technology

[0005] At present, the current sterilization process of tobramycin sulfate injection at 100°C for 30 minutes cannot meet the requirements of the above-mentioned "Notice" for the SAL of the product after sterilization. After testing, it cannot adopt the terminal sterilization process. Therefore, the current The preparation process is improved