FIELD: pharmacology.
SUBSTANCE: invention relates to a method for preparation of a stabilized pharmaceutical composition in the form of an aqueous solution which can be used to prepare a drug for intravenous administration containing succinic acid, nicotinamide, inosine and riboflavin mononucleotide sodium as active components and having cytoprotective properties. In the method for preparation of a stabilized pharmaceutical composition in the form of an aqueous solution containing succinic acid, inosine, nicotinamide, riboflavin sodium mononucleotide as active components, by dissolving them in water with subsequent sterilizing filtration, the followin is further added to the composition as a stabilizing agent: one or more pharmaceutically acceptable components selected from the group consisting of sodium hydroxide, trisoxymethylaminomethane (TRIS), ethanolamine, diethanolamine, sodium carbonate, meglumine, to obtain a stable solution with pH in the range of 6.0 to 8.0 in the following ratio, wt %: succinic acid 5.00-12.50; inosine 1.00-2.40; nicotinamide 0.50-1.20; riboflavin mononucleotide sodium 0.10-0.24; stabilizing agent 3.21-51.30; water to 100.0%, and further thermal sterilisation of the solution at a temperature of 100°C and exposure time of 8 min to 116°C and exposure time of 2 min.
EFFECT: increased method application safety due to thermal sterilisation.
3 cl, 96 ex, 5 tbl
Authors
Dates
2017-08-25—Published
2016-09-29—Filed