--

The invention relates to chemical and pharmaceutical industry and, in particular, to a

method for producing a stabilized pharmaceutical composition presented as an aqueous solution

that may be used to obtain an intravenous drug containing succinic acid, nicotinamide, inosine and

riboflavin mononucleotide as the active ingredients and possessing cytoprotective properties.

The invention objective is to develop a method for producing the known stabilized

pharmaceutical composition presented as an aqueous solution that would enable to enhance its

safety in use through the application ofthermal sterilization. The objective is achieved by a method for producing a stabilized pharmaceutical

composition presented as an aqueous solution containing succinic acid, inosine, nicotinamide,

riboflavin mononucleotide sodium as the active ingredients, by way ofdissolving them in water

with subsequent sterile filtratioru wherein, in accordance with the invention, the composition is

supplemented by one or several ofthe pharmaceutically acceptable components as the stabilizing agent to be selected from the goup including sodium hydroxide,

tris(hydroxymethyl)aminomethane (TRIS), ethanolamine, diethanolamine, sodium carbonate,

meglumine, up to a stable solution with pH from 6.0 to 8.0, the components' ratio,Tow! being as

follows: 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 up to 100.00lo, and the solution is subjected to additional thermal sterilization at l00oC with exposure time of8

minutes to I I 6'C with exposure time of 2 minutes.

In a particular embodiment, the objective is achieved by adding sodium hydrocarbonate to the composition as the stabilizing agent, up to a stable solution with pH of 6.0 to 7.0, the

components' ratio,Yowl. being as follows: succinic acid 5'00-12.50 inosine 1.00-2.40 nicotinamide 0.50-1.20 riboflavin mononucleotide sodium 0.10-0.24

The invention relates to the chemical and pharmaceutical industry. A method for producing a stabilized pharmaceutical composition in the form of an aqueous solution comprising active ingredients which include succinic acid, inosine, nicotinamide and riboflavin mononucleotide sodium salt, wherein a stabilizing agent is further introduced into the composition as one or more pharmaceutically acceptable ingredients selected from the group consisting of sodium hydroxide, tris-(oxymethyl)aminomethane (TRIS), ethanolamine, diethanolamine, sodium carbonate and meglumine to obtain a stable aqueous solution having a pH value in the range of 6.0 to 8.0; the method further comprises a sterilizing filtration of the resulting dissolved composition, and an additional thermal sterilization at temperatures from 100°C and an exposure time of 8 minutes to 116°C and an exposure time of 2 minutes.sodium hydrocarbonate 13.70-17.20 water uP to 100.0%.

Further in particular embodiment, the objective is achieved by additionally introducing

sodium hydrocarbonate to the composition as the stabilizing agent, up to a stable solution with pH

of 6.4 to 7.4, the components' ratio,Towt. being as follows: succinic acid 5.00-12.50 inosine I '00-2.40 nicotinamide 0.50-1.20 riboflavin mononucleotide sodium 0.10-0.24 sodium hydrocarbonate 13.70-17.20 water uP to 100.0%.