FIELD: pharmacology.
SUBSTANCE: invention relates to compositions with 2-ethyl-6-methyl-3-hydroxy pyridine succinate, which can be used in medicine as a pharmaceutical for parenteral administration for the purpose of treatment and prevention of various diseases and pathological conditions of the human body, and how to produce it. The proposed pharmaceutical composition for parenteral administration contains, wt %: 2-ethyl-6-methyl-3-hydroxy pyridine succinate 2.0-6.0, stabiliser 0-0.2, water for injection - up to 100.0. The composition in solution contains impurities of iron ions of not more than 0.003 wt % based on the dry active substance - 2-ethyl-6-methyl-3-hydroxy pyridine succinate. According to the proposed method of producing the above pharmaceutical composition, water for injection, saturated with nitrogen for 10-40 minutes, is added, if necessary, with a stabiliser and 2-ethyl-6-methyl-3-hydroxy pyridine succinate, stirred up to dissolve, then the solution is filtered through a filter with activated carbon or ion-exchange resin column to remove impurities of iron ions, obtaining the final content of impurities of iron ions not more than 0.003 wt % in terms of dry active substance-2-ethyl-6-methyl-3-hydroxy pyridine succinate, and then they carry out sterilisation filtration via a membrane filter with a pore size of 0.22-0.45 mcm with subsequent pouring it in ampoules in the current of nitrogen and subsequent steam sterilisation under pressure in a steam autoclave at a temperature of 100-130°C to obtain a sterile solution.
EFFECT: use of the group of inventions provides a composition that is highly stable, convenient and safe for clinical use.
8 cl, 4 tbl, 7 ex
