FIELD: chemistry.
SUBSTANCE: preparation is obtained as an aqueous solution comprising a digoxine-containing component, propylene glycol, citrate buffer solution, ethanol and water. Wherein 0.5-1.2 wt % alcohol solution of digoxin is pre-prepared, maintained under stirring at room temperature for at least 15 minutes, propylene glycol, citrate buffer and water are introduced thereto in amounts providing the following contents of ingredients in the mixture, wt %: 0.5-1.2 wt % alcohol digoxin solution - 5-6.07;. propylene glycol - 8-12; a mixture of citric acid monohydrate and sodium citrate dihydrate, used for preparing the citrate buffer solution - 0.5-0.6; water - the rest, then pH 7.0±0.1 is established, after which the resulting mixture is heated in a closed volume at 170±20°C for at least 20 min.
EFFECT: receiving digoxin preparation with a minimum amount of ethanol, capable of long-term storage at room temperature.
2 cl, 1 tbl, 3 ex
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Authors
Dates
2017-06-21—Published
2015-10-01—Filed