FIELD: pharmacology.
SUBSTANCE: group of inventions relates to a pharmaceutical composition in the form of a solution for injections, containing glibenclamide as an active ingredient in an amount of 0.0004-0.004 g per ml of the solution, and hydroxyethylstarch 200/0.5 in an amount of 0.025-0.075 g per ml of solution and water for injections (the rest) as auxiliaries, as well as to the method for obtaining such a pharmaceutical composition, according to which hydroxyethylstarch 200/0.5 is added in water for injections preheated to 85-90°C and stirred until complete dissolution, glibenclamide powder is added and stirred at 75-85°C until completely dissolution, water for injections is added to obtain the final solution volume and stirred again; the resulting solution is maintained for 35-40 minutes at 75-85°C, cooled to 20-30°C, sterilised by the method of filtration through filters with the pore diameter of 0.22 mcm and packaged in ampoules, which are additionally sterilized for 8 minutes at a temperature of 120°C.
EFFECT: creation of a new preparation form of glibenclamide, characterized by low formation of undesirable impurities during storage.
2 cl, 3 ex
Authors
Dates
2017-03-21—Published
2016-03-25—Filed