FIELD: pharmaceutics.
SUBSTANCE: present invention relates to pharmaceutical industry and to a method for producing a pharmaceutical formulation of rocuronium bromide in the form of a stable lyophilisate for injection or infusion. Method includes placing the solution rocuronium bromide in ampoules or bottles in a sublimation chamber, where the solution is frozen to (-41)-(-49)°C at the rate (-12)-(-13) deg/h during 7-9 hours, held for 6-9 hours, then the ampoules (bottles) are heated at a rate of 7-10 deg/h during 7-9 % to 20-25 °C and kept at this temperature for 5-9 hours. Pharmaceutical formulation includes rocuronium bromide as an active ingredient, sodium chloride or potassium chloride, acid to bring pH to 3.8-4.8 and water for injections.
EFFECT: pharmaceutical formulation storage life increases up to 5 years.
2 cl, 3 tbl, 1 ex
