FIELD: chemical and pharmaceutical industry.
SUBSTANCE: invention relates to the preparation of agents with hepatoprotective activity. A method of producing ampoules with the active pharmaceutical substance ademethionine 1,4-butane disulfate in the following way: preparing ampoules of the first hydrolytic class according to DIN/ISO 9187 normative documentation with preliminary rinsing of the ampoules with water at a water pressure of 0.2 to 0.25 MPa, an air pressure of 0.15 to 0.2 MPa, circulating water temperature from 50 to 60°C, followed by filling the ampoules with a solution of ademethionine 1,4-butane disulfate, subjected to preliminary sterile filtration, at an overpressure in the reactor of 0.03 MPa, and lyophilization of the drug solution for 80.5 hours, followed by sealing the ampoules with lyophilisate using an inert medium.
EFFECT: obtaining a method of producing ampoules with the active pharmaceutical substance of ademetionine.
1 cl, 1 ex
Authors
Dates
2023-07-04—Published
2022-12-28—Filed