FIELD: pharmaceutics.
SUBSTANCE: present invention relates to a method for preparing a medicinal agent for parenteral use, containing as active substance 1-deoxy-1-N-[methyl-(2-acridone-9-on-10-yl-acetate)]-ammonium-D-glucitol, by dissolving the active substance in water for injections, stirring, filtering the solution through a sterilizing filter, dispensing it into sterile containers, characterized by that N-methylglucamine in an amount of not more than 0.05 wt% is added to the solution as an auxiliary component, stirred until complete dissolution of components at temperature of 55-60°C, then obtained solution is cooled to temperature of 22-25°C, and after the stage of filtration and dispensing, it is subjected to thermal sterilization at temperature of 121°C for 8-15 minutes.
EFFECT: technical result of the present invention is the development of an optimum method for preparing a medicinal preparation for parenteral use containing as active component 1-deoxy-1-N-[-methyl-(2-acridone-9-on-10-yl-acetate)]-ammonium-D-glucitol, which will reduce the amount of impurities in the finished medicinal product and increase its shelf life.
1 cl, 7 tbl, 27 ex
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Authors
Dates
2020-12-22—Published
2020-09-14—Filed