FIELD: pharmaceutical technology.
SUBSTANCE: invention relates to pharmaceutical technology and is a method for producing a suspension containing nanosized particles of a medicinal substance, characterized in that it includes the following stages: the stage of obtaining a carrier substance by dissolving β-cyclodextrin and sodium hydroxide in water at a molar ratio of 1:7-1:8 in the presence of ethanol 15-25% of the volume of the solution, stirring for 2-3 hours at a temperature of 45-50°C, filtering the solution through a membrane filter, adding-layering on the surface of a solution of 95% ethyl alcohol in an amount equal to the volume of the solution, holding for 22-24 hours at room temperature without access to light until crystals begin to form, stirring with shaking, keeping the resulting system for 4-6 hours at a temperature of 50-65°C in a hermetically sealed vessel, further cooling to room temperature for 15-17 hours, holding for 46-48 hours at a temperature of 2-6°C, filtering the precipitate and drying on a filter, transferring the precipitate, which is a powder of the carrier substance, into a separate container and drying the precipitate at a temperature of 45-55°C for 4-6 hours, holding the powder of the carrier substance for 22-24 hours under a vacuum of 0.1-0.01 mBar; a step of obtaining a carrier substance loaded with a drug substance by mixing a drug substance selected from docetaxel and silybin with a carrier substance in a mass ratio of 1:10 and adding a solvent selected from methylene chloride in the case of docetaxel and acetone in the case of silybin, incubating the resulting suspension at room temperature and shaking for 22-24 hours, filtering the suspension, followed by washing the precipitate on the filter with 95% ethyl alcohol, drying the precipitate to constant weight under vacuum; the stage of obtaining a suspension of nanoparticles by introducing a carrier substance loaded with a medicinal substance into water or non-viscous aqueous solutions of sodium chloride 0.9% for injection or glucose 5% for injection in a ratio of 1:1500-1:2000 by weight and stirring until dissolved.
EFFECT: exclusion from the process of labor-intensive and energy-intensive stages.
1 cl, 6 dwg, 2 ex
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Authors
Dates
2021-10-05—Published
2020-12-10—Filed