METHOD OF OBTAINING LYOPHILISATE OF SODIUM AMINODIHYDROPHTHALAZINEDIONE, OR TAMERON MEDICATION

摘要

FIELD: pharmaceuticals.;SUBSTANCE: invention relates to pharmaceuticals and describes a method for producing a drug based on the sodium salt of 5-amino-2,3-dihydrophthalazine-1,4-dione (sodium aminodihydrophthalazinedione) in the form of a lyophilisate. The method includes preparing an aqueous solution of sodium aminodihydrophthalazinedione with a concentration of 03-250 mg / ml; carrying out sterilizing filtration of the resulting solution and dosing the sterile solution into the primary packaging; carrying out lyophilization. Freeze drying is carried out in several stages, while cooling is carried out to minus 75°C - minus 15°C at a rate of 0.5-10 ° C per minute and further drying is carried out until the moisture content in the product is not more than 10%. At the last stage, the freeze-drying chamber is filled with sterile air, sealed and the package is rolled up / sealed. ;EFFECT: method according to the invention allows obtaining a stable and highly purified drug in the form of sodium aminodihydrophthalazinedione lyophilisate with increased ergonomics and conversion of the process.;2 cl, 2 tbl, 7 dwg, 6 ex