METHOD OF OBTAINING ACTIVE PHARMACEUTICAL SUBSTANCE, PRESENTING AMINODIHYDROPHTHALAZINEDIONE OF SODIUM Russian patent published in 2018 - IPC A61K31/502 C07D237/32 

FIELD: medicine; pharmaceuticals.

SUBSTANCE: invention relates to a method for producing an active pharmaceutical substance based on the sodium salt of 5-amino-2,3-dihydro-1,4-phthalazinedione (sodium aminodihydrophthalazalindione). Essence of the method consists in: adding an equivalent amount of a 30 % aqueous solution of sodium alkali to a suspension of luminol in 3 volumes of distilled water, dropwise during cooling, mixing for 2–3 hours until almost complete dissolution, then filtering. Adding 10-fold amount of isopropyl alcohol to the filtrate, cooling to minus 5 °C and re-filtering. Drying. After drying, crystals are obtained which are associates of the hydrated forms of the luminol sodium salt. Resulting crystals are dissolved in water for injection, and then filtered through a filter, containing filtering layers of polyethersulfone membranes with a pore size of 0.2 microns. Resulting sterile solution is rapidly cooled to a temperature of minus 25 ± 10 °C and placed in a freeze drying unit. Sterile sodium-aminodihydrophthalazinedione drug is obtained at the end of this process, which is used as an active pharmaceutical substance.

EFFECT: technical results is to increase the stability of technological parameters, the representativeness of the obtained substance, minimization of harmful impurities (isomeric micro impurities such as N-aminoisomer and linear sodium oligomers), environmental safety of the process.

1 cl, 4 dwg, 1 tbl