Tsarkov Aleksej Nikolaevich (RU),Царьков Алексей Николаевич (RU),Smurov Sergej Vladimirovich (RU),Смуров Сергей Владимирович (RU),Prezent Mikhail Avramovich (RU),Презент Михаил Аврамович (RU),Volskij
申请号：
RU2017129096
公开号：
RU0002673452C1
申请日:
2017.08.15
申请国别(地区):
RU
年份:
2018
代理人:
摘要：
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 tblИзобретение относится к способу получения активной фармацевтической субстанции на основе натриевой соли 5-амино-2,3-дигидро-1,4-фталазиндиона (аминодигидрофталазиндион натрия). Сущность способа состоит в следующем: к взвеси люминола в 3-х объемах дистиллированной воды прикапывают при охлаждении эквивалентное количество 30%-ного водного раствора натриевой щелочи, перемешивают 2-3 часа до практически полного растворения, затем фильтруют. К фильтрату добавляют 10-кратное количество изопропилового спирта, охлаждают до минус 5°С и вновь фильтр
