METHOD OF PRODUCING A PREPARATION BASED ON 5-AMINO-2,3-DIHYDROPHTHALAZINE-1,4-DIONE SODIUM SALTS
The invention relates to medicine and more particularly to drugs which act upon the immune system and have immunomodulatory, anti-inflammatory, anti-tumor and anti-oxidant activity, as well as to thechemical pharmaceutical production of such drugs. The present method of producing a sterile, lyophili...
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Zusammenfassung: | The invention relates to medicine and more particularly to drugs which act upon the immune system and have immunomodulatory, anti-inflammatory, anti-tumor and anti-oxidant activity, as well as to thechemical pharmaceutical production of such drugs. The present method of producing a sterile, lyophilized medicinal preparation based on 5-amino-2,3-dihydrophtahalazine-1,4-dione sodium salt, by processing a non-sterile anhydrous and/or dihydrous substance of 5-amino-2,3-dihydrophtahalazine-1,4-dione sodium salt, is characterized in that an intermediate product of 5-amino-2,3-dihydrophthalazine-1,4-dione is processed, so as to obtain the sodium salt thereof, by dissolving in an aqueous organic alkaline solution, such that an anhydrous and/or dihydrous substance of 5-amino-2,3-dihydrophthalazine-1,4-dione sodium salt is obtained by means of crystallization at a temperature of minus 5-7 DEG C from said aqueous organic solution of the 5-amino-2,3-dihydrophthalazine-1,4-dione sodium salt, whereupon a sterile, lyophiliz |
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