A PROCESS FOR THE PRODUCTION OF DOUBLE SULFATE OF 1-DESOXY-(5-HYDROXYTRYPTAMINO)-D-FRUCTOSE AND 1-METHYL-HYDANTOIN-2-IMIDE

摘要

A double sulfate salt of 1-desoxy-(5-hydroxytryptamino)-D-fructose (DSF) and 1-methylhydantoin-2-imide (creatinine) represents a new solid crystalline phase of unit composition, pharmaceutical quality and remarkable stability. It is prepared by glycosylation of serotonin with D-glucose, formation of the double salt by addition of sulfuric acid and creatinine and crystallization of the double salt in the presence of ethanol. The DFS is preferably isolated from the reaction medium by way of the addition complex DFS.Ca(OH)2 which is precipitated by the addition of calcium hydroxide. The calcium hydroxide is then eliminated by addition of sulfuric acid and the double salt is crystallized as described above. DFS is the active principle of a medicament effective, in particular, in the treatment of leprosy.