Method for treatment of disease with pure porcine monosialoganglioside gm1

Abstract

A process for preparing pure monosialoganglioside GM1 in the form of its sodium salt. There is provided a process for the isolation and purification of monosialoganglioside GM1 comprising (a) separation of GM1 from a lipidic mixture containing the monosialoganglioside GM1 as the main ganglioside component by ion exchange column-chromatography using an eluent comprising potassium or caesium ions, (b) recovery of the solute from the eluted solution, (c) diafiltration of an aqueous solution of the recovered solute, and (d) second diafiltration after the addition of 1 M NaCl, and recovering GM1. The purity level of GM1 obtained is higher than 99.0%.

1 - 18 . (canceled) 
     
     
         19 . A pharmaceutical composition comprising a monosialoganglioside GM 1  of porcine origin containing less than 0.1% Fucosyl-GM1, produced according to a process for the purification of monosialoganglioside GM1 comprising separating monosialoganglioside GM1 from Fucosyl-GM1 in a lipidic mixture containing the monosialoganglioside GM1 as the main ganglioside component, by ion exchange column-chromatography using an eluent comprising potassium or caesium ions. 
     
     
         20 . The pharmaceutical composition according to  claim 19 , further comprising a pharmaceutically acceptable carrier. 
     
     
         21 . The pharmaceutical composition according to  claim 19 , wherein said porcine monosialoganglioside GM1 is at least 99.0% pure. 
     
     
         22 . The pharmaceutical composition according to  claim 19 , wherein the lipidic mixture containing the monosialoganglioside GM1 as the main ganglioside component has been obtained by acid hydrolysis or enzymatic hydrolysis of a lipid extract containing at least 30% of gangliosides. 
     
     
         23 . The pharmaceutical composition according to  claim 19 , wherein the lipidic mixture containing the monosialoganglioside GM1 as the main ganglioside component has been obtained by enzymatic hydrolysis of a lipid extract with an  Arthrobacter ureafaciens  strain S sialidase or  Vibrio cholerae  sialidase. 
     
     
         24 . The pharmaceutical composition according to  claim 19 , wherein the purification process further comprises the steps of:
 separating GM1 from a lipidic mixture containing the monosialoganglioside GM1 as the main ganglioside component by ion exchange column-chromatography using an eluent comprising potassium or caesium ions;   recovering a solute from the eluted solution;   diafiltrating of an aqueous solution of the recovered solute;   adding a sodium salt and diafiltrating the resulting aqueous solution; and   recovering GM1 in the form of its sodium salt.