Pharmaceutical-grade 20-hydroxyecdysone extract, use of same and preparation thereof

Abstract

The invention concerns a method for preparing an extract from a preparation of approximately 90% pure 20-hydroxyecdysone that comprises the following steps: g) Hot dissolution of approximately 90% pure 20-hydroxyecdysone in methanol, filtration and partial concentration, h) Addition of 1 to 5 volumes of acetone, i) Cooling to a temperature of between 0 and 5° C. while stirring, j) Filtration of the obtained precipitate, k) Successive rinses with acetone and water, and l) Drying.

1 . A method for preparing an extract from a preparation of approximately 90% pure 20-hydroxyecdysone, comprising:
 a) Hot dissolution of approximately 90% pure 20-hydroxyecdysone in methanol, filtration and partial concentration,   b) Addition of 1 to 5 volumes of acetone,   c) Cooling to a temperature of between 0 and 5° C. while stirring,   d) Filtration of the obtained precipitate,   e) Successive rinses with acetone and water, and   f) Drying.   
     
     
         2 . The method according to  claim 1 , wherein the filtration of step a) is carried out via a 0.2 μm particle filter, wherein the partial concentration of step a) is carried out by vacuum distillation, at a temperature of approximately 50° C., in the presence of MeOH, and wherein the step f) of drying is carried out under vacuum at a temperature of approximately 50° C. 
     
     
         3 . An extract of a plant or of a plant part, wherein the extract is obtained by the method according to  claim 1 , said plant being chosen from the plants containing at least 0.5% 20-hydroxyecdysone, by dry weight of said plant, wherein said extract comprises at least 95%, and preferably at least 97%, 20-hydroxyecdysone. 
     
     
         4 . The extract according to  claim 3 , comprising between 0 and 0.05%, by dry weight of the extract, of impurities capable of affecting the safety, the availability or the effectiveness of a pharmaceutical use of said extract. 
     
     
         5 . The extract according to  claim 4 , wherein the impurities are phytoecdysones with 19 or 21 atoms of carbon, such as Rubrosterone, Dihydrorubrosterone or Poststerone. 
     
     
         6 . The extract according to  claim 3 , wherein the plant is chosen from  Stemmacantha carthamoides, Cyanotis arachnoidea  and  Cyanotis vaga.    
     
     
         7 . The extract according to  claim 3 , wherein the plant part is the root of  Stemmacantha carthamoides.    
     
     
         8 . The extract according to  claim 3 , for its use in the treatment of muscular or cardio-metabolic illnesses. 
     
     
         9 . The extract according to  claim 7 , for its use in the treatment and/or the prevention of sarcopenia. 
     
     
         10 . The extract according to  claim 7 , for its use in the treatment of myopathies of genetic origin. 
     
     
         11 . The extract according to  claim 7 , for its use the treatment and/or the prevention of the loss of muscular mass and function after an immobilisation, namely in a post-surgical context. 
     
     
         12 . A composition comprising the extract according to  claim 3  as an active agent.