Novel methods and compositions for treatment of disease

Abstract

An aspect of embodiments of the invention relates to providing novel therapeutic compositions comprising herbal extracts of the plant species Sambucus nigra, Echinacea purpurea , and Centella asiatica . The compositions exhibit increased therapeutic activity for treatment of various inflammatory diseases, in particular, inflammatory diseases of mucosa or skin relative to previously identified compositions. In addition the compositions exhibit increased solubility relative to previously identified compositions. In an embodiment of the invention, the ratio of Sambucus nigra:Echinacea purpurea:Centella asiatica is 7:1:2. An embodiment of the invention provides methods for preparing an aqueous therapeutic composition comprising extracts of the aforementioned plant species, using at least two extractions.

1 . A method for preparing an aqueous therapeutic composition comprising:
 combining hydroalcoholic herbal extracts of  Sambucus nigra, Echinacea purpurea , and  Centella asiatica  with water to form an aqueous mixture;   combining the aqueous mixture with an alcohol to form an alcoholic mixture having a concentration of over 50% alcohol;   separating insoluble materials and alcohol from alcoholic mixture to produce an aqueous therapeutic composition.   
     
     
         2 . The method according to  claim 1  wherein the alcoholic mixture comprises about 70% alcohol. 
     
     
         3 . The method according to  claim 1  wherein the aqueous therapeutic composition is further dried to form a dried therapeutic composition. 
     
     
         4 . The method according to  claim 1  wherein the alcohol is ethanol. 
     
     
         5 . The method according to  claim 1  wherein insoluble materials are separated from the alcoholic mixture using centrifugation, filtration or settling. 
     
     
         6 . The method according to  claim 1  wherein alcohol is separated from the alcoholic mixture using vacuum. 
     
     
         7 . The method according to  claim 3  wherein the aqueuous therapeutic composition is dried by spray drying or freeze drying. 
     
     
         8 . The method according to  claim 3  further comprising combining the dried therapeutic composition with at least one pharmaceutically acceptable excipient. 
     
     
         9 . The method according to  claim 8  wherein the excipient is selected from the group consisting of: propylene glycol, polyethylene glycol, glycerin and essential oil. 
     
     
         10 . The method according to  claim 1  wherein hydroalcoholic herbal extracts of  Sambucus nigra, Echinacea purpurea , and  Centella asiatica  are prepared by mixing the plant matter in a solvent comprising about 70% alcohol. 
     
     
         11 . The method according to  claim 10  wherein the plant matter is mixed for about 8 hours. 
     
     
         12 . The method according to  claim 11  wherein the ratio of plant matter to solvent is approximately 1:8. 
     
     
         13 . The method according to  claim 10  further comprising removing solvent from the mixture of plant matter and solvent to form a hydroalcoholic herbal extract. 
     
     
         14 . An herbal extract comprising hydroalcoholic herbal extracts of each of  Sambucus nigra, Echinacea purpurea , and  Centella asiatica , the extract comprising naringenin concentration of greater than or equal to 0.055%. 
     
     
         15 . The herbal extract according to  claim 14  having solubility in a 20% solution in propylene glycol. 
     
     
         16 . The herbal extract according to  claim 14  wherein the ratio of  Sambucus nigra:Echinacea purpurea:Centella asiatica  is about 7:1:2. 
     
     
         17 . A pharmaceutical composition comprising an herbal extract according to  claim 14  and a pharmaceutically acceptable carrier. 
     
     
         18 . (canceled) 
     
     
         19 . The pharmaceutical composition according to  claim 17  wherein the carrier comprises propylene glycol. 
     
     
         20 . (canceled) 
     
     
         21 . A method for treating a disease comprising administering a pharmaceutically acceptable amount of a pharmaceutical composition according to  claim 17 , wherein the disease is selected from the group consisting of: a disease of the mucosa, a disease of the skin, an inflammatory disease, a disease associated with tissue repair, oral mucositis, inflammatory bowel disease, radiation induced proctitis, atrophic vaginits, periodontal disease, gingivitis, aphthous ulceration, mechanical trauma, thermal trauma, lichen planus, bullous pemphigoid, pemphigus vulgaris, dermatitis herpetiformis, angular chelitis and recurrent herpes. 
     
     
         22 . (canceled) 
     
     
         23 . (canceled) 
     
     
         24 . (canceled) 
     
     
         25 . (canceled) 
     
     
         26 . The method according to  claim 21  wherein the amount of herbal extract administered is between 1 mg and 1.5 g per day.