Pharmaceutical composition for enhancing immunity, and extract of Poria

Abstract

A pharmaceutical composition is used to enhance immunity of human body. The composition contains potent components of lanostan compounds. A method is devised to obtain an extract from metabolit, sclerotium, or fermentation product of Poria cocos (Schw) Wolf. The extract contains 5-60% of the lanostane compounds by weight of the extract. The extract is devoid of secolanostane capable of inhibiting immunity development.

What is claimed is:  
     
         1 . A pharmaceutical composition capable of enhancing immunity of a mammal comprising a therapeutically effective amount of lanostane having the following chemical formula (I) as an active ingredient, in admixture of a pharmaceutically acceptable carrier or diluent for the active ingredient:  
       
         
           
           
               
               
           
         
       
       wherein R 1  is either H or CH 3 ; R 2  is OCOCH 3 , C═O or OH; R 3  is H or OH; 
 R 4  is —C(═CH 2 )—C(CH 3 ) 2 R a , wherein R a  is H or OH, or —CH═C(CH 3 )—R b , wherein R b  is CH 3  or CH 2 OH; R 5  is H or OH; and R 6  is CH 3  or CH 2 OH.  
 
     
     
         2 . The pharmaceutical composition according to  claim 1 , wherein the lanostane (I) is  
       
         
           
           
               
               
           
         
       
     
     
         3 . The pharmaceutical composition according to  claim 1  comprising 0.1-60% of the lanostane (I) by weight of the composition.  
     
     
         4 . The pharmaceutical composition according to  claim 1 , which is orally administered.  
     
     
         5 . The pharmaceutical composition according to  claim 1 , wherein said mammal is a human.  
     
     
         6 . A  Poria  extract capable of enhancing immunity of a mammal comprising 5-60% of a lanostane (I) as defined in  claim 1  by weight of the extract, and being substantially devoid of secolanostane.  
     
     
         7 . The  Poria  extract according to  claim 6 , which is prepared by a method comprising the following steps: 
 a) extracting metabolites, fermentation products or sclerotium of  Poria cocos  (Schw) Wolf by water, methanol, ethanol, or a mixed solvent thereof;    b) concentrating the resulting liquid extract from step a);    c) introducing the resulting concentrated substance from step b) into a silica gel column;    d) eluting the silica gel column with an eluent having a low polarity, and collecting the resulting eluate;    e) concentrating the eluate to form a concentrated eluate.    
     
     
         8 . The  Poria  extract according to  claim 7 , wherein the concentrated eluate from step e) has a chromatographic value, Rf, not less than 0.1 in accordance with a thin layer chromatography, which is developed by a mixed solvent of dichloromethane:methanol=96:4 and is detected by an ultraviolet lamp and iodine vapor.  
     
     
         9 . The  Poria  extract according to  claim 7 , wherein the extraction in step a) is carried out by using 95% ethanol.  
     
     
         10 . The  Poria  extract according to  claim 7 , wherein the concentrated substance resulted from step b) is further extracted with a two-phase solvent containing methanol and n-hexane in a volumetric ratio of 1:1, a methanol layer is separated from the two-phase solvent extraction mixture, and the methanol layer is concentrated to form a concentrate, which is used as a feed to the silica gel column in step c).  
     
     
         11 . The  Poria  extract according to  claim 7 , wherein the low polarity eluent is a mixed solvent containing dichloromethane and methanol in a volumetric ratio of 96.5:3.5.  
     
     
         12 . The  Poria  extract according to  claim 6  comprising 10-20% of the lanostane (I).  
     
     
         13 . The  Poria  extract according to  claim 6 , wherein the lanostane (I) is  
       
         
           
           
               
               
           
         
       
     
     
         14 . A method of enhancing immunity of an individual comprising administering to the individual a therapeutically effective amount of the lanostane (I) as defined in  claim 1 .  
     
     
         15 . The method according to  claim 1 , wherein the lanostane (I) is  
       
         
           
           
               
               
           
         
       
     
     
         16 . A method of enhancing immunity of an individual comprising administering to the individual a therapeutically effective amount of the  Poria  extract as claimed in  claim 6 .  
     
     
         17 . A method of enhancing immunity of an individual comprising administering to the individual a therapeutically effective amount of the  Poria  extract as claimed in  claim 7 .  
     
     
         18 . A method of enhancing immunity of an individual comprising administering to the individual a therapeutically effective amount of the  Poria  extract as claimed in  claim 8 .  
     
     
         19 . A method of enhancing immunity of an individual comprising administering to the individual a therapeutically effective amount of the  Poria  extract as claimed in  claim 9 .  
     
     
         20 . A method of enhancing Immunity of an individual comprising administering to the individual a therapeutically effective amount of the  Poria  extract as claim d in  claim 10 .  
     
     
         21 . A method of enhancing immunity of an individual comprising administering to the individual a therapeutically effective amount of the  Poria  extract as claimed in  claim 11 .  
     
     
         22 . A method of enhancing immunity of an individual comprising administering to the individual a therapeutically effective amount of the  Poria  extract as claimed in  claim 12 .  
     
     
         23 . A method of enhancing immunity of an individual comprising administering to the individual a therapeutically effective amount of the  Poria  extract as claimed in  claim 13.