Beta-elemene, method to prepare the same and uses thereof

Abstract

This invention provides an anti-cancer composition of high purity beta-elemene extracted from plant sources. This invention also provides for the use of the composition as well as a low cost method to prepare it by multiple passes through the precision distillation tower.

We claim:  
     
         1 . A method for producing a composition containing beta-elemene from a plant source using a distillation tower comprising the following steps: 
 (a) obtaining said plant source;    (b) extracting oil from said plant source to produce crude product;    (c) loading said crude product into said distillation tower to separate said crude product into fractions; and    (d) collecting the fraction with the highest concentration of beta-elemene, thereby producing a composition of beta-elemene.    
     
     
         2 . A method for producing a composition of beta-elemene as in  claim 1  further comprising the following steps: 
 (a) loading said tower with said fraction collected in said step 1(d);  
 (b) drawing multiple fractions; and  
 (c) collecting the fraction with the highest concentration of beta-elemene, thereby producing a composition of beta-elemene.  
 
     
     
         3 . A method as in  claim 2  wherein said plant source contains at least one of the following: 
   G. Cymbopogon winterianus Jowitt, Zhangzhou Aglaia odorata  flower,  Fuzhou Aglaia odorata  flower,  Chunging Aglaia odorata  flower,  Chunging Aglaia odorata  leaves,  Zhangzhou Aglaia odorata  leaves,  Yibin geranium  leaves,  Kunmin geranium  leaves,  Litchi chenensis  cinnamomifolium, dry  Lauris nobilis, Citrus limona leaves, Vitis vinifera  grape leaves,  Clausena lansium  leaves,  Fortunella margarita  leaves,  Fortunella oborata, C. Wenyujin Chen , and  Magnolia sieboldi;    
 
     
     
         4 . A method for producing a composition of beta-elemene as in  claim 3  further comprising the following steps: 
 (a) using a precision distillation tower as said distillation tower;  
 (b) establishing a vacuum in said precision distillation tower of 2-5 mmHg;  
 (c) heating said tower to a temperature range of 86-93 degrees C.;  
 (d) using a fraction ratio of between 4:1 and 5:1; and  
 (e) using a reaction time of about 10 hours.  
 
     
     
         5 . A method for producing a composition of beta-elemene as in  claim 4  wherein said vacuum is 2 mmHg and said fraction ratio is 4:1.  
     
     
         6 . A method for producing a composition of beta-elemene as in  claim 5  further comprising: 
 (a) a first fractionation comprising the steps of: 
 producing a fraction at a temperature range of 86-88 degrees C.;  
 producing a fraction at a temperature range of 89-90 degrees C.;  
 producing a fraction at a temperature range of 91-93 degrees C.;  
 collecting said fraction produced at said temperature range of 89-90 degrees C.;  
 removing any residual material remaining in the tower; and  
 
 (b) a second fractionation comprising the steps of: 
 loading said composition produced at said temperature range of 89-90 degrees C. into said precision distillation tower;  
 producing a fraction at a temperature range of 86-88 degrees C.;  
 producing a fraction at a temperature range of 89-90 degrees C.;  
 producing a fraction at a temperature range of 91-93 degrees C.; and  
 collecting said fraction produced at said temperature of 89-90 degrees C., thereby producing a composition of beta-elemene.  
 
 
     
     
         7 . A method as in  claim 6  for producing a composition of beta-elemene wherein said precision distillation tower further comprises: 
 said tower having a height and diameter, wherein said height is 1.4 meters and said diameter is 6 cm;  
 said tower having an inside and outside surface wherein said inside surface defines a cavity;  
 3 mm×3 mm empty 120 mesh stainless steel cylinders,  
 wherein said cavity is fitted with as many of said stainless steel cylinders as will fit therein.  
 
     
     
         8 . A method for producing a composition of beta-elemene as in  claim 7  wherein said plant source is  G. Cymbopogon winterianus Jowitt.    
     
     
         9 . A method for producing a composition of beta-elemene as in  claim 8  wherein said composition of beta-elemene comprises at least 96% beta-elemene.  
     
     
         10 . A method of producing a composition of beta-elemene as in  claim 8  wherein said composition of beta-elemene comprises between 96.4 and 97.2% beta-elemene.  
     
     
         11 . A method of producing a composition of beta-elemene as in  claim 8  wherein said composition comprises: 
 about 96.4-97.2% beta-elemene;  
 about 0.8-1.2% elemenol;  
 about 1.3-17% copane;  
 about 0.5% gamma-elemene; and  
 about 0.2% isofuranogermacrene.  
 
     
     
         12 . A method for producing a composition of beta-elemene as in  claim 6  further comprising recycling the byproducts of said fractionation.  
     
     
         13 . A method as in  claim 6  further comprising: 
 combining said fractions produced at said temperature ranges of 86-88 and 91-93 degrees C. with the residue remaining after fractionation; and  
 loading said tower with said combination.  
 
     
     
         14 . The composition produced by the method of  claim 1 ,  2 ,  3 ,  4 ,  5 ,  6 ,  7 ,  8 ,  9 ,  10 ,  11 ,  12  or  13 .  
     
     
         15 . A composition for treating cancer comprising at least 96% beta elemene.  
     
     
         16 . A composition for treating cancer as in  claim 15  further comprising elemenol, copane and isofuranogermacrene.  
     
     
         17 . A composition for treating cancer comprising 96.4-97.2% beta-elemene.  
     
     
         18 . A composition for treating cancer comprising: 
 about 96.4-97.2% beta-elemene;    about 0.5% gamma-elemene;    about 0.8-1.2% elemenol;    about 1.3-1.7% copane; and    about 0.2% isofuranogermacrene.    
     
     
         19 . A composition to treat glioma comprising an effective amount of beta-elemene and a pharmaceutically suitable carrier.  
     
     
         20 . A composition to treat neuroglioma comprising an effective amount of beta-elemene and a pharmaceutically suitable carrier.  
     
     
         21 . A method for treating cancer in a subject comprising: 
 administering to said subject an effective amount of beta-elemene and a pharmaceutically suitable carrier.    
     
     
         22 . A method as in  claim 21  wherein said composition is administered orally, intravenously, topically or by injection into solid tumor.  
     
     
         23 . A method of inducing cellular apoptosis comprising contacting the cell with an effective level of beta-elemene.  
     
     
         24 . A method of inducing cellular apoptosis comprising contacting a cell with the beta-elemene composition as produced in  claim 1 ,  2 ,  3 ,  4 ,  5 ,  6 ,  7 ,  8 ,  9 ,  10 ,  11 ,  12  or  13 .  
     
     
         25 . A method of inducing cellular apoptosis in tumor cells in a subject comprising administering to said subject an effective level of beta-elemene and a pharmaceutically suitable carrier.  
     
     
         26 . A precision distillation tower device for producing a composition of beta elemene comprising: 
 said tower having a height and diameter, wherein said height is 1.4 meters and said diameter is 6 cm;    said tower having an inside and outside surface wherein said inside surface defines a cavity;    3 mm×3 mm hollow 120 mesh stainless steel cylinders, wherein said cavity is fitted with as many of said stainless steel cylinders as will fit therein.