Theaflavin Compositions, Related Processes and Methods of Use

Abstract

A process for producing purified theaflavin extract is provided which comprises combining an organic solvent with tea leaves, extracting polyphenols from the tea leaves to produce an organic stock substrate solution; producing a second batch of tea leaves; grinding the second batch of tea leaves to produce stock fermentation enzyme; combining the stock substrate solution with the stock fermentation enzyme to produce a fermentation mixture; fermentation of the mixture to produce theaflavins; and, separating the theaflavins from the fermentation mixture to produce purified theaflavin extract. Oral dosage forms are provided which comprise an effective amount of the purified theaflavin extract. Methods of treatment of human physiological disorders are provided which comprise administering an oral dosage form.

1 .- 20 . (canceled) 
     
     
         21 . A method for treatment of a human physiological disorder comprising administering to a human diagnosed with the physiological disorder an effective amount of a product composition of theaflavins produced by the process comprising
 providing a first batch of tea leaves;   combining an organic solvent selected from the group consisting of ester, alcohol, ketone, ether, or a combination thereof with the first batch of tea leaves;   extracting polyphenols from the first batch of tea leaves to produce an organic stock substrate solution of polyphenols in the organic solvent;   providing a second batch of tea leaves;   grinding the second batch of tea leaves to produce stock fermentation enzyme;   combining the organic stock substrate solution with the stock fermentation enzyme to produce a fermentation mixture;   fermenting the fermentation mixture in the organic solvent to produce theaflavins; and   separating the theaflavins from the fermentation mixture to produce theaflavin composition.   
     
     
         22 . The method of  claim 21  wherein the first batch of tea leaves are green tea. 
     
     
         23 . The method of  claim 21  wherein the ratio of tea leaves to organic solvent is between about 1:10 and about 1:30. 
     
     
         24 . The method of  claim 21  wherein extracting polyphenols from the tea leaves proceeds for about 20 to about 60 minutes at between about 25° C. and about 60° C. 
     
     
         25 . The method of  claim 21  wherein the organic stock substrate solution is concentrated by removing the organic solvent to yield a solid content of about 0.5% to about 5% w/v. 
     
     
         26 . The method of  claim 21  wherein the second batch of tea leaves are substantially frozen. 
     
     
         27 . The method of  claim 21  wherein the fermentation mixture is a ratio of stock substrate solution to stock fermentation enzyme between about 5:1 to about 20:1 (w:w). 
     
     
         28 . The method of  claim 21  wherein fermentation proceeds between about 4 and about 8 hours at a stirring speed between about 30 and about 150 rpm and at between about 20° C. and about 40° C. 
     
     
         29 . The method of  claim 21  wherein oxygen is added to the fermentation mixture during fermentation. 
     
     
         30 . The method of  claim 21  wherein after fermentation, a resulting organic phase is separated from the fermentation mixture. 
     
     
         31 . The method of  claim 21  wherein water is added to the resulting organic phase in a ratio of between about 1:1 and about 1:25 by weight and substantially all organic solvent is removed to produce aqueous theaflavin extract. 
     
     
         32 . The method of  claim 21  wherein insoluble impurities are separated from the aqueous theaflavin extract to produce purified aqueous theaflavin extract. 
     
     
         33 . The method of  claim 21  wherein the purified aqueous theaflavin extract is lyophilized or spray dried. 
     
     
         34 . The method of  claim 21  wherein the organic solvent is selected from the group consisting of methyl acetate, ethyl acetate, propyl acetate and isopropyl acetate. 
     
     
         35 . The method of  claim 21  wherein the organic solvent is selected from the group consisting of ethyl alcohol, propyl alcohol, and isopropyl alcohol. 
     
     
         36 . The method of  claim 21  wherein the organic solvent is selected from the group consisting of butanone, diethyl ether, dipropyl ether, and methyl-tert-butyl ether. 
     
     
         37 . The method of  claim 21  wherein the organic solvent is ethyl acetate.