Anti-leishmanial activity of betel leaf extract

Abstract

This invention relates to method of treating visceral leishmaniasis or kala-azar by administering effective amount of betel leaf extract or lyophilized extract together with or associated with an additive and a composition comprising betel leaf extract with a pharmaceutically acceptable additive.

1 . A method of treating visceral leishmaniasis or kala-azar in animals including human beings said method comprising administering a pharmaceutically effective amount of betel leaf extract or a composition comprising betel leaf extract to the animal.  
     
     
         2 . A method as claimed in  claim 1  wherein, the composition comprising effective amount of betel leaf extract together with or associated with a pharmaceutically acceptable additive.  
     
     
         3 . A method as claimed in  claim 1  wherein, the additive is selected from nutrients such as proteins, carbohydrates, sugar, talc, magnesium sterate, cellulose, calcium carbonate, starch-gelatin paste and/or pharmaceutically acceptable carriers, excipient, diluent or solvent.  
     
     
         4 . A method as claimed in  claim 1  wherein, the betel leaf extract or the composition comprising betel leafs extract is administered orally or intramuscularly.  
     
     
         5 . A method as claimed in  claim 1  wherein, the oral route is in the form of capsule, syrup, concentrate, powder or granules.  
     
     
         6 . A method as claimed in  claim 1  wherein, the ratio of betel leaf extract to the additive is in the range between 1-10 10-1.  
     
     
         7 . A method as claimed in  claim 1  wherein, the betel leaf extract is obtained by crushing the betel leaf or extracting the crushed leafs with water or organic solvents such as alcohol, carbontetrachloride, chloroform and acetone.  
     
     
         8 . A method as claimed in  claim 1  wherein, the betel leaf extract or the composition comprising betel leafs extract is administered at a dosage level between 10 to 20 mg/kg of body weight for alternate days for one month.  
     
     
         9 . A method as claimed in  claim 1  wherein, the betel leaf extract or the composition comprising betel leaf extract reduces the viability of  L. donovani  promastigotes in vitro by 57 to 79% and reduce splenic and liver parasite load by 93 to 95%.  
     
     
         10 . A pharmaceutical composition useful for the treatment of visceral leishmaniasis or kala-azar in animals including human beings, said composition comprising effective amount of betel leaf extract together with or associated with a pharmaceutically acceptable additive.  
     
     
         11 . A composition as claimed in  claim 10  wherein, the additive is selected in such a manner it does not interfere with the activity of betel leaf extract.  
     
     
         12 . A composition as claimed in  claim 10  wherein the additive is selected from nutrients such as proteins, carbohydrates, sugar, talc, magnesium sterate, cellulose, calcium carbonate, starch-gelatin paste and/or pharmaceutically acceptable carriers.  
     
     
         13 . A composition as claimed in  claim 10  wherein, the composition is administered orally or intramuscularly.  
     
     
         14 . A composition as claimed in  claim 10  wherein, the oral route is in the form of capsule, syrup, concentrate, powder or granules.  
     
     
         15 . A composition as claimed in  claim 10  wherein, the ratio of betel leaf extract to the additive is in the range between 1-10:10-1.  
     
     
         16 . A composition as claimed in  claim 10  wherein, the composition is administered at a dosage level between 10 to 20 mg/kg of body weight for alternate days for one month.  
     
     
         17 . A composition as claimed in  claim 10  wherein, the composition reduce the viability of  L. donovani  promastigotes in vitro by 57 to 79% and reduce splenic and liver parasite load by 93 to 95%.  
     
     
         18 . A composition as claimed in  claim 10  wherein, the betel leaf extract used is having the following properties 
 i) The dried sample is a dark colored material soluble in water and dimethyl sulfoxide,  
 ii) Thin layer chromatography of the active material shows five spots having R f  0.75, 0.64, 0.50, 0.40 and 0.33 in the solvent system of n-butanol, acetic acid and water in the ratio of 9:5:7 respectively, and  
 iii) The HPLC analysis of the active material using Intersil ODS-3 (4.6×250 mm) analytical column, solvent system methanol and water in the ratio of 4:1 and a flow rate of 1.0 ml/min., detection at 217 nm resolved the material into eleven peaks with the retention time of 2.69, 4.27, 5.95, 6.97, 7.49, 9.39, 11.20, 12.40, 15.53, 18.90 and 21.49 min.  
 
     
     
         19 . Use of betel leaf extract or a composition comprising betel leaf extract for the treatment of visceral leishmaniasis or kala-azar in animals including human beings.  
     
     
         20 . Use as claimed in  claim 19  wherein, the betel leaf extract is administered together with or associated with a pharmaceutically acceptable additive.  
     
     
         21 . Use as claimed in  claim 19  wherein, the additive is selected in such a manner that does not interfere with the activity of betel leaf extract.  
     
     
         22 . Use as claimed in  claim 19  wherein, the additive is selected from nutrients such as proteins, carbohydrates, sugar, talc, magnesium sterate, cellulose, calcium carbonate, starch-gelatin paste and/or pharmaceutically acceptable carriers.  
     
     
         23 . Use as claimed in  claim 19  wherein the betel leaf extract or the composition is administered orally or intramuscularly.  
     
     
         24 . Use as claimed in  claim 19  wherein, the ratio of betel leaf extract to the additive is in the range between 1 -10:10-1.  
     
     
         25 . Use as claimed in  claim 19  wherein, the betel leaf extract or composition is administered at a dosage level between 10 to 20 mg/kg of body weight for alternate days for one month.  
     
     
         26 . Use as claimed in  claim 19  wherein, the betel leaf extract or composition reduce the viability of  L. donovani  promastigotes in vitro by 57 to 79% and reduce splenic and liver parasite load by 93 to 95%.