Pharmaceutical composition useful for the treatment of peptic ulcer diseases

Abstract

The present invention deals with the pharmaceutical composition comprising the therapeutically effective amount of a compound oenothein C obtained from the bioactive fraction of plant Woodfordia fruticosa optionally along with one or more pharmaceutically acceptable carriers, additives, lubricants and diluents. Further it also provides a method of treating peptic ulcer diseases in a subject using the said pharmaceutical composition. It also relates to the use of the compound oenothein C in the treatment of peptic ulcer related diseases and a process for the isolation of the said compound.

1 . A pharmaceutical composition useful for the treatment of the peptic ulcer diseases, wherein the said pharmaceutical composition comprising the therapeutically effective amount of the compound oenothein C optionally along with one or more pharmaceutically acceptable carriers, additives, lubricants and diluents. 
     
     
         2 . The pharmaceutical composition as claimed in  claim 1 , wherein the said composition is administered at a dose of 0.005 mg/Kg body weight/day to 0.5 mg/Kg body weight/day. 
     
     
         3 . The pharmaceutical composition as claimed in  claim 1 , wherein the said composition is preferably administered at a dose of at least 0.05 mg/Kg body weight/day. 
     
     
         4 . The pharmaceutical composition as claimed in  claim 1 , wherein the said composition does not show any toxic effect at the single dose level up to 250 mg/kg body weight. 
     
     
         5 . The pharmaceutical composition as claimed in  claim 1  wherein the composition is useful in the treatment of peptic ulcer diseases selected from the group comprising of gastric ulcer, duodenal ulcer and also gastritis, gastro esophageal reflux disorder (GERD). 
     
     
         6 . The pharmaceutical composition as claimed in  claim 1  wherein the compound oenothein C has dual functions in terms of anti gastric proton pump and anti  Helicobacter pylori  activity. 
     
     
         7 . The pharmaceutical composition as claimed in  claim 1  wherein the compound oenothein C inhibits gastric proton pump activity in vitro in the concentration range from 0.13 to 1.3 μM wherein the IC 50  value is 0.6 to 0.8 μM. 
     
     
         8 . The pharmaceutical composition as claimed in  claim 1  wherein the compound oenothein C shows bacteriostatic as well as bactericidal activity against clinical as well as standard strains of  Helicobacter pylori.    
     
     
         9 . The pharmaceutical composition as claimed in  claim 1  wherein the compound oenothein C shows the bacteriostatic activity against  Helicobacter pylori  with minimum inhibitory concentration (MIC) in the range of 6.25 μg/mL to 25.0 μg/mL. 
     
     
         10 . The pharmaceutical composition as claimed in  claim 1  wherein the compound oenothein C shows the bactericidal activity against  Helicobacter pylori  with minimum bactericidal concentration (MBC) in the range of 25.0 μg/mL to 50.0 μg/mL. 
     
     
         11 . The pharmaceutical composition as claimed in  claim 1 , wherein the composition has carriers selected from the group consisting of proteins, carbohydrates, sugar, magnesium stearate, cellulose, calcium carbonate, starch-gelatin paste and pharmaceutically acceptable carriers, excipients, diluents or solvents. 
     
     
         12 . The pharmaceutical composition as claimed in  claim 1 , wherein the compound oenothein C is obtained from the bioactive fraction of plant  Woodfordia fructicosa.    
     
     
         13 . The pharmaceutical composition as claimed in  claim 1 , wherein the administration route for the said composition used is selected from the group comprising oral, intramuscular, intravenous administration. 
     
     
         14 . The pharmaceutical composition as claimed in  claim 1  wherein the composition is used in the form selected from the group comprising of powder, injectable, syrup, capsule, tablet. 
     
     
         15 . A pharmaceutical composition, with a compound oenothein C, substantially as herein described with reference to the examples and figures accompanying this specification.