Optimization and validation of polyherbal formulation by applying Box-Behnken design for the treatment of Inflammatory bowel disease in experimental animals.

Abstract

Background: The use of herbal medicine in inflammatory bowel disease (IBD) had been increased significantly. Allopathic treatment of IBD leads too many side effects therefore use of the herbal formulation is promising. Aegle Marmelos, Bombax malabericum, and Hollarrhena antidysentrica plants have been used to treat IBD. Objective: To evaluate a designed polyherbal formulation in experimentally induced inflammatory bowel disease in rats and To validate mathematical model derived by Box-Behnken experimental design for optimized polyherbal formulation for the treatment of IBD in experimental rats by checkpoint analysis. Method: Three-level Box-Behnken design was selected to optimize the dose. Polyherbal formulation consist of plant extract of Aegle Marmelos (X1), Bombax malabericum (X2), and Hollarrhena antidysentrica (X3) in different ratios were selected as independent variable. Polynomial equations were established based on Analysis of variance (ANOVA). To validate the chosen polynomial equation checkpoint analysis were performed. The percentage of predictive error is presented. Results: ANOVA reveals that X2 plant does not have any significant impact on the response surface. The checkpoint batch showed the experimental value of CMDI and Disease activity index (DAI) as 1.33 and 0.66 respectively. It is worthwhile to note that the observed values were quite close to the calculated values of CMDI. A little difference in the value of DAI may be attributed to the inherent variation observed in animal studies. Conclusion: From this study, it was concluded that a dose of Aegle marmelos 100 mg/kg, a dose of Bombax malabericum 300 mg/kg, and a dose of Holarrhena antidysentrica 200 mg/kg will always be effective in IBD patients.