ANTIMICROBIAL CREAM FORMULATION WITH PIPER BETLE ESSENTIAL OIL AS ACTIVE INGREDIENT

摘要

Piper betle is a glabrous climbing vine from the family Piperaceae used in the Philippines, India, Malaysia and other Asian countries. It has been used as a traditional treatment for various ailments. Betel leaf essential oil, commonly known as Betel oil is the chief constituent of its leaves. The oil was obtained through steam distillation or by the use of Clevenger apparatus. The antimicrobial activity was tested using dilution method and agar diffusion method utilizing two bacteria: Staphylococcus aureus and Streptococcus pyogenes, and two fungi: Candida albicans and Trichophyton mentagrophytes. Freshly extracted Betel oil is pale yellow, soluble in common organic solvents and very slightly soluble in water. The oil was found to be effective against all the test organisms with MIC values of: 125 mg/ml for S. aureus ; 15.60 mg/ml for S. pyogenes; 250mg/ml for C. albicans and 195mg/ml for T. mentagrophytes. The zones of growth inhibition measured to the nearest mm. were: 67.50 mm for S. aureus; 90 mm for S. pyogenes, C. albicans and T. mentagrophytes. The formulated Piper betle cream was tested for its quality based on homogeneity, spreadability, washability. Product Use Test was done to determine acceptability of the cream to 100 respondents. The cream has undergone antimicrobial assay to confirm the previous action using the same test organism. Non-clinical evaluation using rabbits as tests animals was done to determine safety and non-irritancy. It has also undergone Clinical Drug Trial Phase 1 for safety test using 32 volunteers (Merck Manual of Diagnostics and Therapy, 2006). It was found to be safe and no adverse reactions have been reported. It is now undergoing Clinical Trial Phase II on 60 patients (BFAD Regulations, 1992) with skin diseases.