Quality and safety evaluation of a Ghanaian polyherbal product EAF-2011 for the management of superficial mycoses

Abstract

Background: The widespread use of herbal medicines in recent years means that issues concerning their quality, safety and efficacy need to be answered. In the current study, the polyherbal formulation EAF-2011 used in the Centre for Scientific Research into Plant Medicine, Mampong- Akwapemfor the management of superficial mycoses was evaluated for its quality and safety. Aim: The study sought to evaluate the quality and safety of the product in the management of superficial mycoses. Method: The method of standardisation using the basic phytochemical screening and the thin layer chromatography procedures was used. The stability was also assessed using the thin layer chromatography, an antimicrobial assay and the physicochemical properties of the product. A safety evaluation of the product was also performed using a skin sensitisation and chronic toxicity test in male Sprague-Dawley rats. Results: The product demonstrated stability during the study period of one year as results obtained from the thin layer chromatography, physicochemical and biological assay did not indicate any significant change in characteristics. Alkaloids, phenols, flavonoids, sterols and triterpenes were detected in the product. Three spots obtained by the thin layer chromatography were shown to be ideal for use as analytical markers for the product. Haematological, biochemical, urine and histopathological data at the end of the study did not indicate any adverse effect from the herbal treatments. Conclusion: The study thus showed the ointment to be safe for the management of superficial mycoses.

Key words: Analytical markers, chronic toxicity, polyherbal formulation, safety, standardisation, superficial mycoses