Safety efficacy and quality assessments of Ben-Cha-Moon-Yai Remedy

Abstract

Ben-Cha-Moon-Yai remedy is one of the Thai traditional medicines notified in Tum ra paad sard song khor. The remedy is composed of the roots of Aegle marmelos (L.), Oroxylum indicum (L.), Dimocarpus longan Lour., Dolichandrone serrulata (DC.) Seem., and Walsura trichostemon Miq. each in an equal part by weights. This remedy has been used as an antipyretic, anti-inflammatory and analgesic drug for a long time without scientific approved. Therefore, the pharmacognostic specifications of each root species in Ben-Cha-Moon-Yai remedy was developed in order to provided the macroscopic and microscopic specifications, physico-chemical identifications and chemical fingerprints. The ethanol and water extracts from each root species and Ben-Cha-Moon-Yai remedy were evaluated for their safety and efficacy both in vitro and in vivo. The mutagenic and antimutagenic activities of root extracts and Ben-Cha-Moon-Yai remedy were study using the pre-incubation method of Ames test. Most of the extracts exhibited non-mutagenicity without nitrite treatment in the Ames test toward Salmonella typhimurium strains TA98 and TA100. However, the water extract of A. marmelos revealed the mutagenicity on both strains in the present study. Most of the extracts were mutagenicity on both strains of S. typhimurium after being treated with sodium nitrite. In addition, it revealed that most of the extracts exhibited antimutagenic potential against the mutagenic reaction product produced from the reaction of 1-aminopyrene treated with nitrite under acidic condition pH 3-3.5 in the Ames test. Among five root species and Ben-Cha-Moon-Yai remedy extracts, the result demonstrated that the ethanolic extract of A. marmelos showed the highest toxicity against brine shrimp with LC50 of 53.5 µg/ml. Both water and ethanol extracts of A. marmelos showed the highest DNA damage in human lymphocytes with the total score of 250.50 and 187.67, respectively. The ethanol extract from the root of O. indicum and D. longan showed the highest antimicrobial activity against 13 tested microorganisms. These studies have demonstrated that the ethanol extract of D. longan showed the highest antioxidant capacity in various in vitro models. The Ben-Cha-Moon-Yai remedy extract seemed to be the most potent anti-nociceptive, anti-inflammatory and anti-pyretic activities in well-established animal models than individual components due to additive and/or synergistic effects of some herbal roots in the remedy. This might be a reason why Thai traditional doctors use Ben-Cha-Moon-Yai remedy as a therapeutic drug instead of using individual roots.