Assessment of Chronic Toxicity of an Ayurvedic Herbo-Metallic Formulation Rasaraj Rasa in Wistar Rats
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Objectives: This study aimed to assess the adverse effects of Rasaraj Rasa tablets after repeated oral administration for 180 days in Wistar rats. Methods: Wistar rats were divided into five groups, of which three were treated with 54, 162, and 270 mg/kg body weight of Rasaraj Rasa, respectively, which correspond to one, three, and five times the proposed human therapeutic dose, for 180 days consecutively. The fifth group (satellite) also received 270 mg/kg body weight of Rasaraj Rasa for 180 days. Body weight and food intake were measured weekly. At the end of the study, all rats were sacrificed, and their blood, serum, and organs were collected and examined using hematology, serum biochemistry, gross pathology, and histopathology tests. In contrast, the satellite group was kept for 4 weeks after treatment. Results: No significant treatment-related toxicological findings were observed in the clinical features, body weight, laboratory findings, and pathological findings of the high-dose treated groups, when compared to those of the control group. Conclusion: The no-observed-adverse-effect-level for Rasaraj Rasa in Wistar rats is set at 270 mg/kg body weight.
Abstract
Objectives: This study aimed to assess the adverse effects of Rasaraj Rasa tablets after repeated oral administration for 180 days in Wistar rats. Methods: Wistar rats were divided into five groups, of which three were treated with 54, 162, and 270 mg/kg body weight of Rasaraj Rasa, respectively, which correspond to one, three, and five times the proposed human therapeutic dose, for 180 days consecutively. The fifth group (satellite) also received 270 mg/kg body weight of Rasaraj Rasa for 180 days. Body weight and food intake were measured weekly. At the end of the study, all rats were sacrificed, and their blood, serum, and organs were collected and examined using hematology, serum biochemistry, gross pathology, and histopathology tests. In contrast, the satellite group was kept for 4 weeks after treatment. Results: No significant treatment-related toxicological findings were observed in the clinical features, body weight, laboratory findings, and pathological findings of the high-dose treated groups, when compared to those of the control group. Conclusion: The no-observed-adverse-effect-level for Rasaraj Rasa in Wistar rats is set at 270 mg/kg body weight.
참고문헌 (26)
- Chauhan A, "Ayurvedic research and methodology : present status and future strategies", Ayu, 36(4), pp.364~369 (2015)
- Singh SK, "Preparation and characterization of a mercury based Indian traditional drug Ras-Sindoor", Indian J Tradit Knowl, 8(3), pp.346~351 (2009)
- Wang Q, "The anxiolytic effect of cinnabar involves changes of serotonin levels", Eur J Pharmacol, 565(1-3), pp.132~137 (2007)
- Galib, "Therapeutic potentials of metals in ancient India : a review through Charaka Samhita", J Ayurveda Integr Med, 2(2), pp.55~63 (2011)
- Albers JW, "Neurological abnormalities associated with remote occupational elemental mercury exposure", Ann Neurol, 24(5), pp.651~659 (1988)
- Chuu JJ, "Differential neurotoxic effects of methylmercury and mercuric sulfide in rats", Toxicol Lett, 169(2), pp.109~120 (2007)
- Paul S, "Assessing the role of Ayurvedic ‘Bhasms’ as ethno-nanomedicine in the metal based nanomedicine patent regime", J Intell Prop Rights, 16, pp.509~515 (2011)
- Saper RB, "Lead, mercury, and arsenic in US-and Indian-manufactured Ayurvedic medicines sold via the Internet", JAMA, 300(8), pp.915~923 (2008)
- Kumar A, "Bhasmas : unique ayurvedic metallic-herbal preparations, chemical characterization", Biol Trace Elem Res, 109(3), pp.231~254 (2006)
- Payyappallimana U, "Exploring ayurvedic knowledge on food and health for providing innovative solutions to contemporary healthcare", Front Public Health, 4, pp.57~ (2016)
- Kamath SU, "Mercury-based traditional herbo-metallic preparations : a toxicological perspective", Arch Toxicol, 86(6), pp.831~838 (2012)
- Test no.452: OECD guideline for the testing of chemicals:chronic toxicity studies, "OECD", OECD Publication, ~ (2009)
- Burtis CA, "Tietz textbook of clinical chemistry", pp.652~ (1999), W.B. Saunders
- Oberoi K, "Piperine enhances the bioavailability of secnidazole in rats", MOJ Bioequivalence Bioavailab, 3(3), pp.76~81 (2017)
- Gokarn RA, "Toxicological studies of Rasasindura, an Ayurvedic formulation", Indian J Pharm Sci, 79(4), pp.633~640 (2017)
- Joshi N, "Toxicity study of Lauha Bhasma(calcined iron)in albino rats", Anc Sci Life, 35(3), pp.159~166 (2016)
- Prabu PC, "Acute and sub-acute oral toxicity assessment of the hydroalcoholic extract of Withania somnifera roots in Wistar rats", Phytother Res, 27(8), pp.1169~1178 (2013)
- Jamadagni PS, "Repeated dose oral toxicity of Trivanga Bhasma in Swiss albino mice", Ayu, 34(1), pp.118~123 (2013)
- Mitra A, "Evaluation of chemical constituents and free-radical scavenging activity of Swarnabhasma (gold ash), an ayurvedic drug", J Ethnopharmacol, 80(2-3), pp.147~153 (2002)
- Timbrell JA, "Principles of biochemical toxicology" (1982), Taylor and Francis
- Boorman GA, "Pathology of the Fischer rat: reference and atlas" (1990), Academic Press
- Greaves P, "Histopathology of preclinical toxicity studies", pp.466~ (2007), Elsevier
- Pearse G, "Histopathology of the thymus", Toxicol Pathol, 34(5), pp.515~547 (2006)
- Vos JG, "Target organ pathology: a basic text", pp.207~237 (1998), Taylor and Francis
- Chandramouli R, "Designing toxicological evaluation of Ayurveda and Siddha products to cater to global compliance-current practical and regulatory perspective", J Pharm Sci Res, 2(12), pp.867~877 (2010)
- Saad B, "Safety of traditional arab herbal medicine", Evid Based Complement Alternat Med, 3(4), pp.433~439 (2006)