15. Acute and sub-chronic toxicities of phatra tricholes capsule in experimental animals
Main Article Content
Abstract
Phatra Tricholes capsule is a multiplant production planned for dyslipidemia patients. Herein, we assessed the potential toxicity of Phatra Tricholes, applying the protocol of acute and sub-chronic oral administration in experimental animal models. According to the WHO guidelines, the acute toxicity study was conducted on Swiss mice. Sub-chronic toxicity studies were conducted in Wistar rats, and oral administration was done at 0.11 and 0.33 g/kg for 30 consecutive days. As a result, Phatra Tricholes capsule used for mice at the highest dose (19.58 g/kg b.w) did not express acute toxicity in mice. Regarding the subchronic toxicity test, after oral administration of Phatra Tricholes, hematological parameters, hepato-renal functions, and microscopic images of the liver and kidney were unchanged compared with the control group. In conclusion, the Phatra Tricholes capsule did not produce acute and subchronic toxicities in Swiss mice and Wistar rats.
Article Details
Keywords
Phatra Tricholes, acute toxicity, sub-chronic toxicity, experimental animals
References
2. Medicalstudyzone.com D. Katzung Basic and Clinical Pharmacology. 15th edition. McGaw Hill/Medical; 2022.
3. Babadagli HE, Barry AR, Thanassoulis G, Pearson GJ. Updated guidelines for the management of dyslipidemia and the prevention of cardiovascular disease in adults by pharmacists. Can Pharm J CPJ. 2023; 156(3): 117-127. doi:10.1177/17151635231164989.
4. Arnold MJ, O’Malley PG, Downs JR. Key Recommendations on Managing Dyslipidemia for Cardiovascular Risk Reduction: Stopping Where the Evidence Does. Am Fam Physician. 2021; 103(8): 455-458.
5. A TE, Isabelle D. Phytosterols: natural compounds with established and emerging health benefits. Ol Corps Gras Lipides. 2007; 14(5): 259-266. doi:10.1051/ocl.2007.0145.
6. Li C, Zhu Y, Wang Y, Zhu JS, Chang J, Kritchevsky D. Monascus purpureus-fermented rice (red yeast rice): A natural food product that lowers blood cholesterol in animal models of hypercholesterolemia. Nutr Res. 1998; 18(1): 71-81. doi:10.1016/S0271-5317(97)00201-7.
7. Gong X, Li X, Xia Y, et al. Effects of phytochemicals from plant-based functional foods on hyperlipidemia and their underpinning mechanisms. Trends Food Sci Technol. 2020; 103: 304-320. doi:10.1016/j.tifs.2020.07.026.
8. World Health Organization, ed. Report: Working Group on the Safety and Efficacy of Herbal Medicine, Philippines, 5 - 9 October 1992. Regional Office for the Western Pacific of the World Health Organization; 1993.
9. Litchfield. J.T, Wilcoxon. F. A simplified method of evaluating dose-effect experiments. Journal of Pharmacology and Experimental Therapeutics. 1949; 96: 99-113.
10. Brennan FR, Andrews L, Arulanandam AR, et al. Current strategies in the non-clinical safety assessment of biologics: New targets, new molecules, new challenges. Regul Toxicol Pharmacol. 2018; 98: 98-107. doi:10.1016/j.yrtph.2018.07.009.
11. Borgert CJ, Fuentes C, Burgoon LD. Principles of dose-setting in toxicology studies: the importance of kinetics for ensuring human safety. Arch Toxicol. 2021; 95(12): 3651-3664. doi:10.1007/s00204-021-03155-4.
12. Theobald J, Ghanem A, Wallisch P, et al. Liver-Kidney-on-Chip To Study Toxicity of Drug Metabolites. ACS Biomater Sci Eng. 2018; 4(1): 78-89. doi:10.1021/acsbiomaterials.7b00417.
13. Chiranthanut N, Teekachunhatean S, Panthong A, Khonsung P, Kanjanapothi D, Lertprasertsuk N. Toxicity evaluation of standardized extract of Gynostemma pentaphyllum Makino. J Ethnopharmacol. 2013; 149(1): 228-234. doi:10.1016/j.jep.2013.06.027.
14. Velusami CC, Agarwal A, Mookambeswaran V. Effect of Nelumbo nucifera Petal Extracts on Lipase, Adipogenesis, Adipolysis, and Central Receptors of Obesity - PMC. 2013. 2013; 2013: 145925.
15. Binh PQ, Anh PTV, Hien DTT, Thong NT, Phuong PT. Toxicity evaluation of acute and sub-chronic oral toxicity of Hamo NK hard capsule in experimental animals. J Med Res. 2020; 136(12).