ACUTE TOXICITY EVALUATION OF PROTODIOSCIN RICH EXTRACT OF TRIGONELLA FOENUM-GRAECUM L IN RATS
DOI:
https://doi.org/10.22159/ajpcr.2016.v9s3.14706Abstract
ABSTRACT
Objectives: The objective of this study was to investigate the acute toxicity of standardized protodioscin rich extract (PRE) of Trigonella foenumgraecum
L (26.63% w/w; PRE).
Methods: To evaluate the toxicity of PRE, the acute toxicity of the extract on adult rats were investigated. A fixed large dose of 2 g/kg body weight of
PRE was administrated by a single oral gavage, and 1 g/kg body weight of PRE was administered by intravenous according to the Organisation for
Economic Co-operation and Development guidelines.
Results: In 2 weeks, PRE showed no obvious acute toxicity. There were no deaths in either group and no change in the clinical signs. The hematological
and biochemical analyses showed some changes that returned to reference levels without impairment of homeostasis. The treatment did not induce
untoward changes in organs as shown by histological studies. The in vivo results showed that has low toxicity.
Conclusion: PRE is safe and can be potentially used as an aphrodisiac in future studies.
Keywords: Protodioscin, Aphrodisiac, Trigonella foenum-graecum, Organisation for Economic Co-operation and Development, Toxicity,
Histopathological studies.
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References
Pour BM, Latha LY, Sasidharan S. Cytotoxicity and oral acute toxicity studies of Lantana camara leaf extract. Molecules 2011;16(5):3663-74.
Patil S, Jain G. Holistic approach of Trigonella foenum-graecum in phytochemistry and pharmacology. Curr Trends Technol Sci 2014;3(1):34.
Basch E, Ulbricht C, Kuo G, Szapary P, Smith M. Therapeutic applications of fenugreek. Altern Med Rev J Clin Ther 2003;8(1):20-7.
Ulbricht C, Basch E, Burke D, Cheung L, Ernst E, Giese N, et al. Fenugreek (Trigonella foenum-graecum L. Leguminosae): An evidence-based systematic review by the natural standard research collaboration. J Herb Pharmacother 2007;7(3-4):143-77.
Jyothi D, Koland M. Formulation and evaluation of an herbal anti-inflammatory gel containing trigonella foenum greacum seed extract. Int J Pharm Pharm Sci 2015;8(1):41-4.
Priyanka K, Singh R. A systematic review on Indian floral biodiversity as eminent reserves for alternative treatment strategy of diabetes mellitus. Int J Pharm Pharm Sci 2016;8(4):10-9.
EMA/HMPC/146220/2010, Assessment Report on Trigonella foenum-graecum L., Semen, Committee on Herbal Medicinal Products (HMPC), European Medicines Agency; 2010.
Department of AYUSH, Ministry of Health and Family Welfare, Govenment of India.
Herbal Medicines Compendium (HMC). U.S. Pharmacopeial Convention (USP). Rockville, MD: Herbal Medicines Compendium (HMC); 2013.
Adimoelja A, Adaikan PG. Protodioscin from herbal plant Tribulus terrestris L improves the male sexual functions, probably via DHEA. Int J Impot Res 1997;9(1):S1-70.
Gauthaman K, Adaikan PG, Prasad RN. Aphrodisiac properties of Tribulus terrestris extract (protodioscin) in normal and castrated rats. Life Sci 2002;71(12):1385-96.
Gauthaman K, Ganesan AP. The hormonal effects of Tribulus terrestris and its role in the management of male erectile dysfunction – An evaluation using primates, rabbit and rat. Phytomedicine 2008;15(1-2):44-54.
Gauthaman K, Ganesan AP, Prasad RN. Sexual effects of puncturevine (Tribulus terrestris) extract (protodioscin): An evaluation using a rat model. J Altern Complement Med 2003;9(2):257-65.
Goswami SK, Pandre MK, Jamwal R, Dethe S, Agarwal A, Inamdar MN. Screening for Rho-kinase 2 inhibitory potential of Indian medicinal plants used in management of erectile dysfunction. J Ethnopharmacol 2012;144(3):483-9.
Iacono F, Prezioso D, Ruffo A, Di Lauro G, Romis L, Illiano E. Analyzing the efficacy of a new natural compound made of alga ecklonia bicyclis, Tribulus terrestris and Biovis in order to improve male sexual function. J Mens Health 2011;8(4):282-7.
Jamil M, Ansari J, Ali A, Ahamad J, Ali M, Tamboli E. Pharmacological scientific evidence for the promise of Tribulus terrestris. Int Res J Pharm 2012;3(5):403-6.
Kistanova E, Zlatev H, Karcheva V, Kolev A. Effect of plant Tribulus terrestris extract on reproductive performances of rams. Biotechnol Anim Husbandry 2005;21(1-2):55-63.
Singh S, Nair V, Gupta YK. Evaluation of the aphrodisiac activity of Tribulus terrestris L. In sexually sluggish male albino rats. J Pharmacol Pharmacother 2012;3(1):43-7.
Goel PK. Extract Obtained by a Commercially Viable Process for the Extraction of Furostanolic Saponins from Fenugreek Seeds, in Which One of the Compounds in the Extract is Protodioscin; 2012.
Hibasami H, Moteki H, Ishikawa K, Katsuzaki H, Imai K, Yoshioka K, et al. Protodioscin isolated from fenugreek (Trigonella foenum-graecum L.) induces cell death and morphological change indicative of apoptosis in leukemic cell line H-60, but not in gastric cancer cell line KATO III. Int J Mol Med 2003;11(1):23-6.
Variya K, Parmar V. A validated high-performance thin-layer chromatographic method for the quantitation of protodioscin in Trigonella foenum-graecum and its herbal formulations. J Planar Chromatogr Mod TLC 2015;28(6):458-65.
OECD. Acute Oral Toxic Class Method Guideline 423. Guideline for the Testing of Chemicals. Paris: Organization for Economics Cooperation and Development-OECD; 2000.
Clemo FA. Response to utility of clinical pathology reference ranges in preclinical safety studies. Toxicol Pathol 1997;25(6):650.
Lang P. Serum Chemistry Parameters for the Crl: CD® BR rat. Wilmington, MA: Charles River Laboratories, Inc.; 1993.
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