TOXICITY STUDIES OF A DEVELOPED HEPATOPROTECTIVE POLYHERBAL FORMULATION IN EXPERIMENTAL RATS
Objective: In the present study acute, sub acute and sub chronic toxicity studies were performed on scientifically developed hepatoprotective polyherbal formulation (PF). PF consists of dried methanolic extracts of dried rhizome of Curcuma longa, dried leaves of Murraya koenigii, Nyctanthes arbortristis, and Occimum sanctum. Methods: In acute toxicity study, PF was administered once orally at doses ranging from 250mg/kg -5000 mg/kg. Body weight and food consumption was noted for a period of 14 days. Animals were also observed daily for any behavioral or other toxic changes. In sub acute toxicity study animals were administered drugs in dose range of 500-2000 mg/kg p.o. for 28 days. Sub chronic toxicity study was also performed. Drug in dose range of 250-1000 mg/kg was administered once daily for 90 days. At the end of the study blood was withdrawn for hematology and biochemical estimations. Animals were then sacrificed and liver, kidney, heart and brain were dissected out which were observed for any gross morphological changes. Weight of organs was also noted. Results: The results showed no evidence of any changes in body weight and food intake, hematological parameters, liver and kidney function test when compared with control. The organs did not show any evidence of gross morphological changes. Conclusion: It is concluded that PF, at a dose of 1000 mg/kg, is safe for long term treatment of hepatic disorders.
Key Words: polyherbal formulation, hepatoprotective, acute, sub acute, sub chronic toxicity
A.Subramonium,P. Pushpangadan: Development of phytomedicines for liver diseases, Indian journal of pharmacology 1999;31:166-175.
Sharma A: Antihepatotoxic activity of some plants used in herbal formulations. Fitoterapia 1991;62:131-138
Thyagarajan S: Herbal medicine for liver diseases in India, Journal of Gastroenterology and Hepatology,2002;17:S370-S376
Arun, N. and Nalini, N.: Efficacy of turmeric on blood sugar and polyol pathway in diabetic albino rats. Plant Foods Hum. Nutr. 2002, 57, 41â€“52.
Sewan R, Subrana L.: The antioxidant activity of Curcuma longa. Journal of Ethno pharmacology 1995; 47(2):59-67.
Anil Kumar et al.: A review on spice of life Curcuma longa(turmeric) .IJABPT, 2011;2(4):371-379
Ajay S et al :Comprehensive review: Murraya koenigii Linn Asian Journal of Pharmacy and Life Science, 2011 ;1 (4):417-425
Sethiya NK, Nahata A, Mishra SH, Dixit VK.: An update on Murraya koenigii Spreng: a multifunctional Ayurvedic herb. J Chin Integr Med. 2011; 9(8): 824-833.
Srivastava VK and Prasad DN: Analgesic, antipyretic and ulcerogenic activities of Nyctanthes arbortristis leaf extract. J Ethnopharmacol. 1987;19:193-200
Bimlesh Kumar, et al: An update on Nyctanthes arbor-tristis Linn Internationale Pharmaceutica Sciencia 2011 ;1(1):77-86
Govind Pandey: Madhuri S Pharmacological activities of Occimum sanctum: A review International Journal of Pharmaceutical Sciences Review and Research 2010; 5( 1):61-65
Godhwani S, Godhwani JL, Vyas DS.: Ocimum sanctum: an experimental study evaluating its anti-inflammatory, analgesic and antipyretic activity in animals. J Ethnopharmacol 1987; 21(2): 153-163.
Joshua AJ, Goudar KS, Sameera N etal.: Safety assessment of herbal formulation, Rumbion &Tyrel in albino wistar rats.: Am J Pharm.& Toxicol.2010;5(1):42-47
Quality standards of Indian Medicinal plants 2003: .ICMR, New Delhi.
Organization for Economic Co-operation and development (OECD) OECD guidelines for testing of chemicals, Toxicity guideline no. 420, acute oral toxicity, fixed dose method Adopted: 17th December 2001
Organization for Economic Co-operation and development (OECD) OECD guidelines for testing of chemicals, Toxicity guideline no. 407, repeated dose 28 day oral toxicity study in rodents. Adopted: 3 October 2008
Organization for Economic Co-operation and development (OECD) OECD guidelines for testing of chemicals, Toxicity guideline no. 408, repeated dose 90 days oral toxicity study in rodents Adopted: 21st September 1998
Ghai, C.L:. A textbook of practical physiology,Jaypee Brothers, India 1995 p.119
King, J: The transferases alanine and aspartate transaminases. In Practical clinical enzymology Nostrand comp.Ltd. London 1965; p.91
Slot C: Plasma creatinine determination: a new and specific Jaffe reaction method.j.clin.Investigation 1965:17;381
Anaigu, S.O., Nwinyi, Toxicity studies in rats fed nature cure bitters 2005 :Afr.J.Biotechnol,4;72-78
Allan JJ, Bhide RM,Agarwal A : Safety assessment of zigbir ,a polyherbal formulation in Sprague dawley rats.J Toxicol 2012; 2012 :589520
Tatke PA.Nidhiya IS, Deshpande SG: Safety profile of a polyherbal formulation (Gynocare capsules) in female rats by subchronic oral toxicity study. Toxicol Int 2012 May ;19(2):
Minemura M, K Tajiri: Systemic abnormalities in liver disease :World J Gastroenterl,2009;15:2960-29
Shiva raj, Gowda prakash, B desai: Markers of renal function tests. N Am J Med Sci. 2010 April; 2(4):170-173
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