STUDIES ON ACUTE TOXICITY OF HEPTOPLUS IN EXPERIMENTAL RATS Original Article M. SANKAR*, JOHANNA RAJKUMAR Department of Biotechnology, Rajalakshmi Engineering College, Chennai, Tamilnadu, India Email: sankar7950@gmail.com Received: 06 Jul 2016 Revised and Accepted: 09 Sep 2016 ABSTRACT Objective: To evaluate acute toxicity of Heptoplus (polyherbal drug) in Sprague-Dawley rats and to identify the active ingredients of the herbal drug. Methods: Heptoplus was subjected to preliminary phytochemical screening and the HPTLC fingerprint profile of herbal drug was documented. OECD guideline 423-Acute toxic class method was followed to evaluate the oral toxicity of Heptoplus in Sprague-Dawley rats. In acute toxicity studies, Group I (control) rats received 0.5% of carboxymethyl cellouse (Vehicle). Group II rats received 2000 mg/kg b. w of Heptoplus. The rats were observed on the day of dosing and thereafter for 14 d, for any toxic effect. Results: Preliminary phytochemical analysis of Heptoplus revealed total phenol, flavonoid, carbohydrate, and tannins as its major constituents. The total phenol and flavonoid content of Heptoplus was found to be 170 μg of gallic acid and 162 μg of quercetin equivalent. HPTLC analysis proved that phyllanthin is an active compound of Heptoplus. Acute oral toxicity assays showed Heptoplus administration did not result in any treatment- related mortality, abnormal clinical signs, and loss of body weight or gross pathological changes in rats. Hence, LD50 Conclusion: Heptoplus contain phyllanthin as an active ingredient. LD value of Heptoplus was found to be greater than 2000 mg/kg b. wt. 50 Keywords: Heptoplus, Phyllanthin, Acute toxicity value of Heptoplus was found to be greater than 2000 mg/kg b. wt. © 2016 The Authors. Published by Innovare Academic Sciences Pvt Ltd. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4. 0/) DOI: http://dx.doi.org/10.22159/ijpps.2016v8i11.13934 INTRODUCTION In the ancient times, larger use of plants as medicines have been reported which were initially taken in the form of crude drugs such as tinctures, elixirs, poultices, powders, and other herbal formulations. However, use of these herbal products, without scientific origin, is totally useless and unsafe. Furthermore, irrational use of these herbal products may cause serious toxicity to the humans. Unfortunately, many people have an underestimation about the toxicity of natural products, and even they do not realize that these agents could be as toxic as or more than that of synthetic drugs. Toxicology study is one of the important aspects of pharmacology, which deals with the adverse effects of the bioactive substances on living organisms, before use as a drug for ailments. So OECD guideline was established, in order to maintain the safety and efficiency of a new drug. It is extremely important that every new drug has to undergo toxicology studies in animals like mice, rat, guinea pig, dog, rabbit, monkey, etc. under various conditions of the drug [1]. Toxicology studies help us to make a decision, whether a new drug should be adopted for clinical use or not. So OECD 401, 423 and 425 classes emphasize that any new drug before coming to the market has to undergo clinical trial and toxicity studies [2]. The present study is designed to reveal the phytochemical constituents present in the heptoplus and to determine their LD 50 value, by performing acute oral toxicity assay in Sprague-Dawley rats. Heptoplus is a polyherbal drug. Heptoplus contains Phyllanthus amarus (Euphorbiaceae), Eclipta Alba (Asteraceae), Tephrosia purpurea (Fabaceae), Curcuma longa (Zingiberaceae), Picrorhiza kurroa (Plantaginaceae), Withania somnifera (Solanaceae), Pinius succinifera (Pinaceae), Pistacia lentiscus (Anacardiaceae), Orchis mascula (Orchidaceae) and Cycas circinalis (Cycadaceae) as ingredients MATERIALS AND METHODS . Chemicals and reagents The chemicals, used in this study were of analytical grade, procured from Ganesh Scientific Suppliers, Chennai, Tamil Nadu. Heptoplus Heptoplus (Tamil Nadu state-licensed drug, Lic. No 616) a polyherbal drug was procured from Care and Cure Herbs Pvt Ltd, Chennai, India, in the form of a capsule. Each capsule has the following composition, which is described in table 1. Table 1: Composition of heptoplus S. No. Herbal plants Parts of the plant used Quantity (mg) 1 Phyllanthus amarus Whole plant 100 2 Eclipta alba Leaves 50 3 Tephrosia purpurea Leaves 30 4 Curcuma longa Rhizome 30 5 Picrorhiza kurroa Root 20 6 Withania somnifera Root 100 7 Pinus succinifera Amber 37.50 8 Pistacia lentiscus Resinous exudate 25.00 9 Orchis mascula Endosperm 25.00 10 Cycas circinalis Flower Male 62.50 International Journal of Pharmacy and Pharmaceutical Sciences ISSN- 0975-1491 Vol 8, Issue 11, 2016