Recent Research in Science and Technology 2011, 3(11): 76-79 ISSN: 2076-5061 www.scholarjournals.org www.recent-science.com 76 RRST-Ayurveda Chronic Toxicity Study For Tamra Bhasma (A Generic Ayurvedic Mineral Formulation) in Laboratory Animals M.K. Vahalia * , K.S. Thakur S. Nadkarni, V.D. Sangle Shree Dhootapapeshwar Ayurvedic Research Foundation, Arogya Mandir, Tilak Road, Panvel-410206, India Article Info Abstract Article History Tamra Bhasma – a generic Ayurvedic mineral formulation was studied for its toxicity in laboratory animals. Chronic toxicity was conducted in albino rats (wistar strain). In this study Tamra Bhasma was administered orally, daily to different groups of albino rats in TD (Tamra Bhasma) and 2 TD (Tamra Bhasma 2 x Therapeutic Doses) doses for 3 months. Tamra Bhasma was found to be relatively safe at these dose levels. There was no mortality. No significant behavioural changes were noted in any of the group studied. No major alterations were observed in haematology, serum biochemical, necropsy and histopathology at the administered dose level. The overall chronic toxicity study data indicates that the test substance at its TD and 2TD level is very well tolerated since no toxicity symptoms of serious cause could be observed in any of the parameters analysed. Received : 11-07-2011 Revised : 28-09-2011 Accepted : 28-09-2011 *Corresponding Author Tel : +91-2227452216 Fax : +91-2227452967 Email: resanarya@yahoo.com kst@sdlindia.com mkv@sdlindia.com ©ScholarJournals, SSR Key Words: Tamra, Chronic Toxicity, Ayurvedic formulation Introduction Bhasma has its unique place in Ayurvedic Therapeutics. Bhasmas are basically made from metals and minerals [Dhatus and Khanij Dravya]. The process of Bhasmikaran is used to transform Dhatus and Khanij into Bhasmas. Synthesis of Tamra bhasma involves treating metallic copper with Herbal juices and then repeated calcinations in presence of air in controlled environment to a form traditionally known as ‘bhasma’ [1]. Bhasma- an integral part of Ayurveda describes about using metals & minerals for chronic disorders in various combinations, dosages forms & at various levels of purities. Tamra Bhasma which is Ushna, Teekshna & Srotoshodhak acts on liver. It induces secretion, circulation of Yakrut Pitta (Bile) properly. It is effective in reducing any inflammation or edema with its ‘Lekhan’ property. Deficiency of copper in the body causes weight loss, bone disorders, microcytic hypochromic anaemia, hypopigmentation, graying of hair and demyelination of nerves etc [2]. Safety and efficacy depends upon the methodology adopted for the preparation and any deviation from the classical preparation method will not yield desired results. Tamra Bhasma has been in use since long for many types of liver and gastro intestinal tract disorders [3]. The present study was aimed at screening the drug for its safety/toxicity studies in animal model. Materials and Methods Tamra Bhasma used for study was manufactured by Shree Dhootapapeshwar Ltd., Panvel, Navi Mumbai, India. The drug was prepared as per classical literature [1]. The test substance was dispensed in plastic bags labelled properly and was dispatched to an approved Animal House facility no.136/1999/CPCSEA, Biomedical Services Unit, Shree Dhootapapeshwar Ayurvedic Research Foundation, for Toxicity studies without interruption of the custody chain. Test substances were coded to blind the identity of the drug. A total of 18 Wistar strain albino rats of either sex with average body weight 150 to 250 g were obtained from in- house breeding facility of SDARF. They were maintained in ideal laboratory conditions in the prevailing ambient temperature (22±02ºC) and humidity (65±05%). The experiments were carried out in accordance with the guidelines of the Institute’s Animal Ethics Committee after obtaining its permission. Dose for experimentation was calculated with reference to suggested human doses i.e.60 - 125 mg. For toxicity study, higher dose was selected to ascertain its safety potential. The animals were divided into three groups (Group-I, II and III) containing six rats in each. Group-I rats received Tamra Bhasma at a dose equivalent to human therapeutic dose (TD- 2.25 mg/200g), Group-II rats received 2 times the dose equivalent to human therapeutic dose (2TD- 4.5 mg/200 g), p.o. for 90 days. Group-III was kept as control. Test drug was given as suspension in distilled water by gavage with a control group receiving the vehicle (distilled water). Toxicity was evaluated by observing the test drug effect on body weight and gross behaviour changes, gross and histological appearance of vital organs (brain, heart, lungs, liver, spleen, kidney and adrenals). Further effect on different biochemical variables like total cholesterol, triglycerides, urea nitrogen, creatinine, alkaline phosphatase (ALP), total protein, lactate dehydrogenase (LDH), alanine aminotransferase (ALT), aspartate aminotransferase (AST) and creatinine phosphokinase were estimated with the help of an autoanalyzer (ERBA CHEM-5, Trans Asia Biomedicals Ltd).