Impact of <i>Amritikarana</i> Procedure on Safety Aspect of <i>Somanathi Tamra Bhasma</i>

Somanathi Tamra Bhasma is a unique method of preparation of Tamra Bhasma. In the classics, it is mentioned that if Tamra Bhasma has been used without Amritikarana in therapeutics, it produces ill effects. Hence it should be recommended after Amritikarana process only. Actual impact of this procedure in the preparation of Somanathi Tamra Bhasma has not evaluated till date. This is the first attempt towards preparing Somanathi Tamra Bhasma with Amritikarana (STBA) and evaluate its safety. Three batches of STBA were prepared as per the classical guidelines. In acute toxicity, STBA was administered at a maximal dose of 2000 mg/kg to overnight fasted rats and observed closely for behavioural changes, signs of toxicity and mortality if any, continuously for the first six hours and thereafter periodically up to 14 days. In the repeated dose 90-days oral toxicity evaluation, the test drug was administered daily at the doses of 67.5, 337.5 and 675 mg/kg along with Pippali Churna and honey as an adjuvant to rats for 90 days in divided dose followed by a 30-day recovery period. Animals were sacrificed on the 91st day and haematological, serum biochemical parameters and histopathology of organs were studied. In acute toxicity, STBA at the dose of 2000 mg/kg did not produce any observable toxic effects or mortality. STBA did not produce any significant changes in haematological, biochemical and histopathological parameters at TED and TED x 5 dose levels but mild fatty and inflammatory changes were observed in liver at TED x 10 dose level. These changes were returned to normal at recovery groups. Based on these observations, it can be concluded that STBA is safe at therapeutic dose levels when used judiciously along with specified adjuvants.