A Scientific approach on the Validation of Santha Santhrothaya Mathirai a Siddha Herbo Mineral Preparation for its Safety and Efficacy in the Management of Hepatic disorders

Abstract

Santha Santhrothaya Mathirai (SSM) is a herbo-mineral formulation widely prescribed for hepatic disorders. The ingredients of SSM include mercurous chloride, borax, turmeric and lemon juice all of which are said to possess hepatoprotective activity. Although, the medicinal preparations mentioned in Siddha literature are time-tested standard preparations it is need of the hour to document standardization procedures by using sophisticated instrumental analysis to maintain quality control. In the present study the preparation of SSM was standardized initially and then it was scientifically validated by adopting various analytical techniques. Toxicity and pharmacological studies were also performed to understand the safety and efficacy of the traditional drugs. Over all SSM was found to contain notable quantity of mercury in the form of organometallic complex. This study clearly demonstrated the traditional mercury containing drugs are safe for oral administration plausibly may be due to the traditional purification and preparation protocols employed during the process of formulation. It is concluded that the trial drug SSM a classical Siddha formulation, was well formulated ensuring the quality by complying with the GMP and GLP standards at every step right from procurement, authentication ,purification to final product analysis. The toxicological profiling of SSM reveals that it has a large margin of safety on acute, sub acute and sub chronic toxicity in experimental rats. Also the pharmacological studies on SSM has proved it to be hepatoprotective and efficacious in the therapeutic dosage for treating liver diseases. The reverse pharmacological work to re-validate the traditional formulation, SSM confirms the safety profile and effectiveness by adopting the modern scientific and acceptable methods to satisfy the present day demands. Hence through this work, an effort has been made to bring out SSM as evidence based safe Siddha medicine for Liver disorders. newline