16 Pre-clinical toxicological profiling of Siddha formulation Sambirani Poo Kuligai by Acute and Sub-acute toxicity studies in accordance with OECD Guidelines Authors: M Vijibala Pre-clinical toxicological profiling of Siddha formulation Sambirani Poo Ku... 2019/Nov/16 ( 0 downloads) Abstract In recent times use of traditional medicines has been conventionally increased globally. Short-term and long-term toxicity studies with rodents are generally conducted for 14 or 28 days. Results of these studies can help to predict appropriate doses of the test substance for future sub – chronic or chronic toxicity studies .It can be used to determine NOELs (No observable effect level) for some toxicology endpoints. According to the recent regulatory guidelines preclinical toxicity evaluation of the siddha formulations is mandatory to ascertain the possibility of adverse event in humans upon short and long term usage of the drugs. The main objective of the toxicity study is to establish the safety margin of the drugs at preclinical level as the siddha preparations being prescribed widely to the larger category of people since several years it’s become regulatory essential for the researcher to justify the safety in humans and animals as well. Siddha system of medicine is a traditional practice that concerns the cultural interpretation of health, disease, and illness. In siddha the practice of ethnomedicine is a complex multidisciplinary system constituting the usage of herbs that has been the source of healing for people since several centuries. Sambirani poo kuligai (SPK) is poly herbal preparation which comprises of Styrax benzoin, Felbovinum purifactum, Syzygium aromaticum and Piper betel .The main aim of the present investigation is to establish the safety profile of the test drug SPK by acute and sub-acute oral toxicities in accordance with OECD guidelines. In the acute study, a single dose of 2000 mg/kg was orally administered and animals were monitored for 14 days. In the sub-acute study, repeated doses (100 and 200 mg/kg/day) of the test drug SPK were administered for 28 days followed by this biochemical and hematological parameters were evaluated. Results of the present investigation showed that there was no sign of toxicity and no mortality after single and repeated administration of the test drug SPK in experimental animals. The mean body weight and most of the biochemical and hematological parameters showed normal levels in rats treated with SPK at both the dose levels. The results of the present investigation has provided an evidence based data’s that clearly justified that the siddha drug Sambirani poo kuligai has wide margin of safety and it didn’t alters any of the physiology, behavioral and other functional parameters of the treated animals. Keywords: Preclinical toxicity, OECD guidelines,Siddha system, Sambirani poo kuligai, Biochemical, Hematological parameters.