Preclinical Safety Evaluation of "Annapavala Chendhuram”

Raw drug of Annapavala chenduram was procured from the reputed shop in Chennai and got authentication from Department of Geology, University of Madras, Chennai. ❖ As per the literature, APC was prepared in Gunapadam Laboratory, National Institute of Siddha, Tambaram sanatorium, Chennai. ❖ Standardisation was done as per PLIM guidelines. ❖ Physico – chemical analysis of APC revealed its quality standard. ❖ Qualitative analysis of acid and basic radicals for APC showed the acid radicals such as sulphate, chloride, phosphate, carbonate and nitrate. The basic radicals present in the drug were Aluminium, zinc, Iron, calcium, magnesium, potassium and sodium. ❖ The SEM analysis of the drug APC revealed that irregular shape and uniformity of the drug which was 200nm in size. ❖ The EDAX associated with SEM showed the presence of elements like carbon, oxygen, iron, magnesium, Sulphur, Chlorine, Calcium. ❖ The XRD patterns of samples indicated the presence of dominating peaks Fe2O3. ❖ The FTIR analysis of APC revealed that the presence of alcohol, amine, alkane, carbonyl and alkyl halides (Fe- O) group which is ranged from 400 to 4000cm-1. ❖ Animal toxicity was done as per WHO guideline. ❖ There was no mortality or drug related toxicity during acute toxicity study. ❖ The long-term toxicity study did not show any toxic effects in the animals. ❖ Hematological, Serological and histopathology reports revealed the no toxic effects during throughout the study period. CONCLUSION: Annapavala Chendhuram has been used for thyroid dysfunction by many practitioners. The qualitative and quantitative analysis of Annapavala Chendhuram was done as per PLIM guidelines. It revealed that the quality standard of drug. From the animal study, it is concluded that Annapavala chenduram along with proper adjuvant is not toxic on acute administration at a maximum oral dose level of 2000 mg/kg in Wistar rats. There was no mortality and drug related toxicity noted. In long term toxicity, hematological, biochemical and histopathological studies showed no significant adverse effects during the 90 days of the study. Hereby, safety of Annapavala chenduram has been proven through this study. Further efficacy studies and clinical trials on Annapavala Chendhuram will be more beneficial for the researchers and world