Preclinical Safety Evaluation of Annabethi Chendhuram

Annabethi chendhuram is used for the treatment of Paandu (Anaemia), Suram (fever), Seetha bethi (Dysentry) as mentioned in the Siddha literature. The raw drugs were procured from a reputed shop in Chennai. The herbal and mineral drugs were identified and authenticated by Botanist and Dept. of Gunapadam HOD, National Institute of Siddha. The raw drugs were purified and the medicine was prepared as mentioned in the Siddha literature. On organoleptic examination, the finished product seems to be dark brown in colour. In a physicochemical analysis of Annabethi Chendhuram, loss on drying at105oC of 3.03%w/w. Total Ash value, Acid value, insoluble Ash value, Water, and Alcohol soluble Extractive values reveal the purity of the test drug. Qualitative Analysis of Annabethi Chendhuram demonstrates the presence of Iron, Sodium, Magnesium, Zinc, Aluminium, Lead, Phosphate, Carbonate, Alkaloids. The result of AAS confirms that Iron concentration in Annabethi Chendhuram. ICPOES results confirm Heavy metals like Lead, Mercury, Arsenic and Cadmium were found below detection level. SEM result confirmed the presence of nano-sized, and spherically shaped particles with a smooth surface in even distribution. Analysis of Annabethi Chendhuram by Forier transform infrared spectroscopy (FTIR) revealed the Infrared absorption pattern of Feso4 stretching was absorbed in the region of 493cm-1 to, 542cm-1. The sharp absorption peak observed in the region of 594 cm-1. The absorption peak at 3407 cm-1 corresponds to O-H stretching which is bonded. The wide absorption peak at 1624 cm-1 may be due to the vibrational intensity of C=C group. The toxicological evaluations of Annabethi Chendhuram was conducted as per WHO guidelines. In acute toxicity study, no signs of toxicity and mortality were observed throughout the study period up to the dose of 250 mg/kg/ b.Wt. Thus, the LD50 value of Annabethi Chendhuram was found to be greater than 250mg/kg/ b.Wt. In 90 days long term Toxicity Study, behaviour signs parameters there was no toxic signs were observed in all the control and treated groups. The body weight, food intake, water intake significant changes were observerd in treated groups when compared to control group. In haematological parameters except (MCV), Lipid profile except(TGL), Renal parameters, and Hepatic parameters was normal in treated groups when compared to control group. The histopathological study on the organs such as brain, heart, lung, liver, spleen, kidney, stomach, testes, and ovary was normal in high dose groups when compared to control group. CONCLUSION: The results of analytical studies of ANNABETHI CHENDHURAM (ABC) reveals the Purity and Bioavailability of the drug and thus it proves that ABC involves scientific and systematic detoxification process with enhanced therapeutic potential. The heavy metals were found to be below detection level. In vivo toxicity studies indicate that there was no mortality and signs of toxicity observed for the acute oral administration of ABC up to 250 mg/Kg b.Wt. A single oral dose of 250mg/Kg b.Wt. was concluded as LD50 from the result. In long-term toxicity study, there were no abnormal significant changes in the biochemical parameter in ABC treated groups (Low,Mid and High dose) when compared to the control group. The histopathology report also confirms that there were no remarkable cellular changes at high dose level. Based on these results it can be concluded that the safer dose of Annabethi chendhram is 65 to 130 mg (BD/day)) for human consumption which is narrated in Gunapadam Thathu Jeeva Vaguppu. Thus ABC can be safely used in the management of Anaemia in pregnant women and children which is the current public health challenge our country is facing. In future, the research findings of the present study will be the first step in the evaluation of chronic toxicity study, teratogenicity and genotoxicity study of ABC