The aim of the research work was to study the safety of the experimental formulation by acute and long term toxicity studies in the animal models. The ingredients were purchased from standard raw drug markets. All the individual components have been purified as per the Siddha literature and formulation was prepared in NIS Gunapadam lab. 

Idivallathi mezhugu was analysed qualitatively and quantitatively with, PHYSICO CHEMICAL, CHEMICAL, MICROBIAL LOAD, AFLATOXIN, PESTICIDE RESIDUE, AAS ANALYSIS and to evaluate safety by acute and long term toxicity studies. Initially the test drug was subjected to physico chemical analysis. It reveals the increased bioavailability and purity of the drug. Then the samples were analysed for chemical constituents. It reveals the presence of constituents like Sodium, Sulphate, Chloride, Carbonate, Calcium, Potassium, Sodium, Mercury, Starch, Reducing sugar, Iron, Alkaloids, Anti pyrine, Aliphatic amino acid and meconic acid and presence of phyto constituents like alkaloids, carbohydrates, glycosides, flavonoids, diterpenes and quinone. Microbial load aflatoxin and pesticide residue level were quantitatively measured in Idivallathi mezhugu the result indicate the below detectable limit of them. Heavy metal analysis was carried out in Idivallathi mezhugu by AAS to ensure the absence of Arsenic, Mercury, Cadium, and Lead.

 In Acute toxicity study there was no abnormal signs reported at the dose level of (720 mg/kg b.wt) within 24hours in Wistar Albino Rats. No mortality and No pathological changes have been seen in the internal organs of both control and treated groups in the 14 days study period. And the Body weight, food intake and water intake of animals are normal. Long term Toxicity Study was conducted for about 90 days as per WHO guideline in 3 doses low dose (72 mg/kg b.wt), mid dose (360 mg/kg b.wt), high dose (720 mg/kg b.wt). Animals were observed throughout the period. There was no significant change in body weight (Table: 10&9), water (Table: 12), and food intake (Table: 11). After 90 days animals were sacrificed and blood samples were collected, investigated. The results revealed that there were significant in RBC count and very significant changes in WBC and Lymphocyte count. In biochemical parameter significant changes seen in SGOT and very significant changes in HDL. The histopathological study on the organs such as brain, heart, lungs, kidney, spleen, liver, stomach, uterus, ovary and testis was normal in control, low dose, mid dose and high dose groups.

From the results of this study, the Qualitative analysis of Idivallathi mezhugu (IVM) reveals the Purity and Bioavailability of the drug. As heavy metals were found to be within the permissible limit, the drug is safe enough for oral consumption. In vivo toxicity studies indicate that there was no mortality and signs of toxicity observed for acute oral administration of IVM till the dose of ten times the therapeutic dose (720mg/kg b.wt) in the prescribed manner. In long term toxicity study there was significantly changes in haematological, biochemical parameter in IVM treated groups when compared to control group but the levels were within physiological limit. The histopathology report also confirms that there are no remarkable cellular changes at all the dose levels. It clearly demonstrates that there was No Observed Adverse Effect Level (NOAEL) upto the high dose level (720 mg/kg b.wt) , which is ten times that of therapeutic dose. Based on these results it can be conclude that , the dose level of Idivallathi mezhugu 0.8gm( Sundai alavu) for a duration of oru mandalam (45 days) (BD/day) mentioned in the Siddha literature Siddha vaithiya thirattu is safe dosage for human consumption. In future it is to be carried out to study the pharmacological activity and clinical trial to prove the efficacy of the drug.

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