Preclinical Safety Evaluation of Mandura Chenthooram

The branch of toxicology (Nanju Murivu Maruthuvam) was developed in Siddhar’s period itself. Being a toxicology student the author is interested to take the drug Mandura Chenthooram to evaluate its safety profile. The name, Mandura Chenthooram comes from its ingredients manduram useful to treat various blood disorders. Mandura Chenthooram is a Siddha formulation prepared from purified Manduram (Ferroso ferric oxide), Pasuneer (Cow urine), Vetrilai (Piper betel), Vellattupaal (Goat milk), Vellattu neer (Goat urine), Notchi (Vitex negundo), and Katrazhai (Aloe vera). The test drug was chosen from the Siddha literature Kannusamy Parambarai Vaithiyam. The raw drugs were procured from Ramasamy Chetti shop and authenticated at Department of Gunapadam, National Institute of Siddha, Chennai-47. The Herbal drugs were identified and authenticated by Assistant Professor, Department of Medicinal Botany, National Institute of Siddha, Chennai-47. The ingredients were purified and the medicine was prepared as mentioned in the Siddha literature. Mandura Chenthooram was analyzed qualitatively with physico chemical, biochemical analysis, and spectroscopically with AAS, ICP-OES, XRD, SEM analysis. Acute and repeated dose 28 days oral toxicity studies were conducted as per the OECD guidelines 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 Biochemical constituents. It reveals the presence of constituents like Silicate, Sulphate, Carbonate, Iron, Calcium, Alkaloid, Starch, Anti pyrine, Aliphatic amino acid and Meconic acid. The Atomic Absorption Spectroscopy result shows the presence of heavy metal iron in Mandura Chenthooram and the Iron content of test drug is 22.60%. The Inductively Coupled Plasma Optical Emission Spectrometry (ICP-OES) shows that Aluminium, Arsenic, Cadmium, Copper, Mercury, Nickel and Lead were found below detection level. It also shows the presence of physiologically important minerals like Calcium, Copper, Sodium, Magnesium, Potassium, Sulphur and Phosphorus. EDAX analysis shows the presence of elements in the sample Iron, Oxygen, Sodium, Aluminium, Silicate, Potassium, and Calcium. The SEM imaging of the Medicine prepared from iron oxide sample shows that the particles are in micro size and irregular in shape. The particles are aggregate and individual particles are seen on the top of the clusters since the size of the particles collected from the raw iron oxide (Rust) is large. In Acute Toxicity Study, carried out as per OECD guidelines 423, there were no treatment related death or signs of toxicity developed in wistar albino rat at dosage levels of 300 and 2000 mg/kg b.wt throughout the study period. Further, no gross pathological changes have been seen in the internal organs of both control and treated groups. Thus, the LD50 value was found to be greater than 2000mg/kg body weight. Repeated Oral 28 Days Toxicity Study was conducted for about 28 days as per the OECD guideline-407 in 4 doses. Control group were given 1ml of honey with 1 ml distilled water. Low dose, mid dose and high dose were 2.34mg, 11.7mg and 23.4mg respectively. There was no significant change in body weight, water and food intake. There were no significant changes in the haematological and biochemical parameters. Histopathological study shows that, organs such as brain, heart, lungs, stomach, liver, spleen, kidney, testes, ovary and uterus was normal in control, and high dose groups. CONCLUSION: Mandura Chenthooram had been used by Siddhars for long time to treat various diseases such as Anaemia, Dropsy, Jaundice, Ascites, Cough, and Diarrhoea. Since Iron Oxide is present in Mandura Chenthooram, which is observed by the quantitative analysis, the drug can be easily absorbed in intestine. Acute toxicity study shows that the test drug can be used up to the dose of 2000mg/kg body weight as a single dose. As per Siddha literature, the test drug was used as a minimal dose medicine. No notable abnormalities were observed in test group of animals when compared with control group of animals. Hence, we conclude that the dosage of Mandura Chenthooram, 130mg twice a day narrated in Kannusamy Parambarai Vaithiyam is a safer therapeutic dose for uses of human. The author hopes that this study will be a footprint to future research of chronic toxicity study, Carcinogenicity, Teratogenicity regarding Mandura Chenthooram