Abstract: The ingredients of GANDHAGA MATHIRAI were purified and the drug was prepared according to the process mentioned in Anuboga Vaidhya Navaneetham (Part – 6, Pg.No. 89, Second Edition - 2002, Hakim P. Mohamed Abdulla Sahib). The drug was selected for evaluating the toxic effect and mortality when given in short and long duration. The aim of this study is to evaluate the safety of the drug GANDHAGA MATHIRAI by administering it to Wistar albino rats at various dose
levels.
In review of literature, the ingredients of GANDHAGA MATHIRAI were discussed in depth with a special attention paid to their medicinal uses and toxicological aspects.
The ingredients of GANDHAGA MATHIRAI are gandhagam and changan leaf. The Gandhagam were purchased from Palani and Changan leaf collected from Pattukkottai.
The raw samples were taken for purification and test medicine was prepared, as per the method narrated in the literature.
Biochemical analysis of GANDHAGA MATHIRAI indicated the presence of calcium, sulphate, chloride, ferrous iron and Unsaturated compounds. Heavy metals such as lead, mercury, arsenic, and zinc were absent.
Phytochemical analysis of GANDHAGA MATHIRAI shows the presence of carbohydrates, glycosides, tannins, alkaloids, fixed oil and fats.
FTIR study of GANDHAGA MATHIRAI shows the presene of functional groups such as Alkanes, Aldehydes, -lactone, Aromatic compounds, Acyl and phenyll, Aliphatic iodo and chloro compounds, Alkyl halides, Phosphines, Water. Scanned Electron Microscope study of end product shows that the particles were stabilized and have irregular morphology. The particles were distributed in range 10μm and the size is below 5 μm.
In acute toxicity study all the animals were active and did not showed any signs of toxicity. The motor activities were normal in all the 5 groups of animals. This acute toxicity study results reveals that GANDHAGA MATHIRAI was nontoxic upto a dose level of 2000mg/kg body weight of the animal. The Acute toxicity study was conducted to know single dose toxicity of
GANDHAGA MATHIRAI on female Wistar Albino Rats. The study was conducted using 15 female Wistar Albino Rats. The female animals were selected for study of 6 weeks old with weight range of within ±20% of mean body weight at the time of randomization. The groups were numbered as group I, II, III, IV and V and dose with control, 5mg/kg, 50mg/kg, 300mg/kg and 2000mg/kg of GANDHAGA MATHIRAI.
The drug was administered by oral route as single dose and observed for 14 days. Daily the animals were observed for clinical signs and mortality. Body weight of animals was recorded once in a week. There were no physical and general behavioral changes observed in wistar albino rats of 5mg/kg, 50mg/kg, 300mg/kg and 2000mg/kg to rats during 14 days. Body weight of all animals did not reveal any significant change as compared to vehicle control group. Food consumption of all group animals was normal. Mortality was not observed in all treated groups. In Sub-acute toxicity animals were selected randomly grouped into four different groups containing minimum 6 animals (3 male + 3 female) per groups. The groups were numbered as group I, II, III and dose with control, 12.5mg/kg (low dose), 25mg/kg (Middle dose) and 50mg/kg (High dose) of GANDHAGA MATHIRAI. The GANDHAGA MATHIRAI was administered as single dose for 28 days and all animals were observed daily once. These observations were also performed on week ends.
The observations included clinical signs of toxicity, food intake, water intake, body weight. No signs of toxicity were observed. There was no significant changes in food intake, water intake and body weight. No mortality occurred till the last day of the study.
The blood samples are used to evaluate Hematological parameters (like RBC, WBC, HB,DC) and evaluate biochemical parameters (like SGOT, SGPT, ALP, UREA and CREATININE). No changes in haematological parameters and biochemical parameters in low and middle dose (12.5 mg/kg, 25 mg/kg) and mild changes in high dose (50mg/kg).
On completion of the 28days of drug administration, Wistar Albino Rats were sacrificed. In macroscopic examination the Heart, Kidneys and Liver organs were weighed. The organs were normal when compared with control group.
Histopathological examination revealed normal architecture in comparison with control and treated animal in low and middle doses (12.5 mg/kg, 25 mg/kg) and mild changes in high dose (50mg/kg).
Publication Year: 2019
Publication Date: 2019-10-01
Language: en
Type: dissertation
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