Palraj, R (2020) Preclinical Safety Evaluation of "Vishathirku Poora Mathirai". Masters thesis, National Institute of Siddha, Chennai.
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Abstract
The test drug Vishathirku Poora Mathirai formulation was adopted from the text “Ramadevar Ennum Yakobhu eluthiya Vaithya Sindhamani 700’’ for the evaluation of safety. The test drug was prepared with the ingredients of Purified Rasam (Mercury Hydragyrum), Purified Pooram (Calomel), and Purified Gandhagam (Sulphur), Kuppai Meni leaf juice (Acalypha indica). The toxicity of the test drug VPM was assessed by universal accepted scientific methods the ingredients were purchased from standard raw drug markets. The ingredients of VPM were identified and authenticated by the concerned departments. All the individual ingredients purified as per Siddha literature and formulation was prepared in NIS Gunapadam Lab. The preparation of trial drug was standardized primarily by physicochemical and biochemical analysis and then safety of the drug was evaluated by acute and sub chronic toxicity studies. The physicochemical analysis of the test drug showed increased bioavailability and purity of the test drug. The bio chemical analysis of VPM indicates the presence of Calcium, Ferrous Iron, Sulphate, Chloride, Phosphate, Oxalate and alkaloids. Microbial load, Aflatoxin and Pesticide residue were quantitatively measured in Vishathirku Poora Mathirai the result indicate the below detectable limit of them. Heavy metal analysis was carried out in Vishathirku Poora Mathirai by AAS to ensure the absence of Arsenic, Mercury, Cadmium and Lead. The acute toxicity study showed that Vishathirku Poora Mathirai did not produce any toxic effect at dose of 300mg/kg and 2000 mg/kg within 24 hours in Wister albino rats. No mortality and pathological changes had been noted in the internal organs of both control and treated groups on the 15th day of the study. Body weight, feed intake and water intake is normal. In sub chronic toxicity study of test drug Vishathirku Poora Mathirai can be considered safe, as it did not cause either any lethality or adverse changes with general behaviour of rats and also there was no observable detrimental effects (90, 180 & 360 mg/kg body weight) over a period of 90 days. Animals were observed throughout the period. There were no significant changes in feed intake, water intake, and no significant changes in body weight. On 91st day animals were sacrificed and blood samples were collected and investigated. The results suggest that there were no significant changes in biochemical parameter there were no significant changes in RFT, LFT, and Lipid profile. In organs of control group and drug treated groups no abnormality was detected. Histopathological examination revealed normal architecture in comparison with control and treated drug treated groups. These results had demonstrated that the Vishathirku Poora Mathirai is relatively safe when administered orally in rats. CONCLUSION: From the results of analytical evaluation of the test drug Vishathirku Poora Mathirai, it was inferred that quality and stability was good when prepared under the standard protocol mentioned in this study. Qualitative analysis of VPM revealed the purity and bioavailability of the drug. The heavy metals were found to be within the permissible limit so the drug is safe for oral consumption. In acute toxicity study revealed that the drug VPM did not show any mortality and signs of toxicity up to 2000 mg/kg bodyweight in acute oral administration. In 90 days repeated oral toxicity study there was no significant changes in hematological, biochemical parameter in VPM (90mg, 180mg &360mg /Kg bodyweight) treated group. The histopathology report of the internal organs also confirmed that there were no remarkable cellular changes at all the dose level. Based on the results, it can be concluded that, the dose level of Vishathirku Poora Mathirai is Panavedai alavu (488 mg) mentioned in “Ramadevar Ennum Yakobhu eluthiya Vaithya Sindhamani 700” is a safe dosage for human consumption. In further study is to be carried out to evaluate the pharmacological activity of the test drug Vishathirku Poora Mathirai.
| Item Type: | Thesis (Masters) |
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| Additional Information: | 321716201 |
| Uncontrolled Keywords: | Preclinical Safety Evaluation, Vishathirku Poora Mathirai. |
| Subjects: | AYUSH > Nanju Noolum Maruthuva Neethi Noolum |
| Depositing User: | Subramani R |
| Date Deposited: | 27 Sep 2021 03:20 |
| Last Modified: | 26 Mar 2024 05:17 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/18139 |
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