Ajithkumar, A (2022) Preclinical Safety Evaluation of Vajrakandi Mathirai. Masters thesis, National Institute of Siddha, Chennai.
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Abstract
The test drug Vajrakandi mathirai consists of Lingam, Rasa chenduram, Veeram, Pooram and extract of Lime and Ginger which was adopted from the text Anuboga vaithiya Navaneetham Part 5. The aim of the research work was to study the safety of Vajrakandi mathirai by acute and Repeated dose 28 days’ oral toxicity study in the wistar rat as per OECD Guidelines ❖ The Standardization procedures such as organoleptic characters, Physicochemical analysis and biochemical analysis were analyzed primarily. ❖ The physicochemical analysis of the test drug showed the increased bioavailability and purity of the drug. ❖ The disintegration time of Vajrakandi mathirai is 33 minutes (Normal range is below12 minutes). As per results the disintegration time is high but it become not significant when it is taken as powder form along with honey. ❖ Qualitative analysis showed the presence of Calcium, Phosphate, Chloride, sulphate, iron in Vajrakandi mathirai. ❖ Result of HR-SEM showed , Most of the particles were very tiny, unarranged and irregular in shape with amorphous in nature. ❖ The SEM with EDAX report showed the presence of Carbon, Oxygen, Sulphur, Chlorine, Mercury, in different proportions ❖ ICP-OES result showed that the presence of 21.02 μg/g of Copper, 2.48 μg/g of Manganese, 153.3 μg/g of Ferrous iron, 774.8 μg/g of Potassium,80 μg/g of Lead, 83.9 μg/g of Magnesium, 1.99 %w/w of Mercury, 1.36%w/w of Arsenic in Vajrakandi mathirai ❖ Acute toxicity study of Vajrakandi mathirai showed no abnormal signs at the dose level of 2000 mg / Kg b.wt. No mortality, morbidity and pathological changes have been seen in internal organs of treated groups during the study period. ❖ Repeated dose 28 days’ oral toxicity study results did not reveal any behavioral changes, mortality and morbidity. The body weight, feed intake and water intake of all the animals were gradually increased during the study period. ❖ Hematological parameters of all the test animals were normal and did not show any changes when compared with control group. Bio-chemical analysis of all animals were normal. ❖ Histopathological examination of internal organs did not show any abnormalities in all test drug treated animals. ❖ So, it is observed that the test drug does not cause any damage to the tissues and thus the safety of drug is proved. CONCLUSION: Vajrakandi mathirai was taken as a test drug, the quality parameters and safety profile of the drug were analyzed as per standard protocol. The qualitative and quantitative analysis of Vajrakandi mathirai proved the quality and purity of the drug. The quality assessment results will be used as standard for future research on Vajrakandi mathirai. The Acute toxicity study results did not show any mortality, behavioral changes and drug related toxicity. From the Acute toxicity study, it is revealed that Vajrakandi mathirai is not toxic at a maximum oral dose level of 2000 mg/kg in Wistar rats. So, the maximum tolerable dose (MTD) of Vajrakandi mathirai is greater than 2000 mg / Kg b.wt. In Repeated Dose 28 Days oral toxicity study, haematological and biochemical parameters of 250mg/kg b.wt test drug treated animals were within normal limit and histopathological parameters showed no significant changes in internal organs compared with the control group. So, the No Observed Adverse Effect Level (NOAEL) of Vajrakandi mathirai is greater than 250mg/kg.b.wt. Hence, the safety of Vajrakandi mathirai is proved through this study. From the study results, it is concluded that the therapeutic dose of Vajrakandi mathirai 130-195mg (1- 1 1/2 Kundri) is safe for human consumption. Further clinical trials, Pharmacological studies and efficacy studies will be carried out on Vajrakandi mathirai to prove the efficacy of drug.
| Item Type: | Thesis (Masters) |
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| Additional Information: | Ref.No.321916202 |
| Uncontrolled Keywords: | Preclinical, Safety, Evaluation, Vajrakandi Mathirai. |
| Subjects: | AYUSH > Nanju Noolum Maruthuva Neethi Noolum |
| Depositing User: | Subramani R |
| Date Deposited: | 01 May 2023 18:49 |
| Last Modified: | 24 Feb 2024 12:13 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/21238 |
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