Aarthi, R (2022) Preclinical Safety Evaluation of Kothanthi Thalaga Parpam. Masters thesis, National Institute of Siddha, Chennai.
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Abstract
The test drug kothanthi thalaga parpam consists of thalagam and nayuruvi sambal which was adopted from the text Anupoga vaithiya navaneetham part-6. The aim of the research work was to study the safety of kothanthi thalaga parpam by acute and Repeated dose 28 days oral toxicity study in the wistar albino 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. ❖ Qualitative analysis of acid and basic radicals showed the presence of acid radicals such as sulphate, sulphite, fluoride& oxalate and the basic radicals such as Arsenic, iron, calcium, potassium, sodium in kothanthi thalaga parpam. ❖ Heavy metal content of KTP was analysed by using ICP-OES method. It result revealed that the heavy metal is present within below detection limit except Arsenic in Kothanthi thalaga parpam. The variation in results due to composition of major element in test drug. ❖ XRD technique of test drug that result showed that crystalline nature (calculated from the full width half maximum data of the XRD peaks) and grain size were investigated in test drug. ❖ Acute toxicity study of Kothanthi thalaga parpam 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. CONCLUSION: Kothanthi thalaga parpam was taken as test drug, the quality parameters and safety profile of the drug were analyzed as per standard protocol. The qualitative and quantitative analysis of Kothanthi thalaga parpam proved the quality and purity of the drug. The Acute toxicity study results did not show any mortality, behavioural changes and drug related toxicity. From the Acute toxicity study, it is revealed that Kothanthi thalaga parpam is not toxic at a maximum oral dose level of 2000 mg/kg in Wistar rats. So, the median lethal dose (LD50) of Kothanthi thalaga parpam is greater than 2000 mg/Kg b.wt. In Repeated Dose 28 Days oral toxicity study, upto highdose level(150mg/kg b.w) no changes were observed haematological and histopathological parameters showed no significant changes in internal organs compared with control group.No Observed Adverse Effect Level (NOAEL) of Kothanthi thalaga parpam is greater than 150mg/kg.b.wt. Hence, the safety of Kothanthi thalaga parpam is proved through this study. From the study results, it is concluded that the therapeutic dose of Kothanthi thalaga parpam 32.5mg-65mg(Arisi edai -1/4 Kundri) is safe for human consumption. Further clinical trials, Pharmacological studies and efficacy studies will be carried out on Kothanthi thalaga parpam to prove the efficacy of drug.
| Item Type: | Thesis (Masters) |
|---|---|
| Additional Information: | Reg.No.321916201 |
| Uncontrolled Keywords: | Preclinical Safety Evaluation, Kothanthi Thalaga Parpam. |
| Subjects: | AYUSH > Nanju Noolum Maruthuva Neethi Noolum |
| Depositing User: | Subramani R |
| Date Deposited: | 01 May 2023 18:48 |
| Last Modified: | 24 Feb 2024 07:06 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/21237 |
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