Srinivasan, M R (2020) Preclinical Safety Evaluation of Nilavembu Kudineer: A Siddha Poly Herbal Formulation. Masters thesis, National Institute of Siddha, Chennai.
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Abstract
The experimental formulation Nilavembu Kudineer has been choosen for my dissertation work based on Siddha Vaithiya Thirattu. Nilavembu Kudineer prepared with the ingredients of Purified Nilavembu (Andrographis paniculata), Vettiver (Vertiveria zieanioides), Vilamichuver (Plectranthus vettiveroides), Santhanasiraai (Santalum album), Peippudal (Tricosanthes cucuerino), Parppadagam (Hedyotis corymbosa), Koraikkizhangu (Cyperus rotundus), Sukku (Zingiber officinale), Milaku (Piper nigrum), it has been mentioned for Suram. The aim of the research work was to study the safety of the experimental formulation by acute and 28 days repeated oral toxicity study in the wister albino rat as per OECD Guidelines. The ingredients such as Nilavembu were collected from National Institute of Siddha, Herbal Garden, Chennai - 47 and other drugs were purchased from standard raw drug market. The drugs were identified and authenticated by Assistant Professor of Medicinal Botany, National Institute of Siddha, Chennai - 47. All the ingredients have been purified as per Siddha literature and formulation was prepared in Gunapadam Lab of National Institute of Siddha, Chennai - 47. Nilavembu Kudineer Choornam was analyzed quantitatively and qualitatively with Organoleptic Characters, Physico-chemical analysis, Aflotoxin, Pesticide residue, Microbial contamination, Nilavembu Kudineer was analyzed quantitatively and qualitatively with Phyto-chemical analysis, Bio-chemical analysis, Instrumental analysis (HPTLC analysis), Acute and 28 days repeated oral toxicity studies. CONCLUSION: Nilavembu Kudineer was taken as test drug and analyzed its quality parameters and safety profile as per standard procedure. Quality parameters assessment of Nilavembu Kudineer results showed purity and bio availability of the drug. The results obtained by quality assessment of Nilavembu Kudineer will be used as standard for future research. Safety profile of Nilavembu Kudineer was analyzed by acute and 28 days repeated oral toxicity study as per OECD guidelines 423 and 407. In acute toxicity study results suggested the LD50 of Nilavembu Kudineer is greater than 5000 mg / Kg b.wt. So Nilavembu Kudineer falls under Category - 5 in Globally Harmonised System (GHS) Classification. 28 days repeated oral toxicity study of Nilavembu Kudineer was studied in different dose levels such as 6 ml/kg.b.wt, 12 ml/kg.b.wt, 48 ml/kg.b.wt and satellite group – 48 ml/kg.b.wt. 28 days repeated oral toxicity study result showed no significant changes in haematological, biochemical and histopathology of vital organs in all treated groups compared with control group. These result suggests NOAEL of Nilavembu Kudineer is great than 48ml/kg.b.wt. This dosage is fourfold of human human effective dosage of Nilavembu kudineer. In conclusion the above toxicity study results suggest the human effective dosage of Nilavembu Kudineer 60 ml/ twice a day is safe for consumption. Efficacy of Nilavembu kudineer will be analyzed by invivo methods in future is necessary to strengthen the therapeutic usage of Nilavembu Kudineer.
| Item Type: | Thesis (Masters) |
|---|---|
| Additional Information: | 321716205 |
| Uncontrolled Keywords: | Preclinical Safety Evaluation, Nilavembu Kudineer, Siddha Poly Herbal Formulation. |
| Subjects: | AYUSH > Nanju Noolum Maruthuva Neethi Noolum |
| Depositing User: | Subramani R |
| Date Deposited: | 27 Sep 2021 03:04 |
| Last Modified: | 25 Mar 2024 11:38 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/18135 |
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