Nithya Kalyani, M (2022) Preclinical Safety Evaluation of Naga Rasa Parpam. Masters thesis, National Institute of Siddha, Chennai.
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Abstract
The Siddha formulation Naga Rasa Parpam has been chosen for my dissertation work from The Hand Book of Indian Medicine- The Gems of Siddha System. Naga Rasa Parpam prepared with the ingredients of purified Zinc, Hydrargyrum, Keezha nelli (phyllanthus amarus), Panai kuruththu (palm tuber). It’s used to treat Hemorrhoid, Fistula-in-ano, Gonorrhea and Cancer. ❖ The aim of the research work is to study the safety of Naga Rasa Parpam by acute and 28 days repeated oral toxicity in the wister albino rat as per OECD Guidelines 423 and 407. ❖ The Zinc and lingam were purchased from raw drug market, Chennai. Keezha nelli collected from Nationa Institute of Siddha, Herbal Garden,. Panai kuruththu collected from Tenkasi district. Zinc, Lingam, Keela nelli and Panai kuruththu are identified and authenticated by Gunapadam Department and Botany department, National Institute of Siddha. All the ingredients were purified and meicine was prepared in Gunapadam Lab at National Institute Siddha as per Siddha Literature. ❖ Naga Rasa Parpam was analyzed by qualitatively and quantitatively by Physico-chemical analysis, Biochemical analysis and Instrumental analysis. ❖ Initially the trail drug - Naga Rasa Parpam was subjected to organoleptic character and physico-chemical analysis. It reveals the purity and quality of the drug. ❖ Then the Naga Rasa Parpam was analyzed for chemical constituents. It showed the presence of Zinc, Mercury, Calcium, Chloride, Carbonate and Alkaloids. ❖ SEM results showed the presence of evenly distributed Cloudy and spongy shaped particles ranging 10 – 60 μg with smooth surface. ❖ EDAX analysis confirm the present of Zinc and Mercury, Carbon, Oxygen in the sample. ❖ ICP-OES analysis of Naga Rasa Parpam showed that the presence of Zinc, Mercury, Iron, Copper, Lead, Magnesium, Pottasium, Cobalt, Cadmium and Arsenic. ❖ FTIR analysis confirms the presence of corbonate, Nitrate and Sulfide compounds. ❖ In Acute toxicity there was no behavioural changes, Mortality and Morbidity observed all test animals. A acute toxicity study revealed the LD50 of Naga Rasa Parpam is greater than 2000 mg / Kg b.wt. ❖ 28 days Repeated oral toxicity study results showed Naga Rasa Parpam did not produced any behavioural changes, mortality and morbidity with in study period. The feed intake, water intake and Body weight of all the test drug treated animals were gradually increased during the study period but no significant changes observed when compared with control group. But significantly increased feed intake at first week (41±5.7**, p<0.01) and body weight at 4th week (185.2±18.7**, p<0.01)in low dose treated group. ❖ Hematological parameters revealed that all the test drug treated animals were normal when compared with control group. Bio-chemical analysis also ithin normal level when compare with control group. Histopathological examination of Naga Rasa Parpam treated animal results revealed that Naga Rasa Parpam did not induce any lesion of toxicological significance in all the vital organs examined under the experimental conditions. ❖ This 28 days repeated oral toxicity study suggest the No Observed Effect Level (NOAEL) of Naga Rasa Parpam is greater than 48 ml/ Kg b.wt. CONCLUSION: The quality parameters assessment of Naga Rasa Parapam results showed purity and bio availability of the drug. The results obtained by quality assessment of Naga Rasa Parpam will be used as standard for future research. ❖ Safety profile of Naga Rasa Parpam was analyzed by acute and 28 days repeated oral toxicity study as per OECD guidelines 423 and 407. ❖ In acute toxicity study the LD50 of Naga Rasa Parpam is greater than 2000mg / Kg b.wt. So Naga Rasa Parpam classified under category – 5 in Globally Harmonised Classification System. ❖ The 28 days repeated oral toxicity study of (260 mg / day) was studied in wistar albino rats at different dose levels such as 12 mg / kg.b.wt, 60 mg / kg.b.wt and 120 mg / kg.b.wt. This study results showed the NOAEL of Naga Rasa Parpam is greater than 120 mg / kg.b.wt. The animal effective dose of 120 mg/kg b.wt is four fold of human effective dose of Naga Rasa Parpam. ❖ In conclusion the human effective dose of Naga Rasa Parpam 130mg twice a day is safe for consumption. ❖ Efficacy of Naga Rasa Parpam will be analyzed by invivo methods in future is necessary to strengthen the therapeutic usage of Naga Rasa Parpam.
| Item Type: | Thesis (Masters) |
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| Additional Information: | Reg.No.321916205 |
| Uncontrolled Keywords: | Naga Rasa Parpam, Preclinical Safety Evaluation. |
| Subjects: | AYUSH > Nanju Noolum Maruthuva Neethi Noolum |
| Depositing User: | Subramani R |
| Date Deposited: | 01 May 2023 18:46 |
| Last Modified: | 24 Feb 2024 07:05 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/21235 |
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