Murugavel, R (2018) Preclinical Safety Evaluation of Rasa Karpoora Kuligai. Masters thesis, National Institute of Siddha, Chennai.
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Abstract
The test drug Rasa Karpoora Kuligai is selected from the text, Gunapadam Thathu Jeevam for the evaluation of safety, efficacy and therapeutic potency. Aim of the dissertation is to study the toxicity of the test drug Rasa Karpoora Kuligai by universal accepted scientific methods. The review of the literatures and scientific research reveals pepper, garlic, betel leaf, mother milk that, are having anti cancer, anti-oxidant, anti-inflammatory activities. The test drug was prepared properly by the given procedure all the ingredients were identified and authenticated by the concerned departments. The preparation of trial drug was standardized primarily by physicochemical and biochemical analysis The physicochemical analysis the drug shows brown in colour with pleasant odour and bitter mixed light pungent in taste. In physiochemical analysis the total Ash value of test drug is 6.87 which shows the total inorganic content (ammonium, potassium, calcium, chloride, iron) present in the drug. These contents are having important role in physiological functions of the body. Biochemical analysis shows the presence of calcium, sulphate, chloride, starch, phosphate, ferrous iron these compounds are protect the body from the risk of cancer. In instrumental analysis the ICP-OES result shows the toxic heavy metals such as As, Hg, Cd, Pb, Al, Cu, Ni are in Below Detection Limit(BDL) . The main ingredient of the drug is mercuric II chloride, but the final product RKK shows below detection limit of the mercury. SEM analysis of the Rasa karpoora kuligai shows that the uniform distribution of particles presents in the entire field. Most of the particles present in the sample is nano size and near nano size, average particle size is 4.64µm - 7.51µm which increase the efficacy and bio availability of the test drug. The acute toxicity study shows that Rasa Karpoora Kuligai did not produce any toxic effect at dose of 300mg/kg, and 2000 mg/kg to rats. So No-Observed- Adverse-Effect-Level (NOAEL) of Rasa karpoora kuligai is above 2000mg/kg.Bw. In sub acute toxicity study test drug Rasa Karpoora Kuligai can be considered safe, as it did not cause either any lethality or adverse changes with general behaviour of rats and also there were no observable detrimental effects (230, 450 & 600 mg/kg body weight) over a period of 28 days. These results have demonstrated that the Rasa Karpoora Kuligai is relatively safe when administered orally in rats. In organs of control group and drug treated groups no abnormality was detected. Histopathological examination revealed normal architecture in comparison with control and treated animal. CONCLUSION: From the results of analytical evaluation of the test drug Rasa Karpoora Kuligai, it is inferred that quality and stability was good when prepared under the standard protocol mentioned in this study. Qualitative analysis of RKK reveals the purity and bioavailability of the drug. As heavy metals were found to be with in the permissible limit so the drug is safe for oral consumption. The particle size of the test drug was determined by SEM analysis. In vivo toxicity study reveals the drug RKK shows no mortality and signs of toxicity upto 2000 mg/Kg bodyweight in acute oral administration. In 28 days repeated oral toxicity study there was significantly changes in haematological, biochemical parameter in RKK (230mg, 450mg & 600mg /Kg bodyweight) treated group but the levels were with in physiological limits. The histopathology report also confirms that there are no remarkable cellular changes at all the dose level. Based on the results, it can be concluded that, the dose level of Rasa Karpoora Kuligai is sundai alavu (0.798mg) mentioned in Gunapadam Thathu Jeevam is a safe dosage for human consumption.
| Item Type: | Thesis (Masters) |
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| Additional Information: | (Reg.No.321516206) |
| Uncontrolled Keywords: | Preclinical Safety Evaluation ; Rasa Karpoora Kuligai. |
| Subjects: | AYUSH > Nanju Noolum Maruthuva Neethi Noolum |
| Depositing User: | Subramani R |
| Date Deposited: | 29 Dec 2018 10:44 |
| Last Modified: | 29 Dec 2018 10:44 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/10283 |
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