Prithiviraj, K (2020) Preclinical Safety Evaluation of "Mahavallathy Legiyam". Masters thesis, National Institute of Siddha, Chennai.
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Abstract
The test drug Mahavallathy Legiyam formulation is adopted from the text “Bohar Vaithiyam 700 for the evaluation of safety, efficacy and therapeutic potency. The Literature review reveals that there was no safety related research has been done in Mahavallathy Legiyam. An initial Step in this study is a part of Standardization and preclinical safety evaluation of this drug was done. The test drug is prepared as per Siddha literature which is indicated for Skin diseases, venereal diseases, colic, leprosy, paralysis, leucorrhea, rheumatism, arthritis, chancres, ulcers, eczema, itches, piles, fistula and toxemic states, also in carbuncles and cancer. Aim of this dissertation is to study the safety of test drug by acute, Sub acute and sub chronic toxicity study in animal model. The toxicity of the test drug Mahavallathy Legiyam is done by universal accepted scientific methods. The study drug Mahavallathy legiyam was obtained from IMPCOPS pharmacy, kalki Krishnamurthy salai, Thiruvanmiyur, Chennai-600041, Tamilnadu. The preparation of trial drug was standardized primarily by physicochemical, Phytochemical and biochemical analysis and then evaluated safety of the drug by Acute, sub acute and sub chronic toxicity studies. The physicochemical analysis of the test drug shows increased bioavailability and purity of the test drug. The phytochemical analysis of Mahavallathy Legiyam indicates the presence of Alkaloids, Flavonoids, Glycosides, Quinones, and Fixed Oil & Fat. The bio chemical analysis of Mahavallathy Legiyam indicates the presence of Calcium, Carbonate, Aluminium, Ammonium, Mercury, Arsenic, Ferrous Iron, Sulphate , Chloride, Phosphate, Oxalate and alkaloids. Microbial load, Aflatoxin and Pesticide residue were quantitatively measured in Mahavallathy Legiyam, the result indicates the acceptable limit of them. Heavy metal analysis was carried out in Mahavallathy Legiyam by AAS to ensure the absence of Arsenic, Mercury, Cadmium and Lead. HPTLC finger printing analysis of the sample reveals the presence of five prominent peaks corresponds to presence of five versatile phyto components. Rf value of the peaks ranges from 0.06 to 0.79. The acute toxicity study shows that Mahavallathy Legiyam does not produce any toxic effect at the dose up to 2000 mg/kg within 24 hours in Wistar albino rats. Body weight, feed intake and water intake is normal during the treatment period. No mortality and pathological changes have been noted in the internal organs of both control and treated group on the 15th day of the study. In sub acute toxicity study of test drug Mahavallathy Legiyam can be considered safe, as it does not cause either any lethality or adverse changes with general behavior of rats and also there was no observable toxic effects (500, 1000 & 1500 mg/kg body weight) over a period of 28 days. There were no significant changes in feed intake, water intake, and slightly no significant changes in body weight. The results reveals that there were no significant changes in biochemical parameter, hematological parameter and lipid profile and also Histopathological examination revealed normal architecture in comparison with control and treated animal. These results have demonstrated that the Mahavallathy Legiyam is relatively safe when administered orally in rats. In sub chronic toxicity study of test drug Mahavallathy Legiyam can be considered safe, as it does not cause either any lethality or adverse changes with general behavior of rats and also there was no observable toxic effects over a period of 90 days. There was no significant changes in feed intake, water intake, and no significant changes in body weight. The results shows that there was no significant changes in biochemical parameter, hematological parameter and Lipid profile. In satellite group the hematological and biochemical parameters were almost restored to that of the control indicating the safety of the drug. In addition, Histopathological study of control, high dose and satellite group revealed that there was no significant pathological changes observed when compared to control group. These results have demonstrated that there is no toxic effects in all organs treated with Mahavallathy Legiyam. Hence, Mahavallathy legiyam is safe when administered orally. CONCLUSION: From the results of analytical evaluation of the test drug Mahavallathy Legiyam, it is inferred that quality and stability was good when prepared as per literature. The Qualitative analysis of Mahavallathy Legiyam reveals the purity and bioavailability of the drug. The heavy metals were found to be within the permissible limit. In acute toxicity study reveals the drug Mahavallathy legiyam shows no mortality and signs of toxicity up to 2000 mg/kg bodyweight. In 28 days repeated oral toxicity study & 90 days repeated oral toxicity study there was no significant changes in hematological, biochemical parameter and lipid profile in Mahavallathy Legiyam (500mg, 1000mg &1500mg /Kg b.wt) treated group. The histopathology report of the internal organs also confirms that there was no remarkable cellular changes at all the dose level. For further confirmation of safety profile of Mahavallathy legiyam, the toxicity studies are also done in satellite group which revealed that there is no toxic signs in longer duration of administration. Based on the results, it can be concluded that, the dose level of Mahavallathy Legiyam is 3gm mentioned in “Bohar Vaithiyam 700” is a safe dosage for human consumption.
| Item Type: | Thesis (Masters) |
|---|---|
| Additional Information: | 321716202 |
| Uncontrolled Keywords: | Preclinical Safety Evaluation, Mahavallathy Legiyam. |
| Subjects: | AYUSH > Nanju Noolum Maruthuva Neethi Noolum |
| Depositing User: | Subramani R |
| Date Deposited: | 27 Sep 2021 03:16 |
| Last Modified: | 25 Mar 2024 11:45 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/18138 |
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