Rasi, M (2022) A Toxicity study on Irunelli Karpam. Masters thesis, Government Siddha Medical College, Palayamkottai.
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Abstract
Analysis of Irunelli Karpam by various methods, provided the vital outcome. ❖ The research medicine( INK) ingredients were purified and the drug was prepared according to the process mentioned in, The Siddha Formulary of India –First Edition (English Version), Pg no: 6. The drug was selected for evaluating the toxic effect and mortality when given in short and long duration. The main aim of this study is to access the safety of the siddha drug “Irunelli Karpam” on wistar albino rats under various dose levels of drug administration especially in acute and subacute toxicity studies. ❖ The formulation prepared with ingredients of Purified Gandhagam (Sulphur), Nellikai saaru (juice of phyllanthus emblica). The chosen formulation has been prescribed for treating mainly used in Sori, sirangu. ❖ These minerals are purchased from registered raw material supply shop – Rajendra herbal store, Thuckalay, Kanyakumari District. ❖ The drugs are authenticated by Department of Medicinal Botany and Department of Gunapadam, Government Siddha Medical College, Palayamkottai, Tirunelveli. ❖ The raw samples were taken for purification and test medicine was prepared, as per the method narrated in the literature. ❖ Then the medicine was prepared in GSMC Gunapadam lab as per the literature. In review of literature, the ingredients of Irunelli Karpam were discussed in depth with a special attention paid to their medicinal uses and toxicological aspects. ❖ Physiochemical study Irunelli Karpam reveals the sample description, solubility profile and confirmatory specifications. ❖ The Biochemical analysis of INK indicated the presence of reducing sugar, Tannic acid, Ferrous Iron, Amino acid. ❖ The Biological screening (sterility test, specific pathogen Aflatoxins & Pesticide residue) reveals results of the Irunelli Karpam shows the specific pathogen are not detected Aflatoxins B1, B2, G1, G2 are not detected. And then Organo chlorine pesticide :Alpha BHC, Beta BHC, gamma BHC, Delta BHC, DDT and endosulphan are not detected. Organo Phosphorus: Malathion, Dichlorovus and chlorpyriphos are not detected. Oragano carbomates, carbofuran not detected, Pyrethroides: Cypermethrin are not detected. ❖ Instrumental Analysis: ◉ ICP OES results shows the formulation of Irunelli Karpam is safe as it contains heavy metals within specified limits.The results showed the heavy metals of As, Ca, Cd, Cu, Hg, Pb below detection limit level (BDL). It also shows the presence of physiologically important minerals like C, Fe, K, Mg, Na, P, S, Zn. This reveals the safety of the drug and it has free from toxic substances and has no side effects. ◉ GCMS Study of Irunelli Karpam shows the compounds presence of different fatty acids, heterocyclic compounds etc. ◉ HPTLC finger printing analysis of the sample reveals the presence of nine prominent peaks corresponds to presence of nine versatile phytocomponents present with in it. Rf value of the peaks ranges from 0.02 to 0.86. ◉ The FTIR results shows the observed waterO-H stretch, O-H stretch, H-C-H stretch, C=O stretch, N-H stretch, C-C=C symmetric stretch, H-C-H bend, C-O stretch, C -H bend, C-C stretch which indicates that the presence of functional groups Amide, Phenols and alcohols, Alkanes, Aldehyde, Amine, Alkenes, Ester, ether, Alkyne. ◉ The high intensity of XRD lines in the XRD pattern suggests its crystalline nature. It has been reported that nano particles exhibited a size dependent uptake from the intestine, and its passage via the mesentery lymph supply and lymph nodes to the liver with significant absorption for particles less than 200nm. Therefore, uptake of INK with a crystallite size of less than 200 nm through the intestine can be expected. ❖ Toxicity study results: In acute oral toxicity was done as per OECD guideline- 423 with levels four different dose (5mg/50mg/300mg/2000mg) of Irunelli Karpam were administred stepwise manner. throught out the 14 days of observation period, body weight of animals were recorded once in a week. There is no mortality and Daily the animals were observed for clinical signs of toxicity were observed in INK treated groups. The results of the acute oral toxicity study indicate that the LD50 is more than 2000 mg/kgb.wt of the animal. There were no physical and general behavioural changes observed in wistar albino rats. Body weight of all animals did not reveal any significant change as compared to vehicle control group.Food consumption of all group animals were normal. Finally, the Mortality was not observed in all treated groups. The motor activities were normal in all the 5 groups of animals This acute toxicity study results reveals that Irunelli Karpam was nontoxic upto a dose level of 2000 mg/kg body weight of animal. ❖ Repeated oral toxicity study was conducted for 28 days as per the OECD guideline – 407 in 4 doses. All animals from control and all the treated dose groups survived throughtout the dosing period of 28 days. control group were 1 ml of ghee with 1 ml of distilled water. low dose, mide dose, high dose 300 mg/ 1000mg/ 2000mg respectively. There was no significant change in water and food intake. There were no significant changes in the haematological and biochemical parameters. Histopathology study shows that, organs such as brain, heart, lungs, stomach, liver, spleen, kidney, testes, ovary and uterus was normal in control and high dose groups. ❖ The observations included clinical signs of toxicity, food intake, water intake, body weight. No signs of toxicity were observed. There was no significant changes in food intake, water intake and body weight. No mortality occurred till the last day of the study. ❖ The blood samples are used to evaluate haematological parameters (like SGOT, SGPT and ALP, Urea, Creatinine, Bilirubin). No changes in haematological parameters and biochemical parameters in low, middle and high dose (300 mg/kg, 1000mg/kg, 2000mg/kg). ❖ On completion of the 28 days of drug administration, wistar albino rats were sacrificed. In macroscopic examination the heart, kidneys, liver, brain and spleen were weighted. The organs were normal when compared with control group. Histopathological examination does not reveal any abnormalities, in all treated dose group level when compared with control group, reveals the action of drug in every dose level does not damage the organs. There is no pathological changes occur in all group of animals during the study period. Histopathology analysis was necessary to elucidate the safety of the medicine. These findings were desire the safety of Irunelli Karpam used in siddha system of medicines. CONCLUSION: Acute and subacute toxicity were carried out in WISTAR albino rats according to OECD guidelines (423). This drug has no acute toxicity as there was no mortality seen. Sub acute toxicity is carried by repeated dose of test drug for 28 days. Mortality, the functional observation, haemotological and biochemical investigations were done. There were no significant changes in the biochemical and haematological profile. From acute toxicity study it was observed nsp >0.05 that the administration of Irunelli Karpam (INK)at a dose of 2000 mg/kg to the rats do not produce drug-related toxicity and mortality. And No-Observed-Adverse-Effect- Level (NOAEL) at Irunelli Karpam (INK) is 2000 mg/kgSo the toxicological study of these test drug, INK establish the safety of the drug for long time administration.
| Item Type: | Thesis (Masters) |
|---|---|
| Additional Information: | Reg.No.321916007 |
| Uncontrolled Keywords: | Irunelli Karpam, Toxicity study. |
| Subjects: | AYUSH > Nanju Noolum Maruthuva Neethi Noolum |
| Depositing User: | Subramani R |
| Date Deposited: | 01 May 2023 18:42 |
| Last Modified: | 24 Feb 2024 07:00 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/21230 |
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