Chandraleka, B (2022) A Toxicity study on Gandhi Mezhugu. Masters thesis, Government Siddha Medical College, Palayamkottai.
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Abstract
Gandhi Mezhugu is prepared according to the process found in the text The Siddha Formulary of India Tamil (Part -1). This well known drug is used in Siddha practices, by a large number of siddha physicians. ❖ The aim of this dissertation is to study the acute and chronic toxicity of the drug Gandhi Mezhugu, administered at various presumed moderate dosage, in the experimental animals. ❖ In Review of literature, the ingredients of Gandhi Mezhugu are discussed in depth, with focus of special features and medicinal uses, especially for the diseases such as Meganeer noigal like Vegumoothiram, Sori, Sirangu, Tholnoi, Eruvaimulai noigal. ❖ These minerals are purchased from registered raw material supply shop - Rajendra herbal store. Thuckalay, Kanyakumari District. ❖ The drugs are authenticated by the HOD, Department of Gunapadam, Government Siddha Medical College and Hospital, Palayamkottai, Thirunelveli. ❖ 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. ❖ Physiochemical study: Qualitative parameters of GM is Semisolid, Nonsticky, Garlic odour, water soluble, Pungent. ❖ Quantitative parameters of GM: The percentage of loss on drying og GM was1.20±0.540. since the loss on drying of GM is with in the normal limit. So, the stability of the drug is higher. The water soluble and acid soluble extract values provide an indication of the extent of polar and non-polar copmpounds respectively present in GM. The extract values of water in GM is 8.70±0.510. ❖ Biochemical analysis of GM indicated the presence of Sulphate, Chloride, Starch, Ferrous iron, Unsaturated compound, Amino acid. ❖ Biological screening (sterility test, specific pathogen Aflatoxins& Pesticide residue) reveals results of the Gandhi Mezhugu shows the specific pathogen are not detected and AflatoxinsB1, 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: ◉ FTIR ANALYSIS: It shows the presence of Alcohol, Amine salt, Carboxyclic acid, Conjugated acid halide, Carboxyclic acid, 1,2,4-Trisubtituted , Alkene, Halo compound, Alkyl & Aryl Halides. ◉ ICP OES results reveal that below detection limit level (BDL) of Aluminium, Arsenic, Calcium, Cadmium, Chloride, Copper, Iron, Mercury, Lead And result indicates the presence of Carbon, phosphorous, sulphur elements in the Gandhi Mezhugu. ◉ SEM: Observed from Scanning Electron Microscope (SEM) photographs that particles were stabilized and have irregular morphology. The particles were distributed in rage 5 microns and the size is below 10 microns. ◉ GCMS Study The phyto chemical analysis by GCMS analysis of the GM revealed the presence of five compounds namely, 4,6 Dimethoxxynaphthalen-1-y)methylene, 4,6,9-Nonadecatrine, Strychane, 1 acetyl-20a –hydroxy-16methylene, Hexadecanoic acid, methyl ester, Dasycarpidan 1-methanol, acetate (ester). ◉ HPTLC finger printing analysis of the of the Gandhi Mezhugu reveals the presence of four prominent peaks corresponds to presence of four versatile phyto components present with in it. Rf value of the peaks ranges from 0.03 to 0.92. ◉ Toxicity study results: In acute oral toxicity was done as per OECD guideline- 423 with levels four different dose (5mg/50mg/300mg/2000mg) of Gandhi Mezhugu 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 GM 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 Gandhi Mezhugu was non toxic upto a dose level of 2000 mg/kg body weight of animal. ◉ Sub acute toxicity study-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 throughout the dosing period of 28 days. control group were 1 ml of milk with 1 ml of distilled water. low dose, mid dose, high dose 36 mg/ 180mg/ 360mg 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 (36 mg/kg, 180mg/kg, 360mg/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. These findings were desire the safety of Gandhi Mezhugu used in siddha system of medicines CONCLUSION: Gandhi Mezhugu was studied for its acute and sub-acute toxicity effect using laboratory animals. In acute study GM did not produce any specific toxicity or mortality even at the dose of 2000 mg/kg in wistar albino rats. so no observed adverse effect level (NOAEL) of GM is 2000 mg/kg body weight of animal. In sub-acute toxicity 36mg/kg, 180mg/kg,360 mg/kg of GM was used and it was administered once daily for 28 days through oral route so the result clearly demonstrate the Gandhi Mezhugu can be considered safe, as it did not cause either lethality or adverse changes with general behaeviour of rats and there was no observable detrimental effects (36mg/kg, 180mg/kg.360mg/kg) over the period of 28 days. Haematological and histopathological parameters are normal limits and no significant abnormality present in internal organs. These finding confirm that the therapeutic dose level of 100- 200mg/kg b.w for man which is mentioned in "The Siddha formulary of India part-I (Tamil)" is safe dosage for clinical use. From the biological and pesticide screening, physiochemical analysis, biochemical analysis, instrumental analysis, it is inferred that safety of the drug was once again confirmed. Taken as a whole safety profile of the Gandhi Mezhugu was well established. This is just a preliminary study and it will be useful for further researches.
| Item Type: | Thesis (Masters) |
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| Additional Information: | Reg.No.321916002 |
| Uncontrolled Keywords: | Gandhi Mezhugu, Toxicity study. |
| Subjects: | AYUSH > Nanju Noolum Maruthuva Neethi Noolum |
| Depositing User: | Subramani R |
| Date Deposited: | 01 May 2023 18:37 |
| Last Modified: | 24 Feb 2024 06:55 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/21225 |
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