Sangeetha, A (2022) A Toxicity study on Sindhu Vallathi Mezhugu. Masters thesis, Government Siddha Medical College, Palayamkottai.
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Abstract
Analysis of SINDHU VALLATHI MEZHUGU by various methods, provided the vital outcome. ❖ The research medicine (SVM) ingredients were purified and the drug was prepared according to the process mentioned in Gunapadam Thathu jeeva vaguppu (Indian Medicine and Homeopathy). The Siddha formulary of India part –II (First Edition Tamil Version Govt of India, Dept of AYUSH New Delhi). 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 “SVM” on wistar albino rats under various dose levels of drug administration especially in acute and subacute toxicity studies. ❖ The formulation prepared with ingredients of Palam puli (Tamarindus indica), Serankottai (Semecarpus anacardium), Murungai elai (Moringa oleifera), Kariyuppu (Sodium chloride), Venkaram (Borex), Vediyuppu (Potassium nitrate) with luke warm water. Indication: Neeradaipu, Soolai (Pain), Gunmavayu, Bavuthiram (Fistula), Kalladaipu (Kidney stone), Andavayu, Sathaiadaippu, Kudalpaduvan, Peruneerkovai, uthiravatham. ❖ These raw drugs are purchased from registered raw material supply shop – Rajendra herbal store, Thuckalay, Kanyakumari District. ❖ The drugs are authenticated by SCRI. Arumpakkam, Chennai, Department of medicinal botany 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. ◉ Physiochemical screening: Physiochemical study of SVM reveals the sample description, solubility profile, confirmatory specifications. ◉ Biochemical screening: The Bio chemical analysis of siddha trial drug SVM which shows the presence of Sulphate, Chloride, Unsaturated compound, Ferrous Iron in it. ◉ Phytochemical screening: The Phytochemical analysis of siddha trial drug SVM which shows the presence of Alkaloids, Flavonoids, Glycosides, Steroids, Phenol, Tannin, Saponins, Sugar in it. ◉ Biological and pesticide screening: The Biological and Pesticide residue screening (Sterility test, specific pathogen, Aflatoxins) reveals results of the SVM shows the no growth / colonies was observed in any of the plates inoculates with the test sample by sterility test. The research sample product is free from specific pathogen like Escherichia coli, salmonella, pseudomonas aeruginosa, staphylococcus aureus. In Aflatoxins B1, B2, G1, G2 are not detected. the test results of pesticide residue shows there were no traces of pesticides residues such as organo chlorine, organo phosphorus, organo carbamates and pyrethroide in the sample for analysis (Organo chlorine pesticides like Alpha BHC, Beta BHC, gamma BHC, Delta BHC, DDT and endosulphan not detected. The Organo Phosphorus pesticides like Malathion, Dichlorovos and chlorpyriphos are not detected. Oragano carbomates like carbofuran not detected. Pyrethroides, Cypermethrin are not detected). ◉ Instrumental screening: ● FTIR groups in the SINDHU VALLATHI MEZHUGU shows the presence of Alcohols, Alkanes, Alkenes, Acids, Amines, Aliphatic, Aromatic, Alkyl Halides and Ether. ● ICP-OES results showed the heavy metals like As, Ca, Cd, Cu, Fe, Hg, K, Pb, Zn were found below detection level. It also shows the presence of physiologically important minerals like calcium, magnesium, sulphide, sodium, phosphorous, sulphur. This reveals the safety of the drug and it has free from toxic substances and has no side effects. ● GCMS Study of SVM shows the compounds presence of n- Hexadecylsuccnic anhydride, 1- Hexadecanamine, 9,15- octadecadienoic acid, methyl ester, Spiro (androstane- 3,2’- thiazolidine) (5a’), Corynan-17-01,18,19-didehydro-10-methoxy-acetate,1H-cyclopropa (3,4) benz (1,2-e) azulene derivatives. ● XRD peaks of SVM were identical with those reported for the standard sodium element, crystalline nature. ● TLC And HPTLC finger printing analysis of the SVM reveals the presence of five prominent peaks corresponds to presence of five versatile phyto components present with in it. Rf value of the peaks ranges from 0.01to 0.25. ● SEM photographs that particles were stabilized and have irregular morphology. The particles were distributed in rage 2 microns and the size is below 3 microns. ❖ TOXICITY STUDY RESULTS: ● In acute toxicity, carried out as per OECD guidelines 423, with levels of four different dose 5mg, 50mg, 300mg, 2000mg of SVM were administered in stepwise manner, were all the animals very active and did not showed any signs of toxicity. The motor activities are normal in all groups of animals. No mortality and no gross pathological changes have seen in the internal organs of both control and treated groups in 14 days of the study period and the body weight, food intake and water intake of animals were normal in both control and treated groups. The acute toxicity study results reveals that SVM was non toxic up to a dose level of 2000mg /kg body weight of animal. ● Repeated oral toxicity study was conducted for 28 days as per OECD guidelines- 407. In sub-acute toxicity study in low dose (180mg/kg), mid dose (900mg/kg) and high dose (1800mg/kg) no signs of toxicity were observed. There was no 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 (180mg/kg, 900mg/kg, 1800mg/kg). 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 group when compared with control group, reveals the action of drug in every dose level does not damage the organs. There was 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 SVM used in siddha system of medicines. CONCLUSION: The Sindhu vallathi mezhugu was prepared using authenticated siddha literature source. And it was characterized by black colour, semi solid state, pungent odour, sour with bitter taste. The following biochemical substances such as Sulphate, Chloride, Ferrous iron, Unsaturated compound were found. The phytochemical substances such as Alkaloids, Flavonoids, Glycosides, Steroids, Phenol, Tannin, Saponins, Sugar were found. The SVM is free from Microbes, Aflatoxins, pesticides residues. ● SVM was studied for its acute and sub-acute toxicity effect using laboratory animals. In acute study SVM 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 SVM is 2000 mg/kg body weight of animal. In sub-acute toxicity 180mg/kg, 900mg/kg,1800 mg/kg of SVM was used and it was administered once daily for 28 days through oral route. So the result clearly demonstrate the SVM can be considered safe, as it did not cause either lethality or adverse changes with general behaviour of rats and there was no observable detrimental effects (180mg/kg,900mg/kg,1800mg/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 500mg to 1g twice a day for man which is mentioned in “The Siddha formulary of India part –II” is safe dosage for clinical use. ● Finally, it assessed the safety of SVM in standard of siddha drugs by characterization through instrumental analysis and toxicity studies through animal experiments. ● So, the recommended human dose may not produce any ill effects and this must be proved by further animal studies and also by clinical studies by volunteers. This dissertation work is the first step for continuous research in this title.
| Item Type: | Thesis (Masters) |
|---|---|
| Additional Information: | Reg.No.321916009 |
| Uncontrolled Keywords: | Sindhu Vallathi Mezhugu, Toxicity study. |
| Subjects: | AYUSH > Nanju Noolum Maruthuva Neethi Noolum |
| Depositing User: | Subramani R |
| Date Deposited: | 01 May 2023 18:43 |
| Last Modified: | 24 Feb 2024 07:01 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/21232 |
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