Ganapathi, R (2022) Preclinical Safety Evaluation of Thirimoorthi Mai. Masters thesis, National Institute of Siddha, Chennai.
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Abstract
A preclinical safety evaluation of Thirimoorthi Mai was carried out for the dissertation. The drug was chosen from the Siddha literature Yaakobu Vaithiya Kallaadam. The ingredients of Thirimoorthi Mai are metallic and herbal compounds like Rasam (Mercury), Ganthagam (Sulphur), Nervaalam (Croton tiglium), Charcoal of Coconut shell, coconut milk, Palm Jaggery and Honey. It cures the Vaatha Thosam (Disease Of Altered Vaatha Kutram), Nalamilla Pen Thosam, Suraththin Thosam (Complications/Effects Of Fever), Suram (Fever), Saththippu (Vomit), Vikkal (Hiccup), Melmoochu (dyspnea), Sayam (Cough), Eelai (Asthma), Mathimayakkam (Confusion), Nethira Thosam ( Disease Of Eye), and Silethumaththaal Kanda Thosam (Disease Of Altered Silethuma Kutram). ❖ The raw drugs were procured from a reputed raw drug shop, Broadway, Chennai and the drugs were identified and authenticated by Dept. of Gunapadam, and by the Botanist, National Institute of Siddha, Chennai. The ingredients were purified and the medicine was prepared as mentioned in the Siddha literature. Thirimoorthi Mai taken up for biochemical analysis, heavy metal analysis by using ICP-OES, HPTLC analysis, analysis for Pesticide Residue, analysis for Microbial contamination, and test for the specific pathogen and test for Aflatoxin. And then, Acute and Repeated oral 28-day toxicity study were conducted as per the OECD guidelines 423 & 407 respectively. ❖ On the 29th day all animals were sacrificed and blood was collected. After blood collection, all the animals were euthanized for gross pathological examinations of all major internal organs. The blood samples were sent to a lab for haematological and biochemical analysis. The organs were weighed and preserved in 10% buffered formalin solution before sending for histopathological study. All the reports were statistically analysed. ❖ The biochemical analysis indicates the presence of magnesium, calcium, iron, zinc, mercury, sulphate, carbonate, and reducing sugar in Thirimoorthi Mai. ❖ The Inductively Coupled Plasma Optical Emission Spectrometry (ICP-OES) of Thirimoorthi Mai results showed that the Heavy metals like Mercury (0.52%) was found within the permissible level in Thirimoorthi Mai. Heavy metals like Arsenic, Cadmium, Lead are shown below the detection levels. ❖ HPTLC fingerprinting analysis of the Thirumoorthi Mai sample reveals the presence of four prominent peaks corresponding to the presence of four versatile Phyto components present within it. ❖ Analysis for Pesticide Residue in Thirimoorthi Mai shows that the results indicate the presence of that there were no traces of pesticide residues such as Organochlorine, Organophosphorus, Organo carbamates and pyrethroids in the sample provided for analysis. It indicates the quality of raw cultivation and storage. ❖ Analysis for Microbial contamination (STERILITY TEST) in Thirimoorthi Mai indicates, that no growth/colonies were observed in any of the plates inoculated with the test sample. It defines the Quality of the preparation and storage. ❖ Test for the specific pathogen of Thirimoorthi Mai shows that no growth/colonies were observed in any of the plates inoculated with the test sample. It defines the Quality of the preparation and storage. ❖ Test for Aflatoxin showed that there were no spots being identified in the test sample loaded on TLC plates when compared to the standard which indicates that the sample was free from Aflatoxin B1, Aflatoxin B2, Aflatoxin G1, and Aflatoxin G2. It will also define the purity and quality of the raw drug. ❖ Then the drug was subjected to Acute and Sub acute toxicity study as per OECD guidelines. ❖ In the Acute Oral Toxicity study, throughout the 14 days of the observation period, no mortality and signs of toxicity were observed in Thirumoorthi Mai treated groups. The results of the Acute Oral Toxicity study. So the drug Thirumoorthi Mai comes under category 5 as per GHS (Globally Harmonized System of Classification). ❖ In the 28-days repeated dose oral toxicity study, there was no mortality and morbidity was observed. ❖ Food and water consumption of the animals significantly differs When Thirumoorthi Mai is treated with drugs compared to the control group. But they are within laboratory limit, and this study reveals that it does not adversely affect the basic metabolic processes of the experimental animals. ❖ The body weight of the animals significantly differed When Thirumoorthi Mai was treated with drugs compared to the control group. But they are within the laboratory limits. ❖ The results of the haematological investigation, reveal no significant changes in all Thirumoorthi Mai treated groups as compared with the control groups except for total differential count, and hematocrit but the values are within the normal laboratory limits. ❖ The results of biochemical investigations, in test groups there were significant changes present when compared with the control group. But the values were within normal laboratory limits. ❖ The result of the liver function test and renal function test, reveals no significant changes in all Thirumoorthi Mai treated groups as compared with the control groups. ❖ No abnormality was observed in histopathological examinations of all organs in Thirumoorthi Mai treated groups as compared with the control groups. ❖ So the ‘No Observed Adverse Effect Level’ (NOAEL) of Thirumoorthi Mai may be greater than 90 mg/kg b.wt which is ten times that of a therapeutic dose. CONCLUSION: The study shows that the qualitative analysis of Thirimoorthi Mai, reveals the Purity and Bioavailability of the drug. Heavy metals were found to be within the permissible limit, free from pesticides, micro-organisms and their toxins. so the drug is safe for oral consumption. Toxicity study reveals the drug Thirimoorthi Mai, shows no mortality and signs of toxicity up to 2000 mg/kg.b.wt in acute oral administration. In Sub-acute toxicity study there were significant changes in haematological, and biochemical parameters in Thirimoorthi Mai, treated groups when compared to the control group but the levels were within the laboratory limits. The histopathology report also confirms that there are no remarkable cellular changes at all the dose levels. And No Observed Adverse Effect Level (NOAEL) high dose level (90 mg/kg b.wt), which is ten times that of a therapeutic dose. Based on these results it can be concluded that the dose level of Thirimoorthi Mai, Panavedai mentioned in the Siddha literature Yaakobu Vaithiya Kallaadam is a safe dosage for human consumption. In future, it is to be carried out to study the pharmacological activity and clinical trials to prove the efficacy of the drug.
| Item Type: | Thesis (Masters) |
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| Additional Information: | Reg.No.321516204 |
| Uncontrolled Keywords: | Preclinical Safety Evaluation, Thirimoorthi Mai. |
| Subjects: | AYUSH > Nanju Noolum Maruthuva Neethi Noolum |
| Depositing User: | Subramani R |
| Date Deposited: | 01 May 2023 18:45 |
| Last Modified: | 24 Feb 2024 07:02 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/21234 |
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