Elamathi, S (2022) Preclinical safety evaluation of “Vasanthakusumakara Mathirai”. Masters thesis, National Institute of Siddha, Chennai.
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Abstract
The test drug Vasanthakusumakara Mathirai was taken from the text “Siddha VaithiyaThirattu” for evaluation of safety.The Literature review reveals that there was no safety related research has been done in VKM. 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 various respiratory disorders, Aiyairumal (cough due to kabadiseas), Siruneernoi (Renal disorders), Thagam(Excessive thirst), Eppam (Belching), Mookkadaippu (Nasal polyp). ❖ Aim of this dissertation is to study the safety of test drug by acute, Sub acute study in animal model. The toxicity of the test drug VKM is done by universal accepted scientific methods. The study drug VKMwas obtained from IMPCOPS pharmacy, kalki Krishnamurthy salai, Thiruvanmiyur , Chennai-600041, Tamil Nadu. The preparation of trial drug was standardized primarily by physicochemical, biochemical analysis and Heavy metal analysis then evaluated safety of the drug by Acute and Sub- acute toxicity study. ❖ Organoleptic Character of VKM showed it has solid state, brick red in colour, mild aromatic and soft in nature. Initially the trial drug VKM was subjected to physio - chemical analysis. The loss on drying of VKM stipulates higher stability of drug. Uniformity of weight shows average weight of VR (0.102gm) within prescribed limit. Disintegration time of VKM is within 20 minutes. It indicates tablet was easily disintegrated and its absorption would be good. Hardness of VKM revealed the tablets are withstands up to 2.3 kg of compression. Total Ash value (43.52%) indicates purity of VKM. Water soluble and alcohol soluble extractive test of VR shows 10.75% and 9.35%, it reveals quality as well as purity of drug. PH of VKM was 5.35% in 10% of solution, so the drug was weakly acidic in nature. The bio chemical analysis of VKM indicates the presence of Sulphate, silicate, carbonate, sodium, chloride, borate, lead, mercury, zinc, Aluminium, Iron and Calcium. ❖ Heavy metal analysis was carried out in VKM by ICP-OES to ensure the absence of Arsenic, Mercury, Cadmium and Lead. ICP-OES result showed that the presence of 0.39 μg/g of Arsenic, BDL of Cadmium, 73.54 μg/g of Copper, 73.64 μg/g of Lead, 54 μg/g of Manganese, 1.17 (% w/w) of Mercury, and 24.16 μg/g of Zinc in VKM. Results showed heavy metals in the test drug are present in allowed level. ❖ The acute toxicity study shows that VKM 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 Repeated dose 28 days oral toxicity study, totally 5 groups of Wistar albino rats of both sexes were used. Each group contains 5 males and 5 females. Group I which was set as control received RO water and Group II, III, IV, and V received 36, 180, 360, 360 mg/Kg b.wt of test drug respectively by oral administration. All the test animals were observed throughout the study period of 28 days and the satellite group for further 14 days. VKM did not produce any behavioural changes in all group of animals. ❖ There was no significant changes in feed intake, water intake, and body weight. On 29th day animals were sacrificed and blood samples was collected and investigated.The results reveals that there were no significant changes in biochemical parameter,hematological parameter and lipid profile and Histopathological examination revealed normal architecture in comparison with control and treated animal.There is no abnormality was detected in organs of both control and test drug treated groups.These results have demonstrated that there is no toxic effects in all organs treated with VKM. Hence, VKM is safe when administered orallyin Wistar albino rats. ❖ These 28 days repeated oral toxicity study results suggest the No Observed Adverse Effect Level (NOAEL) of Vasanthakusumakara Mathirai was found to be 360mg /Kgb.wt.so the drug is safe for human consumption. CONCLUSION: Vasanthakusumakara mathirai is one of the Siddha medicine which are widely used by the siddha system. It has specific indication to kaba diseases (Disease due to vitiated kabam),and also widely used for Respiratory disease.So the VKM was selected for preclinical study. ❖ Vasanthakusumakara mathirai was taken as test drug, the quality parameters and safety profile of the drug were analyzed as per standard protocol. The qualitative and quantitative analysis of Vasanthakusumakara mathirai proved the quality and purity of thed rug. The quality assessment results will be used as standard for future research on Vasanthakusumakara mathirai. ❖ The Acute toxicity study results did not show any mortality, behavioral changes and drug related toxicity. From the Acute toxicity study, it is revealed Vasanthakusumakara mathirai that is not toxic at maximum oral dose level of 2000mg/kg in Wistar rats, So, the median lethal dose MTD of is Vasanthakusumakara mathirai Less than 2000mg/Kgb.wt. ❖ In Repeated Dose 28 Day oral toxicity study, There was no significant changes in hematological and biochemical parameters in vasanthakusumakara mathirai (360mg/kg b.wt) and histopathological parameters showed no significant changes in internal organs compared with control group. So, the No Observed Adverse Effect Level (NOAEL) of vasanthakusumakara mathirai was found to be 360mg/kg.b.wt.so the drug safe for human consumption. ❖ Hence, the safety of vasanthakusumakara mathirai is proved through this study. From the study results, it is concluded that the therapeutic dose of 200mg (1-2 Mathirai) vasanthakusumakara mathirai is safe for human consumption. ❖ Further clinical trials, Pharmacological studies and efficacy studies will be carried out on vasanthakusumakara mathirai to prove the efficacy of drug.
| Item Type: | Thesis (Masters) |
|---|---|
| Additional Information: | Reg.No:321516203 |
| Uncontrolled Keywords: | Preclinical safety evaluation, Vasanthakusumakara Mathirai. |
| Subjects: | AYUSH > Nanju Noolum Maruthuva Neethi Noolum |
| Depositing User: | Subramani R |
| Date Deposited: | 01 May 2023 18:44 |
| Last Modified: | 24 Feb 2024 07:02 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/21233 |
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