Author ORCID Identifier

https://orcid.org/0000-0001-7202-2100

Biosketch

Dr. K.Malarvizhi is a dedicated and accomplished pharmaceutical professional who recently completed a Doctor of Philosophy degree in 2025 from SASTRA Deemed to be University, Thanjavur. Specializing in the intersection of traditional medicine and modern pharmaceutical science, their doctoral research focused on "A Contemporary Approach for Exploring the Influence of Detoxification and Standardization of Traditional Metallopharmaceutical Product: Pharmacological and Toxicological Aspects". This work was supported by the prestigious Women Scientist fellowship (WOS-B) from the Kiran Division, Department of Science and Technology (DST), Government of India.

With a robust academic background that includes an M.Tech in Pharmaceutical Technology (2013) and a B.Tech in Pharmaceutical Technology (2011) from SASTRA Deemed to be University and Anna University of Technology, respectively, their expertise is well-rounded.

Date of Award

17-8-2025

Document Type

Thesis

School

School of Chemical & Biotechnology

Programme

Ph.D.-Doctoral of Philosophy

First Advisor

Dr.D.Ramyadevi

Keywords

Metallopharmaceutical, Sivanar Amirtham, Detoxification Process, Pharmacological, Toxicological Characteristics

Abstract

Polyherbomineral formulation possess unique medicinal properties due to the presence of metals and minerals as integral part, as processed in addition to specific herbals. There is an increased interest in metallopharmaceuticals in clinical and research areas, because of their immense therapeutic efficiency towards multiple diseases and evidence for non-toxic claim. Sivanar Amirtham is one of the polyherbomineral Siddha medicine recommended for the treatment of various respiratory diseases and other ailments including antidote therapy for poisonous bites. The present research work attempted for standardization of Sivanar Amirtham preparation as per the traditional standard protocols (including the detoxification process of raw materials) followed by characterization through modern analytical techniques to assess the physicochemical properties responsible for the stability, quality and efficacy, and the in-vivo toxicity studies to evidence the safety of administered dose.

The foremost step was the detoxification of the ingredients viz., Sulphur, Mercury, Arsenic trisulphide, Borax, Dryopteris filix-mas and Aconitum ferox, as per Siddha texts to remove the physical and chemical impurities. Secondly, Kajjali was prepared with the combination of Sulphur and Mercury, followed by the addition of other ingredients in the appropriate ratio to obtain the final product of Sivanar Amirtham. To understand the significance of detoxification process and quality of the preparation, the characterization studies were performed for the raw materials, processed materials, intermediate samples, finished product and commercial samples through analysis of particle size and zeta potential by zeta sizer, surface morphology by SEM, chemical interactions by FTIR, thermal behavior and stability by TG-DSC, crystalline property by XRD, elemental composition by EDAX and XPS, herbal composition by HPTLC and sulphur analysis by Raman spectroscopy.

In-vitro pharmacological screening was performed to elucidate the therapeutic efficacy of Sivanar Amirtham for anti-bacterial, anti-tuberculosis and anti-HIV therapeutics, and toxicity profile by hemolytic assay. The anti-bacterial study was performed against both gram-positive and gram-negative pathogens including Staphylococcus aureus (ATCC 29213 - MSSA), Methicillin-resistant Staphylococcus aureus (ATCC 43300 - MRSA), Enterococcus faecalis (ATCC 29212), Pseudomonas aeruginosa (PA14) and Vibrio cholerae (MTCC 3905) by agar well diffusion assay, wherein the highest zone of inhibition was identified for MRSA (20.7 mm) and V. cholerae (34.3 mm) at 25 mg/mL. The anti-tuberculosis activity experimented by microtitre alamar blue assay against M. tuberculosis (ATCC 27294) had demonstrated significant activity at the concentration range of 12.5 - 100 μg/mL. The anti-HIV efficacy was carried out by syncytia inhibition method using C8166 cell lines infected with HIV-1IIIB showed a significant therapeutic efficacy. The in-vitro toxicity assay proved Sivanar Amirtham to be non-haemolytic and haemocompatible.

In-vivo toxicity studies were performed to evaluate acute and sub-acute toxicity profile in wistar rat models as per the OECD guidelines. The acute study was conducted by administering single oral dose administration of 2000 mg/Kg for the animals, followed by observation for 14 days. The sub-acute study was carried out for 28 days using 7 groups of rats, administered with different doses of Sivanar Amirtham. From the histopathology, hematology and biochemical parameters, the formulation was found to be non-toxic at the recommended dose. The findings of the research could provide scientific proof-of-evidence to overcome the limitations of the product owing to the standard quality and safety concern of the metal- mineral ingredients that are present in the polyherbomineral formulation.

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