PRECLINICAL SAFETY EVALUATION OF MANDOORATHY MATHIRAI: IN VITRO CYTOCOMPATIBILITY AND IN VIVO ACUTE AND SUB-ACUTE TOXICITY ASSESSMENT IN RODENT MODELS
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Keywords
Mandoorathy Mathirai, Siddha medicine, toxicity, safety evaluation, OECD guidelines, cytocompatibility.
Abstract
Background: Mandoorathy Mathirai (MM) is a classical Siddha formulation used traditionally for managing hepatic and haematological disorders. Despite its therapeutic potential, its safety profile has not been thoroughly established through systematic preclinical evaluation.
Objective: To assess the in vitro cytocompatibility, and in vivo acute and sub-acute toxicity profile of MM in rodent models, with a focus on haematological, hepatic, renal, lipid, and organ weight parameters.
Materials and Methods: Cytotoxicity of aqueous (CAE), methanolic (CME), and chloroform (CCE) extracts of MM was evaluated in murine splenocytes, hepatocytes, and thymocytes using the MTT assay (20–100 µg/mL). Acute oral toxicity was assessed in Wistar rats according to OECD 423 guidelines. Sub-acute oral toxicity was evaluated following OECD 407, with rats receiving 12, 59, or 117 mg/kg MM daily for 28 days. Body weight, food and water intake, haematology, serum biochemistry (hepatic, renal, lipid profiles), and organ weights were measured.
Results: MTT assay results showed high cell viability (>87%) in all extracts across all concentrations, indicating negligible cytotoxicity. Acute toxicity studies revealed no mortality or clinical abnormalities at 2000 mg/kg. In sub-acute studies, MM produced no adverse effects on body weight, feed/water intake, haematological indices, hepatic and renal biomarkers, lipid profile, or relative organ weights. Minor variations observed (e.g., slight HDL increase, marginal chloride elevation) remained within physiological limits and had no associated pathological findings.
Conclusion: MM demonstrated an excellent in vitro cytocompatibility profile and in vivo safety in both acute and sub-acute studies, supporting its safe use at therapeutic doses and justifying further pharmacological and clinical evaluations.
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Manikandan B
Associate professor, Maria Siddha Medical College and Hospital, Attur, Kanniyakumari District 629177, Tamil Nadu, India.
Elansekaran S
Professor, Department of Siddha, National institute of Siddha, Chennai, Tamil Nadu, India.
Uma K.S
Associate professor, Department of Siddha, The Tamil Nadu Dr.MGR Medical University, Chennai, Tamil Nadu, India.