ABSTRACT:
ABSTRACT: Siddha system of medicine always plays an imperative role in the global healthcare system. The worldwide increase in the demand for Siddha medicines created a need to standardize Siddha medicines to determine their quality and purity. This research aims to standardize the Siddha poly-herbal formulation Thoothuvalai Nei. The Standardization of the Siddha poly-herbal formulation Thoothuvalai Nei by analyzing various standardization parameters such as Organoleptic properties, Physico-chemical analysis, Test for Aflatoxins, Test for Specific pathogens, HPTLC and TLC analysis, and Heavy metal analysis. The outcomes attained by the research of the trial drug Thoothuvalai Nei show that it has a yellow-colored semisolid texture with a pleasant odor and is slightly bitter in taste. Specific gravity/drug Weight/ml is 0.9535g/ml, pH value is found to be 4. Loss on drying at 105C is 0.2677% w/w, Viscosity is 1.20P spindle-L3. The Acid Value is found to be 1.13, it passes the rancidity test. The Iodine Value is 31.2, the Saponification Value is 252 and the Unsaponifiable Matter percentage is 0.5374% w/w. The value of Peroxide is 1.17, the Free Fatty Acids percentage is 0.3mL of 0.1M Sodium hydroxide and the Total Fatty Matter percentage is 79.6%w/w. The refractive Index is found to be 1.461. HPTLC fingerprinting shows twelve spots. Test for Mineral oil, Aflatoxins, Microbial Contamination, and Specific pathogens shows Negative/absent. Test for Heavy Metals / toxic metals as well as Pesticide Residues show BQL (Below Quantification Limit). As the values obtained from these analyses are within the limits of PLIM guidelines, it determines the quality and purity of the Siddha poly-herbal formulation Thoothuvalai Nei and gives authenticity to the medicine preparation.