Preparation, Quality control and Standardization of a Destructive Distillate Swasakasa Nei (SKN), A Traditional Siddha Herbal Pharmaceutic for Swasakasam (Bronchial Asthma)

Standardization is essential to ensure the quality and reliability of traditional medicines. This study aimed to collect, authenticate and purification of raw materials, preparation of Swasakasa Nei (SKN) according to SOP, and Quality evaluation and Standardization procedures following Pharmacopoeial Laboratory of Indian Medicine (PLIM) guidelines. SKN, prepared as Kuzhithylam, is used to treat Swasakasam (Bronchial Asthma) in the Siddha system of medicine. The organoleptic characters of Swasakasa Nei reveal that SKN was a black, thick semisolid with a smoky odour, greasy consistency, and free-flowing nature drug. Physicochemical analysis showed values for Saponification Value (202.19), Iodine Value (30), Acid Value (7.25%), Peroxide Value (0.58%), Refractive Index (1.462), Specific Gravity (0.9131 g/ml), Loss on Drying (34.17%), Total Fatty Matter (60.18%), Free Fatty Acids (1.06%), and Unsaponifiable Matter (0.98%). The congealing point was 19°C, with no mineral oil and definite oxidation on rancidity. HPTLC fingerprint analysis revealed multiple prominent peaks at various wavelengths. Microbial contamination tests showed no specific microbes, and aflatoxin assays confirmed SKN was free from Aflatoxins B1, B2, G1, and G2. Pesticide residue analysis detected no organochlorine, organophosphorus, or pyrethroids, and heavy metal analysis showed no trace elements or heavy metals. These standards affirm the authenticity, genuineness, and safety of SKN, contributing to its scientific validation.