Standardization and Quality Control of Sanjeewanie Kameshwari Rasayanaya
Nallaperuma DM
Herapathdeniya SKMK
Sandakelum HMDS
ABSTRACT
Modaka is a special preparation in Bhaisajya Kalpana, prepared by grinding powdered ingredients with bases such as bee honey and ghee. Among the various Modaka formulations, Kameshwari Modaka is well known for its rejuvenative and aphrodisiac properties and is marketed in Sri Lanka as Sanjeewani Kameshwari Rasayanaya (SKR). The present study aimed to evaluate the safety and quality of SKR using a comprehensive set of analytical methods. SKR was prepared according to the Sri Lankan Ayurveda Pharmacopeia at the Sanjeewani Ayurveda Drug Company, Embilipitiya. Quality and safety assessments included physicochemical analysis (loss on drying, ash values, total sugar, free fatty acids), microbiological and aflatoxin screening, heavy metal detection using microwave digestion, and phytochemical as well as chromatographic profiling (TLC and HPTLC) of the dichloromethane extract. Physically, SKR exhibited loss on drying (3.6%) and total ash (2.8%), both within standard limits. Microbiological evaluation revealed acceptable values, with aerobic plate count (1.9×10^4), yeast and mold (<100), Staphylococcus aureus (<10), Escherichia coli and Salmonella spp. absent, and Pseudomonas aeruginosa (<100). Toxicological assessment confirmed the absence of lead, cadmium, arsenic, mercury, aflatoxins (B1, B2, G1, G2 and total), and synthetic dyes. Total sugar and free fatty acids were 27.7% and 2.0% respectively. Phytochemical screening of the dichloromethane extract indicated the presence of alkaloids, tannins, saponins, flavonoids, steroids, cardiac glycosides, terpenoids, and carbohydrates, while proteins were absent. HPTLC fingerprinting (Ethyl acetate: Dichloromethane: Cyclohexane 0.1:3.4:1.5) revealed six peaks with Rf values 0.01, 0.38, 0.53, 0.66, 0.69, and 0.85, establishing a reproducible profile for the formulation. Overall, SKR complied with established quality and safety standards, supporting its acceptance as a standardized Ayurveda drug.
Keywords: Aphrodisiac, Kameshwari Modaka, Sanjeewani, Rejuvenation, Safety