Physicochemical Standardization and Evaluation of Antimicrobial Activity of a Polyherbal Formulation Safūf-i Aslussūs

Objectives:

Safūf-i Aslussūs (SA), a polyherbal Unani formulation, has long been used to manage premature ejaculation. The objective of this study was to establish the physicochemical standardization procedures and screen for antimicrobial activity of SA.

Materials and

Methods:

SA was prepared according to Qarabadin-i Majidi , and standardization procedures were developed. The formulation was analyzed through organoleptic evaluation, powder drug microscopy, physicochemical evaluation, phytochemical evaluation, thin-layer chromatography (TLC) and high-performance TLC (HPTLC) evaluation, safety evaluation, and antimicrobial screening.

Results:

SA was observed reddish-brown with a characteristic odor and sweet taste. Microscopic evaluation showed starch grains, layers of cork cells, oil globules, reddish pigment cells, and calcium oxalate crystals. Physicochemical analysis showed total Ash values as 4.8096 ± 0.03–4.8669 ± 0.07% w/w, bulk density as 0.3433 ± 0.005–0.3533 ± 0.005 g/ml, pH value as 4.57 ± 0.01–4.62 ± 0.01 in 1% aqueous solution, and limit of detection ranged as 8.9307 ± 0.0802–9.4449 ± 0.0434% w/w. In phytochemical screening, alkaloids, carbohydrates, flavonoids, and saponins were adequately present. TLC and HPTLC analysis showed five major spots under ultraviolet (UV) 366 nm at R f values –0.10 (blue), 0.14 (light green), 0.17 (light blue), 0.81 (light blue), and 0.91 (light blue) and under UV 254 nm showed six major spots at R f values –0.06, 0.14, 0.20, 0.37, 0.64, and 0.99 (all black). Total bacterial count was found between 4 × 10 ² /g-8 × 10 ² /g in all three samples, which exhibited Salmonella Species, Escherichia coli , and the total yeast count was under the permissible limit as set by WHO guidelines. Aflatoxins –B1, B2, G1, and G2 and heavy metals were not detected. Antimicrobial screening showed that the methanolic extract of the study formulation exhibited maximum antibacterial activity against all bacterial pathogens.

Conclusions:

SOPs, standardization, safety, and antimicrobial screening data of SA were obtained, which could be used for setting limits for quality control purposes.