From Salvia dumetorum Hydroethanolic Extract to Tablet Formulation: Integrated Phytochemical, Biological, and Preclinical Safety Evaluation

Yana К. Levaya, Karakoz Zh. Badekova, Gulnissa K. Kurmantayeva, Mussa E. Zholdasbayev, Gülmira Özek, Temel Özek, Izabela Korona‐Głowniak, Wirginia Anna Kukula-Koch, Elina M. Smagulova, Gayane A. Atazhanova

Molecules, 2026

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DOI 10.3390/molecules31213802
Data confidence 85 high
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Abstract

Background/Objectives: Salvia dumetorum Andrz. ex Besser is a relatively understudied medicinal plant with promising biological potential, but its phytochemical characteristics and the safety of preparations developed from its extract remain insufficiently investigated. This study aimed to characterize the phytochemical composition and biological properties of S. dumetorum extract and to evaluate the preclinical safety of tablets developed on its basis. Methods: The hydroethanolic extract was obtained by microwave-assisted extraction and characterized by HPLC-ESI-QTOF-MS/MS, while total phenolic content (TPC), total flavonoid contents (TFC), antioxidant, α-amylase inhibitory, and antimicrobial activities were determined using spectrophotometric and microbiological assays. Results: The extract TPC and TFC were 40.15 ± 2.25 mg GAE/gextrt and 40.55 ± 5.56 mg QE/gextr, respectively. HPLC-QTOF-ESI-MS/MS profiling revealed a diverse spectrum of phenolic, flavonoid, diterpenoid, and organic acid constituents. The extract demonstrated strong antioxidant activity, with trolox equivalent antioxidant capacity (TEAC), total antioxidant capacity (TAC), and ferric reducing antioxidant power (FRAP) values of 1.88 ± 0.07 mM, 250.43 ± 12.08 mg AsAE/gextr, and 427.91 ± 9.74 mg TE/gextr, respectively, and a DPPH IC50 of 0.03 ± 0.00 mg/mL. α-Amylase inhibitory activity was 5.63 ± 0.51 mg AcrE/gextr, while antimicrobial activity against the tested microorganisms was observed at MICs of 1.25–10 mg/mL. The resulting tablets retained measurable antioxidant and α-amylase inhibitory activities, although their activity profiles differed from those of the original extract. Comprehensive in vivo evaluation demonstrated no treatment-related adverse effects following repeated administration, including no significant effects on immune parameters, female reproductive function, embryofetal development, skeletal ossification, or sensitization. Conclusions: S. dumetorum extract demonstrated diverse biological activities, while the tablet formulation showed a favorable preclinical safety profile. These findings extend the available acute toxicity data and support the further pharmaceutical development of this tablet formulation.