Preparation and Evaluation of a <i>Dracocephalum kotschyi</i> Herbal Cough Syrup: Formulation, Physicochemical Characterization, and Microbial Quality Assessment

Abstract

Background: Acute sore throat (pharyngitis) is a common condition, and its clinical symptoms, including cough, affect many individuals annually. Dracocephalum kotschyi, a plant endemic to Iran, has a long history of use in traditional medicine. Laboratory studies have confirmed its antibacterial and anti-inflammatory properties, particularly cyclooxygenase enzyme inhibition. Given patient preference for syrups and the need to reduce unnecessary antibiotic use, this study aimed to formulate an herbal cough syrup derived from D. kotschyi. Objectives: This study aimed to develop and evaluate two herbal cough remedies derived from D. kotschyi, including a simple syrup and a formulation suitable for patients with diabetes. Methods: A hydroalcoholic extract of the plant was prepared, and its phenolic compound content was evaluated using the Folin-Ciocalteu reagent. The extract was then standardized. Two syrup formulations were prepared: a sucrose-based simple syrup and a stevia-based sugar-free syrup suitable for patients with diabetes. The syrups were evaluated for stability, pH, specific gravity, viscosity, and microbial limits in accordance with United States Pharmacopeia (USP) standards. Results: The syrups exhibited acceptable pH, specific gravity, and viscosity values of approximately 100 - 120 cP, supporting local efficacy in the throat region. Microbial limit testing was performed in accordance with USP standards, including enumeration of bacteria, yeasts, and molds, expressed as CFU/mL. The results were within normal limits. The absence of Escherichia coli further indicated compliance with the required USP quality-control standards for oral syrups. Conclusions: These findings suggest that the formulated syrups may be promising therapeutic options for managing inflammation and symptoms associated with acute sore throat and cough.