基于益生菌乳酸菌和天然成分光果甘草的组合药剂的安全性评估

Natural products, including medicinal plants, are an important source of medicines. However, the natural origin does not exclude undesirable effects with prolonged use, which requires a systematic assessment of their safety. Background/Objectives: The aim of this work is to evaluate the safety of an antituberculous medicinal agent based on the probiotic association of lactic acid bacteria Lacticaseibacillus rhamnosus 7n, Lacticaseibacillus paracasei B-3/43, Lacticaseibacillus casei 14d/13 and 1% licorice extract (Glycyrrhiza glabra) with repeated administration. Methods: The experimental study was conducted on laboratory mice in accordance with a 60-day oral administration protocol at doses of 25 mg/kg, 250 mg/kg, and 2500 mg/kg body weight. The control group of animals received saline solution. The analysis included hematological, biochemical parameters, and a study of urine composition, as well as macro- and histological examinations of organs. The work was performed in accordance with the basic principles of GLP. Results: The agent did not cause general toxic effects, behavioral disorders and changes in feed intake were not noted. Morphofunctional changes were not detected. Macroscopic examination revealed no pathological changes in the internal organs. Histological analysis confirmed the absence of signs of degeneration and necrosis in the tissues of organs. Hematological parameters were within the limits of physiological norms. Blood biochemical parameters showed no significant differences compared to the control group. The parameters of the general urinalysis were without significant changes between the groups and gender. Conclusions: The medicinal agent showed a favorable safety profile without signs of toxicity.