Multianalytical Investigation of <i>Psilocybe cubensis</i> Mushrooms: Physicochemical Characterization and Biological Evaluation of Psilocybin and Psilocin Compounds

Mental disorders of the global population have been evaluated statistically by decades. Psilocybin has medicinal properties with potential pharmaceutical applications for treatment of psychological disorders. This component is present naturally in mushrooms of the <i>Psilocybe</i> genus and is primarily responsible for their psychoactive properties. It exhibits a low risk of acute toxicity and has shown no evidence of neurotoxicity, carcinogenicity, or mutagenicity in current toxicological assessments. This study aimed to develop an active pharmaceutical ingredient (API) derived from <i>Psilocybe</i> mushrooms for application in the management of mental health disorders. The primary objectives include extraction of bioactive compounds, quantitative analysis, and evaluation of their physicochemical and biological properties. Following the extraction procedures, the experiments achieved yields of approximately 20%, demonstrating effective isolation of the target compounds. The presence of alkaloids was confirmed through phytochemical screening and validated by high-performance liquid chromatography (HPLC) analysis. The obtained API exhibited thermal and spectroscopic characteristics consistent with those of edible mushroom extracts, enabling a comprehensive understanding of its physicochemical behavior. Additionally, analytical assays demonstrated high solubility, low toxicity, and compliance with acceptable limits for heavy metal content and microbial load, including aerobic microorganisms, fungi, and yeasts. Quantitative HPLC analysis revealed psilocybin and psilocin contents of 3.26 and 0.34%, respectively, supporting the formulation of drug delivery systems with standardized concentrations of psilocybin. The results indicated that the extracted API is stable, highly pure, and compatible with polymeric matrices for controlled release applications. Furthermore, the assays confirmed high solubility in polar solvents and minimal risk of adverse effects. In conclusion, the study showed that the development of a psilocybin- and psilocin-based API is feasible and represents a significant advancement in the treatment of mental disorders, standing out as a promising solution in the pursuit of innovative therapeutic alternatives.