Sergei V. Denisov , Maria T. Khandy, Maria N. Povydysh
Drug Development and Registration 2026; 15(3): 38-50
Introduction. Fungi represent an evolutionarily distinct group of heterotrophic organisms that occupy a unique position in the system of wildlife. Currently, they are considered by modern medicine as promising sources of new biologically active compounds. Despite a millennia-long history of use in traditional medicine and an increasing number of studies on the biological activity of various groups of fungal substances, the incorporation of this raw material into pharmaceutical practice remains limited. The key problem lies in the difficulty of standardization due to the absence of regulatory documentation. Unlike plants, the number of pharmacopoeial monographs on fungal raw materials (fruit bodies, mycelium, extracts) is very low, and unified approaches to quality assessment are lacking. Thus, the development and harmonization of standards for fungal raw materials will enable the realization of their therapeutic potential. Text. This article addresses the issues of standardization of fungal raw materials. The main areas of application of macromycetes are described. The principal species of higher fungi used in medicine are named, and the prospects for using other potential candidates are discussed. The types of confirmed biological activity for specific fungal species, including antitumor, immunomodulatory, and antioxidant activities, are described. The increasing number of studies on higher fungi as sources of biologically active compounds is demonstrated. The pharmacopoeias of Russia, China, Japan, India, the USA, Brazil, and other countries were analyzed for the presence of monographs on mushrooms. The materials for this review include various pharmacopoeial editions available in open access in English and Russian. The species of pharmacopoeial fungi are identified, along with similarities and differences in standardization approaches. Quality parameters used for standardization in different pharmacopoeias are presented. Examples of medicinal products and biologically active food additives based on mushrooms registered in Russia are given. The problems of developing regulatory documentation, quality standards, and analytical methods for fungal raw materials are outlined. Conclusion. It has been determined that the regulatory framework governing the quality of fungal raw materials is extremely limited. The expansion of the lists of pharmacopoeial fungal species used for the production of medicines and dietary supplements is necessary.
