Fomitoid Polypores: Justification of Regulatory Requirements for Raw Material Quality

INTRODUCTION. The relevance of this study is driven by the growing interest in polypore fungi as an accessible and renewable source of biologically active compounds with proven pharmacological activity, particularly phenolic and triterpene compounds. Despite the widespread occurrence of fomitoid polypores, their raw materials remain largely unstandardized and are not represented in the pharmacopoeias of most countries, which limits their introduction into medical practice. The lack of unified approaches to quality assessment and the selection of analytical markers, combined with the high variability of their chemical composition, complicates the standardization of the raw material. Therefore, substantiating quality criteria and standardization methods for raw materials derived from fomitoid polypores is an important task.

AIM. To substantiate quality criteria for raw materials of fomitoid polypores that can be used for the development of regulatory documentation on the quality of fungal raw materials.

MATERIALS AND METHODS. At least 20 batches of fruiting bodies of Fomes fomentarius (L.) Fr., Fomitopsis pinicola (Sw.) P. Karst., Ganoderma applanatum (Pers.) Pat., Piptoporus betulinus (Bull.) P. Karst., Phellinus igniarius (L.) Quél., collected in various regions of the Republic of Belarus and the Russian Federation, were studied. The following parameters were determined using spectrophotometric and gravimetric methods: loss on drying, total ash, acid-insoluble ash, total extractives, total phenolic compounds, and total steroid and triterpene compounds.

RESULTS. Inter- and intraspecific variability of quality indicators was demonstrated. It was established that, depending on the species, the specification limits for total phenolic compounds range from 0.10% to 0.25%, for total steroid and triterpene compounds from 0.05% to 0.30%, and for extractives from 0.5% to 14.0%. The values of total ash, acid-insoluble ash, and loss on drying fall within the ranges of 1.0–5.0%, 1.0–3.0%, and 10.0–12.0%, respectively.

CONCLUSIONS. Quality indicators for raw materials of fomitoid polypores have been developed and may be used for the preparation of regulatory documentation on the quality of raw materials of fungal origin.

1. Badalyan SM, Barkhudaryan A, Rapior S. Recent progress in research on the pharmacological potential of mushrooms and prospects for their clinical application. In: Agrawal D, Dhanasekaran M, eds. Medicinal mushrooms. Singapore: Springer; 2019. https://doi.org/10.1007/978-981-13-6382-5_1

2. Sergeeva EO, Ayrapetova AYu, Konovalov DA, Dementieva TM. Hepatoprotective activity of biologically active substances of medicinal polypore on a model of hepatosis in rats. Medical Bulletin of Bashkortostan. 2023;18(3):54–60 (In Russ.). EDN: NPHBKO

3. Grienke U, Zöll M, Peintner U, Rollinger JM. European medicinal polypores — a modern view on traditional uses. J Ethnopharmacol. 2014;154(3):564–83. https://doi.org/10.1016/j.jep.2014.04.030

4. Harbatsevich HI. Antioxidant activity of extracts of fomitoid polypores growing in the territory of the Republic of Belarus. Humans and Their Health. 2025;28(3):72–8 (In Russ.). EDN: WZKPVY

5. Harbatsevich HI, Panibrat OV, Khanchevsky MA. Antiproliferative activity of polypore fungi extracts against human leukemia cell lines. In: Innovative technologies in pharmacy: Proceedings of the XII All-Russian scientific-practical conference. Irkutsk: IGMU; 2025. P. 170–5 (In Russ.). EDN: YQVPYV

6. Ravnikar M, Štrukelj B, Otašević B, Sirše M. Fomentariol, a Fomes fomentarius compound, exhibits anti-diabetic effects in fungal material: An in vitro analysis. Nutraceuticals. 2024;4(2):273–82. https://doi.org/10.3390/nutraceuticals4020017

7. Zang Y, Xiong J, Zhai WZ, et al. Fomentarols A–D, sterols from the polypore macrofungus Fomes fomentarius. Phytochemistry. 2013;92:137–45. https://doi.org/10.1016/j.phytochem.2013.05.003

8. Yoshikawa K, Inoue M, Matsumoto Y, et al. Lanostane triterpenoids and triterpene glycosides from the fruit body of Fomitopsis pinicola and their inhibitory activity against COX-1 and COX-2. J Nat Prod. 2005;68(1):69–73. https://doi.org/10.1021/np040130b

9. Yu H, Chen Q, Xu TC, et al. Bioactive terpenoids and sterols from the fruiting bodies of Fomitopsis pinicola. Phytochemistry. 2025;236:114510. https://doi.org/10.1016/j.phytochem.2025.114510

10. Luo Q, Yang XH, Yang ZL, et al. Miscellaneous meroterpenoids from Ganoderma applanatum. Tetrahedron. 2016;72(30):4564–74. https://doi.org/10.1016/j.tet.2016.06.019

11. Baby S, Johnson AJ, Govindan B. Secondary metabolites from Ganoderma. Phytochemistry. 2015;114:66–101. https://doi.org/10.1016/j.phytochem.2015.03.010

12. Harbatsevich HI, Zenevich LS, Batalova IR, et al. Chemical composition and antioxidant activity of Ganoderma lingzhi and Ganoderma lucidum fruiting body extracts. Regulatory Research and Medicine Evaluation. 2024;14(6):686–97 (In Russ.). https://doi.org/10.30895/1991-2919-2024-609

13. Harbatsevich HI. Antimicrobial activity of fomitoid fungi extracts growing in the territory of the Republic of Belarus. Aspirantskiy Vestnik Povolzhiya. 2025;25(2):56–62 (In Russ.). https://doi.org/10.35693/AVP678202

14. Mo S, Wang S, Zhou G, et al. Phelligridins C−F: cytotoxic pyrano[4,3-c][2]benzopyran-1,6-dione and furo[3,2-c] pyran-4-one derivatives from the fungus Phellinus igniarius. J Nat Prod. 2004;67(5):823–8. https://doi.org/10.1021/np030505d

15. Tsong Y, Wang T, Hu X. Statistical considerations in setting quality specification limits using quality data. In: Liu R, Tsong Y, eds. Pharmaceutical statistics. Vol. 218. Springer Proceedings in Mathematics & Statistics. Cham: Springer; 2019. P. 3–12. https://doi.org/10.1007/978-3-319-67386-8_1

16. Dong X, Tsong Y, Shen M, Zhong J. Using tolerance intervals for assessment of pharmaceutical quality. J Biopharm Stat. 2015;25(2):317–27. https://doi.org/10.1080/10543406.2014.972512

17. Harbatsevich HI, Parkhach ME, Antonenko ED, Knyazeva AV. Justification for the choice of extractant for biologically active substances from Ganoderma lingzhi fruiting bodies. In: BSMU at the forefront of medical science. Issue 15. Minsk; 2025. P. 559–563 (In Russ.). EDN: BSYVSG

18. Harbatsevich HI, Komlach IA. Substantiation of extraction conditions for phenolic and triterpenoid compounds from fruiting bodi­ es of Phellinus igniarius. In: Modern trends in health-saving technologies. Proc. XII Int. Sci. Conf. of young scientists. Moscow; 2024. P. 160–3 (In Russ.). EDN: TRJMQH

19. Harbatsevich HI. Substantiation of harvesting and processing conditions for Fomes fomentarius as a source of a new class of natural antioxidants. In: XXV International Congress PHYTOPHARM 2024. Saint Petersburg; 2024. P. 46–7 (In Russ.). EDN: BSPUQP

20. Harbatsevich HI. A study of the nature of the solvent for the triterpenoid composition of Fomitopsis pinicola fruiting body extracts. In: Kalinichenko EN, ed. Belarusian Medicines. Proceedings of the International Scientific and Practical Conference. Minsk: Information and Communication Center of the Ministry of Finance; 2025. P. 229 (In Russ.).

21. Harbatsevich HI, Stankevich DV, Savchuk SS. Optimization of photometric reaction conditions for the quantitative determination of phenolic compounds in polypore fungi. In: From plants to medicines. Proceedings of the International Scientific Conference dedicated to the 95th anniversary of VILAR. Moscow; 2026 (In Russ.).

22. Singleton VL, Orthofer R, Lamuela-Raventós RM. Analysis of total phenols and other oxidation substrates and antioxidants by means of Folin-Ciocalteu reagent. Methods Enzymol. 1999;299:152–78. https://doi.org/10.1016/S0076-6879(99)99017-1

23. Harbatsevich HI, Komlach IA. Development and validation of a spectrophotometric method for quantitative determination of the total triterpenoid and steroid compounds in polypore fungi. Zhurnal Prikladnoii Spektroskopii. 2026;93(1):78–85 (In Russ.). EDN: KYPNSU