Medicinal Plant Research 2024, Vol.14, No.5, 259-274 http://hortherbpublisher.com/index.php/mpr 269 gaps in the current research limit its widespread application. Most existing studies on Sanghuangporus have been conducted in vitro or in animal models, with only a limited number of human clinical trials available to substantiate its efficacy and safety in treating chronic diseases. While these preclinical studies have provided valuable insights into the potential therapeutic effects of Sanghuangporus, they do not fully account for the complexities of human physiology and disease. There is a need for more well-designed, large-scale clinical trials to determine the effective dosages, long-term safety, and therapeutic outcomes of Sanghuangporus in humans. Additionally, while some studies have investigated the mechanisms underlying Sanghuangporus's pharmacological activities, a comprehensive understanding of how Sanghuangporus interacts with cellular and molecular pathways in various disease states is still lacking (Ryu et al., 2022). This knowledge gap limits the ability to fully harness Sanghuangporus's therapeutic potential and identify specific conditions for which it may be most beneficial. 7.2 Variability inSanghuangporus extract composition and quality control issues One of the significant challenges in developing Sanghuangporus-based products is the variability in the composition of Sanghuangporus extracts. The pharmacological activity of Sanghuangporus is largely attributed to its bioactive compounds, such as polysaccharides, triterpenoids, and flavonoids. However, the concentration and composition of these compounds can vary widely depending on factors such as the geographical origin of the fungus, growing conditions, part of the fungus used (e.g., fruiting body vs. mycelium), and extraction methods employed (Gao et al., 2017). This variability can lead to inconsistencies in the efficacy and safety of Sanghuangporus products. For instance, different extraction solvents and techniques can result in varying concentrations of active components, thereby affecting the biological activity of the final extract. Standardization of Sanghuangporus extracts is crucial for ensuring quality control and consistent therapeutic outcomes. However, the lack of standardized protocols for the extraction and quantification of bioactive compounds poses a significant hurdle. Establishing quality control measures, such as defining the minimum content of key bioactive compounds and setting specifications for contaminant levels, is essential for the safe and effective use of Sanghuangporus-based products. These measures would not only ensure product consistency but also facilitate regulatory approval for the use of Sanghuangporus in clinical settings. 7.3 Challenges in translating preclinical findings to clinical practice While preclinical studies have demonstrated the potential therapeutic effects of Sanghuangporus in various chronic diseases, translating these findings into clinical practice presents several challenges. First, the doses of Sanghuangporus used in preclinical studies often differ significantly from those that are feasible or safe for human consumption. Determining the optimal dosage for humans that is both effective and safe requires careful dose-escalation studies and clinical trials. Additionally, the bioavailability and pharmacokinetics of Sanghuangporus's bioactive compounds in humans need to be thoroughly investigated. The absorption, distribution, metabolism, and excretion of these compounds can vary between humans and animal models, potentially leading to different therapeutic outcomes. Furthermore, the complexity of chronic diseases in humans, which often involve multifactorial and individualized pathologies, poses a challenge for translating preclinical success into clinical efficacy. Sanghuangporus's effects observed in isolated cell cultures or animal models may not fully capture the interactions and responses in human disease contexts. For example, the immune-modulating effects of Sanghuangporus demonstrated in vitro may differ in human patients with varying immune system status and comorbidities (Ku and Kang, 2022). To address these challenges, it is necessary to conduct comprehensive clinical studies that account for patient heterogeneity and evaluate the efficacy of Sanghuangporus in real-world settings. In summary, while the pharmacological effects of Sanghuangporus are promising, several limitations and challenges must be addressed to facilitate its development into reliable therapeutic agents. Bridging the gaps in research, standardizing extract quality, and overcoming the challenges of clinical translation are essential steps toward realizing the full potential of Sanghuangporus in the prevention and treatment of chronic diseases.
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