由于其广谱的抗菌活性和非毒性，抗菌肽成为治疗目的的有希望的候选药物。组氨酸肽-5（Hst-5）是一种显著的唾液抗菌肽，展示了在口腔中的治疗特性。口腔粘膜炎是癌症治疗后口腔的急性炎症。目前的口腔粘膜炎治疗方法效果不佳。本研究的目的是设计、制备和表征一个Hst-5黏附凝胶将其用于口腔粘膜炎的治疗。在Hst-5黏附凝胶的开发中使用了Carbopol 934和羟丙基甲基纤维素（HPMC），并通过Box-Behnken设计进行优化。根据黏附力、粘弹性、可扩展性、释放速率、多肽二级结构分析、抗菌活性和贮存稳定性对优化配方进行了体外评估。通过化疗诱导的粘膜炎模型对Hst-5凝胶的疗效进行了体内评估。结果显示新制剂对Hst-5的持续释放。Hst-5凝胶对金黄色葡萄球菌、绿脓杆菌、大肠杆菌和白色念珠菌具有抗菌活性。组织病理学、免疫组化和统计分析显示Hst-5凝胶在体内具有伤口愈合活性。本研究的发现表明该化合物作为一种新型高效治疗剂在管理口腔粘膜炎方面具有希望。此外，结果表明该化合物在商业上具有可行性，可进一步开发和利用。© 2023.作者，独家授权给美国制药科学家协会。

Antimicrobial peptides have appeared to be promising candidates for therapeutic purposes due to their broad antimicrobial activity and non-toxicity. Histatin-5 (Hst-5) is a notable salivary antimicrobial peptide that exhibited therapeutic properties in the oral cavity. Oral mucositis is an acute inflammation of the oral cavity, following cancer therapy. The current treatment methods of oral mucositis have low effectiveness. The aim of this study was to design, formulate and characterize a mucoadhesive gel delivery system for Hst-5 usage in the treatment of oral mucositis. Carbopol 934 and hydroxypropyl methylcellulose (HPMC) have been used in the development of a Hst-5 mucoadhesive gel that was optimized by using Box-Behnken design. The optimized formulation was evaluated in-vitro, based on mucoadhesive strength, viscoelasticity, spreadability, release rate, peptide secondary structure analysis, antimicrobial activity, and storage stability. The efficacy of Hst-5 gel was assessed in vivo in a chemotherapy-induced mucositis model. The results showed a sustained release of Hst-5 from the new formulation. Hst-5 gel exerted antimicrobial activity against Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, and Candida albicans. The histopathological, immunohistochemical and statistical analysis showed that the Hst-5 gel had wound healing activity in vivo. The findings of this study indicate that the mentioned compound possesses promising potential as a novel and efficient therapeutic agent in managing oral mucositis. Moreover, the results suggest that the compound is commercially feasible for further development and utilization.© 2023. The Author(s), under exclusive licence to American Association of Pharmaceutical Scientists.