Background: Oral inflammatory ulcers are one of the common complaints of patients attending out-patient clinics. Previous in vivo studies had shown that an Aqueous M. citrifolia Fruit Extract (AMFE) possessed anti-inflammatory and ulcer healing activities. Therefore, a standardized topical bioadhesive gel containing AMFE-phytosome was developed and determined for its oral ulcer healing efficacy in a rabbit model.

Methods: The AMFE phytosome (AMFE-P) was prepared by a complexation method with the required amount of AMFE: Phosphatidylcholine: Tween 80 to weigh ratio of 2:1:0.2. Poloxamer 407 was used as a gelling agent. The oral ulcer was induced in male New Zealand white rabbits by topical application of acetic acid. Each test compound was applied to the ulcer for 10 days beginning on the second day after the ulcer induction. Complete ulcer healing on the specimen obtained on day 12 was observed histologically using the histological scoring protocol.

Results: The optimized gel containing AMFE-P equivalent to AMFE 10%w/w (10%AMFE-P gel) showed the best bioadhesive gel quality, a smooth and homogeneous texture with an optimum viscosity and pH range used in human oral cavity, a good physical and chemical stability and the highest percentage cumulative release of total phenolic and scopoletin content. It was found that a daily application of 10% AMFE-P gel exerted a superior ulcer healing efficacy and a significantly rapid ulcer healing process than a twice daily application of topical gel containing AMFE 10%w/w or chlorhexidine 0.2%.

Conclusion: These findings demonstrated that 10% AMFE-P gel has potential as a safe and effective alternative therapeutic agent for oral ulcers.

背景：口腔炎症性溃疡是门诊患者常见的主诉之一。先前的体内研究表明，柑桔分枝杆菌果实提取物（AMFE）具有抗炎和溃疡愈合的作用。因此，开发了一种包含AMFE微粒体的标准化局部生物粘附凝胶，并确定了其在兔模型中的口腔溃疡愈合功效。

方法：通过络合方法制备AMFE的植物体（AMFE-P），所需量的AMFE：磷脂酰胆碱：吐温80的重量比为2：1：0.2。泊洛沙姆407用作胶凝剂。通过局部应用乙酸在雄性新西兰白兔中诱发口腔溃疡。从溃疡诱导后第二天开始，将每种测试化合物施用于溃疡10天。使用组织学评分方案在组织学上观察在第12天获得的标本上的溃疡完全愈合。

结果：含有相当于AMFE 10％w / w的AMFE-P的优化凝胶（10％AMFE-P凝胶）显示出最佳的生物粘附凝胶质量，光滑均匀的质地以及在人类口腔中使用的最佳粘度和pH范围，良好的理化稳定性和最高的总酚和东pole碱含量累积释放百分比。已经发现，每天两次使用10％w / w或0.2％洗必泰的局部凝胶与每天两次使用局部凝胶相比，每天应用10％AMFE-P凝胶可发挥优异的溃疡愈合功效和明显的溃疡愈合过程。

结论：这些发现表明10％AMFE-P凝胶具有作为口腔溃疡的安全有效替代疗法的潜力。