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目的:评价盐酸多西环素(Doxycycline Hydrochloride,DXY)微球温敏凝胶剂(DXY-MS-GEL)的体外特性和对大鼠实验性牙周炎的治疗效果。方法:通过胶凝化温度和体外释药曲线评价DXY-MS-GEL的体外特性。采用内毒素隔日注射法建立Wistar大鼠牙周炎动物模型。将大鼠随机分为3组,空白对照组不予处理,实验组给以自制的DXY微球温敏性凝胶,阳性对照组给以盐酸米诺环素(派丽奥)软膏,隔日注射1次×5。末次给药后1 d测定牙龈出血指数、牙周指数、牙周探诊深度、菌斑指数、牙槽骨丧失量,观察组织病理学切片。结果:DXY-MS-GEL在室温下为自由流动的液体,37℃的平均凝胶时间为1.1±0.3 min,可持续释药24 h,体外释药曲线符合Higuchi方程,R~2=0.9948。与空白对照组相比,实验组和阳性对照组各观测指标差异均具有统计学意义(P<0.05),而实验组和阳性对照组之间对比差异无统计学意义。结论:DXY微球温敏性凝胶对牙周炎的局部治疗效果显著。
Objective: To evaluate the in vitro characteristics of Doxycycline Hydrochloride (DXY) microsphere temperature-sensitive gel (DXY-MS-GEL) and its therapeutic effect on experimental periodontitis in rats. Methods: The in vitro characteristics of DXY-MS-GEL were evaluated by gelation temperature and in vitro release profiles. Animal models of periodontitis in Wistar rats were established by endotoxin injection every other day. The rats were randomly divided into three groups, the blank control group did not deal with, the experimental group given home-made DXY microspheres temperature-sensitive gel, the positive control group was given minocycline hydrochloride (Palio) ointment injected every other day 1 × 5. Gingival bleeding index, periodontal index, periodontal exploration depth, plaque index and alveolar bone loss were measured on the first day after the last administration, histopathological sections were observed. RESULTS: DXY-MS-GEL was a free-flowing liquid at room temperature. The average gelation time at 37 ℃ was 1.1 ± 0.3 min and sustained release was 24 h. The in vitro drug release curves were in agreement with Higuchi’s equation, R 2 = 0.9948. Compared with the blank control group, there were significant differences between the experimental group and the positive control group (P <0.05), but there was no significant difference between the experimental group and the positive control group. Conclusion: DXY microspheres thermo-sensitive gels have significant therapeutic effect on periodontitis.