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目的:以β-环糊精为原料,采用共沉淀法制备茶碱β环糊精聚合物(CDP)微球。方法:通过L9(34)正交试验设计对制备工艺进行了优化,并采用体外动态释药法评价其释药特征。分别用激光粒度分布仪、红外光谱仪、综合热分析仪、X射线衍射仪对茶碱β-CDP载药微球进行表征。结果:最佳工艺条件是β-CDP微球1 g、茶碱0.02 g、蒸馏水30 mL、反应时间3h、温度60℃。合成的载药微球形态良好,平均粒径为162.35μm,载药量为1.79%,包封率为89.50%。茶碱β-CDP微球体外释药规律符合一级释放方程和Korsmeyer-Peppas模型方程。结论:茶碱载药微球具有一定缓释效果,其制备方法合理可行。
OBJECTIVE: To prepare theophylline β-cyclodextrin polymer (CDP) microspheres by using coprecipitation method using β-cyclodextrin as raw material. Methods: The preparation process was optimized by orthogonal design of L9 (34), and its release characteristics were evaluated by dynamic in vitro release method. The theophylline β-CDP drug loaded microspheres were characterized by laser particle size distribution, infrared spectroscopy, integrated thermal analysis and X-ray diffractometer. Results: The optimal conditions were 1 g β-CDP microspheres, 0.02 g theophylline, 30 mL distilled water, reaction time 3 h and temperature 60 ℃. The prepared drug-loaded microspheres were in good morphology with an average particle size of 162.35 μm, drug loading of 1.79% and encapsulation efficiency of 89.50%. The in vitro release of theophylline β-CDP microspheres was in accordance with the first-order release equation and the Korsmeyer-Peppas model equation. Conclusion: Theophylline drug loaded microspheres have a sustained release effect, and its preparation method is reasonable and feasible.