制备缓释给药系统三维打印工艺参数的选定

Selecting of 3DP Parameters for Fabricating Sustained-release DDS

目的:选择制备缓释给药系统的合适的三维打印成形工艺参数,为缓控释给药系统的研发提供新的策略和途径。方法:通过自设试验选择合适的粉末粒径、打印液溶剂、喷涂层间隔时间;通过滴试验、线试验和条带试验确定喷涂滴间距、线间距及喷涂次数;制备给药系统,通过硬度、脆碎度和体外溶出试验进行评价。结果:所制备给药系统硬度为4.81kg·cm-2、脆碎度为0.57%,药物连续释放11h,具有较好的机械性能和缓释效果。结论:所建立方法简单、有效、易行,可为三维打印工艺的进一步应用提供参考。

OBJECTIVE：To select parameters for preparing drug delivery systems （DDS） using three- dimensional printing （3DP） to supply new methods and passway for the sustained and controlled release DDS. METHODS： The diameters of particles, the type of solvents and the time intervals between two printing layers were determined by self-proposed methods. The drop- to- drop spacing, the line- to- line spacing and printing passes were choosed based on the drop tests, line and ribbon tests. The mechanical performance of the DDS was evaluated through hardness , friability tests and the in vitro dissolution tests. RESULTS： The prepared DDS had a hardness of 4.81 kg · cm^-2, a friability of 0.57% and released the drug continuously over a period of 11 h, showing fine mechanical properties and sustained release effect. CONCLUSIONS： The methods that had established were simple,effective and exercisable, and also useful for further applications of 3DP in pharmaceutics and other fields.