不同方法制备的控释膜力学与药物渗透性能研究

Mechanical Properties and Permeability of Controlled-release Films Preparedby Different Techniques

分别采用平面铸膜法和喷雾法制备游离的 Eudragit RS10 0控释包衣膜 ,通过张力仪测定了膜力学性能 ,并以盐酸氨溴索为模型药物测定了膜的渗透性能 ,以考察两种方法制备的控释膜性能的重现性。试验结果显示两法制备的膜力学性能差异显著 ,但重现性均符合要求 ;喷雾法制备的控释膜盐酸氨溴索的渗透速率重现性差而平面铸膜法制备的膜重现性则较好 ,此外平面铸膜法制备的膜其盐酸氨溴索的渗透速率仅由膜本身控释能力决定 ,不受搅拌速率、供给池药物浓度变化等因素影响 ,即实验因素影响小 ,较适用于薄膜试验。

Free films prepared by cast technique and spray technique respectively with Eudragit RS100 were investigated by comparing their mechanical properties using an instron testing apparatus and permeability of ambroxol hydrochloride using a horizontal diffusion cell. Good reproducibility but with marked variation in the mechanical properties was observed for the two preparations. Marked within-run variation in the permeability was observed for the spraying films, but good reproducibility for the casting ones. Moreover the permeability of the casting films were not influenced by different rotation speed and concentration of ambroxol hydrochloride in the donor cell. The results indicated the cast method is more suitable to film trials.