微孔膜渗透泵型胶囊的制备和释药因素研究

Preparation of porous membrane osmotic pump capsules and investigation on their release behavior

目的:探索一种微孔膜渗透泵型胶囊剂的制备方法并研究其释药行为的影响因素,为开发该渗透泵控释制剂奠定基础。方法:以乙酸纤维素为囊膜材料,PEG-400为增塑剂,PEG-2000为致孔剂,采用蘸胶工艺制备胶囊壳,并考察不同的致孔剂用量、内容物促渗剂种类等研究其对对乙酰氨基酚释药行为的影响,通过维拉帕米和沙格雷酯来验证微孔膜胶囊的控释效果,并通过扫描电镜对囊壳表面及断面进行观察。结果:选择不同的致孔剂用量或调节囊内配方,均可使胶囊控制药物在规定时间内缓慢释放。结论:微孔膜渗透泵型胶囊比传统渗透泵控释片优点多,有望发展成为一种新型控释给药系统。

Objective： To prepare porous membrane osmotic pump capsules and investigate the factors influencing release behavior.Methods： With cellulose acetate（CA）as capsule materials,PEG-400 and PEG-2000 as plasticizer and pore former,shell of osmotic pump capsules was prepared by dip plastic method.Different pore-forming materials and osmogents influencing release behavior were investigated with paracetamol as a model drug and the factors were identified by werapamil hydrochloride and sarpogrelate hydrochloride.surface and cross-section of capsule shell were also studied under scanning electron microscope.Results： Porosity membrane osmotic pump capsules can control the release of drug during a desired time according to optimise the pore former contents and osmogents,respectively.Conclusion： Porous membrane osmotic pump capsules enjoy more advantages than ordinary osomotic tablets,which showed poten-tial to be a new controlled-release drug delivery system.