乙基纤维素水性包衣技术Ⅰ.水分散体与有机溶液包衣方法的比较

Aqueous Ethylcellulose Coating TechnologyⅠ .Comparision of Coating Technique between Aqueous Dispersion and Organic Solution

考察了乙基纤维素水分散体(Aquacoat○R、Surelease○R)的基础性质,测定pH值、粘度、最低成膜温度、玻璃化转变温度,进行了处方相容性试验。以盐酸苯丙醇胺为模型药物,在流化床中制备缓释微丸,考察乙基纤维素水分散体的包衣应用特点,并与有机溶液包衣方法在缓释效果、增塑剂用量、包衣喷液方式的影响三方面进行比较。考察了水分散体包衣微丸的稳定性,采用相似因子法评价微丸的体外释放度变化。

Two commercially available aqueous ethylcellulose dispersions,Aquacoat○R and Surelease○R,were chosen as coating material to investigate aqueous coating technology on sustained release pellets preparation.The physicochemical properties of two aqueous dispersions were determined includingp H,viscosity,minimum film forming temperature and Tg.The compatibility of aqueous dispersions and some additives were also studied. Pellets containing phenylpropanolamine hydrochloride were coated with both aqueous dispersions in fluid- bed.The characteristics of aqueous coating technique were compared with organic solution method.Stability tests of pellets were carried out under three conditions,and changes of drug release in vitro were determined by fit factor.