盐酸维拉帕米不溶性微孔膜缓释胶囊的制备和体外释药试验

Preparation of Insoluble Porosity Membrane Sustained-release Capsules Containing Verapamil Hydrochloride and Investigation on Their in Vitro Drug Release

目的制备盐酸维拉帕米不溶性微孔膜胶囊剂并研究其体外释药行为。方法以乙酸纤维素(CA)为囊膜材料,聚乙二醇400为增塑剂,蘸胶法制备囊壳,并从致孔剂种类、比例、不同释放条件和内容物配方等因素考察盐酸维拉帕米的释药行为,通过扫描电镜对释药后囊壳结构进行观察。结果选用泊洛沙姆为致孔剂,增加其用量能使药物释放加快;囊内添加柠檬酸,能使药物释放更平稳。结论维拉帕米不溶性微孔膜缓释胶囊在体外能得到缓释效果,通过胶囊内微环境的控制,可以得到平稳的体外释药速度。

OBJECTIVE To prepare insoluble porosity membrane capsules containing verapamil hydrochloride and investigate their in vitro drug release.METHODS With cellulose acetate（CA） used as capsule materials and PEG400 as plasticizer,the insoluble porosity membrane capsules were prepared by dip plastic method.Effects of different types and ratio of receiving medium and different porosity membrane capsules on drug release behavior were investigated.With scanning electron microscope,surface and cross-section of capsule shell were also observed.RESULTS Drug release rate enhanced with increasing pore-formers Poloxamer（F68）.Profile of drug release showed a stable trend when citric acid was added in capsule formulation.CONCLUSION Insoluble porosity membrane capsules of verapamil hydrochloride give a sustain drug release behaviour in vitro.With monitoring the inner circumstance in capsules,a stable drug release rate can be obtained in vitro.