CAJ | 학술논문

目的：制备硝苯地平缓释微丸片及其体外释放度考察。方法首先筛选载体的种类和用量，确定以新型辅料Soluplus作为载体材料（硝苯地平：Soluplus=1：1），用热熔融挤出法制备硝苯地平固体分散体，采用差式扫描量热法对其进行验证；用挤出-滚圆法制备含药微丸，并以EudragitRS 30D为包衣材料制备缓释微丸，再将缓释微丸压制成片剂。结果体外释放度表明，所制备的硝苯地平缓释微丸片在24 h 内释药平稳且完全，释药规律符合一级释放模型。结论该法制备的硝苯地平缓释微丸片，载药量高，工艺简便，易于操作。
목적：제비초분지평완석미환편급기체외석방도고찰。방법수선사선재체적충류화용량，학정이신형보료Soluplus작위재체재료（초분지평：Soluplus=1：1），용열용융제출법제비초분지평고체분산체，채용차식소묘량열법대기진행험증；용제출-곤원법제비함약미환，병이EudragitRS 30D위포의재료제비완석미환，재장완석미환압제성편제。결과체외석방도표명，소제비적초분지평완석미환편재24 h 내석약평은차완전，석약규률부합일급석방모형。결론해법제비적초분지평완석미환편，재약량고，공예간편，역우조작。
Objective To prepare nifedipine( NF)sustained-release pellet tablets,and study of its release behavior in vitro. Methods Soluplus was selected as a carrier to prepare solid dispersion of NF by hot melt extrusion technique( HME), and the ratio of the drug to carrier was 1:1. The samples were validated as the solid dispersion by differential scanning calorimetry(DSC). Extrusion-spheronization technique was introduced to prepare NF pellets and EudragitRS 30D was used as the coating material. The NF sustained-release tablets were prepared by direct compression of the coated pellets and suitable excipients. Results The release data in vitro proved that the drug release from the tablets was steady and complete over 24 hours. Conclusion The release of NF from sustained-release tablets is slow and steady. The method is easy to operate. The in vitro drug release pattern follows first-order kinetics.