兰索拉唑肠溶微丸胶囊的制备

目的:制备兰索拉唑肠溶微丸胶囊。方法:采用流化床包衣技术,在空白丸芯上依次包以主药层、隔离层和肠溶层,制备成兰索拉唑肠溶微丸,将肠溶微丸装入普通胶囊制成兰索拉唑肠溶微丸胶囊,并考察3批制剂的载药率及在人工肠液和人工胃液中的释放情况。结果:所制微丸圆整度高,外观亮泽,载药均匀、载药率高(平均值在96%以上),包衣效果好;其在人工肠液中45min的体外累积释放率大于(94.3±0.76)%,在人工胃液中2h的释放量小于(6.2±1.6)%。结论:所制兰索拉唑肠溶微丸胶囊工艺可行,重现性良好,质量稳定可靠,具有良好的体外释药性和耐酸力。

Preparation of Lansoprazole Enteric-coated Pellet Capsules

OBJECTIVE： To prepare lansoprazole enteric-coated pellet capsules（LECPC）. METHODS： The lansoprazole enteric-coated pellets were prepared using fluid-bed coating technology through blank pellets being coated with main component layer, insulating layer and enteric layer in order. Enteric-coated pellets were encapsulated into hard gelatin capsules to obtain LECPC. Drug-loading rate and drug release in artificial intestinal fluid and artificial gastric fluid of 3 batches were investigated. RESULTS： The prepared pellets assumed complete round shape, lustrous appearance and coating well with mean drug-loading rate above 96%. The release of 3 batches in artificial intestinal fluid within 45 minutes were greater than （94.3±0.76） % while were smaller than （6.2±1.6）% in artificial gastric fluid within 2 hours. CONCLUSION： The prepared capsule is feasible in technology, reproducible and reliable in quality. It represents satisfactory release in vitro and property of resisting acid.