兰索拉唑肠溶微丸胶囊的制备.pdfVIP

兰索拉唑肠溶微丸胶囊的制备 1＊ 2 2 3 2 2# 张 倩 ，张 晶 ，周 欣 ，阙剑云 ，于西全 ，宋洪涛 （1.福建医科大学药学院，福州市 350004；2.南京军区 福州总医院药学科，福州市 350025；3.厦门大学医学院药学系，厦门市 361005） + 中图分类号 R943；R975.6 文献标示码 A 文章编号 1001- 0408（2010）05- 0433- 03 摘 要 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45 min 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。 关键词 兰索拉唑；肠溶微丸胶囊；制备；流化床包衣；释放 Preparation of Lansoprazole Enteric- coated Pellet Capsules ZHANG Qian （School of Pharmacy ，Fujian Medical University ，Fuzhou 350004，China ） ZHANG Jing ，ZHOU Xin ，YU Xi-quan ，SONG Hong-tao （Dept. of Pharmacy ，Fuzhou General Hospital of Nan- jing Military Region ，Fuzhou 350025，China ） QUE Jian-yun（Dept. of Pharmacy ，Medical College of Xiamen University ，Xiamen 361005，China ） ABSTRACT OBJECTIVE ：To prepare lansoprazole enteric- coated pellet capsules （LECPC ）. METHODS ：The lansoprazole enter- ic- 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 3batches 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 2hours. CONCLUSION ：The prepared capsule is feasible in technology ，reproduc- ible and reliable in quality. It represents