摘要
目的制备双氯芬酸钠肠溶微丸并确定其制备工艺。方法利用离心造粒机制备双氯芬酸钠素丸,以丙烯酸树脂Ⅱ号和Ⅲ号为包衣材料,通过微型流化床包衣机对素丸包衣,并以释放度试验和稳定性试验评价其质量。结果所制得的双氯芬酸钠肠溶微丸在人工胃液中2 h内累积释放度小于10%,在人工肠液中45 min内累积释放度为(82.8±1.31)%。产品的稳定性试验结果符合要求。结论采用该法制备的双氯芬酸钠微丸有良好肠溶效果且稳定性较好。
Objective To prepare diclofenac sodium enteric coated pellets to avoid the irritation of the drug to stomach,and optimize the preparation process of the pellets. Methods The pellets were prepared by centrifugal granulation,and then the pellets were coated by fluid bed coating equipment with the use of coating materials of acrylic resin Ⅱand Ⅲ,the quality was judged by release behavior and stability test. Results The pellets had a lowrelease rate in artificial gastric juice（ accumulated dissolution 10%）,and showed ideal release in artificial intestinal juice（ accumulated dissolution 80%）. The results of stress testing and accelerated testing were qualified. Conclusions The pellets have good enteric release effect and good stability.
出处
《沈阳药科大学学报》
CAS
CSCD
北大核心
2015年第10期749-755,共7页
Journal of Shenyang Pharmaceutical University
关键词
双氯芬酸钠
肠溶
包衣
微丸
diclofenac sodium
enteric
coating
pellets
