摘要
通过考查，辅料比例对丸心成丸率有影响，致孔剂浓度、种类、粘度对控释小丸释药速度有影响，基本筛选出双氯灭痛控释小丸的处方为：丸心，含双氯灭痛５０ｍｇ．、淀粉６０ｍｇ、乳糖２４０ｍｇ；包衣溶液，含３％乙基纤维素、２％聚乙二醇４００、２％羟丙基甲基纤维素（１５ｃｐｓ）的乙醇—水混合溶液。体外释放度试验证明，此控释小丸体外１２ｈ累积释药８９．３％。
According to study, the rate of excipients affects pelleting ratio and the concentration,kinds and viscosity affect the release rate of Diclofenac Sodium contrlled release pellets。The formula of Diclofenac Sodium contrlled release pellets ,is decided :pellet cores contain DC Na 50 mg, starch60 mg, lactose 240mg and coating solution is compcoed of alcohol-water solution of 3%EC,2%PEG400 and 2%HPMc (150ps).Dissolution test proves that the controlled release pellets release DC-Na to reach 89.3%in 12 hours。
关键词
双氯灭痛
控释小丸
体外释放度
工艺
diclofenac sodiunm
controlled release pollet
dlssolution
technology
