非诺洛芬钙缓释片的研制及释药性质研究
Studies on Preparation and Release Properties on Slow Released Fenoprofen Calcium Tablets
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摘要: 为减少非诺洛芬钙(fenoprofencalcium)的胃肠道刺激性和副作用,根据水凝胶骨架释放机理,研制了非诺洛芬钙缓释片。通过测定制剂的体外溶出度评价了该缓释片的处方。结果表明该制剂的体外溶出行为符合Higuchi方程,释药常数(K)主要受原辅料比例的影响。不同处方的释药常数,50%释药时间(T50)和63.2%释药时间(Td)有显著差异(P<0.01)。处方5具有良好的缓释效果,其T50和Td分别为288min和438min。此外,溶出介质pH、转速及溶出试验方法对该制剂的释药速度常数也有影响。Abstract: To decrease the GI irritation and side effect of fenoprofen calcium, slow released tablets of fenoprofen calcium were prepared on the basis of the releasing mechanism of the gel matrix systems. The formulation and preparing procedure of the tablets we