双氯芬酸钠肠溶缓释片的制备及体外释放度的研究

Study on Diclofenac Sodium Enteric-coated Sustained-release Tablets Preparation and in Vitro Release

以HPMC K15M、HPMC K4M制备双氯芬酸钠亲水凝胶骨架片,采用肠溶欧巴代进行包衣,并研究了肠溶缓释片的体外释放度。缓释片处方为主药∶HPMC K15M∶HPMC K4M∶MCC∶乳糖∶硬脂酸镁=75∶50∶20∶115∶40∶3;包衣材料为12%的肠溶欧巴代水溶液,药片增重3%~4%;体外释放情况为2h:37.2%,6h:70.9%,12h:92.2%,对药物的释放情况进行拟合,符合一级方程。

We use HPMC K15M＆HPMC K4M to make preparation of Diclofenac Sodium hydrophlic gel matrix sustained-release tablets, the enteric material is Opadry. And study the in vitro dissolution rate of enteric-coated sustained-release tablets. The formulation of sustained release tablets is Drug： HPMC K15M： HPMC K4M： MCC： lactose： =75： 50： 20： 115： 40： 3. The coating materials is 12% enteric Opadry aqueous solution,tablet weight in- crease of 3% to 4% ;In vitro release of 2h ：37.2% ,6h ：70. 9%, 12h ：92. 2% ,fitting the release of the drug with the first-order equation.