卡马西平缓释片的处方优化研究

Study on Optimization of formulation Carbamazepine Sustained Release Tablets

目的:通过对卡马西平缓释片中缓释材料种类和用量的筛选,确定最佳辅料及其配比,寻找出释放度和稳定性最优的处方。方法:根据美国上市卡马西平缓释片说明书选择阻滞剂、填充剂、润湿剂、润滑剂。用对比试验,通过调整辅料的品种和用量,制定不同的卡马西平缓释片处方,并通过释放度的比较确定最优处方。结果:确定了卡马西平缓释片的最优化处方及制备工艺。结论:该研究筛选出的卡马西平缓释片的处方及制备工艺,符合《中国药典》2010年版标准,其体外释放度及稳定性皆达到最优。

Objective：By screening the slow-releasing material types and amount of Carbamazepine sus-tained-release tablet, determined the best excipients and their proportion, to find out the optimal prescription for the releasing rate and stability . Method：According to the instructions of carbamazepine in the U.S.market, choose block-ers, fillers, wetting agents, lubricants. By comparison test, adjusting the type and amount of excipients, make different prescriptions of the carbamazepine sustained-release tablet and determine the optimal one by the releasing rate comparison. Result：The optimal formulation and preparation technics of carbamazepine sustained release tablet had been determined. Conclusion：The screened carbamazepine sustained-release tablet formulation and preparation technics in this study were in line with the＆quot;Chinese Pharmacopoeia＆quot;2010 edition standard, the in vitro release and stability were optimal.