卡马西平口腔速崩片处方筛选和制备工艺研究  

The study on orally disintegrating tablets of Carbamazepine

作　　者：苏金龙[1] 马永恒[1] 焦海胜[1] 李敏[1] 卫晓晓[1] 

机构地区：[1]甘肃省兰州大学第二医院药剂科,730030

出　　处：《中国现代药物应用》2010年第9期11-14,共4页Chinese Journal of Modern Drug Application

摘　　要：目的为了方便老人、儿童和吞咽困难的患者服药,提高卡马西平的生物利用度,优化处方制备卡马西平口腔速崩片(CBZ-ODT)。方法筛选恰当的崩解时间测定方法,以崩解时间和口感为主要评价指标,通过实验选择最佳制备工艺及配方,并通过单因素试验选取对崩解时间影响大的成分的含量为变量进行三因素四水平的L16(43)正交试验设计,确定最优处方。结果采用全粉末直接压片法,用乳糖作为填充剂,硬脂酸镁做为润滑剂,交联羧甲基纤维素钠(CCNa)作为崩解剂,以崩解时间、硬度和口感为评价指标筛选出最佳处方组合压制三批卡马西平口腔速崩片,片面光洁圆整,无斑点,经测试,崩解时间在(21±3)s。结论采用全粉末直接压片法压片,工艺简单且能满足要求。采用崩解仪改良法测量崩解时间更为接近于人体口腔内的测定结果,所制备的卡马西平口腔崩解片崩解时间短,硬度适中,口感好,具备临床应用价值。Objective To optimize pharmaceutical formulation and prepare carbamazepine orally disin- tegrating tablets （CBZ-ODT）. For the convenience of the elderly, children and patients with difficulty swallowing to take medicine and increase the bioavailability of carbamazepine. Methods Chose the most appropriate meth- od to measure the disintegrating time and combined disintegrating time and taste as the main evaluation to select the prescription and the way of preparation through test. Then through single factor experiment studied the main factor which can influence the disintegrating time andusing the amount of these factors as variance to carry out L16（43 ）orthogonal experimental design of third factor and four levels to optimize pharmaceutical formulation. Results Used the direct compression method（DCM） to prepare CBZ-ODT, using lactose as a filler, magnesium stearate as a lubricant, croscarmellose sodium（CCNa） as a disintegrating agent, the disintegration time, hard- ness and taste as the ebaluation indicators, to prepared three batches of CBZ-ODT which one-sided smooth , no spots and disintegration time （21± 3 ）second. Conclusion Using the direct compression method （DCM）to pre- pare CBZ-ODT is simple and feasible. The study indicated the CBZ-ODT has clinical value as it＇ s characteris- tics of short disintegration time, moderate hardness and taste good.

关 键 词：卡马西平 口腔速崩片 崩解时间 

分 类 号：R944[医药卫生—药剂学]