盐酸氟桂利嗪口腔崩解片的制备及质量评价  

The preparation and the quality evaluation of Flunarizine Hydrochloride Orally Disintegrating Tablets

作　　者：王景翔[1,2] 常明[1] 曹德英[2] 赵越[1] 

机构地区：[1]石家庄学院化工学院,河北石家庄050035 [2]河北医科大学药学院,河北石家庄050017

出　　处：《中国医药导报》2011年第12期71-73,共3页China Medical Herald

摘　　要：目的:研究盐酸氟桂利嗪口腔崩解片的处方及制备工艺,并对其进行质量评价。方法:通过考察辅料种类及不同用量对制剂崩解时限和口感的影响,用正交试验筛选最优处方;直接压片制备口腔崩解片,并测定其有关质量指标。结果:通过筛选的优化处方为:盐酸氟桂利嗪5.94 g、微晶纤维素36 g、甘露醇60 g、乳糖3.66 g、PVPP 12 g、矫味剂1.2 g、润滑剂1.2 g,共制1 000片。选择的最佳工艺条件为:过筛次数为3次,硬度控制在30～40 N,制备的口腔崩解片口感良好,体内外崩解时限均小于30 s,在3 min内累积溶出度达95%以上,含量均匀度小于15%。结论:处方合理,制备工艺简便,测定方法可靠,结果准确。Objiective： To study the prescription and preparation of Flunarizine Hydrochloride Orally Disintegrating Tablets, and to evaluate its quality. Methods： By examining effects made by types and amount of accessories on the disintegration time of preparation and taste, the orthogonal test was used to get the optimum formulation, in which the orally disintegrating tablets was made by direct compression and the relevant quality indicators was determined. Results： The optimized formulation was as follows： Flunarizine hydrochloride 5.94 g, microcrystalline cellulose 36 g, mannitol 60 g, lactose 3.66 g, PVPP 12 g, flavoring agents 1.2 g, lubricants 1.2 g, a total of 1000 tablets. The optimal conditions were cribration for 3 times, hardness between 30 N and 40 N. The prepared orally disintegrating tablets tasted good, in vivo disintegration time was less than 30 s, 3 min cumulative dissolution was more than 95%, content uniformity was less than 15%. Conclusion： The prescription is reasonable with simple preparation, reliable determination and accurate results.

关 键 词：盐酸氟桂利嗪 口腔崩解片 正交设计 

分 类 号：R944.9[医药卫生—药剂学]