富马酸喹硫平口腔崩解片的研制及质量控制初探  

Development and quality control of quetiapine fumarate orally disintegrating tablets

作　　者：朱娜[1] 李见春[1] 张红敏[1] 龙科帆 田勇[1] 

机构地区：[1]蚌埠医学院药学系,安徽蚌埠233030

出　　处：《中国医院药学杂志》2017年第4期344-347,367,共5页Chinese Journal of Hospital Pharmacy

基　　金：蚌埠医学院研究生科研创新计划项目(编号:Byycxz1419);蚌埠医学院自然科学基金(编号:BYKY1409ZD)

摘　　要：目的:研制富马酸喹硫平口腔崩解片并评价其质量。方法:以富马酸喹硫平为主药,采用粉末直接压片法制备口腔崩解片,以外观、口感及体外崩解时间为考察指标设计L_9(3~4)正交试验,并对其硬度、溶出度及含量进行测定。结果:微晶纤维素20%,甘露醇50%,交联聚维酮6%,矫味剂为阿斯巴甜/草莓香精,按2∶1的比例占处方量的6%时所制备的处方表面光滑,口感良好,体内外崩解时间均在30 s内;采用高效液相色谱法测得富马酸喹硫平平均回收率为98.56%,平均RSD为1.85%,日内和日间精密度RSD均小于15%。结论:处方设计合理,制备工艺可行,符合用药要求;建立的高效液相色谱法重现性好、专属性强,测定准确快速,产品质量可控。OBJECTIVE To prepare quetiapine fumarate orally disintegrating tablets and to evaluate its quality. METHODS Quetiapine fumarate was used as principal drug of formulation and was studied by appearance,taste and disintegration time in vitro.The best dose of prescription was optimized by L_9（ 3~4） orthogonal test,and their hardness,dissolution and content were examined. RESULTS When the tablet consisted of 6% PVPP as disintegrant,20% MCC,50% mannitol and 6% correctant of aspartame/strawberry essence at the ratio of 2∶ 1,it was integrated and smooth with desirable taste and feel in the mouth. The disintegration time of the tablet was within 30 s. The average recovery rate and average RSD of quetiapine fumarate were 98. 56% and 1. 85%. The RSDs of intra-and inter-day were all less than 15%. CONCLUSION The process of preparation is reasonable and feasible,conforms to the requirements of the drug. The HPLC method is specific,reproducible and accurate for determination of quetiapine fumarate orally disintegrating tablets.

关 键 词：富马酸喹硫平 口腔崩解片 正交试验 高效液相色谱 质量控制 

分 类 号：R943[医药卫生—药剂学]