富马酸喹硫平口腔崩解片的研制及质量控制初探

发布时间：2018-06-30 17:43

本文选题：富马酸喹硫平 + 口腔崩解片　；参考：《中国医院药学杂志》2017年04期

【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。
[Abstract]:Objective: to prepare quinthiapine fumarate oral disintegrating tablets and evaluate its quality. Methods: oral disintegrating tablets were prepared by direct powder pressing with quinthiapine fumarate as the main drug. L9 (3D4) orthogonal test was designed with appearance, taste and disintegration time in vitro as the index, and its hardness, dissolution and content were determined. Results: microcrystalline cellulose 20, mannitol 50, crosslinked polyviridone 6 and aspartame / strawberry flavor were used as the flavor correction agent. The prescription prepared by 6% of prescriptions at 2:1 had smooth surface and good taste. The disintegration time in vivo and in vitro was within 30 s. The average recovery of quetiapine fumarate by HPLC was 98.566.The average RSD was 1.85. The RSD of intra-day and inter-day precision was less than 15. Conclusion: the formulation is reasonable, the preparation process is feasible and meets the requirements of drug use, the established HPLC has good reproducibility, strong specificity, accurate and rapid determination, and controllable product quality.
【作者单位】：蚌埠医学院药学系;
【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)
【分类号】：R943

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