本文選題：富馬酸喹硫平 + 口腔崩解片��； 參考：《中國醫(yī)院藥學雜志》2017年04期

【摘要】：目的:研制富馬酸喹硫平口腔崩解片并評價其質量。方法:以富馬酸喹硫平為主藥,采用粉末直接壓片法制備口腔崩解片,以外觀、口感及體外崩解時間為考察指標設計L_9(3~4)正交試驗,并對其硬度、溶出度及含量進行測定。結果:微晶纖維素20%,甘露醇50%,交聯(lián)聚維酮6%,矯味劑為阿斯巴甜/草莓香精,按2∶1的比例占處方量的6%時所制備的處方表面光滑,口感良好,體內外崩解時間均在30 s內;采用高效液相色譜法測得富馬酸喹硫平平均回收率為98.56%,平均RSD為1.85%,日內和日間精密度RSD均小于15%。結論:處方設計合理,制備工藝可行,符合用藥要求;建立的高效液相色譜法重現性好、專屬性強,測定準確快速,產品質量可控。
[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.
【作者單位】： 蚌埠醫(yī)學院藥學系;
【基金】：蚌埠醫(yī)學院研究生科研創(chuàng)新計劃項目(編號:Byycxz1419);蚌埠醫(yī)學院自然科學基金(編號:BYKY1409ZD)
【分類號】：R943

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