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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 develop oral quetiapine disulfide fumarate tablets and evaluate its quality. Methods: Orally disintegrating tablets were prepared by powder direct compression method with quetiapine fumarate as the main drug. The appearance, taste and disintegration time in vitro were used as indexes to design L_9 (3-4) orthogonal test. Its hardness, dissolution and content were determined. Results: Microcrystalline cellulose 20%, mannitol 50%, crospovidone 6%, flavoring agent aspartame / strawberry flavor, at a 2: 1 ratio of 6% of the prescription prepared The surface of the prescription was smooth and the taste was good. The disintegration time in vitro and in vivo was within 30 seconds. The average recovery of quetiapine fumarate was 98.56% and the average RSD was 1.85% by HPLC. The intra- and inter-day precision The degree of RSD is less than 15%. Conclusion: The prescription is reasonable in design, the preparation process is feasible and meets the requirements of medication. The established HPLC has good reproducibility, specificity, rapid and accurate determination and controllable product quality.