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目的:制备拉莫三嗪口腔崩解片,并评价其质量。方法:粉末直接压片法制备口腔崩解片,以崩解时限为参数,以溶出度及含量为指标,采用正交试验设计法优化处方。结果:所得的最优处方为:MCC与L-HPC的比例为36%∶4%,PVPP为8%。所得片剂在21 s内崩解完全,5 min的体外溶出度超过90%。采用Kromasil C18(4.6 mm×250 mm,5μm)色谱柱,以甲醇-0.05%磷酸二氢钾(70∶30)为流动相,检测波长309 nm,流速1.0mL·min-1条件下拉莫三嗪在0.281~144μg·mL-1范围内线性关系良好;加样回收率为98.42%;日内和日间的RSD均小于5%。结论:选择合适的辅料,可制备出崩解快、方便患者服用的口腔崩解片;建立的HPLC方法准确、快捷,稳定性、重现性良好,可用于拉莫三嗪口腔崩解片的质量控制研究。
OBJECTIVE: To prepare lamotrigine orally disintegrating tablets and evaluate its quality. Methods: Orally disintegrating tablets were prepared by powder direct compression method. The disintegration time was taken as the parameter and the dissolution and content were used as indexes to optimize the prescription by orthogonal experimental design. Results: The optimal prescription was: MCC to L-HPC ratio of 36%: 4%, PVPP of 8%. The tablets disintegrated completely in 21 s, and the dissolution in vitro in 5 min exceeded 90%. A mobile phase of Kromasil C18 (4.6 mm × 250 mm, 5 μm) was used with methanol-0.05% potassium dihydrogen phosphate (70:30) as the mobile phase. The detection wavelength was set at 309 nm and the flow rate was 1.0 mL · min-1. The linearity was good in the range of 0.281-144 μg · mL-1. The recovery rate was 98.42%. The RSDs were less than 5% in both days and days. Conclusion: The suitable excipients can be prepared orally disintegrating tablets which can be disintegrated quickly and conveniently for patients. The established HPLC method is accurate, rapid, stable and reproducible. It can be used in oral administration of lamotrigine orally disintegrating tablets Quality Control Research.