拉莫三嗪口腔崩解片的制备及质量评价  

Preparation and quality evaluation of oral disintegrating tablets of lamotrigine

作　　者：李见春[1] 张红敏[1] 张文静[1] 朱娜[1] 高美佳 张艳[1] 

机构地区：[1]蚌埠医学院药学系,安徽蚌埠233000

出　　处：《中国医院药学杂志》2016年第3期172-175,共4页Chinese Journal of Hospital Pharmacy

基　　金：国家级大学生创新训练项目(编号:20121036701);蚌埠医学院研究生科研创新计划项目(编号:Byycxz1419);安徽省大学生创新创业计划项目(编号:AH20141037052)

摘　　要：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 oral disintegrating tablets of lamotrigine, and evaluate its quality. METHODS Direct tabletting method was used to prepare oral disintegrating tablets. Orthogonal experiment design was used to optimize the best dosage of prescription with disintegration time as the parameter and dissolution and content as indexes. RESULTS The opti- mum prescription was composed of PVPP of 8% and MCC/L-HPC ratio 9：1 （36%：4%）. The tablet was disintegrated com- pletely in 21 s and dissolved by more than 90% in 5 rain. HPLC method was carried out using Kromasil C18 （4. 6 mm× 250 mm, 5μm） as an analytic column, methanol-potassium dihydrogen phosphate （70：30） solution as a mobile phase at a flow rate of 1.0 mL· min^- 1 and the wavelength at 309 nm. The assay was linear in range from 0. 281 to 144 μg·mL^-1. The method has a recovery range of 98. 42%. The RSDs of one day and three different days were less than 5%. CONCLUSION Proper excipi- ents can produce patient friendly oral tablets with rapid disintegration and rapid absorption. HPLC method is simple, accurate and reliable, and can be used for quality assess of lamotrigine and related preparations.

关 键 词：拉莫三嗪 口腔崩解片 正交试验 高效液相法 质量评价 

分 类 号：R943[医药卫生—药剂学]