摘要
目的制备阿戈美拉汀口腔崩解片(AGO-ODT)并对其质量进行评价。方法饱和水溶液法制得AGO-羟丙基-β-环糊精包合物后与辅料混匀直接压制成AGO-ODT,测定其崩解时限、溶出度和人体适应性,高效液相色谱法检测AGO-ODT的含量。结果 AGO-ODT平均崩解时限为13.17 s,8 min内溶出度大于95%,口感和吞咽舒适度均比未包合片好,AGO在1.0～40.0μg/ml范围内,色谱峰面积与浓度呈线性关系,回收率均在98%～102%之间,RSD小于2%。结论所制备的AGO-ODT能够快速崩解并溶出;所建立含量测定方法专属性强、简便、重现性好,三批样品的含量均符合要求。
Objective To prepare the agomelatine orally disintegrating tablets （AGO-ODT） and evaluate their quality. Meth- ods The AGO-hydroxypropyl-β-cyclodextrin inclusion complex was prepared by saturated water solution method, and then mixed with auxiliary materials and compressed into ODT. The disintegration, dissolution and acceptability of the ODT were evaluated, and AGO content was measured by the HPLC method. Results The mean disintegration time of AGO-ODT was 13. 17 s and the cumulative dissolu- tion was higher than 95% at 8 minutes. The taste, swallowing and feeling of AGO-ODT were desirable. In addition, good linearity was ob- tained between chromatographic peak area and AGO concentration in the range of 1.0-40. 0 μml, and the recovery was between 98%- 102% with the RSD less than 2%. Conclusion The disintegration and dissolution of prepared AGO-ODT work well. The test method is sim- ple, exclusive and reproducible and it can be used as quality evaluation for AGO-ODT.
出处
《国际药学研究杂志》
CAS
2012年第5期433-436,共4页
Journal of International Pharmaceutical Research
基金
国家重大新药创制科技重大专项(2012ZX09301003-001-009)
