正交试验优化灯盏花素分散片的处方工艺  

Formula Screening and Optimizing for the Dispersible Tablets of Breviscapine by Orthogonal Experiment

作　　者：丁艳[1,2] 黄桂华[1] 

机构地区：[1]山东大学药学院,山东济南250012 [2]山东省医药技师学院,山东泰安271000

出　　处：《中药材》2010年第3期455-458,共4页Journal of Chinese Medicinal Materials

摘　　要：目的:制备灯盏花素分散片,验证处方、工艺的稳定性。方法:以崩解时限为指标,采用正交试验设计优化最佳处方,制备灯盏花素分散片,通过初步稳定性试验评价该制剂的质量。结果:L-HPLC和CMS-Na两种崩解剂采用内外加法联合使用效果最优,最佳处方崩解时间为89 s,30 min体外溶出百分率为(97.75±1.32)%,明显高于普遍片,初步稳定性试验表明制剂质量稳定。结论:自制灯盏花素分散片处方组成合理,制备工艺可操作性强、重现性好,能适应工业大生产的要求。Objective ： To establish a suitable formulation for the dispersible tablets of brevisicapine. Methods ： To prepare and optimize the breviscapine dispersible tablets by orthogonal experiment design using disintegration time as the index. The quality of breviscapine dispersible tablets was evaluated by the initial stability test. Results ： The disintegration time of optimized prescrition formulation was 89 s. L-HPC and CMS-Na were used by combining exterior and interior and the dissolution percent in vitro was obviously superior to the convetional tablets, and the quality of the dispersible tablets was very good in stability test. Conclusion： The formulation screened out for the dispersible tablets of breviscapine is reasonable, stable and suitable for the production on a large scale.

关 键 词：灯盏花素 分散片 正交设计 崩解时限 

分 类 号：R944.4[医药卫生—药剂学]