盐酸吡贝地尔口崩片的处方筛选

Formula Optimization of Piribedil Hydrochloride Oral-Disintegrating Tablets

目的:采用正交试验筛选盐酸吡贝地尔口崩片处方并进行相关指标考察。方法:以崩解剂交联聚乙烯吡咯烷酮(PVPXL)、填充剂预胶化淀粉和助流剂微粉硅胶的用量为考察因素,以口崩片的崩解时间、润湿时间和混悬稳定性等为评价指标进行正交试验,确定最佳处方,绘制最优处方制剂的溶出曲线。结果:筛选的盐酸吡贝地尔口崩片最佳处方为PVPXL、预胶化淀粉、微粉硅胶用量分别为15%、20%、15%,所制制剂约在30s内崩解完全,药物在2min内基本溶出。结论:经筛选的制备工艺所制制剂符合《中国药典》相关要求。

OBJECTIVE： To optimize the formula of piribedil hydrochloride orally disintegrating tablets and to investigate their related indexes. METHODS： Taking the contents of crospovidone （PVP XL） （disintegrating agent）, amylum pregela tinisatum （loading agent） and Gum Acacia （glidant） as factors, the disintegrating time（td）, the wet time （t） and the suspend stability（△A） as the evaluate indexes to carry on the orthogonal experimental to optimize the formula. The dissolution curve of the optimized formula was drawn. RESULTS： The optimized formula for the piribedil hydrochloride orally disintegrating tablets were as follows： the contents of crospovidone （PVP XL）, amylum pregelatinisatum and Gum Acacia were 15%, 20%, and 15% respectively. The prepared orally disintegrating tablets disintegrated completely within 30s and dissolved basically within 2min. CONCLUSION： The prepared preparation can meet the related standards specified of China Pharmacopeia.