摘要
目的采用流化床一步制粒工艺制备盐酸安非他酮缓释片。方法以释放度的相似因子f2为评价指标,对处方进行响应面分析法优化设计。结果星点设计-效应面法确定的自变量最优区域选取3点进行验证试验,样品的累计释放度相似因子f2值高达80,含量和有关物质测定结果均优于原研产品,体内外相关性良好。结论研制的盐酸安非他酮缓释片处方合理、工艺可行,符合缓释片的质量要求。
OBJECTIVE To prepare the Bupropion hydrochloride extended-release tablets by one-step granulation technology. METHODS The formulate of Bupropion hydrochloride extended-release tablets was optimized in terms of the similarity factor f2 by Response surface methodology designing. RESULTS Compared with desirable release percentage at certain interval,the cumulative release of similarity factor f2 values of three batches up to 80 which was found to meet the expected target. Under the optimized formulation,content and related substances were superior to the original drug. CONCLISION The prepared of Bupropion hydrochloride extended-release tablets is reasonable in formula,feasible in technology and it meets the quality standards.
引文
[1]Goldstein MG.Bupropion extended release and smoking cessation[J].J Clin Psychiatry,1998,59(supp 14):66-72.
[2]崔福德.药剂学[M].第六版.北京:人民卫生出版社,2007,441.
[3]国家药典委员会编.国家食品药品监督管理局标准YBH06632008.
[4]高欣.盐酸安非他酮渗透泵控释片的研究[D].沈阳:沈阳药科大学,2006,52.
[5]康大力,沈小钟.响应曲面法优化喜树碱的超声提取工艺[J].西北药学杂志,2014,29(4):350-353.
[6]张青,王志祥.响应曲面法优化超声提取芒果叶中芒果苷的工艺研究[J].西北药学杂志,2014,29(3):237-241.