星点设计-响应面法优化盐酸安非他酮缓释片

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 were 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. Conclusion The prepared bupropion hydrochloride extended-release tablet is reasonable in formula and feasible in technology,it meets the quality standards.