星点设计法优化盐酸安非他酮缓释片

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英文篇名：Optimization of the Preparation of Bupropion Hydrochloride Extended-release tablets using Response Surface Methodology 作者：岳莉 ; 王江涛 ; 吴海妹 英文作者：YUE Li;WANG Jiang-tao;WU Hai-mei;Di Sha Pharmaceutical Group; 关键词：盐酸安非他酮 ; 缓释片 ; 响应面分析法 英文关键词：Bupropion hydrochloride;;Extended-release tablets;;Response surface methodology 中文刊名：HAIX 英文刊名：Strait Pharmaceutical Journal 机构：迪沙药业集团; 出版日期：2015-05-15 出版单位：海峡药学 年：2015 期：v.27;No.184 语种：中文; 页：HAIX201505008 页数：5 CN：05 ISSN：35-1173/R 分类号：27-31

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

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