实用药物与临床
實用藥物與臨床
실용약물여림상
Practical Pharmacy and Clinical Remedies
2015年
10期
1218-1222
,共5页
岳莉%王江涛%吴海妹%龙连清
嶽莉%王江濤%吳海妹%龍連清
악리%왕강도%오해매%룡련청
盐酸安非他酮%缓释片%响应面分析法%星点设计
鹽痠安非他酮%緩釋片%響應麵分析法%星點設計
염산안비타동%완석편%향응면분석법%성점설계
Bupropion hydrochloride%Extended-release tablets%Response surface methodology%Central composite design
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.
目的 採用流化床一步製粒工藝製備鹽痠安非他酮緩釋片. 方法 以釋放度的相似因子f2 為評價指標,對處方進行響應麵分析法優化設計. 結果 星點設計-效應麵法確定的自變量最優區域選取3 點進行驗證試驗,樣品的纍計釋放度相似因子f2 值高達80,含量和有關物質測定結果均優于原研產品,體內外相關性良好. 結論 研製的鹽痠安非他酮緩釋片處方閤理、工藝可行,符閤緩釋片的質量要求.
목적 채용류화상일보제립공예제비염산안비타동완석편. 방법 이석방도적상사인자f2 위평개지표,대처방진행향응면분석법우화설계. 결과 성점설계-효응면법학정적자변량최우구역선취3 점진행험증시험,양품적루계석방도상사인자f2 치고체80,함량화유관물질측정결과균우우원연산품,체내외상관성량호. 결론 연제적염산안비타동완석편처방합리、공예가행,부합완석편적질량요구.
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.
