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[摘要]
目的 筛选盐酸决奈达隆片的处方组成,并评价其溶出度.方法 以盐酸决奈达隆的溶出度为指标,采用L9(34)正交试验优化盐酸决奈达隆片处方主要因素填充剂乳糖-淀粉比例、黏合剂聚维酮K30的乙醇体积分数、增溶剂波洛沙姆用量、崩解剂交联聚维酮用量.以赛诺菲-安万特公司原研制剂迈达龙为参比制剂,采用f2相似因子法进行盐酸决奈达隆溶出曲线的相似度评价.结果 盐酸决奈达隆片的最佳处方为填充剂比例2:1,选用5% PVP K30 40%乙醇溶液为黏合剂,泊洛沙姆188用量为2%,交联聚维酮用量为3%.在不同pH值的溶出介质中,自制制剂和参比制剂的溶出曲线f2相似因子均大于50.结论 自制制剂与参比制剂在不同pH值的溶出介质中得体外溶出行为相似.
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[Abstract]
Objective To optimize the prescription of Dronedarone Hydrochloride Tablets, and to evaluate its dissolubility. Methods The main factors, such as the filler proportion of lactose and starch, concentration of 5% adhesive povidone K30 ethanol solution, content of solubilizing agent Poloxamer 188, and content of disintegrant polyvinylpolypyrrolidone were optimized by L9(34) orthogonal test with dissolubility of dronedarone hydrochloride as index. Dronedarone Hydrochloride Tablets (Multaq) from Sanofi-Aventis were selected as reference preparation, and the similarity of dissolubility curves were evaluated by the similarity factor (f2) method. Results The optimized prescription of Dronedarone Hydrochloride Tablets was as follows: filler proportion of lactose and starch was 2:1, ethanol concentration of 5% adhesive povidone K30 was 40%, content of solubilizing agent Poloxamer was 2%, and content of disintegrant polyvinylpolypyrrolidone was 3%. In various dissolution media with different pH values, the dissolubility curves of Dronedarone Hydrochloride Tablets between self-prepared preparations and reference Multaq were compared, and similar factors f2 were above 50. Conclusion The dissolution behaviors of self-prepared preparations and reference Multaq in various dissolution media with different pH values are similar.
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