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.

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.