摘要
目的测定多潘立酮片在5种溶出介质中的溶出曲线,并与参比制剂的溶出曲线进行比较,为全面评价药品体外溶出行为提供参考。方法采用桨法,转速为50 r·min^-1,以pH值为1.2的盐酸与pH值为4.5,6.0和6.8的磷酸盐(PBS)缓冲液以及水为溶出介质,采用HPLC法测定累积溶出量并绘制溶出曲线,采用f 2因子法计算相似度。结果被测样品在5种介质中与参比制剂的溶出曲线相似。结论被测样品具有与参比制剂相似的体外溶出行为。
Objective To determine the dissolution profiles of Domperidone Tablets in 5 dissolution media,to compare with the reference preparations and to provide the basis for a comprehensive evaluation of drug dissolution behavior of Domperidone Tablets.Methods The paddle method was adopted at 50 r·min^-1,and hydrochloric acid solution with pH 1.2,phosphate buffer saline(PBS)with pH 4.5,6.0,6.8 and water as the dissolution media,profiles were determined with HPLC,and comparatively analyzed by f 2 factor method.Results The dissolution curves of the tested samples are similar to the reference preparation in the 5 dissolution media.Conclusion The dissolution behavior of the tested sample was similar to the reference preparation in vitro.
作者
刘雪峰
王荣
妙苗
王荪璇
王嫦鹤
LIU Xuefeng;WANG Rong;MIAO Miao;WANG Sunxuan;WANG Changhe(Shaanxi Institute for Food and Drug Control,Xi′an 710065,China;Xi′an Medical University,Xi′an 710021,China)
出处
《西北药学杂志》
CAS
2020年第5期706-709,共4页
Northwest Pharmaceutical Journal
基金
重大新药创制专项-药物一致性评价关键技术与标准研究项目(编号:2017ZX09101001)。
