伊潘立酮片体外溶出及有区分力溶出曲线的研究  

Study on In Vitro Dissolution and Discriminatory Dissolution Curves of Iloperidone Tablets

作　　者：李大伟 刘正平 陈倩倩 毛楷凡 张岱州 LI Da-wei;LIU Zheng-ping;CHEN Qian-qian;MAO Kai-fan;ZHANG Dai-zhou(NMPA Key Laboratory for Technology Research and Evaluation of Drug Products,Shandong Academy of Pharmaceutical Sciences,Jinan 250101,China;Shandong Provincial Key Laboratory of Mucosal and Skin Drug Delivery Technology,Shandong Freda Pharmaceutical Group Co.,Ltd.,Jinan 250101,China)

机构地区：[1]山东省药学科学院,国家药监局药物制剂技术研究与评价重点实验室,山东济南250101 [2]山东福瑞达医药集团有限公司,山东省黏膜与皮肤给药技术重点实验室,山东济南250101

出　　处：《食品与药品》2022年第6期519-522,共4页Food and Drug

摘　　要：目的 研究伊潘立酮片原研及自制产品的体外溶出行为,并确定有区分力的溶出曲线。方法 采用桨法,以0.1 mol/L盐酸溶液、pH 4.5醋酸盐缓冲液、pH 6.8磷酸盐缓冲液和纯化水为溶出介质,经优化,选择介质体积500 ml,转速50 r/min,采用紫外-可见分光光度法测定溶出曲线。结果 伊潘立酮片在0.1 mol/L盐酸溶液、pH 4.5醋酸盐缓冲液、pH 6.8磷酸盐缓冲液中15 min溶出度均达85%以上,在纯化水中120 min溶出度达85%以上,在4种溶出介质中均可全部溶出,纯化水为介质时对不同处方工艺的产品具有区分力。结论 该方法对不同工艺制备的伊潘立酮片具有较好的区分力,可用于体外评价。Objective To study the in vitro dissolution profile of original and self-prepared Iloperidone Tablets and determine the discriminatory dissolution curves.Methods The paddle method was adopted in this study,and 0.1 mol/L hydrochloric acid solution,pH 4.5 acetate butter solution,pH 6.8 phosphate butter solution and purified water were selected as the dissolution medium.After optimization,the volume of the medium was 500 ml,the rotation speed was 50 r/min,and the dissolution curves were determined by UV spectrophotometry.Results In 0.1 mol/L hydrochloric acid solution,pH 4.5 acetate butter solution and pH 6.8 phosphate butter solution,the dissolution rate of Iloperidone Tablets all reached more than 85 % in 15 minutes and reached more than 85 % in 120 minutes in purified water.The preparations could be dissolved completely in 4 kinds of dissolution media.Conclusion The method has good discriminatory power between Iloperidone Tablets prepared by different processes,and can be used for in vitro evaluation.

关 键 词：伊潘立酮片 溶出曲线 参比制剂 相似因子 

分 类 号：R943[医药卫生—药剂学]