米拉贝隆缓释片自制制剂与参比制剂体外溶出一致性评价  

Study on in vitro release consistency between self-prepared Mirabegron Sustained-Release Tablet and Reference preparation

作　　者：梁胜群 邹梅娟[1] LIANG Sheng-qun;ZOU Mei-juan(Shenyang Pharmaceutical University,Shenyang 110016;Shenzhen Main Luck Pharmaceuticals Inc.,Shenzhen 518029,China)

机构地区：[1]沈阳药科大学,沈阳110016 [2]深圳万乐药业有限公司,广东深圳518029

出　　处：《中国处方药》2017年第8期32-34,共3页Journal of China Prescription Drug

摘　　要：目的建立米拉贝隆缓释片的体外释放度检测方法并进行方法学研究,以所建立方法对米拉贝隆缓释片自制制剂(规格:25 mg)与参比制剂体外释放行为的一致性进行评价。方法用HPLC法测定米拉贝隆原料药在不同pH值溶出介质中的溶解度,绘制米拉贝隆"pH-溶解度"曲线,测定自制制剂与参比制剂在4种不同pH值溶出介质(pH 1.2盐酸溶液、pH 4.5醋酸盐缓冲液、pH 6.8磷酸盐缓冲液、水)中的累积释放度,绘制释放曲线,用相似因子法进行拟合。结果在所选4种不同pH值溶出介质下,自研制剂与参比制剂的释放曲线相似因子f2值均大于50。结论自制制剂与参比制剂能够达到体外释放行为一致。Objective To establish a method for determining the dissolution of mirabegron sustained-release tablet in vitro and study the methodology of the determination method.The consistency of the in vitro release behavior between self-prepared mirabegron sustained-release tablet and reference listed drμg were evaluated by constructed method.Methods HPLC method was applied to detect the cumulative release percentage of self-prepared mirabegron sustainedrelease tablet and reference listed drμg in four kinds of release media(water,pH1.2hydrochloric acid solution,pH4.5acetate buffer,pH6.8phosphate buffer).Similarity factor(f2)was used to evaluate the similarity of release curves.Results The f2factors between r reference listed drμg and self-prepared mirabegron sustained-release tablet in four different media were more than50.Conclusion The two preparations are equivalent in four different pH dissolution media in vitro.

关 键 词：米拉贝隆 释放曲线 一致性评价 相似因子 

分 类 号：R927[医药卫生—药学]