依折麦布阿托伐他汀钙片体外溶出度测定  

In Vitro Dissolution Determination of Ezetimibe Atorvastatin Calcium Tablets

作　　者：饶萌 李丹 张雨轩 叶露 陈雪 叶璠 郭晓霞 苏江涛 RAO Meng;LI Dan;ZHANG Yuxuan;YE Lu;CHEN Xue;YE Fan;GUO Xiaoxia;SU Jiangtao(School of Bioengineering and Food,Hubei Univ.of Tech.,Wuhan 430068,China)

机构地区：[1]湖北工业大学生物工程与食品学院,湖北武汉430068

出　　处：《湖北工业大学学报》2024年第5期87-90,共4页Journal of Hubei University of Technology

基　　金：湖北工业大学“111”引智基地开放基金(XBTK-2021009)。

摘　　要：以高效液相色谱法检测依折麦布阿托伐他汀钙片体外溶出度。对比自制片与市售片的体外相似因子f2,自制片与市售片分别通过高效液相色谱法测定不同介质中的溶出曲线,用相似因子f2测评两片溶出的相似程度。依折麦布在1.20~17.97μg/mL范围内浓度与峰面积的线性关系良好(r=1.0000),阿托伐他汀钙在4.47~66.98μg/mL范围内浓度与峰面积的线性关系良好(r=1.0000),依折麦布与阿托伐他汀钙的平均回收率分别为99.65%和99.63%。自制品与市售品在各溶出介质中的f2因子均符合标准。通过高效液相色谱法创建的依折麦布与阿托伐他汀钙溶出度测定方法稳定可行。To investigate the in-vitro-dissolution of ezetimibe atorvastatin calcium tablets by high performance liquid chromatography,and compare similarity factor f 2 between self-produced tablets and commercially available tablets,the dissolution curves of the self-produced and commercially available tablets were determined by high performance liquid chromatography in various media,and the similarity factor f 2 was used to assess the similarity of the dissolution of the two tablets.The linear relationship between ezemibe concentration and peak area was good in the range of 1.20~17.97μg·ml-1(r=1.0000),and the linear relationship between atorvastatin calcium concentration and peak area was good in the range of 4.47~66.98μg·ml-1(r=1.0000).The mean recoveries of ezetimibe and atorvastatin calcium were 99.65%and 99.63%.The f 2 factors of two products in each dissolution medium met the criteria.The method for the determination of ezetimibe and atorvastatin calcium solubility created by high performance liquid chromatography is stable and feasible.

关 键 词：依折麦布 阿托伐他汀钙 溶出度 f2相似因子 

分 类 号：R94[医药卫生—药剂学]