非洛地平片在不同介质中的溶出度考察  

In-vitro dissolution behavior of felodipine tablets in different media

作　　者：李艳[1] 孙进[1] 何仲贵[1] 

机构地区：[1]沈阳药科大学药学院

出　　处：《中国药剂学杂志（网络版）》2009年第6期425-430,共6页Chinese Journal of Pharmaceutics：Online Edition

基　　金：国家药品监督管理局科研计划项目“化学药物制剂生物有效性再评价”课题

摘　　要：目的为《中华人民共和国药典》建立非洛地平片的溶出度标准提供依据。方法采用紫外分光光度法测定非洛地平片在水,0.1mol·L-1盐酸-异丙醇溶液(体积比3:2),0.25、0.5、1.0、3.0、5.0、10.0g·L-1Tween 80水溶液中的溶出度;采用HPLC法测定非洛地平在不同质量浓度Tween 80水溶液中的溶解度。结果3种非洛地平片在0.1mol·L-1盐酸-异丙醇溶液中的溶出行为基本一致,但在不同质量浓度的Tween 80水溶液中呈现出一定的差异性,在低质量浓度Tween 80水溶液中有显著性差异;Tween 80对非洛地平有显著的增溶作用。结论推荐《中华人民共和国药典》在制定非洛地平片的体外溶出度标准时,以1.0g·L-1Twee 80水溶液为溶出介质,采用紫外吸光光度法测定药物在溶出介质中的含量。Objective To provide the basis for the Chinese Pharmacopoeia to establish felodipine tablet dissolution standards by investigating in vitro dissolution behavior of felodipine tablets of three different brands in different media. Methods UV spectrophotometry was used to measure the dissolution rate of felodipine tablets in water, 0.1 mol·L-1 hydrochloric acid-isopropanol (V:V=3:2), as well as in different concentrated Tween 80 solutions (0.25,0. 5,1.0,3.0,5.0,10.0 g·L-1). HPLC was used to determine felodipine solubility in different concentrated Tween 80 solutions. Results The dissolution behavior of tested felodipine tablets in 0.1 mol·L-1 hydrochloric acid-isopropanol was basically the same, but showed some differences in different concentrated Tween 80 solutions, particularly in Tween 80 solutions with low concentration. Tween 80 presented significantly solubilization ability for felodipine. Conclution It is recommended that the Chinese Pharmacopoeia adopts 1 g·L-1 Tween 80 solution as dissolution medium to determine the dissolution rate by UV spectrophotometric method and improve dissolution standard for felodipine tablet.

关 键 词：药剂学 溶出度 紫外分光光度法 非洛地平 溶解度 

分 类 号：R927.2[医药卫生—药学]