瑞格列奈片的溶出度研究  

Dissolution of repaglinide tablets

作　　者：马红玲[1,2] 林聪[1,2] 孔丽[1,2] 徐平声[1] 

机构地区：[1]中南大学湘雅医院药剂科,长沙410008 [2]中南大学药学院,长沙410013

出　　处：《中南药学》2012年第11期822-825,共4页Central South Pharmacy

摘　　要：目的考察自制药瑞格列奈片在4种介质中的溶出度及溶出曲线,评价其内在质量。方法分别以水、0.1 mol L-1盐酸、pH=5.0枸橼酸-磷酸盐缓冲液和pH=6.8磷酸盐缓冲液作为溶出介质,溶出液采用高效液相色谱-荧光检测法测定,f2相似因子法用于结果判定。结果自制瑞格列奈片在4种介质中的溶出行为与参比瑞格列奈片相似。结论自制瑞格列奈片与参比瑞格列奈片相比,溶出度无显著差异。Objective To investigate the dissolution of generic repaglinide tablets in 4 media and evaluate the internal quality.Methods Water,0.1 mol ？ L-1 hydiochlorie acid solution,pH=5.0 citrate phosphate buffer solution and pH=6.8 phosphate buffer solution were selected as the 4 dissolution media.HPLC and fluorescence detection were used for the determination.f2 similar factor method was used to judge the results.Results The dissolution behavior of generic repaglinide tablets was similar to that of the reference in the 4 media.Conclusion There is no obvious diversity between generic repaglinide tablets and reference repaglinide tablets.

关 键 词：瑞格列奈片 溶出度 相似因子 

分 类 号：R917[医药卫生—药物分析学]