格列吡嗪制剂溶出曲线考察  

Inspection of dissolution curve of glipizide preparation

作　　者：钱伟光[1] 田仲铭[1] 张晓玲[1] 徐杰[1] 杜兴[1] 

机构地区：[1]甘肃省药品检验所,兰州730000

出　　处：《药物分析杂志》2011年第7期1364-1367,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:通过对全国40家格列吡嗪制剂的生产企业各选取1批样品进行4种不同pH值条件下溶出曲线考察。方法:采用迪马C18柱(4.6mm×250mm,5μm),0.1mol.L-1磷酸二氢钠溶液(用2.0 mol.L-1氢氧化钠溶液调pH至6.00±0.05)-甲醇(55∶45)为流动相,检测波长为225nm;结果:大部分企业的产品与原研制剂相比尚存在一定差距。结论:本法选用的4种溶出方法效果好,可用于格列吡嗪制剂生物等效性的考察。Objective：through 40 nationwide production enterprises which involves to this sampling select 1 batch of samples to carry on under respectively the different pH value condition for the dissolution curve inspection.Methods：Dima C18（4.6mm×250mm,5μm）was adopted with 0.1mol·L-sodium dihydrogen phosphate（adjusted to pH 6.00±0.05 with 2.0 mol·L-1 sodium hydroxide）-methanol as mobile phase,and the detecting wavelength was 225nm.Results：the majority of enterprise＇s product and the original preparation still has certain disparity.Conclusion：The four methods chosen dissolution method effective,available in glipizide preparation bioequivalence inspection.

关 键 词：格列吡嗪 制剂 溶出曲线 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]