格列吡嗪制剂溶出曲线考察

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磷酸二氢钠溶液(用2.0 mol·L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.