摘要
目的考察国内不同厂家兰索拉唑口服制剂的体外释放度情况。方法紫外分光光度法,检测波长为284nm,测定不同厂家的5个品种的体外释放度。结果兰索拉唑浓度线性范围是1.5-18.0μg/mL(γ=0.9998),平均加样回收率为99.5%-100.1%(RSD=0.20%-0.31%),各个品种的释放度都大于75%。结论不同厂家兰索拉唑口服制剂释放度都符合要求。
Objective To investigate the dissolulion in vitro of different oral lansoprazole products. Methods UV spectrophotoretric method in wavelength 284nm,we detected the dissolution degree of five lansoprazole products of different pharmaceulical factories.Results Lansoprazole had linear in the range between 1.5-18.0mg/mL (γ=0.9998).The recover rate was 99.5%-100.1% (RSD=0.20%-0.31%).Every dissolution degree of all products was over 80%.Conclusion The dissolution degree of lansoprazole products reached the standard but the dissolution unitormil was different significantly.
关键词
兰索拉唑
释放度
紫外分光光度法
Lansoprazole
Dissolution degree
UV spectrophotoretric method