奥美拉唑肠溶胶囊溶出度测定的不确定度评定  

Evaluation of Uncertainty in Dissolution Test of Omeprazole Enteric-coated Capsules

作　　者：韩志云[1] 金鹏[1] 滕海堂[1] 王宣 HAN Zhi-yun;JIN Peng;TENG Hai-tang;WANG Xuan(Huaian Institute for Food and Drug Concrol,Huaian 223001,China)

机构地区：[1]淮安市食品药品检验所,江苏淮安223001

出　　处：《海峡药学》2020年第5期48-51,共4页Strait Pharmaceutical Journal

摘　　要：目的对奥美拉唑肠溶胶囊溶出度测定的不确定度进行分析和评价。方法高效液相色谱法测定奥美拉唑肠溶胶囊的溶出度,评定所得结果的不确定度。结果本实验方法测量结果的扩展不确定度U=4.4%(k=2),置信概率95%。结论分析并量化了检测方法的不确定度,为优化实验方法提供科学依据。OBJECTIVE To evaluate uncertainty in dissolution test of omeprazole enteric-coated capsules.METHODS The dissolution of omeprazole enteric-coated capsules was determined by HPLC,and the uncertainty of the results was evaluated.RESULTS The extended uncertainty of measurement results of this method was U=4.4%(k=2),with confidence probability 95%.CONCLUSION Evaluation of the uncertainty can optimize the experiments,the more reliable result of the measurement could be obtained.

关 键 词：高效液相色谱法 奥美拉唑肠溶胶囊 溶出度 不确定度评定 

分 类 号：R927[医药卫生—药学]