摘要
目的分析奥美拉唑肠溶胶囊仿制药的质量一致性,以促进临床用药选择的有效与安全。方法计算机检索中国知网、万方和中国生物医学文献数据库,纳入对比不同奥美拉唑肠溶胶囊制剂的体外溶出度、耐酸力试验,按类型进行定性或定量分析。结果分别纳入溶出度试验14篇、耐酸力试验7篇。纳入评价的大部分仿制制剂溶出度试验均符合中国药典标准,但部分仿制制剂的溶出行为与原研药不一致,不同国产制剂间的溶出行为也存在显著差异;p H=1. 2时,所有仿制制剂的耐酸力符合中国药典标准,但p H=5. 8或者6. 0时,原研药的溶出行为优于大部分纳入评价的仿制制剂。结论奥美拉唑肠溶胶囊的国产仿制制剂与原研药在药品质量方面可能存在一定差距。
Objective To evaluate consistency among generic omeprazole enteric-coated capsules,and promote effectiveness and safety in clinical drug utilization.Methods CNKI,Wanfang and CBM databases were electrically searched.Dissolution tests and acid resistance tests comparing domestic formulations and original developed drug were included.Qualitative or quantitative analysis was conducted.Results Fourteen dissolution tests and 7 acid resistance tests were finally included respectively.The dissolution rates of most included domestic formulations were in line with the standards of Chinese pharmacopoeia,but some were significantly different from the original developed drug.There were also significant differences in dissolution behavior between domestic preparations.At pH=1.2,the acid resistance of all the included generic preparations met the standards of Chinese pharmacopoeia.But at pH=5.8 or pH=6.0,the acid resistance of the original developed medicine is superior to that of the most included generic preparations.Conclusion There may be a certain gap between generic omeprazole enteric-coated capsules and original developed drug in drug quality.
作者
张茜
李鹏飞
谷清
ZHANG Xi;LI Peng-fei;GU Qing(Department of Pharmacy,West Campus,Beijing Chaoyang Hospital,Capital Medical University,Beijing 100043,China;Department of Pharmacy,Beijing Chaoyang Hospital,Capital Medical University,Beijing 100020,China)
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2019年第11期1207-1210,共4页
The Chinese Journal of Clinical Pharmacology
基金
十三·五重大新药创制课题资助项目(2017ZX09101001)
关键词
奥美拉唑肠溶胶囊
仿制药一致性
溶出度
耐酸力
omeprazole enteric-coated capsule
generic drug consistency
dissolution rate
acid resistance
