摘要
目的探讨已上市肠溶制剂的质量评价方法。方法按照日本"药品品质再评价工程"的相关方法,测定奥美拉唑肠溶制剂在pH1.0、pH6.0、pH6.8缓冲液及纯化水中的释放曲线。结果奥美拉唑肠溶制剂在不同pH介质中的释放行为存在极显著性差异。结论采用不同pH介质中释放曲线的测定结果来评价肠溶制剂更能区分其内在质量。
OBJECTIVE To study the method for quality evaluation of post-market enteric-coated drug products.METHODS To test and draw the dissolution profiles of Omeprazole enteric-coated preparations in pH1.0 HCl solution,pH6.0 buffer solution,pH6.8 buffer solution and pure water according to the Japanese drug quality revaluation engineering.RESULTS The release behavior of Omeprazole enteric-coated preparations showed significant differences in different media.CONCLUSION Dissolution profiles obtained in media with different pH can more effectively distinguish the immanent quality of the enteric-coated drug products.
出处
《华西药学杂志》
CAS
CSCD
北大核心
2011年第5期476-478,共3页
West China Journal of Pharmaceutical Sciences
关键词
已上市药品
质量评价
肠溶制剂
奥美拉唑
释放曲线
Post-market drugs
Quality evaluation
Enteric-coated drug products
Omeprazole
Dissolution profiles
