文章摘要
顾玉兰,沈琦.建立奥美拉唑肠溶胶囊质量一致性评价方法[J].药学与临床研究,2018,26(6):401~404
建立奥美拉唑肠溶胶囊质量一致性评价方法
Develop a Method for Quality Consistency Evaluation of Omeprazole Enteric-coated Capsules
投稿时间:2018-05-08  修订日期:2018-12-11
DOI:
中文关键词: 奥美拉唑肠溶胶囊  质量一致性评价  物理特性  质量属性  溶出曲线
英文关键词: Omeprazole enteric-coated capsules  Quality consistency evaluation  Physical characteristics  Quality attributes  In vitro dissolution curves
基金项目:
作者单位E-mail
顾玉兰 上海交通大学 yulan_pellet@126.com 
沈琦 上海交通大学  
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中文摘要:
      目的:建立奥美拉唑肠溶胶囊质量一致性评价方法,为其仿制制剂的开发提供合理有效的技术手段。方法:采用物理特性、质量属性和体外溶出曲线评价方法,对仿制药和原研药进行对比研究。结果:仿制药和原研药质量属性一致。物理属性和体外溶出曲线区分力强,可用于“肢解”和“剖析”产品。结论:在进行一致性评价研究时,需要结合品种自身的特点,从物理特性、质量属性和体外溶出曲线等方面与原研药进行全面的、深入的对比研究,从而首先保证体外药学一致,进一步保障体内生物等效和临床安全有效。
英文摘要:
      Objective: To establish a quality consistency evaluation method for Omeprazole enteric-coated capsules, and to provide a reasonable and effective technical means for the development of generic products. Methods: Physical characteristics, quality attributes and in vitro dissolution curves were used to compare the generic and the reference products. Results: The generic products are consistent with the reference product on quality attributes. Physical characteristics and in vitro dissolution curves are discriminative and can be used for ‘dismembering’ and ‘dissecting’ products. Conclusion: During the study of quality consistency evaluation, it is necessary to consider the characteristics of the product itself, and make an in-depth comparison with the reference products on physical characteristics, quality attributes and in vitro dissolution curves, so as to guarantee in vitro pharmaceutical consistency and further guarantee bioequivalence and clinical safety and effectiveness.
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