卡托普利片生物等效性研究基本考虑  

General consideration for the bioequivalence study of captopril tablets

作　　者：王玉 王静 刘力力 刘冬 陈镕 李瑞飞 魏春敏 杨进波 WANG Yu;WANG Jing;LIU Li-li;LIU Dong;CHEN Rong;LI Rui-fei;WEI Chun-min;YANG Jin-bo(Office of Biostatistics and Clinical Pharmacology,Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)

机构地区：[1]国家药品监督管理局药品审评中心统计与临床药理学部,北京100022

出　　处：《中国临床药理学杂志》2020年第12期1603-1605,共3页The Chinese Journal of Clinical Pharmacology

摘　　要：卡托普利为血管紧张素转换化酶抑制药,其制剂临床上用于治疗高血压和心力衰竭。由于其化学结构的特殊性,在生物等效性研究的生物样品分析过程中,需要对样品处理方法、检测方法进行充分考察,所用方法不同,最终得出的检测结果也不尽相同。无论采用何种处理方法,都应对该方法进行科学全面的验证,以确保最终结果的可靠性。Captopril is an angiotensin converting enzyme inhibitor,and its preparation is used to the treatment of hypertension and heart failure.Due to the particularity of its chemical structure,in the biological sample analysis process of bioequivalence research,it is necessary to fully investigate the sample processing method and detection method.The final results are different by different methods.No matter which treatment method is adopted,it should be verified scientifically and comprehensively to ensure the reliability of the final result.

关 键 词：卡托普利 生物等效性研究 二硫化物 生物样品分析 

分 类 号：R97[医药卫生—药品]