生物效价检测研究进展

Progress in the Study of Biological Potency Detection

目的介绍生物效价的含义、检测方法及近年来在生化药物、化学药物和中药领域中的研究进展,以期为药品质量控制方法研究提供思路和借鉴。方法概述生物效价检测的基本概念,包括生物效价含义、检测方法分类及其选用标准、检测思路,重点论述了生物效价检测在生化药物、化学药物、中药领域中的应用情况。结果和讨论生物效价检测将作为一种常规的分析手段应用于药品的质量控制中,生物检测结合化学检测的模式将是药物质量控制的必由之路。

OBJECTIVE To introduce the definition and determination of biological potency and process in the application in drugs of biochemicals,chemicals and herbs,and to provide ideas and references for studying the quality control of drugs.METHODS Describe the basic concepts of biological potency,including definition,classification and standard of determination,and detection ideas.Emphasize on the wide use of the application in drugs of biochemicals,chemicals and herbs.RESULTS AND CONCLUTION It is illustrated the importance of determination of biological potency as a routine analytical tool in quality control of drugs in the future.The model of combination biological potency detection with chemical analysis is a powerful tool for drug quality control.