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生物评价(biological assay)是药品质量控制的重要方法,由于中药成分的复杂性、功效的多样性特点,依靠化学成分理化分析的方法对中药进行品质评价还存在很大的局限性。近年来中药品质的生物评价日益得到广泛关注与应用。从中药历史发展的角度来看,中药品质生物评价的理念和方法自古有之,尤其是近年来我国CFDA及美国FDA强调了生物评价在中药或植物药新药注册与评审中的重要作用及意义,这标志着生物评价已成为国内外中药和植物药质量评控发展的共识性方向,当前正进入中药品质的生物评价时代。从回顾历史与展望发展的视角,对中药品质的生物评价进行了系统地梳理与总结,提出了以生物评价为核心的“中药整合质量观”。
Biological assay is an important method for quality control of pharmaceuticals. Due to the complexity of TCM components and the diversity of efficacy, there are still some limitations in relying on the physical and chemical analysis of chemical components to evaluate the quality of TCM. In recent years, the biological evaluation of the quality of Chinese medicine has been widely concerned and applied. From the perspective of historical development of traditional Chinese medicine, the concepts and methods of quality assessment of traditional Chinese medicine have existed since ancient times, especially in recent years CFDA and the United States FDA have emphasized the important role and significance of biological evaluation in the registration and review of new drugs of traditional Chinese medicines or botanical drugs. This indicates that biological evaluation has become the consensus direction of the quality control of traditional Chinese medicine and botanical medicine both at home and abroad and is currently entering the era of biological evaluation of the quality of traditional Chinese medicine. From the perspective of reviewing the development of history and outlook, the biological evaluation of traditional Chinese medicine was systematically reviewed and summarized, and the concept of integrated TCM quality was put forward with the core of biological evaluation.