中药品质生物评价的历史与发展

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"。

History and development of biological assay for quality of Chinese materia medica

Biological assay is an important method for quality control of drugs. There are limitations in the quality control system of Chinese materia medica (CMM) based on physico-chemical analysis methods due to the complicated chemical constituents and multifold pharmacodynamics of CMM. Recently, the application of biological assays to CMM attracted much attention and application. From the historical development perspective, the idea and method of biological assay for the quality control of CMM have existed since the ancient times. Especially in recent years, the introduction of biological assay to botanical drugs and CMM submitted in new drug applications were emphasized by both the U. S. and Chinese Food and Drug Administration. This means that a common view has been formed that using biological assay in the quality control of CMM and botanical drugs is proper. Now, a new era of biological assay for the quality control of CMM has come. Based on the review and expectation of biological assay for the quality control of CMM, we creatively put forward an integrated quality concept for CMM which takes biological assay as core.