中药的优质性和稳定性是保证临床疗效的关键因素,中药的质量评控方法应以保证临床疗效为最终目标,如何在复杂的中药质量影响因素中寻求一条以临床应用为导向的方法对中药的质量评控具有重要的意义。为此,通过对现行中药质量评控模式的分析,结合课题组开展的中药生物评价与控制模式研究的基础上,提出了构建效应当量的中药质量控制与评价模式的新设想,并对其研究思路进行阐释,以期为中药质量评控方法的构建提供参考。
The high quality and stability of Chinese materia medica (CMM) are the key factors to ensure clinical curative effect, and the ultimate goal of quality control (QC) for CMM is to ensure clinical efficacy. It is of significance how to establish a method for QC which could be related to clinical efficacy. According to the current situation and major problems of the QC for CMM, we first propose the efficacy-equivalent (EE) of CMM, and the research approach about EE has been elucidated, hoping to provide the reference for the establishment of the method of QC for CMM.