中药复方和欧盟草药复方的质量评估要求的比较研究

Comparison on requirements of quality assessment between Chinese herbal formula and European Union herbal combination

阐述了中药复方和欧盟草药复方质量评估的法律基础,着重分析了中药复方和欧盟草药复方质量评估的一般要求以及复方中活性成分的识别和含量测定的要求,并从评估方法、分析检测等方面比较了中欧双方在质量评估要求的差异,为中药复方更好的适应欧盟草药复方质量评估要求的法律性规范起到了指引的作用。

The paper elaborates the legal basis of Chinese herbal formula and European Union herbal combination,analyzes the general requirements of quality assessment,the identification,and assay of each active substance in Chinese herbal formula and European Union herbal combination.It also compares the difference on the requirements of quality assessment,such as the assessment methodologies,the analysis and detection,etc,between China and European Union to provide instructions for Chinese herbal formula to follow the legal practice on quality assessment of European Union.