生物等效性在新药研究、非专利药开发和药品上市后评价中具有重要作用，也是中药规范化、现代化进程中必不可少的环节。随着中药现代化进程的加快，不同厂家生产的中药制剂产品质量不一，疗效相差较大，因此加强生物等效性研究在中药制剂产品中的应用、确保产品有效性和安全性中显得尤为重要。系统地介绍了生物等效性的研究方法，并阐述“组分结构”理论的思想对中药制剂生物等效性研究的意义，以期完善中药制剂生物等效性评价体系。

Bioequivalence has an important role in the new drug research, development of non-patent medicine, and post-marketing evaluation of drugs and is an essential step in the standardization and modernization of Chinese materia medica (CMM). With the acceleration of modernization of CMM, CMM preparation products made by different manufacturers differ in quality, resulting in different effects. Therefore, it is very important to strengthen the application of bioequivalent study in CMM preparation products to ensure the effectiveness and safety. In this paper, the research methods of the biological equivalence were introduced systematically, and the significance of the "component structure theory" to the study on biological equivalent of the CMM preparations has been elaborated, in order to improve the evaluation system of the biological equivalent for CMM preparations.

国家自然科学基金资助项目（81573620，81473394）；江苏省“六大人才高峰”项目（YY-012）；江苏省博士后基金项目（1601023C）；江苏省“333高层次人才培养工程”项目；苏州市医疗器械与新医药专项（ZXY2013022）