中文摘要：

中药制剂质量评价以化学成分分析为主,而物种成分分析近年来引起了中医药界的极大关注,特别是对于丸剂类中药制剂的质量评价更为重要。建立中药制剂物种成分的快速、准确、系统的分析方法,是实现中药现代化、产业化和国际化的关键之一。中药制剂物种成分分析的实质是对包含多个生物物种的混合体系（混合生物样本）的物种鉴定。基于高通量测序和大数据挖掘技术的元基因组学方法是目前认识、分析生物混合体系结构和功能最有效、最重要的方法之一。利用元基因组学方法将有助于建立中药制剂的物种评价方法。通过选择合适的DNA分子标记,可对配伍处方药材物种进行鉴别,同时通过大规模数据分析和挖掘鉴别制剂中的混伪品、有毒动植物或受保护动植物的成分,以及在生产过程引入的生物杂质,从而为中药制剂的有效性、安全性和合法性提供评价依据。

英文摘要：

The quality of traditional Chinese medicines （TCMs） has been mainly evaluated based on chemical ingredients, yet recently more attentions have been paid on biological ingredients, especially for pill-based preparations. It is a key approach to establish a fast, accurate and systematic method of biological ingredient analysis for realization of modernization, industrialization and internationalization of TCMs. The biological ingredient analysis of TCM preparations could be abstracted as the identification of multiple species from a biological mixture. The metagenomic approach based on high-throughput-sequencing （HTS） and big-data-mining has been considered as one of the most effective methods for multiple species analysis of a biological mixture,which would also be helpful for the analysis of biological ingredients in TCMs. Simultaneous identification of diverse species, including the prescribed species, adulterants, toxic species, protected species and even the biological impurities introduced through production process, could be achieved by selecting appropriate DNA biomarkers, as well as applying large-scale sequence comparison and data mining. By this approach, it is prospective to offer an evaluation basis for the effectiveness, safety and legality of TCM preparations.