本文综述中药质量控制和评价研究的进展，回顾了我国中药质量标准的历史和现状，并描述了中药质量控制和评价模式向“整体”、“综合”的发展趋势；介绍了具有“整体”特征的指纹图谱在中药的真实性鉴别、质量的一致性和稳定性评价和控制及与药效相关性研究中的应用；描述了系统生物学的各种“组学”在中药材的种质资源和质量控制、中药整体药效物质研究及中药的安全性评价和预测等方面的研究进展。系统生物学的引入将促进中药质量控制和评价模式的发展。

The advance in the quality control and evaluation of traditional Chinese medicines (TCM) is reviewed in this review. The history, current status of TCM quality standard and its development trend towards "holistic" are described. The application of fingerprint, characterized by "integrity", to the identity detection, evaluation of quality uniformity and stability of TCM and to the study related with effectiveness is briefly presented. The recent progress in the evaluation for therapeutic effect and safety of TCM studied with systems biology including metabonomics, proteomics and genomics is highlighted. The introduction of systems biology into TCM quality study would promote the development of quality control pattern, and a synthetic control and evaluation of TCM quality be achieved.

国家自然科学基金项目（30472168）：中药精选小复方抗骨质疏松的活性成分群及作用机理研究，负责人：李发美；国家自然科学基金项目（20705021）：骨碎补补肾壮骨药效物质基础的代谢组学研究，负责人：熊志立。