本文回顾总结了过去20 年来中药配方颗粒在化学成分分析、临床、药理药效、质量控制及生产工艺等方面的研究工作，着重综述了业内较为关注的单煎与合煎的等效性和配方颗粒的质量控制研究进展。等效性研究对中药配方颗粒的生产、质量控制和临床应用具有一定的参考价值，色谱分析已成为配方颗粒的常用质控方法，动态提取、浓缩新工艺、冷冻干燥、一步制粒等新技术新工艺已用于配方颗粒生产；单煎与合煎的等效性还需要更多设计科学的系统深入研究，配方颗粒的质量标准需要反映其整体质量，质量控制方法的科学选择是中药配方颗粒质量控制的关键，为确保配方颗粒质量稳定有效需要建立基于全成分分析的质量控制方法，正确计算浓缩比，配方颗粒生产工艺应该规范化研究。

In the present paper, the chemical analysis, clinic, pharmacology, quality control and production process of Chinese medicine dispensing granule in the past two decades were reviewed. The emphases of this paper are paid on the equivalence between single dispensing granule and mixed decoction and quality control of dispensing granule. The equivalence research data has certain reference value for manufacture, quality control and clinical application of dispensing granule. The Chromatography is suitable techinique used for quality control of dispensing granule. The advanced technology and process about dynamic extraction, concentration technology, freezing drying and one-step granulation has been used in production of dispensing granule. The equivalence between single dispensing granule and mixed decoction needs further systematic and deep scientific research. The quality control standard should reflect the integrated quality of dispensing granule. The scientific selection of the method is the key for quality control of dispensing granule. To ensure the quality consistency of dispensing granule, the quality control method based on "holistic" components analysis should be established, the concentrating ratio for dispensing granule should be calculated, and the production process of dispensing granule should be standardized.

国家自然科学基金重点项目（81130069）：道地药材形成的生物学实质，负责人：陈士林，徐宏喜。