质量源于过程控制水平。目前，中药质量控制缺乏系统性，难以满足产品均一、稳定的要求。从而致使我国中药制剂质量参差不齐，影响中药制剂的疗效及安全稳定。从保证中药制剂产品“均一、稳定”出发，结合中药质量标志物（Q-Marker）的核心概念，提出在中药制剂质量过程控制中建立基于Q-Marker的“原料-工艺-产品质量”为一体的质量过程控制方法，为提高中药制剂稳定性、均一性、质量过程控制水平提供参考。

The quality depends on the process control level. At present, there are still some defects in the quality control standards of traditional Chinese medicine (TCM), which can hardly meet the requirements of uniformity and stability of products. As a result, the quality of TCM preparations varies, affecting the efficacy, safety and stability of TCM preparations. In order to guaranteeing the uniformity and stability of traditional Chinese medicine preparations, a quality process control method based on Q-marker was established, which holds “raw materials-process-product quality” as a whole. The control method provides reference for improving the uniformity, stability and quality control process of TCM preparations.

R283.6

国家重点研发计划项目（2017YFC1702904）；江西中医药大学校级项目（JXSYLXK-ZHYAO004）；江西中医药大学校级项目（2019WBZR003）