目的 基于“成分反映活性，活性指向功效”的中药质量控制研究思路，建立用于丹参饮片等级评价的Logistic回归模型。方法 采用超高效液相色谱法（UPLC）测定丹参质量标志物（quality marker，Q-marker）含量，以凝血酶时间（thrombin time，TT）、羟自由基抑制率、DPPH自由基清除率作为生物活性评价指标，运用Logistic回归分析法将质控指标和生物活性指标进行关联分析，最后建立Logistic回归模型。结果 Logistic模型结果显示，31批丹参饮片被分成了优、良、中、差4个等级，样本等级预测概率（P）值均大于90%，说明本研究所建立的模型其准确性和预测能力均较好。结论 基于含量测定及生物活性结果建立的Logistic回归模型可用来评价丹参饮片质量高低，为丹参整体质量控制提供参考依据。

Objective A logistic regression model for grade evaluation of Salvia miltiorrhiza medicinal slices was constructed based on the quality control idea of traditional Chinese medicines that "ingredients reflect activity and activity expresses effect". Methods Q-marker content in S. miltiorrhiza was tested by ultra-high performance liquid chromatography (UPLC). Thrombin time (TT) inhibition rate of hydroxyl radical and DPPH clearance rate were used as evaluation indexes of biological activity. Correlations between quality control indexes and bioactivity indexes were analyzed by the logistic algorithm. Finally, A Logistic regression model was established. Results The results of Logistic model showed that 31 batches of S. miltiorrhiza medicinal slices were divided into four grades:excellent, good, medium and poor. P values of sample grade prediction were higher than 90%, indicating the high accuracy and prediction ability of the Logistic model. Conclusion The Logistic model based on content determination and biological activity can be used to evaluate quality of S. miltiorrhiza and provide some reference for quality control.

R286.2

陕西省“特支计划”青年拔尖人才项目；国家中药标准化项目（ZYBZH-C-QIN-45）；基于多维整合分析策略的盘龙七片质量标志物发现与大品种技术提升研究（2020ZDLSF05-08）