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目的:建立基于药物体系的丹参饮片质量表征及关联分析方法,全面评价丹参饮片质量。方法:采用HPLC同时测定16批丹参饮片中药物体系关联成分丹参素钠、迷迭香酸、丹酚酸B、隐丹参酮、丹参酮Ⅰ、丹参酮ⅡA含量及其和,并使用非关联系数(、非关联度、关联度等相关概念表征各批号丹参饮片与基准饮片质量关联性。结果:批号4、10、11、15、5、1、6饮片中有效指标性成分总体含量高于基准批号16,批号1、5、7、11、15、6与基准批号16关联性最高,综合评价得出批号1、5、11、15、6、4、10、16、7优良度居前。结论:基于药物体系质量评价模式,综合有效指标性成分含量及与具有确切药效的基准饮片的关联度,可综合精准评价丹参饮片质量优次,为丹参饮片筛选、药物原料质量控制及应用提供了依据,同时为中药质量评价提供了方法学及其应用借鉴。
Objective: To establish quality characterization and correlation analysis method of Salviae Militaris based on drug system, and to fully evaluate the quality of Salviae Militaris. METHODS: Simultaneous determination of drug components associated with Danshensu sodium, rosmarinic acid, salvianolic acid B, cryptotanshinone, tanshinone I, and tanshinone IIA in 16 batches of Salviae Miltiorrhiza Pieces was performed by HPLC, and non-associated coefficients were used. Relatedness concepts such as relevance degree, relevance degree, etc. characterize the quality relevance of each lot of Danshen’s decoction pieces and benchmark decoction pieces.Results: The overall content of effective indicator components in batches 4, 10, 11, 15, 5, 1, and 6 is higher than the benchmark lot number 16. Lot Nos. 1, 5, 7, 11, 15, and 6 have the highest correlation with the benchmark lot No. 16. The overall evaluation shows that Lot Nos. 1, 5, 11, 15, 6, 4, 10, 16, and 7 rank among the top grades. The quality evaluation model of the drug system, the comprehensive effective index component content and the correlation degree with the benchmark decoction pieces with specific drug efficacy can comprehensively and accurately evaluate the quality of the Danshen decoction pieces, and provide basis for the selection of the Danshen decoction pieces, the quality control and application of the drug raw materials. At the same time, it provides methodology and its application for the evaluation of quality of traditional Chinese medicine.