目的 建立同时适用于泽泻汤药材、饮片与基准样品的HPLC特征图谱检测方法，研究泽泻汤基准样品的物质群量值传递研究。方法 依据古代医籍记载的方法制备泽泻汤基准样品，采用HPLC-TOF/MS飞行时间高分辨质谱技术对泽泻汤化学成分进行鉴定和推导，初步阐述泽泻汤主要化学成分；建立基于HPLC-UV-ELSD的基准样品特征图谱方法，明确其特征图谱的相似度及峰归属，结合指标性成分23-乙酰泽泻醇B、蔗果三糖的含量范围和转移率范围以及出膏率，进行基准样品制备过程中物质群的的量值传递相关性分析。结果 在基准样品特征图谱中，泽泻汤的基准样品中共指认18个特征峰，其中10个特征峰来自泽泻、5个特征峰来自白术；指标性成分23-乙酰泽泻醇B质量分数为0.06～0.11 mg/g，平均转移率为（5.11±1.53）%；指标性成分蔗果三糖质量分数为4.29～7.41 mg/g，平均转移率为（71.11±21.33）%；15批基准样品的出膏率控制在13.00%～15.10%。结论 采用整体物质群控制的特征图谱方法、制备工艺过程中物质量值传递研究思路与技术经济指标评价相结合的模式，建立了科学合理的泽泻汤基准样品的评价方法，且明确了药材-饮片-基准样品的传递规律，为经典名方泽泻汤的进一步开发及相关制剂的质量控制提供依据。

Objective To establish a high-performance liquid chromatography (HPLC) characteristic chromatographic pattern detection method applicable simultaneously to the herbal materials, decoction pieces, and material reference of Zexie Decoction (泽泻汤, ZD), aiming to study the transfer of quantitative values of material groups in ZD. Methods The material reference of ZD was prepared based on methods recorded in the ancient medical literature. ZD’s chemical components were identified and deduced using HPLC time-of-flight high-resolution mass spectrometry (HPLC-TOF/MS) techniques. Additionally, a material reference characteristic chromatographic method based on HPLC-UV-ELSD was established to precisely determine its similarity range and peak attribution of its characteristic chromatographic pattern. This method, combined with an analysis of the quantitative transfer of material groups during the preparation of the material reference, involved considering the content range, transfer rate, and yield rate of marker components 23-acetyl alisol B and kestose. Results Within the material reference characteristic chromatographic pattern, 18 characteristic peaks were identified, with 10 peaks attributed to Zexie (Alismatis Rhizoma, AR) and five peaks to Baizhu (Atractylodis Macrocephalae Rhizoma, AMR). The marker component 23-acetyl alisol B ranged from 0.06 to 0.11 mg/g, with an average transfer rate of (5.11 ± 1.53)%. The mass fraction of the marker component kestose ranged from 4.29 to 7.41 mg/g, with an average transfer rate of (71.11 ± 21.33)%. The yield rate of 15 batches of reference samples was controlled from 13.00% to 15.10%. Conclusion By adopting a model that combines a characteristic chromatographic method for controlling the overall material group, along with the research approach focusing on the quantitative transfer of materials during the preparation process, and the evaluation of technological and economic indicators, a scientifically reasonable evaluation method for the material reference of ZD was established. Moreover, it delineated the transfer law among herbal materials, decoction pieces, and material references, thereby providing a basis for subsequent development and quality control of related formulations of the classic formula ZD.

R283.6

安徽省中央引导地方科技发展专项“泽泻颗粒的开发与产业化”项目（202007d06050008）