目的 建立经典名方猪苓汤基准样品的定性和定量检测方法，为其质量标准的建立及复方制剂的开发提供数据支撑和研究基础。方法 建立猪苓汤基准样品HPLC特征图谱，采用国家药典委员会出版的“中药色谱指纹图谱相似度评价系统”（2012年版）计算相似度；确定基准样品含量测定指标成分并通过HPLC建立含量测定方法，进行相关方法学考察；研究建立猪苓汤中处方药味薄层鉴别方法；计算15批基准样品的干膏率及指标成分转移率、水分。结果 特征图谱共标定8个共有峰，分别归属泽泻和阿胶，其中指认3个共有峰，分别为泽泻醇A（峰1）、泽泻醇B（峰2）、23-乙酰泽泻醇B（峰3），15批猪苓汤基准样品质量评价结果表明相似度均大于0.95，可表征猪苓汤基准样品的质量特性；含量测定指标成分确定为阿胶中的L-羟脯氨酸、甘氨酸、丙氨酸、脯氨酸，并建立含量测定方法，方法学考察均符合要求；同时建立猪苓、茯苓、泽泻的薄层鉴别方法。计算15批猪苓汤基准样品的平均干膏率为21.53%，平均水分为3.64%，指标成分L-羟脯氨酸、甘氨酸、丙氨酸、脯氨酸平均转移率分别为90.89%、90.25%、90.29%、91.28%，所有数据均未出现离散。结论 建立的经典名方猪苓汤基准样品质量标准，能够较全面的反映基准样品关键质量属性，综合体现了处方各药味的信息，为后期经典名方猪苓汤复方制剂的研究提供参考。

Objective To establish qualitative and quantitative detection methods for reference samples of the classic famous Zhuling Decoction to provide a data basis for the establishment of its quality standards and the development and utilization of compound preparations. Methods The HPLC characteristic map of Zhuling Decoction benchmark samples was established. The similarity was calculated using the “Chinese Medicine Chromatographic Fingerprint Similarity Evaluation System” (2012 edition) published by the State Pharmacopoeia Commission. The index component content of the benchmark sample was determined and a content determination method by HPLC was established, and the related methodological investigations were conducted. The thin-layer chromatography method for identifying the taste of prescription medicines in Zhuling Decoction was establish. The paste yield, index component transfer rate and moisture of 15 batches of benchmark samples were calculated. Results A total of eight common peaks were demarcated in the characteristic map, which belonged to Zexie (Alismatis Rhizoma) and Ejiao, respectively. Among them, three common peaks were identified, namely alisitol A (peak 1), alisitol B (peak 2), and 23-acetyl alisitol B (peak 3). The quality evaluation results of 15 batches of Zhuling Decoction benchmark samples showed that the similarity was greater than 0.95, which could characterize the quality characteristics of Zhuling Decoction benchmark samples. The content determination index components were determined as L-hydroxyproline, glycine, alanine and proline in donkey-hide gelatin. The content determination method was established, and the methodological investigations all met the requirements. At the same time, a thin-layer identification method for Zhuling (Polyporus), Fuling (Poria) and Alismatis Rhizoma was established. The average yield of 15 batches of Zhuling Decoction benchmark samples was calculated to be 21.53%, and the average moisture content was 3.64%. The average transfer rates of the index components L-hydroxyproline, glycine, alanine and proline were 90.89%, 90.25%, 90.29% and 91.28%, respectively. All data were not discrete. Conclusion The quality standard for the benchmark samples of the classic Zhuling Decoction established in this study can more comprehensively reflect the key quality attributes of the benchmark samples and comprehensively reflect the information of the prescriptions. It can provide a reference for the later study of the classic and famous Zhuling Decoction compound preparations.

R283.6

国家重点研发计划（2018YFC1706306）；山东省重点研发计划项目（2019JZZY020907）；聊城市重点研发计划（重大科技创新工程）项目（2021ZD07）