皂角刺饮片与标准汤剂量值传递规律研究

目的 研究皂角刺饮片到标准汤剂的量值传递规律。方法 采用18批皂角刺饮片制备标准汤剂，测定18批皂角刺标准汤剂的出膏率、浸出物含量，建立18批皂角刺饮片和标准汤剂超高效液相色谱特征图谱，采用高分辨质谱对特征峰进行成分鉴定，建立皂角刺饮片和标准汤剂中指标性成分东莨菪内酯和花旗松素的含量测定方法，以出膏率、浸出物含量、指标性成分含量、转移率、特征图谱为指标，研究饮片到标准汤剂的量值传递规律。结果 18批标准汤剂出膏率为3.66%~5.99%，浸出物质量分数为33.38%~47.62%，饮片特征图谱共标定8个特征峰，均能传递到标准汤剂中，并指认出其中6个成分，饮片与标准汤剂对照特征图谱的相似度>0.90，特征图谱可作为共性质量特征用于皂角刺的鉴别和质量控制。指标性成分东莨菪内酯和花旗松素的平均转移率分别为67.32%、24.10%。结论 可为皂角刺药材及其制剂质量标准的提高、皂角刺配方颗粒国家标准的制定提供参考。

Quantity Transfer Law of Decoction Pieces to Standard Decoction of Gleditsiae Spina

Objective To study the quantity transfer law of decoction pieces to standard decoction of Gleditsiae Spina.Methods Eighteen batches of Gleditsiae Spina decoction pieces were used to prepare standard decoctions. The yield rate and extract of the 18 batches of standard Gleditsiae Spina decoctions were determined. Ultra-high-performance liquid chromatography (UHPLC) fingerprints were established for both Gleditsiae Spina decoction pieces and standard decoctions. High-resolution mass spectrometry was employed for component identification of characteristic peaks. Quantitative determination methods for the indicator components, scopoletin and taxifolin, in Gleditsiae Spina decoction pieces and standard decoctions were established. Using yield rate, extract content, indicator component content, transfer rate, and characteristic fingerprints as indicators, the quantity transfer law of decoction pieces to standard decoction was investigated.Results The yield rates of the 18 batches of standard decoctions ranged from 3.66% to 5.99%, and the extract content ranged from 33.38% to 47.62%. Eight characteristic peaks were identified in the chromatographic fingerprints of the decoction pieces, all of which were successfully transferred to the standard decoctions, and six components were identified. The similarity between the characteristic fingerprints of the decoction pieces and standard decoctions was greater than 0.90. These characteristic fingerprints can be used as common quality features for the identification and quality control of Gleditsiae Spina. The average transfer rates of the indicator components, scopoletin, and taxifolin, were 67.32% and 24.10%, respectively.Conclusion This study provides a reference for improving the quality standards of Gleditsiae Spina medicinal materials and their preparations, while also laying the foundation for the formulation of national standards for Gleditsiae Spina-containing formula granules.