基于传统煎药工艺的大枣饮片标准汤剂制备及其质量评价方法分析

目的 选择5个不同产地的15批大枣饮片，按照传统的水煎药方式制备成标准汤剂，对所得样品进行质量评价。方法 采用超高效液相色谱法（UPLC）测定指标成分环磷腺苷的含量，计算出膏率、转移率和特征图谱的相对保留时间和相对峰面积。结果 测定15批大枣标准汤剂的出膏率为36.90%~55.73%，平均出膏率为（47.94±14.38）%，环磷腺苷转移率为48.06%~72.86%，平均转移率为（59.82±17.95）%，采用“中药色谱指纹图谱相似度评价系统”（2012版）进行分析，标定了11个特征峰，并指认了其中的峰5、峰6和峰11分别为鸟苷、环磷腺苷和芦丁。大枣标准汤剂的特征图谱相似度结果均超过0.90。结论 建立的工艺标准及质量评价方法精密度、稳定性和重复性良好，适用于大枣标准汤剂的制备及质量控制，可为大枣配方颗粒质量控制提供参考。

Preparation and Quality Evaluation of Standard Decoction of Jujubae Fructus Based on Traditional Decocting Process

Objective To evaluate the quality of 15 batches of the standard decoction prepared with Jujubae Fructus (prepared in pieces for use) from five different producing areas based on traditional decocting process.Methods The content of cyclic adenosine monophosphate (cAMP) was determined by ultra-performance liquid chromatography (UPLC). Then the extraction rate and the transfer rate of cAMP were calculated and the fingerprints were established.Results The extraction rate was in the range of 36.90%-55.73%, with the average of (47.94±14.38)%. The transfer rate of cAMP ranged from 48.06% to 72.86%, with the average of (59.82±17.95)%. Besides, the SOP of Similarity Evaluation System for Chromatographic Fingerprint of TCM (version 2012) was employed to analyze and compare the fingerprints. A total of 11 common peaks were found in the fingerprints, among which peak 5, peak 6, and peak 11 were identified as guanosine, cAMP, and rutin, respectively. The fingerprints of the standard decoction were evaluated, and the similarities were more than 0.90.Conclusion The methods are precise, stable, and repeatable. Therefore, they can be used for quality evaluation of standard decoction of Jujubae Fructus.