基于标准汤剂的石榴皮配方颗粒质量评价研究  

Quality Evaluation of Granati Pericarpium Dispensing Granules Based on Standard Decoctions

作　　者：秦金淼 宁波 刘羽康 张京华 张风超 刘兴村 张玉伟 曹桂云 孟兆青 QIN Jinmiao;NING Bo;LIU Yukang;ZHANG Jinghua;ZHANG Fengchao;LIU Xingcun;ZHANG Yuwei;CAO Guiyun;MENG Zhaoqing(Shandong Hongjitang Pharmaceutical Group Co.Ltd.,Jinan 250103,China)

机构地区：[1]山东宏济堂制药集团股份有限公司,济南250103

出　　处：《西南大学学报（自然科学版）》2025年第2期195-204,共10页Journal of Southwest University(Natural Science Edition)

基　　金：山东省重点研发计划(2021CXGC010511)。

摘　　要：基于标准汤剂建立石榴皮配方颗粒的质量评价方法。制备15批石榴皮标准汤剂和3批配方颗粒,测定出膏率,基于高效液相色谱法(HPLC)建立特征图谱,并进行相似度评价,采用化学计量学方法包括无监督的聚类分析(HCA)、主成分分析(PCA)和有监督的偏最小二乘判别分析(PLS-DA)对特征图谱数据进行分析,针对指标成分进行HPLC含量测定,计算石榴皮标准汤剂和配方颗粒中指标成分的转移率。结果表明:石榴皮配方颗粒与标准汤剂特征图谱的相似度均大于0.9。15批石榴皮标准汤剂出膏率为27.95%~41.32%,标准汤剂中石榴皮鞣素、安石榴苷、鞣花酸的转移率分别为21.49%~39.00%、18.99%~33.62%、53.37%~95.45%。按照标准汤剂数据制定石榴皮配方颗粒中上述指标成分的含量限度应为10.58~19.64 mg/g、29.91~55.55 mg/g、10.51~19.52 mg/g。石榴皮配方颗粒出膏率为41.9%~43.1%,配方颗粒中指标成分的转移率与标准汤剂接近,指标成分的含量在根据标准汤剂所制定含量限度范围内。本研究基于标准汤剂建立了石榴皮配方颗粒的质量控制标准,为石榴皮配方颗粒的质量控制以及后续的工艺研究提供参考。To establish a quality evaluation method for Granati Pericarpium formula granules based on standard decoctions,15 batches of Granati Pericarpium standard decoctions and 3 batches of dispensing granules were prepared,the extraction rates were determined.The specific chromatogram was established based on high performance liquid chromatography(HPLC),and the similarity was evaluated.The chemometric methods including unsupervised cluster analysis(HCA),principal component analysis(PCA)and supervised partial least squares discriminant(PLS-DA)were also used for analysis of the characteristic chromatogram data.The content of the index components were detected with HPLC,and the transfer rates of these components in standard decoctions and dispensing granules were calculated.The results showed that similarity of the specific chromatograms between standard decoctions and dispensing granules were all above 0.9.Extraction rates of 15 batches of Granati Pericarpium standard decoctions were 27.95%-41.32%.The transfer rates of punicalin,punicalagin and ellagic acid in standard decoctions were 21.49%-39.00%,18.99%-33.62%,53.37%-95.45%,respectively.The allowable concentration ranges of those components in dispensing granules were 10.58-19.64 mg/g,29.91-55.55 mg/g,10.51-19.52 mg/g,respectively.Extraction rates of dispensing granules were 41.9%-43.1%.The transfer rates of index compounds in dispensing granules were close to these in standard decoctions,and the contents of these compounds in dispensing granules was within the scope of the quality standard.In this study,the quality control standard of Granati Pericarpium formula granules was established based on the standard decoction,which provided a reference for the quality control and process research of Granati Pericarpium formula granules.

关 键 词：石榴皮 标准汤剂 配方颗粒 特征图谱 高效液相色谱法 

分 类 号：R283[医药卫生—中药学] S665.4[医药卫生—中医学]