半夏厚朴汤基准样品量值传递研究  

A Study on Quantitative Transmitting of Benchmark Samples of Banxia Houpo Decoction

作　　者：王龙 闫子轩 杨应莲 范荫荫 吴卫刚 陈伟 周桂芳 李文龙 WANG Long;YAN Zi-xuan;YANG Ying-lian;FAN Yin-yin;WU Wei-gang;CHEN Wei;ZHOU Gui-fang;LI Wen-long(College of Pharmaceutical Engineering of Traditional Chinese Medicine,Tianjin University of Traditional Chinese Medicine,Tianjin 301617,China;Haihe Laboratory of Modern Chinese Medicine,Tianjin301617,China;Jiuxin(Wuhan)Institute of Traditional Chinese Medicine Co.,Ltd.,Wuhan 430050,China;Shanghai Zhen Ren Tang Pharmaceutical Co.,Ltd.,Shanghai 200000,China)

机构地区：[1]天津中医药大学中药制药工程学院,天津301617 [2]现代中医药海河实验室,天津301617 [3]九信(武汉)中药研究院有限公司,湖北武汉430050 [4]上海真仁堂药业有限公司,上海200000

出　　处：《分析测试学报》2024年第11期1774-1783,共10页Journal of Instrumental Analysis

基　　金：上海市2022年度“科技创新行动计划”生物医药科技支撑专项项目(22S21904600);武汉市科技计划项目(2020020602012116)。

摘　　要：在前期文献考证明确处方组成的基础上,制备了15批半夏厚朴汤(BHD)基准样品,建立了其超高效液相色谱(UPLC)指纹图谱,并进行峰归属和相似度分析。随后,建立了BHD中迷迭香酸、6-姜酚、和厚朴酚与厚朴酚的含量测定方法,通过测定基准样品中多种成分含量,开展饮片到基准样品的量值传递规律研究。发现BHD基准样品的指纹图谱有16个共有峰,且与对照指纹图谱的相似度均大于0.95。鉴定的色谱峰包括咖啡酸、野黄芩苷、迷迭香酸、6-姜酚、厚朴酚与和厚朴酚。从饮片到基准样品的过程中,各指标成分的平均转移率如下:迷迭香酸为81.77%,转移率范围为64.57%~110.96%;6-姜酚为28.58%,转移率范围为11.22%~36.94%;和厚朴酚与厚朴酚为3.51%,转移率范围为1.60%~6.03%。结合指纹图谱和多指标成分含量测定模式总结了BHD基准样品的量值传递规律,并初步建立了稳定可靠的BHD基准样品质量评价方法,可为经典名方制剂的质量控制及后续BHD的制剂研究提供参考。This study aims to establish benchmark samples of Banxia Houpo Decoction(BHD)using ultra performance liquid chromatography(UPLC)fingerprinting and a multi-component quantitative analysis method,and to thoroughly investigate the quantitative transmitting,laying the foundation for further research on BHD compound preparations.Based on the previous literature review to confirm the formulation composition,15 batches of BHD reference samples were prepared,and a UPLC fingerprint was established,with peak assignment and similarity analysis conducted.Subsequently,methods for determining the content of rosmarinic acid,6-gingerol,honokiol and magnolol in BHD were developed.By measuring the content of multiple components in the material standard,a study on the transfer laws from crude herbs to substance benchmark was carried out.The study revealed that the BHD benchmark samples fingerprint displayed 16 common peaks,with a similarity to the control fingerprint exceeding 0.95.Identified chromatographic peaks included caffeic acid,scutellarin,rosmarinic acid,6-gingerol,honokiol,and magnolol.The average transfer rates of each indicator component from crude herbs to material standard were as follows:rosmarinic acid at 81.77%,with a transfer rate range of 64.57% to 110.96%;6-gingerol at 28.58%,with a transfer rate range of 11.22% to 36.94%;honokiol and magnolol at 3.51%,with a transfer rate range of 1.60% to 6.03%.By combining the fingerprinting and multi-indicator component content determination model,the quantitative transmitting law of BHD benchmark samples was summarized,and a stable and reliable quality evaluation method of BHD benchmark samples was initially established,which provides a certain reference for the quality control of the classical prescription preparation and the subsequent research on the preparation of BHD.

关 键 词：半夏厚朴汤 基准样品 量值传递 指纹图谱 含量测定 

分 类 号：O657.7[理学—分析化学] R284.2[理学—化学]