经典名方黄芪桂枝五物汤不同形态基准物质质量评价及分析  

Quality Evaluation and Analysis of Different Forms of Reference Substances in Classic Prescription Huangqi Guizhi Wuwu Decoction

作　　者：谢思梅 陈盛君[2] 祝倩倩 王协和 李媚 何雨晴 文红梅[1] XIE Simei;CHEN Shengjun;ZHU Qianqian;WANG Xiehe;LI Mei;HE Yuqing;WEN Hongmei(School of Pharmacy,Nanjing University of Chinese Medicine,Nanjing 210023,China;Jiangyin Tianjiang Pharmaceutical Co.,Ltd.,Jiangyin 214434,China)

机构地区：[1]南京中医药大学药学院,江苏南京210023 [2]江阴天江药业有限公司,江苏江阴214434

出　　处：《南京中医药大学学报》2024年第7期710-721,共12页Journal of Nanjing University of Traditional Chinese Medicine

基　　金：江苏省中药配方颗粒制备与质量控制关键技术重点实验室课题(BM2019003)。

摘　　要：目的建立经典名方黄芪桂枝五物汤(Huangqi Guizhi Wuwu Decoction,HGWD)物质基准;研究HGWD饮片-水煎液-浓缩液-冻干粉全过程量值传递规律,为含挥发性物质的经典名方基准样品的制备方法和科学评定提供借鉴。方法根据国家发布的《古代经典名方关键信息表(25首方剂)》制备15批HGWD水煎液;建立其多指标含量测定和特征图谱分析方法,开展特征峰归属及相似度评价;考察比较HGWD水煎液、冻干粉中多指标含量,分析其在水煎液-浓缩液-冻干粉制备过程中量值传递规律,科学合理确定基准样品的物理形态,并拟定HGWD基准样品中各成分的含量和转移率范围,建立HGWD物质基准。结果HGWD中桂皮醛、肉桂醇在浓缩干燥过程中显著降低,其余指标成分在水煎液、浓缩液与冻干粉间能较完整地传递;15批HGWD基准样品的特征图谱相似度均>0.9,确定8个特征峰,分别来自于方中白芍、桂枝和生姜;出膏率范围8.0%~11.0%;指标成分黄芪甲苷含量为0.04%~0.07%,转移率为9.0%~18.0%;芍药苷含量为1.5%~3.0%,转移率为33.0%~62.0%;肉桂醇含量为0.02%~0.04%,转移率为25.0%~47.0%;桂皮醛含量为0.02%~0.05%,转移率为0.7%~1.5%;肉桂酸含量为0.03%~0.06%,转移率为17.5%~34.0%;6-姜辣素含量为0.04%~0.08%,转移率为7.0%~14.0%。结论确定以水煎液作为HGWD基准样品物理形态,为含挥发性物质的经典名方基准样品物理形态的科学选择提供参考;建立了HGWD物质基准各项质量指标,并对其量值传递规律进行分析,为该经典名方复方制剂开发提供依据。OBJECTIVE To ascertain the substance benchmarks of the classic prescription Huangqi Guizhi Wuwu Decoction(HGWD),examine the quantitative value transfer throughout the entire process of HGWD,from herb pieces to decoction,concentrated solution and finally freeze-dried powder,and provide a valuable reference for the preparation method and scientific evaluation of benchmark samples of classic prescriptions containing volatile substances.METHODS According to the Key information table of Ancient Classic Prescriptions(25 prescriptions)released by China,15 batches of HGWD were prepared.The multi-index content determination and characteristic chromatogram analysis methods were established,and the characteristic peak attribution and similarity evaluation were carried out.The multi-index contents of HGWD and its freeze-dried powder were investigated and compared,and the quantitative value transfer in the preparation process of decoction-concentrated solution-freeze-dried powder was analyzed.The physical form of the benchmark samples were scientifically and reasonably determined,and the content and transfer rate range of each component in the HGWD benchmark samples were determined,and the HGWD substance benchmarks were established.RESULTS The contents of cinnamaldehyde and cinnamyl alcohol in HGWD decreased significantly during the concentration and drying process,and the other index components could be transferred more completely between the decoction,concentrated solution and freeze-dried powder.The similarity of the characteristic chromatograms of 15 batches of HGWD benchmark samples were all over 0.9,and 8 characteristic peaks were identified,which were from Paeoniae γ adix Alba,Cinnamomi γ amulus and Ginger.The paste-forming rate ranged from 8.0% to 11.0%.The content of Astragaloside Ⅳ was 0.04%-0.07%and the transfer rate was 9.0%-18.0%.The content of paeoniflorin was 1.5%-3.0% and the transfer rate was 33.0%-62.0%.The content of cinnamyl alcohol was 0.02%-0.04%,and the transfer rate was 25.0%-47.0%.The content of c

关 键 词：黄芪桂枝五物汤 物质基准 水煎液 浓缩液 冻干粉 量值传递 

分 类 号：R284[医药卫生—中药学]