温胆汤传统汤剂、配方颗粒汤剂中化学成分比较  

Comparison of chemical constituents in traditional decoction and formula granule decoction of Wendan Decoction

作　　者：薛潭 许曼文 范雪花 董峰宇 苗妍 孙嘉宁 施钧瀚[1] 张璐[1] 姚静[1,4,5,6] 刘瑞新 XUE Tan;XU Man-wen;FAN Xue-hua;DONG Feng-yu;MIAO Yan;SUN Jia-ning;SHI Jun-han;ZHANG Lu;YAO Jing;LIU Rui-xin(Department of Pharmacy,The First Hospital Affiliated to Henan University of Chinese Medicine,Zhengzhou 450003,China;College of Pharmacy,Henan University of Chinese Medicine,Zhengzhou 450046,China;Jiangsu Kangyuan Pharmaceutical Co.,Ltd.,Lianyungang 222067,China;Henan Provincial Research Center for Clinical Application,Evaluation and Transformation Engineering of Traditional Chinese Medicines,Zhengzhou 450000,China;Collaborative Innovation Center for Prevention and Treatment of Respiratory Diseases with Traditional Chinese Medicine Co-founded by Henan Province and MOST,Henan University of Chinese Medicine,Zhengzhou 450046,China;Henan Provincial Key Laboratory for Clinical Pharmacy of Traditional Chinese Medicine,Zhengzhou 450000,China;Ministry of Education Engineering Research Center for Pharmaceutical Manufacturing and New Drug Development of Traditional Chinese Medicine,Beijing 100029,China)

机构地区：[1]河南中医药大学第一附属医院药学部,河南郑州450003 [2]河南中医药大学药学院,河南郑州450046 [3]江苏康缘药业股份有限公司,江苏连云港222067 [4]河南省中药临床应用、评价与转化工程研究中心,河南郑州450000 [5]河南中医药大学呼吸疾病中医药防治省部共建协同创新中心,河南郑州450046 [6]河南省中药临床药学中医药重点实验室,河南郑州450000 [7]中药制药与新药开发教育部工程研究中心,北京100029

出　　处：《中成药》2025年第2期384-394,共11页Chinese Traditional Patent Medicine

基　　金：河南省自然科学基金项目杰出青年科学基金项目(242300421023);河南省卫生健康中青年学科带头人专项(HNSWJW-2020014);河南省卫生健康委国家中医临床研究基地科研专项(2021JDZY036);2022年青年岐黄学者培养项目(国中医药人教函[2022]256号)。

摘　　要：目的比较经典名方温胆汤传统汤剂、配方颗粒汤剂中的化学成分。方法建立HPLC指纹图谱,测定腺苷、辛弗林、甘草苷、柚皮苷、橙皮苷、6-姜酚、环磷酸腺苷的含量,聚类分析、主成分分析、多维标度分析考察成分差异,校正配方颗粒当量。结果10批传统汤剂HPLC指纹图谱的相似度高于9批配方颗粒汤剂HPLC指纹图谱的(P<0.01)。传统汤剂中腺苷、辛弗林、甘草苷、橙皮苷、环磷酸腺苷含量高于配方颗粒汤剂中(P<0.05);6-姜酚含量低于厂家A、C所产后者中(P<0.05),高于厂家B所产后者中(P<0.01)。各批传统汤剂、配方颗粒汤剂可明显区分开,腺苷、辛弗林、橙皮苷对主成分分析分类的影响较大,厂家C所产配方颗粒汤剂质量与传统汤剂更接近。当量校正后,厂家A、C所产配方颗粒汤剂中各成分含量与传统汤剂中比较,差异无统计学意义(P>0.05)。结论不同厂家温胆汤配方颗粒质量存在差异,故应优化该制剂制备、提取工艺以提高质量,并根据实际需求校正当量比以保证其临床应用的科学合理。AIM To compare the chemical constituents in traditional decoction and formula granule decoction of classical famous prescription Wendan Decoction.METHODS The HPLC fingerprints were established,after which the contents of adenosine,synephrine,liquiritin,naringin,hesperidin,6-gingerol and adenosine cyclophosphate were determined,cluster analysis,principal component analysis and multidimensional scaling analysis were adopted in the investigation of component differences,and the equivalent of formula granules was adjusted.RESULTS The similarities of HPLC fingerprints for 10 batches of traditional decoctions were higher than those of HPLC fingerprints for 9 batches of formula granule decoctions(P<0.01).Adenosine,synephrine,liquiritin,hesperidin and cyclic adenosine monophosphate demonstrated higher contents in traditional decoctions than those in formula granule decoctions(P<0.05),6-gingerol displayed lower content than that in the latter produced by manufacturers A,C(P<0.05),which was higher than that in the latter produced by manufacturer B(P<0.01).Various batches of traditional decoctions and formula granule decoctions could be obviously distinguished,adenosine,synephrine and hesperidin exhibited great influences on the classification of principal component analysis,and the quality of formula granule decoctions produced by manufacturer C was closer to that of traditional decoctions.After equivalent correction,the contents of various constituents in formula granule decoctions produced by manufacturers A,C showed no significant differences as compared with those in traditional decoction(P>0.05).CONCLUSION The formula granules of Wendan Decoction from different manufacturers exist quality differences,so the preparation process and extraction process of this preparation should be optimized to improve quality,and equivalent ratio should be adjusted according to actual requirements to ensure its scientific and rational clinical application.

关 键 词：温胆汤 传统汤剂 配方颗粒 化学成分 HPLC指纹图谱 聚类分析 主成分分析 多维标度分析 

分 类 号：R283.6[医药卫生—中药学]