多指标降维判别分析方法在中药配方颗粒汤剂与传统汤剂等效性对比中的应用  

The Application of Multi-index Dimension Reduction Discriminant Analysis Method in the Comparison of Equivalence between Dispensing Granule of Chinese Medicine Decoction and Traditional Decoction

作　　者：苗妍 路露 谢梦迪 岳佑凇 桂新景 宋明坤 王艳丽[2,3,4,5] 姚静 施钧瀚[2,3,4,5] 张璐 李学林[2,3,4,5] 刘瑞新 MIAO Yan;LU Lu;XIE Meng-di;YUE You-song;GUI Xin-jing;SONG Ming-kun;WANG Yan-i;YAO Jing;SHI Jun-han;ZHANG Lu;LI Xue-in;LIU Rui-xin(School of Pharmacy,Henan University of Chinese Medicine,Zhengzhou 450046,China;The First Affiliated Hospital of Henan University of Chinese Medicine,Zhengzhou 450000,China;Henan Province Engineering Research Center for Clinical Application,Evaluation and Transformation of Traditional Chinese Medicine,Zhengzhou 450000,China;Co-construction Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases by Henan&Education Ministry of P.R.China,Henan University of Chinese Medicine,Zhengzhou 450046,China;Henan Key Laboratory for Clinical Pharmacy of Chinese Medicine,Zhengzhou450000,China;The First Affiliated Hospital of Henan University of Chinese Medicine of Zhongyi Group Company,Zhengzhou 450000,China)

机构地区：[1]河南中医药大学药学院,河南郑州450046 [2]河南中医药大学第一附属医院,河南郑州450000 [3]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 [4]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 [5]河南省中药临床药学中医药重点实验室,河南郑州450000 [6]河南中医药大学第一附属医院中一集团公司,河南郑州450000

出　　处：《分析测试学报》2024年第3期361-372,共12页Journal of Instrumental Analysis

基　　金：国家自然科学基金面上项目(81773892);国家重点研发计划中医药现代化重点专项(2017YFC1703400);河南省中医药拔尖人才培养项目资助(2019ZYBJ07);河南省高层次人才特殊支持“中原千人计划”-“中原青年拔尖人才”项目(ZYQR201912158);河南省卫生健康中青年学科带头人专项(HNSWJW-2020014)。

摘　　要：针对传统汤剂和配方颗粒汤剂等效性评价方法不直观,未从多维度指标综合评价等问题,该研究建立了一种基于多指标(化学成分、药效作用)降维判别分析二者等效性关系的评价方法。为验证方法的有效性,将A、B、C厂炙甘草,D、E厂白芍,F、G、H厂砂仁配方颗粒汤剂与传统汤剂的化学成分等数据进行验证分析。结果显示建立的判别方法可快速、直观判别两者之间的关系,A、B、C三厂的炙甘草配方颗粒在当量比校正前均不能判定与其传统汤剂等效,经当量比校正后,代表传统汤剂和配方颗粒汤剂的两个置信椭圆部分相交或包含,表明二者可部分或完全替代;D、E厂白芍,F、G、H厂砂仁的配方颗粒在当量比校正前和校正后均不能判定与传统汤剂等效,二者无法相互替代。所建立的方法通过图形化形式快速直观综合判断配方颗粒汤剂与传统汤剂之间的关系,可用于二者之间的等效性评价。To address the problems that the existing analytical methods for evaluating the relation⁃ship between traditional decoction and dispensing granule decoction are not intuitive and not compre⁃hensive from multi-dimensional indexes.In this study,an evaluation method based on multi-index(chemical composition,pharmacodynamic effect)dimension reduction discriminant analysis of the equivalence relationship between traditional decoction and dispensing granule decoction was estab⁃lished.In order to verify the validity of the method,the chemical composition data of the dispensing granule decoction and traditional decoction of baked licorice from manufacturers A,B and C,radix paeoniae alba from manufacturers D and E,and amomi fructus from manufacturers F,G and H were used to verify the analysis.The validation results showed that the established discrimination method could quickly and intuitively discriminate the relationship between traditional decoction and dispens⁃ing granule decoction.The baked licorice dispensing granule from manufacturers A,B and C could not be determined to be equivalent to their traditional decoction before the equivalence ratio correc⁃tion.After the equivalence ratio correction,the two confidence ellipses representing the traditional decoction and the dispensing granule decoction were partially intersected or included,indicating that the two could be partially or completely replaced.The radix paeoniae alba dispensing granule from manufacturers D and E,amomi fructus dispensing granule from manufacturers F,G and H could not be determined to be equivalent to their traditional decoction before and after equivalence ratio correc⁃tion,and the two could not be replaced by each other.The method established in this study can be quickly,intuitively and comprehensively used to evaluate the equivalence between dispensing gran⁃ule decoction and traditional decoction in a graphical form.

关 键 词：传统汤剂 中药配方颗粒汤剂 多指标降维判别分析 等效性 

分 类 号：O657.7[理学—分析化学] R286[理学—化学]