基于熵权TOPSIS-多组分定量分析的小儿豉翘清热颗粒质量控制研究  

Study on Quality Control of Xiao'er Chiqiao Qingre Granules(小儿豉翘清热颗粒)Based on Entropy Weight TOPSIS and Multi-Component Quantitative Analysis

作　　者：戴越 徐郭晔 王晔 DAI Yue;XU Guoye;WANG Ye(Children's Hospital Affiliated to Nanjing Medical University,Nanjing Jiangsu 210008,China;Rudong County Hospital of Traditional Chinese Medicine,Rudong Jiangsu 226499,China;Zhangjiagang Guanghe Hospital of Integrated Traditional Chinese and Western Medicine,Zhangjiagang Jiangsu 215633,China)

机构地区：[1]南京医科大学附属儿童医院,江苏南京210008 [2]如东县中医院,江苏如东226499 [3]张家港市广和中西医结合医院,江苏张家港215633

出　　处：《中医药导报》2023年第7期52-56,62,共6页Guiding Journal of Traditional Chinese Medicine and Pharmacy

基　　金：江苏省卫生计生委医学科研课题(Z2021075)。

摘　　要：目的:建立同时测定小儿豉翘清热颗粒中8种指标性成分含量的方法,采用聚类分析和逼近理想解排序(TOPSIS)法对该制剂进行综合评价,为该中药复方制剂的质量评价及控制提供参考。方法:运用高效液相色谱波长切换法对不同批次制剂中栀子苷、芍药苷、黄芩苷、汉黄芩苷、黄芩素、汉黄芩素、连翘苷、连翘酯苷A 8种化学成分的含量进行同时测定,采用Agilent ZORBAX SB-C_(18)色谱柱(250 mm×4.6 mm,5μm);以乙腈-0.1%磷酸水溶液为流动相体系,梯度洗脱;柱温为35℃;检测波长分别为λ_(1)=230 nm、λ_(2)=275 nm。运用SPSS 22.0软件进行聚类分析,并构建熵权TOPSIS模型进行多指标等级优化。结果:栀子苷、芍药苷、黄芩苷、汉黄芩苷、黄芩素、汉黄芩素、连翘苷、连翘酯苷A分离度良好,分别在10.14~202.74μg/mL(r=0.9999)、6.11~122.22μg/mL(r=0.9998)、10.06~201.12μg/mL(r=0.9996)、2.62~52.40μg/mL(r=0.9999)、0.14~2.84μg/mL(r=0.9997)、0.38~7.50μg/mL(r=0.9998)、1.82~36.35μg/mL(r=0.9999)、4.55~90.91μg/mL(r=0.9996)的范围内线性关系良好;8种成分的平均加样回收率分别为100.60%(RSD=0.99%)、101.22%(RSD=0.93%)、100.82%(RSD=0.94%)、100.35%(RSD=0.53%)、101.43%(RSD=1.09%)、101.21%(RSD=0.74%)、100.63%(RSD=0.98%)、100.61%(RSD=0.76%)。聚类分析和TOPSIS分析显示,15批样品可聚为两大类,排名前三的为S8、S6和S3样品,质量较好。结论:同时定量分析了小儿豉翘清热颗粒中8种指标性成分的含量,所建立的方法操作准确、重复性好,结合聚类分析和熵权TOPSIS法综合评价小儿豉翘清热颗粒的内在质量,为中药复方制剂的质量控制提供参考。Objective:To establish a method for simultaneous determination of 8 index components in Xiao'er Chiqiao Qingre Granules,and to evaluate the preparation by cluster analysis and TOPSIS method,so as to provide reference for the quality evaluation and control of the compound preparation of traditional Chinese medicine.Methods:The contents of eight chemical components including geniposide,paeoniflorin,baicalin,wogonoside,baicalein,wogonin,phillyrin and forsythiaside A in different batches of preparations were simultaneously determined by high performance liquid chromatography wavelength switching method.Agilent ZORBAX SB-C_(18) chromatographic column(250 mm×4.6 mm,5μm)was used.Acetonitrile-0.1%phosphoric acid aqueous solution was used as mobile phase system for gradient elution.The column temperature was 35℃.The detection wavelengths were λ_(1)=230 nm and λ_(2)=275 nm,respectively.SPSS 22.0 software was used for cluster analysis,and the entropy weight TOPSIS model was constructed for multi-index grade optimization.Geniposide,paeoniflorin,baicalin,wogonoside,baicalein,wogonin,phillyrin and forsythiaside A were well separated.The linear ranges were 10.14-202.74μg/mL(r=0.9999),6.11-122.22μg/mL(r=0.9998),10.06-201.12μg/mL(r=0.9996),2.62-52.40μg/mL(r=0.9999),0.14-2.84μg/mL(r=0.9997),0.38-7.50μg/mL(r=0.9998),1.82-36.35μg/mL(r=0.9999),4.55-90.91μg/mL(r=0.9996),respectively.The average recoveries were 100.60%(RSD=0.99%),101.22%(RSD=0.93%),100.82%(RSD=0.94%),100.35%(RSD=0.53%),101.43%(RSD=1.09%),101.21%(RSD=0.74%),100.63%(RSD=0.98%),100.61%(RSD=0.76%),respectively.Cluster analysis and TOPSIS analysis showed that 15 batches of samples could be clustered into two categories,and the top three were S8,S6 and S3 samples with good quality.Conclusion:The contents of 8 index components in Xiao'er Chiqiao Qingre Granules were simultaneous quantitatively analyzed.The established method was accurate and reproducible.Combined with cluster analysis and entropy weight TOPSIS method,the internal quality of Xiao'er Chiqiao Qingr

关 键 词：小儿豉翘清热颗粒 高效液相色谱波长切换法 聚类分析 逼近理想解排序法 熵权法 质量控制 

分 类 号：R284.1[医药卫生—中药学]