多成分定量测定联合化学计量学及加权TOPSIS分析的止咳橘红胶囊综合质量评价  

Comprehensive Quality Evaluation of Zhike Juhong Capsules Based on Multi-component Quantitation Combined with Chemometrics and Weighted TOPSIS

作　　者：李杨杨 任颖玲 张旭东 洪占梅 丁炜 王雅 蔡宏亮 周莉莉 LI Yangyang;REN Yingling;ZHANG Xudong;HONG Zhanmei;DING Wei;WANG Ya;CAI Hongliang;ZHOU Lili(Department of Pharmacy,The 901st Hospital of the PLA Joint Logistics Support Force,Hefei 230031,China;College of Pharmacy,Anhui Medical University,Hefei 230032,China)

机构地区：[1]中国人民解放军联勤保障部队第九〇一医院药剂科,安徽合肥230031 [2]安徽医科大学药学院,安徽合肥230032

出　　处：《中国现代中药》2025年第4期771-778,共8页Modern Chinese Medicine

基　　金：安徽省教育厅高校优秀拔尖人才培育资助项目(gxbjZD2020061)。

摘　　要：目的:建立止咳橘红胶囊多成分定量方法,比较批次间各成分含量的差异,利用化学计量学及加权优劣解距离法(EW-TOPSIS)建立其质量评价模型,评价不同批次止咳橘红胶囊质量。方法:以新芒果苷、芒果苷、异芒果苷、去芹糖桔梗皂苷E、桔梗皂苷E、桔梗皂苷D_3、柚皮芸香苷、柚皮苷、麦冬甲基黄烷酮A、甲基麦冬二氢高异黄酮B、3,29-二苯甲酰基栝楼仁二醇、3,29-二苯甲酰基栝楼仁三醇的含量及崩解时限为评价指标,利用化学计量学及EW-TOPSIS对各项指标进行统计分析,建立16批止咳橘红胶囊质量评价模型。结果:16批止咳橘红胶囊中新芒果苷、芒果苷、异芒果苷、去芹糖桔梗皂苷E、桔梗皂苷E、桔梗皂苷D_3、柚皮芸香苷、柚皮苷、麦冬甲基黄烷酮A、甲基麦冬二氢高异黄酮B、3,29-二苯甲酰基栝楼仁二醇、3,29-二苯甲酰基栝楼仁三醇含量同时测定方法符合《中华人民共和国药典》 2020年版方法学验证要求。明确了质量差异因子为柚皮苷、3,29-二苯甲酰基栝楼仁三醇、新芒果苷、柚皮芸香苷、芒果苷和桔梗皂苷E。EW-TOPSIS结果显示,16批止咳橘红胶囊的相对贴近度为0.227 6~0.680 4。结论:所建多组分定量联合化学计量学及EW-TOPSIS可用于止咳橘红胶囊的质量评价。Objective:To establish a multi-component quantification method for Zhike Juhong Capsules,compare the content differences of each component between batches,and establish a quality evaluation model by chemometrics combined with weighted technique for order preference by similarity to an ideal solution(EW-TOPSIS)to evaluate the quality of different batches of Zhike Juhong Capsules.Methods:The content of neomangiferin,mangiferin,isomangiferin,platycoside G1,platycoside E,platycodin D3,narirutin,naringin,methylophiopogonanone A,methylophiopogonanone B,3,29-O-dibenzoyloxykarounidiol,and 3,29-dibenzoyl rarounitriol and the disintegration time limit were used as evaluation indexes.The indexes were statistically analyzed by chemometrics and weighted TOPSIS,and a quality evaluation model for 16 batches of Zhike Juhong Capsules was established.Results:The simultaneous determination method of neomangiferin,mangiferin,isomangiferin,platycoside G1,platycoside E,platycodin D3,narirutin,naringin,methylophiopogonanone A,methylophiopogonanone B,3,29-O-dibenzoyloxykarounidiol,and 3,29-dibenzoyl rarounitriol in 16 batches of Zhike Juhong Capsules met the methodological requirements in the Pharmacopoeia of the People′s Republic of China(2020 edition).The factors contributing to quality differences were identified as naringin,3,29-dibenzoyl rarounitriol,neomangiferin,narirutin,mangiferin,and platycoside E.The results of weighted TOPSIS showed that the relative closeness of the 16 batches of Zhike Juhong Capsules was between 0.2276 and 0.6804.Conclusion:The established method of multi-component quantification combined with chemometrics and weighted TOPSIS can be used for the quality evaluation of Zhike Juhong Capsules.

关 键 词：止咳橘红胶囊 高效液相色谱法 化学计量学 加权优劣解距离法 综合质量评价 

分 类 号：R286[医药卫生—中药学]