摘要
建立康妇消炎栓中11种成分定量控制的方法,并结合化学计量学及熵权优劣解距离法(EW-TOPSIS)技术对康妇消炎栓综合质量进行评价.采用J'Sphere M80色谱柱,乙腈-0.4%磷酸为流动相,梯度洗脱,流速1.0 m L/min,检测波长320 nm(0-17 min)、220 nm(17-47 min)和275 nm(47-65 min),采用外标法同时测定18批康妇消炎栓中菊苣酸、穿心莲内酯、新穿心莲内酯、脱水穿心莲内酯、槐果碱、苦参碱、槐定碱、氧化苦参碱、左旋紫草素、去氧紫草素和β,β'-二甲基丙烯酰阿卡宁含量,采用SPSS26.0和SIMCA 14.1软件建立18批康妇消炎栓质量差异评价模型.康妇消炎栓多成分定量检测外标法方法学验证结果显示,11个成分线性关系良好(r≥0.9991),平均加样回收率(n=9)在96.93%-100.13%之间(RSD≤1.71%),11个成分含量分别为3.465-5.930、1.262-3.693、1.073-1.841、0.521-1.027、0.076-0.184、1.931-3.810、0.181-0.651、2.318-4.955、0.163-0.260、0.049-0.104和2.001-3.436 mg/g.化学计量学分析结果显示,18批样品中各化学成分存在一定的差异,提取出2个主成分,其中相邻生产阶段聚为一组,共聚为3组,筛选出5个导致不同批次康妇消炎栓质量差异的潜在标志成分(VIP>1).EW-TOPSIS模型的综合评价结果显示,18批样品最优解的欧氏贴近度为0.1146-0.7847,其中S13-S18均高于0.6,表明这6批样品质量较优.建立的HPLC多指标成分定量控制方法简便快捷,结合化学计量学、EW-TOPSIS法可为康妇消炎栓综合质量评价体系的完善提供参考.
To establish a quantitative control method of 11 components in Kangfu Xiaoyan Suppository,and to evaluate the comprehensive quality of Kangfu Xiaoyan Suppository by chemometrics and entropy weight-technique for order preference by similarity to ideal solution(EW-TOPSIS)method.The J'Sphere M80 column was used for the analysis with an acetonitrile-0.4%phosphoric acid serving as the mobile phase.The flow rate of 1.0 mL/min,the detection wavelengths were 320 nm(0-17 min),220 nm(17-47 min)and 275 nm(47-65 min),the contents of chicoric acid,andrographolide,neoandrographolide,dehydroandrographolide,sophocarpine,matrine,sophoridine,oxymatrine,shikonin,deoxyshikonin and beta,beta-dimethylacrylalkannin in 18 batches of Kangfu Xiaoyan Suppository were determined by external standard method.The quality difference evaluation model of 18 batches of Kangfu Xiaoyan Suppository was established by SPSS 26.0 and SIMCA 14.1 software.The methodological verification results of external standard method for multi-component quantitative detection of Kangfu Xiaoyan Suppository showed that the linear relationship of 11 components was good(r≥0.9991),and the average recovery rate(n=9)was 96.93%-100.1%(RSD≤1.71%).the contents of 11 components were 3.465-5.930,1.262-3.693,1.073-1.841,0.521-1.027,0.076-0.184,1.931-3.810,0.181-0.651,2.318-4.955,0.163-0.260,0.049-0.104 and 2.001-3.436 mg/g,respectively.The results of chemometrics analysis showed that there were some differences in the chemical components of 18 batches of samples.Two principal components were extracted,among which the adjacent production stages were clustered into one group and clustered into three groups.Five potential marker components(VIP>1)leading to the quality difference of Kangfu Xiaoyan Suppository in different batches were screened out.The comprehensive evaluation results of EW-TOPSIS model showed that the Euclidean closeness of the optimal solution of 18 batches of samples was 0.1146-0.7847,among them,S13-S18 were higher than 0.6,indicating that the quality of these 6 batches of samples was better.The established HPLC multi-index component quantitative control method is simple and fast.Combined with chemometrics and EW-TOPSIS method,it can provide reference for the improvement of the comprehensive quality evaluation system of Kangfu Xiaoyan Suppository.
作者
刘裕
屈彬清
林优美
蒋菲娅
何鸽飞
Liu Yu;Qu Binqing;Lin Youmei;Jinag Feiya;He Gefei(Clinical Trial Research Center,Changsha First Hospital&Changsha Hospital Affiliated to Xiangya School of Medicine of Central South University,Changsha 410005,China;Science and Technology Innovation Center,Hunan University of Chinese Medicine,Changsha 410208,China;Department of Pharmacy,Changsha First Hospital&Changsha Hospital Afiliated to Xiangya School of Medicine of Central South University,Changsha 410005,China)
出处
《南开大学学报(自然科学版)》
北大核心
2025年第2期31-37,共7页
Journal of Nankai University(Natural Sience)
基金
湖南省科学技术厅创新型省份建设专项(2022JJ80036)
长沙市科技计划项目(kq2202013)。
关键词
康妇消炎栓
高效液相色谱法
化学计量学
熵权优劣解距离法
质量评价
Kangfu Xiaoyan Suppository
HPLC
chemometrics
entropy weight-technique for order preference by similarity to an ideal solution(EW-TOPSIS)
quality evaluation
作者简介
刘裕(1981-),女,湖南衡山人,硕士,主管药师,研究方向:中药及制剂质量分析通讯作者:何鸽飞(1974-),女,湖南平江人,硕士,主任药师,硕导,研究方向:临床药学.E-mail:lyjldxxb@163.com。
