摘要
目的建立心神宁片中12个成分的含量测定方法,并对检测结果进行化学计量学分析。方法采用高效液相色谱法,选取栀子苷为含量测定内参物,同时测定15批心神宁片中栀子新苷、山栀子苷、羟异栀子苷、栀子苷、西伯利亚远志糖A5、西伯利亚远志糖A6、远志[口山]酮Ⅲ、3,6′-二芥子酰基蔗糖、斯皮诺素、6′′′-阿魏酰斯皮诺素、酸枣仁皂苷A、酸枣仁皂苷B的含量,采用统计学软件对15批样品进行差异分析。结果12个成分分别在各自范围内线性关系良好(r>0.9990),平均加样回收率(n=9)在96.74%~100.09%之间(RSD<2.0%)。统计学分析显示15批样品聚为3类,聚类分析与主成分分析结果一致;栀子苷、3,6′-二芥子酰基蔗糖、羟异栀子苷、西伯利亚远志糖A5、山栀子苷是影响心神宁片产品质量的主要潜在标志物。结论所建立的多指标成分含量测定、化学计量学及熵权优劣解距离法分析方法简便、准确,可用于心神宁片质量的综合评价。
Objective To establish a method for the content determination of 12 compositions in Xinshenning tablets,and to chemometric analysis the test results.Methods HPLC was used and selected geniposide as internal reference for content determination.The contents of gardoside,shanzhiside,gardenoside,geniposide,sibiricose A5,sibiricose A6,polygalaxanthoneⅢ,3,6′-disinapoyl sucrose,spinosin,6′′′-feruloylspinosin,jujuboside A and jujuboside B in 15 batches of Xinshenning tablets were determined.The differences of 15 batches of samples were analyzed by statistical software.Results The 12 compositions had good linear relationships within their respective ranges(r>0.9990),and the average recovery rate(n=9)was 96.74%-100.09%(RSD<2.0%).Statistical analysis showed that 15 batches of samples were clustered into 3 groups,and the results of cluster analysis and principal component analysis were consistent.Geniposide,3,6′-disinapoyl sucrose,gardenoside,sibiricose A5,shanzhiside were the main potential markers affecting the quality of Xinshenning tablets.Conclusion The quantitative control of QAMS multi-index components established in this study combined with chemometrics and entropy TOPSIS method are simple and accurate,which can be used for the comprehensive evaluation of Xinshenning tablets.
作者
张蕊
徐延昭
张静
许保海
ZHANG Rui;XU Yan-zhao;ZHANG Jing;XU Bao-hai(Department of Pharmacy,Beijing Jishuitan Hospital,Beijing 100035,China;National Institutes for Food and Drug Control,Beijing 100050,China)
出处
《现代中药研究与实践》
CAS
2022年第6期41-48,共8页
Research and Practice on Chinese Medicines
基金
北京市中医管理局第二批中药骨干人才培养项目(京中医科字[2018]213号)。
作者简介
张蕊(1984-),男,副主任药师,硕士,研究方向:中药质量评价、临床药学、医院制剂及协定处方研究。E-mail:fv1280075@163.com;通信作者:许保海(1970-),男,主任药师,本科,研究方向:中药临床药学及中药质量控制。E-mail:xubaohai70@163.com。
