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天麻健脑颗粒的综合质量评价

Comprehensive quality evaluation of Tianma jiannao granules

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目的 建立天麻健脑颗粒(TJG)的指纹图谱及测定含量的方法,结合化学计量学分析综合评价TJG的质量.方法 采用高效液相色谱(HPLC)法建立13批(S1~S13)TJG的指纹图谱,测定肌苷、天麻素、巴利森苷B、巴利森苷E的含量;采用SPSS 20.0和SIMCA 18软件进行聚类分析、主成分分析和正交偏最小二乘法-判别分析,以变量重要性投影(VIP)值大于1为标准,筛选影响质量的标志性成分.结果 13批TJG共标定28个共有峰,其相似度均大于0.9;共指认了 7个共有峰,分别为天麻素、对羟基苯甲醇、巴利森苷B、巴利森苷E、钩藤碱、肌苷、红景天苷.13批TJG聚为3类,其中S1~S2、S8~S10、S12为一类,S3、S7为一类,S4~S6、S11、S13为一类;肌苷的VIP值大于1.肌苷、天麻素、巴利森苷B、巴利森苷E的含量分别为62.637~176.677、17.821~37.642、5.748~16.077、5.660~13.510 μg/g.结论 所建HPLC指纹图谱及含量测定方法稳定可靠、重复性高,结合化学计量学分析可用于评价TJG的质量;肌苷可能是影响TJG质量的标志性成分;13批TJG质量存在差异.
OBJECTIVE To establish the fingerprints of Tianma jiannao granules(TJG)and the method for content determination to evaluate the quality of TJG comprehensively combined with chemometric analysis.METHODS High-performance liquid chromatography(HPLC)was used to establish the fingerprints of 13 batches(S1-S3)of TJG and determine the contents of inosine,gastrodin,parishin B and parishin E.Cluster analysis,principal component analysis,and orthogonal partial least squares-discriminant analysis were performed using SPSS 20.0 and SIMCA 18 software;using variable importance projection(VIP)value greater than 1 as a criterion,marker components that affected quality were screened.RESULTS A total of 28 common peaks were identified in the 13 batches of TJG with similarities greater than 0.9,and 7 common peaks were identified,which were gastrodin,p-hydroxybenzyl alcohol,parishin B,parishin E,rhynchophylline,inosine and salidroside.The 13 batches of TJG were clustered into 3 categories,S1-S2,S8-S10 and S12 were clustered into one category;S3 and S7 were clustered into one category;S4-S6,S11 and S13 were clustered into one category.VIP of inosine was greater than 1.The contents of inosine,gastrodin,parishin B and parishin E were 62.637-176.677,17.821-37.642,5.748-16.077 and 5.660-13.510 μg/g.CONCLUSIONS The established HPLC fingerprints and content determination method are stable,reliable and highly reproducible,which can be used to evaluate the quality of TJG in combination with chemometric analysis.Inosine may be a marker component that affects the quality of TJG.There are differences in the quality of 13 batches of TJG.

Tianma jiannao granulesfingerprintcontent determinationcluster analysisprincipal component analysisorthogonal partial least squares-discriminant analysis

杜锦颜、莫静媛、谢询、黄小玲、伍小玲、王利胜

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广州中医药大学中药学院,广州 510006

东莞市中医院内三科,广东东莞 523000

天麻健脑颗粒 指纹图谱 含量测定 聚类分析 主成分分析 正交偏最小二乘法判别分析

广东省普通高校重点领域专项东莞市高水平医院建设专项东莞市社会发展科技项目

20231800903722

2024

中国药房
中国医院协会,中国药房杂志社

中国药房

CSTPCD北大核心
影响因子:0.956
ISSN:1001-0408
年,卷(期):2024.35(20)