Page 71 - 《中国药房》2021年8期

杜仲补天素丸的HPLC指纹图谱建立、化学模式识别分析及含量

测定 Δ

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1 #
1＊
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刘 敏 ，曹国琼 ，张仕林 ，葛秋平 ，刘 娅 ，张永萍 （1.贵州中医药大学药学院，贵阳 550025；2.贵阳德昌
祥药业有限公司，贵阳 550002）
中图分类号 R284.1 文献标志码 A 文章编号 1001-0408（2021）08-0961-06
DOI 10.6039/j.issn.1001-0408.2021.08.11
摘 要 目的：建立杜仲补天素丸的指纹图谱并进行化学模式识别分析，测定杜仲补天素丸中7个成分的含量，为该制剂的质量
控制提供参考。方法：采用高效液相色谱法（HPLC），以Pntulips BP-C18 Plus为色谱柱，以0.2％磷酸水溶液-乙腈为流动相进行梯
度洗脱，流速为1.0 mL/min，检测波长为330 nm，柱温为35 ℃，进样量为20 μL。以丹皮酚为参照，使用《中药色谱指纹图谱相似度
评价系统软件（2012版）》建立12批杜仲补天素丸（S1～S12）的指纹图谱，确定共有峰并进行相似度评价，通过与对照品比对进行
色谱峰指认。采用SPSS 21.0软件和SIMCA 13.0软件进行聚类分析和主成分分析，对22个共有峰进行评价。采用上述HPLC法
测定12批样品中指认成分的含量。结果：从12批杜仲补天素丸的HPLC指纹图谱中标定共有峰22个，相似度均不低于0.960；共
指认化学成分7个，分别为没食子酸（峰1）、绿原酸（峰3）、甘草苷（峰6）、金丝桃苷（峰7）、毛蕊花糖苷（峰8）、淫羊藿苷（峰14）和丹
皮酚（峰15）。12批样品中，S1、S3～S5、S7、S9、S11聚为一类，S2、S10、S12聚为一类，S6聚为一类，S8聚为一类；22个共有峰被分
为 3 个主成分，主成分 1 的特征值（15.130）和方差贡献率（68.775％）最大，其中峰 3（0.305）和峰 4（0.298）对应成分的得分系数最
高。12批样品中，上述7个成分的含量分别为18.196 2～31.951 3、0.000 6～0.049 4、0.234 8～0.415 9、0.039 5～0.079 1、0.053 5～
0.249 3、0.000 5～0.000 8、0.646 4～1.146 9 mg/g。结论：成功建立了杜仲补天素丸的HPLC指纹图谱。12批样品被聚类分成4类，
峰3（绿原酸）和峰4（未知）可能是造成样品差异的重要因素。7个成分中没食子酸的含量最高。
关键词 杜仲补天素丸；高效液相色谱法；指纹图谱；化学模式识别；含量测定

Establishment of HPLC Fingerprint，Chemical Pattern Recognition Analysis and Content Determination
of Duzhong Butiansu Pill
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LIU Min ，CAO Guoqiong ，ZHANG Shilin ，GE Qiuping ，LIU Ya ，ZHANG Yongping（1. School of Pharmacy，
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Guizhou University of TCM，Guiyang 550025，China；2. Guiyang Dechangxiang Pharmaceutical Co.，Ltd.，
Guiyang 550002，China）
ABSTRACT OBJECTIVE：To establish fingerprint of Duzhong butiansu pills，analyze its chemical pattern recognition，and
determine the contents of 7 components in Duzhong butiansu pills，so as to provide reference for the quality control of the
preparation. METHODS：HPLC method was adopted. The determination was performed on Pntulips BP-C18 Plus column with 0.2％
phosphoric acid water-acetonitrile as mobile phase（gradient elution）at the flow rate of 1.0 mL/min. The detection wavelength was
set at 330 nm，and column temperature was 35 ℃ . The sample size was 20 μ L. With paeonol as the reference，the HPLC
fingerprints of 12 batches of Duzhong butiansu pills （S1-S12） were established with Similarity Evaluation System for TCM
Chromatographic Fingerprint （2012 edition）； common peaks were determined and the similarity was evaluated. The
chromatographic peaks were identified by comparing with the reference substance. SPSS 21.0 and SIMCA 13.0 software were used
for cluster analysis and principal component analysis，and 22 common peaks were evaluated. The contents of the identified
components in 12 batches of samples was determined by the above HPLC method. RESULTS：A total of 22 common peaks were
identified in the HPLC fingerprint of 12 batches of Duzhong butiansu pills，and the similarity was no loss than 0.960. There were 7
chemical components identified，which were gallic acid（peak 1），chlorogenic acid（peak 3），liquiritoside（peak 6），hyperoside
（peak 7），verbascoside（peak 8），icariin（peak 14）and paeonol（peak 15）. Among the 12 batches of samples，S1，S3-S5，S7，
S9 and S11 were classified as one category，S2，S10 and S12
Δ 基金项目：贵州省科技计划项目（No.黔科合支撑〔2020〕4Y091
were clustered into one category，S6 was one category and S8
号）；贵州省高层次创新型人才“百层次人才”项目（No.黔科合人才
was one category. The 22 common peaks were divided into
〔2015〕4030 号）；贵州省科技平台及人才团队计划项目（No.黔科合平
three principal components. The characteristic value （15.130）
台人才〔2017〕5655）
＊硕士研究生。研究方向：中药、民族药新制剂及新剂型。E- and contribution rate （68.775％） of principal component 1
mail：13984149659@163.com were the largest，and the score coefficients of peak 3（0.305）
# 通信作者：教授，博士生导师，硕士。研究方向：中药新制剂及 and peak 4 （0.298） were the highest. Among 12 batches of
新剂型。E-mail：642055255@qq.com samples，the contents of above 7 components were 18.196 2-

中国药房 2021年第32卷第8期 China Pharmacy 2021 Vol. 32 No. 8 ·961 ·