Page 81 - 中国药房2023年10期
P. 81
芪桂苓合剂质量控制方法研究
Δ
#
＊
于晓涛 ，王 博，王 佳，陈可嘉，王 瑞（漯河市中心医院药学部/河南省中药制剂现代化技术研发与临床应
用工程研究中心，河南 漯河 462000）
中图分类号 R917 文献标志码 A 文章编号 1001-0408（2023）10-1223-05
DOI 10.6039/j.issn.1001-0408.2023.10.13
摘 要 目的 建立芪桂苓合剂的指纹图谱和毛蕊异黄酮葡萄糖苷等4种活性成分含量的测定方法，以控制芪桂苓合剂的质量。
方法 采用高效液相色谱（HPLC）法建立 12 批芪桂苓合剂的指纹图谱；采用 SPSS 25.0 软件进行聚类分析、主成分分析，采用
SIMCA 14.1软件进行正交偏最小二乘法-判别分析，并以变量重要性投影（VIP）值大于1.0为标准，筛选差异性成分。以橙皮苷为
内参物，采用一测多评法计算毛蕊异黄酮葡萄糖苷、甘草苷、甘草酸含量，并与外标法的测定结果进行比较。结果 12批样品指纹
图谱中共确认了17个共有峰，相似度均大于0.940；共指认出4个共有峰，分别为毛蕊异黄酮葡萄糖苷（6号峰）、甘草苷（8号峰）、
橙皮苷（12号峰）和甘草酸（17号峰）。12批样品可聚类分为2类，其中S4、S7～S9、S11～S12聚为一类，其他聚为一类；6个主成分
的累计方差贡献率为85.840%；15、14、4、8（甘草苷）、9号峰的VIP值均大于1.0。毛蕊异黄酮葡萄糖苷、甘草苷、甘草酸含量的一测
多评法结果与外标法所得结果的相对误差均小于5%（n＝3）。结论 本研究建立的HPLC指纹图谱和含量测定方法，可用于芪桂
苓合剂的质量控制；甘草苷等5种成分是其差异性成分。
关键词 芪桂苓合剂；指纹图谱；高效液相色谱法；一测多评法；含量测定；质量控制
Study on quality control method of Qiguiling mixture
YU Xiaotao，WANG Bo，WANG Jia，CHEN Kejia，WANG Rui（Dept. of Pharmacy， Luohe Central Hospital/
Henan Engineering Research Center of TCM Preparation Modernization Technology R&D and Clinical
Application， Henan Luohe 462000， China）
ABSTRACT OBJECTIVE To establish the fingerprint of Qiguiling mixture and the method for the content determination of 4
kinds of active components such as calycosin-7-glucoside， so as to control the quality of Qiguiling mixture. METHODS The
fingerprints of 12 batches of Qiguiling mixture were established by HPLC. SPSS 25.0 software was used for cluster analysis and
principal component analysis， and SIMCA 14.1 software was used for orthogonal partial least squares-discriminant analysis. The
variable importance in projection （VIP） value greater than 1.0 was used as the index to screen the differential components. The
contents of calycosin-7-glucoside， glycyrrhizin and glycyrrhizic acid were calculated by the quantitative analysis of multi-
components by single marker （QAMS） with hesperidin as the internal reference， and the results were compared with external
standard method. RESULTS In the fingerprints of 12 batches of samples， 17 common peaks were identified， and the similarities
were more than 0.940. A total of 4 common peaks were identified， which were calycosin-7-glucoside （peak 6）， glycyrrhizin （peak
8）， hesperidin （peak 12）， and glycyrrhizic acid （peak 17）. The 12 batches of samples could be clustered into two categories， S4，
S7-S9 and S11-S12 were clustered into one category， and the other batches of samples were clustered into one category. The
cumulative variance contribution rate of the six principal components was 85.840%， and VIP values of peaks 15， 14， 4， 8
（glycyrrhizin） and 9 were all greater than 1.0. The relative error between the results of QAMS and external standard method was
less than 5% （n＝3） for the contents of calycosin-7-glucoside， glycyrrhizin and glycyrrhizic acid. CONCLUSIONS Established
HPLC fingerprint and content determination method in this study can be used for quality control of Qigiling mixture. Five
components such as glycyrrhizin are the differential components.
KEYWORDS Qiguiling mixture； fingerprint； HPLC； quantitative analysis of multi-components by single marker； content
determination； quality control
Δ 基金项目 中央引导地方科技发展专项（No. 漯财预指〔2020〕 芪桂苓合剂由黄芪、陈皮、桂枝、甘草、茯苓等 14 味
309号）
中药组成，具有益气健脾、宣肺止咳、散寒祛湿、调和营
＊ 第一作者 副 主 任 药 师 。 研 究 方 向 ：中 药 制 剂 。 E-mail： 卫的功效，临床用于病毒性肺炎及流感等引起的恶寒干
lhyxt001@163.com
咳、倦怠乏力、胸闷脘痞或呕恶、便溏等症的治疗，在疫
# 通信作者 主任药师，硕士。研究方向：中药制剂。E-mail：
[1]
wangrui56116@163.com 情期间取得了不错的临床疗效 。方中黄芪具有补气升
中国药房 2023年第34卷第10期 China Pharmacy 2023 Vol. 34 No. 10 · 1223 ·
