固肾丸高效液相色谱指纹图谱的研究  

Study on Fingerprint of Gushen pill by High Performance Liquid Chromatography

作　　者：蔡怡然 汤佐权 黄良永 杜士明[1,2] CAI Yi-ran;TANG Zuoquan;HUANG Liang-yong;DU Shi-ming(Taihe Hospital,Hubei University of Medicine,Shiyan,Hubei 442000,China;Hubei Key Laboratory of Wudang Local Chinese Medi-cine Research,Hubei University of Medicine,Shiyan,Hubei 442000,China;School of Pharmaceutical Sciences,Hubei University of Medicine,Shiyan,Hubei 442000,China)

机构地区：[1]十堰市太和医院·湖北医药学院附属医院 [2]湖北医药学院武当特色中药研究湖北省重点实验室 [3]湖北医药学院药学院,湖北十堰442000

出　　处：《湖北医药学院学报》2022年第4期338-343,共6页Journal of Hubei University of Medicine

基　　金：湖北医药学院武当特色中药研究湖北省重点实验室开放课题项目(WDCM2019019)。

摘　　要：目的:建立固肾丸高效液相色谱(HPLC)指纹图谱的研究方法,并用于该制剂的全面质量评价。方法:采用HPLC梯度洗脱-双波长检测法测定固肾丸的指纹图谱,色谱柱为OMNIBond HPLC column Orca (C,5μm, 250 mm×4.6 mm)。流动相:0.1%磷酸水溶液(A)和乙腈(B),流速:1.0 mL/min;检测波长:235 nm和316 nm;柱温:30℃;进样量:10μL。结果:10批样品的HPLC色谱图经“中药色谱指纹图相似度评价系统(2012.130723版)”自动匹配,获得了固肾丸包含有16个共有峰的HPLC特征指纹图谱;10批样品的HPLC色谱图与特征指纹图谱的相似度≥0.94;16个共有峰相对保留时间的RSD值≤0.227%。并确认4个已知的色谱峰为:绿原酸(4号峰)、芍药苷(7号峰)、二苯乙烯苷(9号峰)、淫羊藿苷(12号峰)。结论:该方法建立的固肾丸指纹图谱可靠,稳定性好,能够较全面反映组方中中药材的组成及质量,为本制剂的全面质量控制提供科学依据。Objective To establish the research method of high performance liquid chromatography(HPLC) fingerprint method for Gushen pill, and use it for the overall quality evaluation of the preparation. Methods The fingerprint of Gushen pills was determined by HPLC gradient elution-dual wavelength detection method, and the chromatographic column was OMNI Bond HPLC column Orca(C, 5 μm, 250 mm×4.6 mm). Mobile phase: 0.1% phosphoric acid aqueous solution(A) and acetonitrile(B);flow rate: 1.0 mL/min;detection wavelength: 235 nm and 316 nm;column temperature: 30 ℃;injection volume: 10 μL. Results The HPLC chromatograms of 10 batches of samples were automatically matched by the "Chinese Medicine Chromatographic Fingerprint Similarity Evaluation System(version 2012.130723)", and the HPLC characteristic fingerprints of Gushen Pill containing 16 common peaks were obtained. The similarity of characteristic fingerprints was ≥0.94;the RSD value of the relative retention time of 16 common peaks was ≤0.227%. And confirmed four known chromatographic peaks: chlorogenic acid(peak 4), paeoniflorin(peak 7), stilbene glycoside(peak 9), icariin(peak 12). Conclusion The fingerprint of Gushen pill established by this method is reliable and stable, which can comprehensively reflect the composition and quality of Chinese herbal medicines, and provide a scientific basis for the overall quality control of this preparation.

关 键 词：固肾丸 高效液相色谱 指纹图谱 质量评价 

分 类 号：R286.0[医药卫生—中药学]