扎冲十三味丸HPLC指纹图谱研究  

Study on HPLC Fingerprint of Zhachong Shisanwei Pill

作　　者：王会品[1] 王金梅[2] 刘丹娜[1] WANG Hui-pin;WANG Jin-mei;LIU Dan-na(The Third People's Hospital of Zhengzhou,Zhengzhou 450000,China;School of Pharmacy,Henan University,Zhengzhou 475000,China)

机构地区：[1]郑州市第三人民医院,郑州450000 [2]河南大学药学院,郑州475000

出　　处：《中国合理用药探索》2022年第12期93-100,共8页Chinese Journal of Rational Drug Use

摘　　要：目的:采用高效液相色谱(HPLC)法建立扎冲十三味丸的指纹图谱。方法:色谱柱为Waters Tnature C_(18)(250mm×4.6mm,5μm),以乙腈-0.1%磷酸溶液为流动相进行梯度洗脱,流速为1.0ml/min,检测波长为254nm,柱温为36℃。采用SPSS 22.0统计学软件和SIMCA-P 14.1软件对14批扎冲十三味丸的色谱数据进行化学计量学分析。结果:对不同产地14批扎冲十三味丸进行指纹图谱研究,共标定了24个峰,指认出其中8个色谱峰,方法学考察结果符合指纹图谱的技术要求,相同厂家的药品聚为一类。经主成份分析,3个主成份因子的累积方差贡献率为90.162%。结论:本研究所建立的HPLC指纹图谱方法结果准确、稳定,可为扎冲十三味丸的质量控制提供参考。Objective:To establish the high performance liquid chromatography(HPLC)fingerprint of Zhachong Shisanwei Pill by HPLC.Methods:Chemometric analysis was performed on the chromatographic data obtained from 14 batches of Zhachong Shisanwei Pills with SPSS 22.0 statistical software and SIMCA-P 14.1 software.Take Waters Tnature C_(18)(250 mm×4.6 mm,5μm)as the column and acetonitrile-0.1%phosphate acid aqueous solution as the mobile phase for gradient elution,flow rate 1.0 ml/min,detection wavelength 254 nm,and column temperature 36℃.Results:The fingerprints of 14 batches of Zhachong Shisanwei Pill from different origin were studied.A total of 24 peaks were spiked and 8 of them were quantitatively analyzed.The results of method validation meet the technical requirements of fingerprint and the products from the same manufacturers could be clustered into a group.Based on the results of principal component analysis,the cumulative variance contribution rate of three principal components reached 90.162%.Conclusion:The established HPLC fingerprint is accurate and stable,which can provide a reference for the quality control of Zhachong Shisanwei Pill.

关 键 词：扎冲十三味丸 高效液相色谱 指纹图谱 聚类分析 主成份分析 质量控制 

分 类 号：R273[医药卫生—中西医结合]