摘要
目的:建立壮腰健身丸UPLC指纹图谱,并结合化学模式识别方法对其进行质量评价研究。方法:基于波长切换技术,采用Waters Acquity UPLC HSS T3色谱柱(1.8μm,100 mm×2.1 mm);以甲醇-0.1%甲酸溶液为流动相,梯度洗脱;流速为0.2 mL/min;柱温为40℃;进样量为2μL。建立壮腰健身丸UPLC指纹图谱,并进行相似度评价、聚类分析、主成分分析及正交偏最小二乘-判别分析。结果:建立的壮腰健身丸指纹图谱共确定15个共有峰,经与对照品比对指认出其中6个峰。不同厂家的壮腰健身丸质量存在一定的差异,并筛选出4个质量差异标志性成分。结论:该研究建立的UPLC指纹图谱方法可进一步为壮腰健身丸的质量控制及质量评价研究提供参考。
Objective:To establish the UPLC fingerprint of zhuangyao jianshen pills and evaluate its quality by chemical pattern recognition.Methods:Based on wavelength switching technology,Waters Acquity UPLC HSS T3 column(1.8μm,100 mm×2.1 mm)was used with methanol-0.1%formic acid solution as mobile phase,gradient elution,flow rate of 0.2 mL/min,column temperature of 40℃and injection volume of 2μL.The UPLC fingerprints of zhuangyao jianshen pills were established,and the similarity evaluation,cluster analysis,principal component analysis and orthogonal partial least squares discriminant analysis were performed.Results:There were 15 common peaks in the fingerprint of zhuangyao jianshen pills,and 6 of them were identified by comparison with the reference substance.There were some differences in the quality of zhuangyao jianshen pills from different manufacturers,and four quality difference markers were screened out.Conclusion:The UPLC fingerprint were established in this study,which can provide a reference for the quality control and evaluation of zhuangyao jianshen pills.
作者
喻何云
任琦
丁银平
赵敏敏
付辉政
游媛
YU Heyun;REN Qi;DING Yinping;ZHAO Minmin;FU Huizheng;YOU Yuan(Jiangxi Institute for Drug Control,NMPA Key Laboratory of Quality Evaluation of Traditional Chinese Patent Medicine,Jiangxi Province Engineering Research Center of Drug and Medical Device Quality,Nanchang Jiangxi 330029,China;Jiangxi University of Traditional Chinese Medicine,Nanchang Jiangxi 330004,China)
出处
《药品评价》
CAS
2021年第23期1424-1428,共5页
Drug Evaluation
基金
江西省食品药品监督管理局科研项目(2017YX09)。
关键词
壮腰健身丸
UPLC
指纹图谱
化学模式识别
质量评价
Zhuangyao jianshen pills
UPLC
Fingerprint
Chemical pattern recognition
Quality evaluation
作者简介
喻何云,本科,高级经济师。研究方向:药品质量监督。E-mail:2221536828@qq.com;通信作者:丁银平,本科,主管中药师。研究方向:中药质量控制与评价。E-mail:365554542@qq.com。
