摘要
目的基于HPLC指纹图谱、化学模式识别分析及多成分分析法对生脉胶囊质量进行综合评价。方法建立14批生脉胶囊指纹图谱相似度评价,并进行OPLS-DA分析,以VIP大于1筛选质量差异物;建立HPLC法同时测定生脉胶囊中质量差异物的含量,采用PCA分析质量差异性成分的含量对样品总体质量的影响。结果14批生脉胶囊指纹图谱共标定出26个共有峰,相似度较好,指认出10个共有峰。经OPLS-DA分析,筛选出8个差异标志物。利用HPLC法测定8个指标成分的含量,经系统适用性、线性、精密度、重复性及准确性验证,方法可行有效;PCA分析结果显示编号为S14的样品综合排名最高。结论建立的生脉胶囊HPLC指纹图谱和含量测定分析方法灵敏、快速且稳定,结合化学模式识别分析,能较全面的反映产量的质量信息,可为生脉胶囊的质量控制和评价提供参考。
OBJECTIVE Quality evaluation of ShengMai capsules based on HPLC fingerprint,chemical pattern recognition and multi-ingredient content determination.METHODS The fingerprint chromatograms of 14 batches of ShengMai capsules were established for similarity assessment.The original data of the shared peaks′peak areas were used to perform by orthogonal partial least squares-discriminant analysis(OPLS-DA),and the variable projection importance analysis value(VIP)greater than 1 was used to screen quality difference substances.An HPLC method was established to simultaneously determine the contents of quality difference substances,and the influence of the quality difference substances on the overall quality was analyzed by PCA.RESULTS There were 26 common peaks in 14 batches of ShengMai capsules with good similarity.10 common peaks were identified by comparing with the reference solution,and 8 quality difference substances were screened by OPLS-DA analysis.The content of the above 8 indica-tor components was determined by HPLC,and the method was feasible and effectivehas by validated for system applicability,linearity,precision,repeatability,and accuracy.The highest comprehensive ranking was the sample S14 by principal component analysis(PCA).CONCLUSION The established HPLC fingerprinting method for ShengMai capsules was sensitive,rapid and stable.Combined with chemical pattern recognition analysis,they can comprehensively reflect the quality information and provide reference for the quality control and evaluation of ShengMai Capsules.
作者
朱静
郭秀秀
ZHU Jing;GUO Xiu-xiu(Luyang District Sanxiaokou Community Heath Service Center,Hefei 230000,China;Suzhou Food and Drug Inspection and Testing Center,Suzhou 234000,China)
出处
《海峡药学》
2025年第11期22-28,共7页
Strait Pharmaceutical Journal
基金
安徽省药品监督管理局科技创新项目(AHYJ-KJ-202420)。
关键词
生脉胶囊
HPLC指纹图谱
正交偏最小二乘-判别分析
主成分分析
多指标成分
ShengMai capsule
HPLC fingerprint
Orthogonal partial least squares discriminant analysis
Principal component analysis
Multi-index component
