基于UPLC色谱指纹图谱及化学模式识别的新保肾片质量控制研究  

Quality Control Research of Xinbaoshen Tablets Based on UPLC Fingerprint Combined with Chemical Pattern Recognition

作　　者：李金慈 乔立业 江静怡 姜俊翔 苏华 Li Jinci;Qiao Liye;Jiang Jingyi;Jiang Junxiang;Su Hua(Manufacturing Department of Pharmacy Division,General Hospital of Eastern Theater Command,Nanjing 210002,China)

机构地区：[1]东部战区总医院药剂科制剂室,南京210002

出　　处：《中国药师》2021年第6期1193-1197,共5页China Pharmacist

基　　金：军队医疗机构制剂标准提高科研专项课题(编号:14ZJZ08)。

摘　　要：目的:建立新保肾片UPLC指纹图谱,结合聚类分析、主成分分析和偏最小二乘法-判别分析,为新保肾片的质量控制提供一种新方法。方法:采用Agilent Poroshell 120 EC-C_(18)(4.6 mm×50 mm,2.7μm)型色谱柱,以甲醇-0.2%冰醋酸水溶液为流动相进行梯度洗脱,流速:0.8 ml·min^(-1),柱温:30℃,检测波长:260 nm,建立新保肾片的指纹图谱,采用"中药指纹图谱相似度评价系统"(2012A版)建立指纹图谱共有模式和相似度计算。结合SPSS和SIMCA软件进行聚类分析(CA)、主成分分析(PCA)和偏最小二乘法-判别分析(PLS-DA),对新保肾片进行整体质量评价。结果:建立了新保肾片的UPLC指纹图谱,确定了16个共有峰,通过对照品比对指认出没食子酸、芦荟大黄素、大黄素、大黄酚、大黄素甲醚5个成分。13批新保肾片相似度均大于0.987,表明药物总体质量较稳定。通过CA、PCA发现样品聚成2类,不同时间生产的药物仍存在差异,通过PLS-DA筛选出批次间的差异性成分主要为5号峰、10号峰和11号峰。结论:本研究所建立的指纹图谱和化学模式识别方法科学可靠、简便易行、高效快速,可更加全面系统地提供新保肾片化学成分信息,为综合评价制剂质量的稳定性和均一性提供了科学依据。Objective:To establish the UPLC fingerprint and chemical pattern recognition model of Xinbaoshen tablets to provide reference for its overall quality evaluation.Methods:The analysis was performed on an Agilent Poroshell 120 EC-C_(18)(4.6 mm×50mm,2.7μm)column with methanol-0.2% acetic acid solution as the mobile phase in a gradient elution mode.The flow rate was0.8 ml·min^(-1),the detection wavelength was 260 nm and the column temperature was 30℃.The UPLC fingerprints of 13 batches of Xinbaoshen tablets were established and their similarity was evaluated by the Similarity Evaluation System for Chromatographic Fingerprint of TCM(2012 edition).SPSS and SIMCA software were used for cluster analysis,principal component analysis and partial least squares discriminant analysis to evaluate the overall quality of Xinbaoshen tablets.Results:The UPLC fingerprint of Xinbaoshen tablets was established.Sixteen common peaks were marked in the fingerprint,and among them,five components were identified as gallic acid,aloe-emodin,emodin,chrysophanol and physcion through the comparison to the standard references.The similarity of 13 batches of samples was higher than 0.987,which indicated that the overall quality of Xinbaoshen tablets was relatively stable.The samples were clustered into 2 groups by CA and PCA,and difference was discovered among the batches with different production time.Through PLS-DA screening,the main difference components among the batches were peak 5,peak 10 and peak 11.Conclusion:The method of UP-LC fingerprint analysis and chemical pattern recognition established in this research is stable,efficient and rapid,which can provide more comprehensive and systematic chemical information of Xinbaoshen tablets,and also can provide scientific basis for the quality control and overall evaluation of Xinbaoshen tablets.

关 键 词：新保肾片 超高效液相色谱指纹图谱 相似度分析 聚类分析 主成分分析 偏最小二乘法-判别分析 质量控制 

分 类 号：TQ460.72[医药卫生—药物分析学]