基于指纹图谱和多成分含量测定的金匮肾气丸质量评价研究  

Study on Quality Evaluation of Jingui Shenqi Pills Based on HPLC Fingerprint and Multi-component Quantitative Analysis

作　　者：曹朴琼 张满常 马光宇[2] 周应硕 李东亮[2] CAO Pu-qiong;ZHANG Man-chang;MA Guang-yu;ZHOU Ying-shuo;LI Dong-liang(Baoshan Institute and Testing Center for Food and Drug Control,Baoshan 678000,China;Baoshan College of Traditional Chinese Medicine,Baoshan 678000,China;Yunnan Tengyao Pharmaceutical Co.,Ltd.,Baoshan 678000,China)

机构地区：[1]保山市食品药品检验检测中心,云南保山678000 [2]保山中医药高等专科学校,云南保山678000 [3]云南腾药制药股份有限责任公司,云南保山678000

出　　处：《食品与药品》2024年第6期498-505,共8页Food and Drug

基　　金：云南省教育厅科学研究基金项目(编号:2023J1808)。

摘　　要：目的基于高效液相色谱(HPLC)指纹图谱、多成分含量测定与化学模式识别相结合的方法评价不同批次金匮肾气丸的质量。方法采用Agilent HC C_(18)色谱柱(250 mm×4.6 mm,5μm),以乙腈-0.3%磷酸溶液为流动相,梯度洗脱,流速为1.0 ml/min,检测波长为240,280,330 nm,柱温35℃,进样量为10μl。以丹皮酚峰为参照峰,建立14批金匮肾气丸指纹图谱,采用“中药色谱指纹图谱相似度评价系统”进行相似度评价,指认共有峰,采用SPSS 19.0进行聚类分析、主成分分析。采用对照品比对指认化学成分并同时测定其含量。结果14批金匮肾气丸的指纹图谱中确定了12个共有峰,相似度均大于0.927,指认出8个共有峰。聚类分析和主成分分析结果显示,14批金匮肾气丸可聚为3类。没食子酸、5-羟甲基糠醛、莫诺苷、马钱苷、毛蕊花糖苷、肉桂酸、桂皮醛、丹皮酚的含量分别为0.165~0.372,0.243~1.216,0.199~0.458,0.227~0.366,0.683~0.884,0.027~0.048,0.043~0.248,0.480~0.974 mg/g。结论建立的金匮肾气丸指纹图谱及多成分含量测定方法,可为该品种的质量控制和评价提供参考。Objective To evaluate the quality of different batches of Jingui Shenqi Pills based on HPLC fingerprint,multi-component quantitative analysis and chemical pattern recognition.Methods The analysis was performed on an Agilent HC-C_(18) column(250 mm×4.6 mm,5μm),with acetonitrile-0.3%phosphoric acid solution as mobile phase for gradient elution.The flow rate was 1.0 ml/min,the detection wavelengths were set at 240,280 and 330 nm,the column temperature was 35℃,and the injection volume was 10μl.Using the peak of paeonol as the reference peak,HPLC fingerprints of 14 batches of Jingui Shenqi Pills were established.Similarity Evaluation System for Chromatographic Fingerprint of Traditional Chinese Medicine was used to evaluate the similarity and identify common peaks.SPSS 19.0 software was used for cluster analysis and principal component analysis.By comparison with reference substances,the chemical components were identified,and their contents were simultaneously determined.Results There were 12 common peaks in the fingerprints of 14 batches of Jingui Shenqi Pills,the similarities were greater than 0.927,and 8 peaks were identified.The results of cluster analysis and principal component analysis showed that 14 batches of Jingui Shenqi Pills could be clustered into 3 categories.The contents of gallic acid,5-hydroxymethyl-2-furaldehyde,morroniside,loganin,verbascoside,cinnamic acid,cinnamaldehyde and paeonol were 0.165-0.372,0.243-1.216,0.199-0.458,0.227-0.366,0.683-0.884,0.027-0.048,0.043-0.248,0.480-0.974 mg/g,respectively.Conclusion The fingerprint and multi-component quantitative analysis method established in this paper can provide reference for quality control and evaluation of Jingui Shenqi Pills.

关 键 词：金匮肾气丸 指纹图谱 聚类分析 主成分分析 多成分测定 

分 类 号：R284.1[医药卫生—中药学]