蒙药三子散质量评价研究:指纹图谱、化学模式识别和多成分分析  

Study on quality evaluation of Mongolian medicine Sanzi powder:fingerprint,chemical pattern recognition and multi-component quantification analysis

作　　者：李君 李荣杰[3] 周枫叶 张谦 张微 张博瀚 王舒 赵曦桐 陈建平 LI Jun;LI Rongjie;ZHOU Fengye;ZHANG Qian;ZHANG Wei;ZHANG Bohan;WANG Shu;ZHAO Xitong;CHEN Jianping(College of Pharmacy,Inner Mongolia Medical University,Hohhot 010110,China;Inner Mongolia Autonomous Region Engineering Research Center of New Pharmaceutical Screening,Hohhot 010110,China;Dept.of Pharmacy,the Affiliated Hospital of Inner Mongolia Medical University,Hohhot 010110,China;The First Clinical Medical College,Inner Mongolia Medical University,Hohhot 010110,China)

机构地区：[1]内蒙古医科大学药学院,呼和浩特010110 [2]内蒙古自治区新药筛选工程研究中心,呼和浩特010110 [3]内蒙古医科大学附属医院药学部,呼和浩特010110 [4]内蒙古医科大学第一临床医学院,呼和浩特010110

出　　处：《中国药房》2025年第4期414-420,共7页China Pharmacy

基　　金：国家自然科学基金项目(No.82460822);内蒙古自治区自然科学基金项目(No.2023QN08012,2024QN08054);内蒙古自治区卫生健康科技计划项目(No.202201187);内蒙古医科大学大学生创新创业项目(No.101322024017);内蒙古医科大学联合项目(No.YKD2024LH005,No.YKD2023LH062)。

摘　　要：目的建立三子散指纹图谱、化学模式识别及多指标定量分析的方法,评价该制剂质量。方法采用高效液相色谱(HPLC)法,利用《中药色谱指纹图谱相似度评价系统(2012版)》建立15批三子散的指纹图谱,并进行聚类分析、主成分分析和正交偏最小二乘法-判别分析;以变量重要性投影(VIP)大于1为标准,筛选潜在质量差异标志物,并以同一HPLC法测定上述标志物的含量。结果15批三子散指纹图谱共有21个共有峰,相似度为0.994~0.999;指认了6个共有峰,分别为没食子酸(3号峰)、栀子苷(10号峰)、柯里拉京(11号峰)、诃子酸(16号峰)、鞣花酸(18号峰)、西红花苷Ⅰ(19号峰);聚类分析和主成分分析、正交偏最小二乘法-判别分析结果显示,15批三子散可被分为两大类,S1、S5、S7、S9、S14聚为一类,S2~S4、S6、S8、S10~S13、S15聚为一类;柯里拉京、诃子酸、鞣花酸等11个成分的VIP值大于1。15批三子散中,柯里拉京、诃子酸、鞣花酸含量分别为2.667~5.152、9.506~13.522、0.891~1.811 mg/g。结论所建三子散HPLC指纹图谱、多指标成分含量测定方法快速、简便,结合化学模式识别分析可用于该制剂的质量评价;柯里拉京、鞣花酸、诃子酸等11个成分可能是影响该制剂质量的潜在质量差异标志物。OBJECTIVE To establish fingerprint,chemical pattern recognition and multi-component quantification analysis of Sanzi powder,and evaluate its quality.METHODS HPLC method was adopted.The fingerprints of 15 batches of Sanzi powder were established by using the Similarity Evaluation System for Chromatographic Fingerprint of Traditional Chinese Medicine(2012 edition).Cluster analysis,principal component analysis and orthogonal partial least squares-discriminant analysis were also conducted.The variable importance in projection(VIP)value greater than 1 was used as the index to screen the differential markers,and the contents of the differential markers were determined by the same HPLC method.RESULTS A total of 21 common peaks in the HPLC fingerprints of 15 batches of Sanzi powder were calibrated,and the similarities of them were 0.994-0.999;6 common peaks were identified,including gallic acid(peak 3),garminoside(peak 10),corilagin(peak 11),chebulinic acid(peak 16),ellagic acid(peak 18),crocinⅠ(peak 19).According to the results of cluster analysis,principal component analysis and orthogonal partial least squares-discriminant analysis,15 batches of samples could be clustered into two categories:S1,S5,S7,S9,S14 were clustered into one category;S2-S4,S6,S8,S10-S13,S15 were clustered into one category.VIP values of 11 differential components such as corilagin,chebulinic acid and ellagic acid were higher than 1.Among 15 batches of samples,the contents of corilagin,chebulinic acid and ellagic acid ranged 2.667-5.152,9.506-13.522,0.891-1.811 mg/g.CONCLUSIONS Established HPLC fingerprint and multi-component quantification analysis of Sanzi powder are rapid and simple,and can be used for quality evaluation of Sanzi powder by combining with chemical pattern recognition.Eleven components such as corilagin,chebulinic acid and ellagic acid are differential markers affecting the quality of Sanzi powder.

关 键 词：三子散 指纹图谱 化学模式识别 含量测定 质量评价 

分 类 号：R917[医药卫生—药物分析学]