基于HPLC指纹图谱和多成分含量综合评价扶正胶囊的质量  

Quality evaluation of Fuzheng capsules based on HPLC fingerprint and multi-ingredient content determination

作　　者：陈松 李运容 农璐蔚 黎丽 江先再 曾翠琼 王柳萍 CHEN Song;LI Yunrong;NONG Luwei;LI Li;JIANG Xianzai;ZENG Cuiqiong;WANG Liuping(Zhuang&Yao Medicine Research and Development Center,Guangxi International Zhuang Medicine Hospital Affiliated to Guangxi University of Chinese Medicine,Nanning 530201,China;College of Pharmacy,Guangxi University of Chinese Medicine,Nanning 530200,China;National Demonstration Center for Experimental Chinese Medicine Education,Guangxi University of Chinese Medicine,Nanning 530200,China)

机构地区：[1]广西中医药大学附属国际壮医医院壮瑶药研发中心,南宁530201 [2]广西中医药大学药学院,南宁530200 [3]广西中医药大学中药学国家级实验教学示范中心,南宁530200

出　　处：《中国药房》2024年第22期2726-2731,共6页China Pharmacy

基　　金：国家中医药管理局全国名老中医药专家传承工作室建设项目——黄汉儒全国名老中医药专家传承工作室、黄瑞松全国名老中医药专家传承工作室(No.国中医药人教函〔2022〕75号);国家卫生健康委、国家中医药管理局第二届全国名中医项目(No.国中医药人教发〔2022〕5号);国家中医药管理局高水平中医药重点学科建设项目——少数民族药学(壮药学)(No.zyyzdxk-2023165);广西中医药大学全国名中医黄汉儒学术思想与临床诊疗传承发展推广中心项目(No.2022V004)。

摘　　要：目的建立壮药制剂扶正胶囊指纹图谱和多指标成分含量的测定方法,并对其进行质量评价。方法采用高效液相色谱(HPLC)法,结合《中药色谱指纹图谱相似度评价系统(2004A)》建立12批扶正胶囊样品的指纹图谱,并进行相似度评价、共有峰确认;以指纹图谱共有峰峰面积为变量,采用SPSS 20.0软件进行聚类分析和主成分分析。采用同一HPLC法测定12批样品中甘草苷、特女贞苷、3,6′-二芥子酰基蔗糖、甘草酸铵的含量。结果12批扶正胶囊样品共有22个共有峰,相似度均大于0.91;指认出甘草苷(峰8)、特女贞苷(峰10)、3,6′-二芥子酰基蔗糖(峰11)、甘草酸铵(峰21)4个共有峰;12批样品可聚为3类,200801、200802、200803为Ⅰ类,样1~样8为Ⅱ类,221101为Ⅲ类;200802的综合得分(2.540)最高。12批样品中,甘草苷、特女贞苷、3,6′-二芥子酰基蔗糖、甘草酸铵的含量分别为0.44~0.73、1.28~2.47、0.08~0.12、1.31~1.81 mg/粒。结论12批扶正胶囊样品的主要成分相似但含量有所差别,以200802的质量最优;所建指纹图谱和多指标成分含量测定方法专属性强、准确度高,结合化学模式识别分析可用于扶正胶囊的质量评价。OBJECTIVE To establish the fingerprint of the Zhuang medicine preparation Fuzheng capsules and a method for the determination of multi-ingredient content for quality evaluation.METHODS High-performance liquid chromatography(HPLC)was used in conjunction with the Similarity Evaluation System for Chromatographic Fingerprints of Traditional Chinese Medicine(2004A edition)to establish the fingerprint of 12 batches of Fuzheng capsules,evaluate their similarity and confirm the common peaks.Cluster analysis and principal component analysis were performed using SPSS 20.0 software with the peak areas of the common peaks in the fingerprint as variables.The same HPLC method was adopted to determine the content of liquiritin,specnuezhenide,3,6′-disinapoyl sucrose and ammonium glycyrrhizinate in the 12 batches of samples.RESULTS A total of 22 common peaks were identified in the fingerprints of the 12 batches of Fuzheng capsules,with the similarities greater than 0.91.Four common peaks were identified as liquiritin(peak 8),specnuezhenide(peak 10),3,6′-disinapoyl sucrose(peak 11),and ammonium glycyrrhizinate(peak 21).The 12 batches of samples could be clustered into 3 categories,with 200801,200802 and 200803 as categoryⅠ,samples 1 to 8 as categoryⅡ,and 221101 as categoryⅢ.The sample 200802 had the highest comprehensive score(2.540).The contents of liquiritin,specnuezhenide,3,6′-disinapoyl sucrose and ammonium glycyrrhizinate in the 12 batches of samples were 0.44 to 0.73,1.28 to 2.47,0.08 to 0.12,and 1.31 to 1.81 mg per capsule,respectively.CONCLUSIONS The main components of the 12 batches of Fuzheng capsules were similar,but the content varied,with the sample 200802 indicating the highest quality.The established fingerprint and multi-ingredient content determination method were highly specific and accurate,which can be used for the quality evaluation of Fuzheng capsules in combination with chemical pattern recognition analysis.

关 键 词：扶正胶囊 指纹图谱 含量测定 化学模式识别分析 质量评价 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学] R284.1[医药卫生—药学]