清胰合剂的指纹图谱建立及8种成分含量测定  

Fingerprint establishment of Qingyi mixture and content determination of 8 components

作　　者：张璠璠 王辙远 王隆隆 陈恒文[2] 刘菊 黄霞 于晓涛[1] 王瑞[1] ZHANG Fanfan;WANG Zheyuan;WANG Longlong;CHEN Hengwen;LIU Ju;HUANG Xia;YU Xiaotao;WANG Rui(Dept.of Pharmacy,Luohe Central Hospital,Henan Luohe 462300,China;Dept.of Pharmacy,Guang’anmen Hospital,China Academy of Chinese Medical Sciences,Beijing 100053,China;Dept.of Pharmacy,Zhengzhou Hospital of Traditional Chinese Medicine,Zhengzhou 450007,China;Laboratory of Traditional Chinese Medicine Research,Henan Provincial Institute for Food and Drug Control,Zhengzhou 450003,China)

机构地区：[1]漯河市中心医院药学部,河南漯河462300 [2]中国中医科学院广安门医院药剂科,北京100053 [3]郑州市中医院药剂科,郑州450007 [4]河南省食品药品检验所中药研究室,郑州450003

出　　处：《中国药房》2022年第17期2077-2081,共5页China Pharmacy

基　　金：国家自然科学基金资助项目(No.82074396);河南省中医药科学研究专项课题(No.20-21ZY3022);河南省工程研究中心项目(No.豫发改高技[2019]569号);漯河市工程技术研究中心项目(No.漯科[2018]88号)。

摘　　要：目的 从定性和定量2个角度为清胰合剂(QM)的质量标准研究提供科学依据。方法 建立QM的高效液相色谱(HPLC)指纹图谱,对其进行化学模式识别分析,同时测定该制剂中绿原酸等8种成分的含量。以Agilent SB-C18为色谱柱、0.1%磷酸溶液-乙腈为流动相进行梯度洗脱,柱温为35℃,流速为0.6 mL/min,检测波长为254 nm。采用《中药色谱指纹图谱相似度评价系统(2012版)》、SPSS 20.0、SIMCA 14.1软件对QM样品进行相似度评价、聚类分析、主成分分析和正交偏最小二乘法-判别分析。结果 15批QM共标定了22个共有峰,相似度均超过0.975。对22个共有峰进行了归属,并指认出了其中8个成分。聚类分析、主成分分析及正交偏最小二乘法-判别分析均将15批QM分为了2类,同时筛选出了5种差异性成分,分别是峰9(菊苣酸)、峰14(黄芩苷)、峰18、峰19和峰21(黄芩素)。绿原酸、阿魏酸、菊苣酸、橙皮苷、黄芩苷、丹酚酸B、黄芩素和丹皮酚8种成分的含量分别为0.077~0.094、0.165~0.190、0.100~0.114、0.083~0.107、0.556~0.615、0.288~0.314、0.152~0.188、0.114~0.128 mg/g。结论 所建HPLC指纹图谱及含量测定方法可为QM的质量标准研究提供参考依据。OBJECTIVE To provide scientific evidence for the quality standard research of Qingyi mixture(QM)qualitatively and quantitatively. METHODS The high performance liquid chromatography(HPLC)fingerprint of QM was established,and the chemical pattern recognition analysis was carried out. At the same time,the contents of 8 components such as chlorogenic acid in the preparation were determined. The determination was performed on Agilent SB-C18column with 0.1% phosphoric acid-acetonitrile as mobile phase(gradient elution) at the flow rate of 0.6 mL/min. The column temperature was 35 ℃,and detection wavelength was set at 254 nm. Similarity Evaluation System of Chromatographic Fingerprint of Traditional Chinese Medicine(2012 edition),SPSS 20.0 and SIMCA 14.1 were used to perform similarity evaluation,cluster analysis(CA),principle component analysis(PCA) and orthogonal partial least squares-discriminant analysis(OPLS-DA) of QM samples. RESULTS A total of 22 common peaks were calibrated by 15 batches of QM,and the similarity was over 0.975. Twenty-two common peaks were assigned and 8 of them were identified. CA,PCA and OPLS-DA divided the 15 batches of QM into two categories.Meanwhile,5 differential components were screened out,i.e. peak 9(cichoric acid),peak 14(baicalin),peak 18,peak 19 and peak 21(baicalein). The contents of 8 components, such as chlorogenic acid, ferulic acid, cichoric acid, hesperidin,baicalin,salvianolic acid B,baicalein and paeonol,were 0.077-0.094,0.165-0.190,0.100-0.114,0.083-0.107,0.556-0.615,0.288-0.314,0.152-0.188 and 0.114-0.128 mg/g,respectively.CONCLUSIONS The established HPLC fingerprint and content determination method can provide reference for the quality standard research of QM.

关 键 词：清胰合剂 指纹图谱 化学模式识别 含量测定 质量标准 高效液相色谱法 

分 类 号：R927.1[医药卫生—药学] R284.1