筋骨草配方颗粒高效液相色谱指纹图谱研究  

HPLC Fingerprint of Jingucao Formula Granules

作　　者：张辉 黄凯伟 郑晓英 赵伟志 仝一丹 谭沛 ZHANG Hui;HUANG Kaiwei;ZHENG Xiaoying;ZHAO Weizhi;TONG Yidan;TAN Pei(China Resources Sanjiu Medical&Pharmaceutical Co.,Ltd.,Shenzhen,Guangdong,China 518110;China Resources Sanjiu Modern Chinese Medicine Pharmaceutical Co.,Ltd.,Huizhou,Guangdong,China 516000)

机构地区：[1]华润三九医药股份有限公司,广东深圳518110 [2]华润三九现代中药制药有限公司,广东惠州516000

出　　处：《中国药业》2023年第8期56-60,共5页China Pharmaceuticals

基　　金：广东省深圳市科技计划项目[JSGG20191129093418578]。

摘　　要：目的建立筋骨草配方颗粒的高效液相色谱(HPLC)指纹图谱。方法采用HPLC法,色谱柱为Agilent ZORBAX Eclipse Plus C_(18)柱(250 mm×4.6 mm,5μm),流动相为甲醇-0.1%磷酸溶液(梯度洗脱),流速为1.0 mL/min,检测波长为207 nm,柱温为25℃,进样量为10μL。以乙酰哈巴苷峰为参照峰,测定15批样品的HPLC指纹图谱。采用中药色谱指纹图谱相似度评价系统(2012版)进行相似度评价,确定共有峰,并进行聚类分析和主成分分析。结果15批样品的HPLC指纹图谱有8个共有峰,指认了其中2个。相似度均在0.975~1.000。15批样品可聚为4类,共提取到两大主成分,累积方差贡献率85.367%,其中峰1和峰4是对样品质量影响较大的主要成分。结论建立的HPLC指纹图谱操作简单,重复性和稳定性均良好,能整体、全面、真实地反映制剂质量的差异,可为其质量控制及整体性评价提供参考。Objective To establish a high-performance liquid chromatography(HPLC)fingerprint of Jingucao Formula Granules.Methods HPLC method was adopted,and the chromatographic column was Agilent ZORBAX Eclipse Plus C_(18) column(250 mm×4.6 mm,5μm),the mobile phase was methanol-0.1%phosphoric acid solution(gradient elution),the flow rate was 1.0 mL/min,the detection wavelength was 207 nm,the column temperature was 25℃,and the injection volume was 10μL.The HPLC fingerprints of 15 batches of samples were determined with the 8-acetylharpagide peak as the reference peak.The Similarity Evaluation System for Chromatographic Fingerprints of Traditional Chinese Medicine(Version 2012)was used to evaluate the similarity and identify common peaks,and the cluster analysis and principal component analysis were performed.The liquid chromatography tandem mass spectrometry(LC/MS/MS)method was used to identify common peaks.Results There were eight common peaks in the HPLC fingerprints of 15 batches of samples,and two of them were identified.The similarity was in the range of 0.975-1.000.The 15 batches of samples could be clustered into four categories,and two principal components were extracted,with a cumulative variance contribution rate of 85.367%.Among them,peak 1 and peak 4 were the principal components which had significant influence on the quality of the sample.Conclusion The established HPLC fingerprint is simple,with good repeatability and stability,and can reflect the quality differences of the preparation in a whole,comprehensive and true way.It also can provide a reference for the quality control and overall evaluation of the preparation.

关 键 词：筋骨草配方颗粒 高效液相色谱法 指纹图谱 质量标准 

分 类 号：R917[医药卫生—药物分析学]