管花肉苁蓉配方颗粒指纹图谱及多成分含量测定研究  

Study on fingerprint and multi-component determination of Guanhuaroucongrong formula particles

作　　者：袁炎炎 郭东晓 刘洪超 齐红 于姗姗 杨纯国 林永强 孟宪波 YUAN Yan-yan;GUO Dong-xiao;LIU Hong-chao;QI Hong;YU Shan-shan;YANG Chun-guo;LIN Yong-qiang;MENG Xian-bo(Ocean University of China,Qingdao 266003,China;Shandong Institute for Food and Drug Control,NMPA Key Laboratory for Quality Evaluation of Gelatin Products,Shandong Engineering Laboratory for Standard Innovation and Quality Evaluation of TCM,Shandong Engineering Research Center of Generic Technologies for Traditional Chinese Medicine Formula Granules,Jinan 250101,China;Jinan Food and Drug Inspection and Testing Center,Jinan 250102,China;Shandong Yifang Pharmaceutical Company Limited,Linyi 276000,China;Zibo Institute for Food and Drug Control,Zibo 255035,China)

机构地区：[1]中国海洋大学,青岛266003 [2]山东省食品药品检验研究院、国家药监局胶类产品质量评价重点实验室、山东省中药标准创新与质量评价工程实验室、中药配方颗粒共性技术山东省工程研究中心,济南250101 [3]济南市食品药品检验检测中心,济南250102 [4]山东一方制药有限公司,临沂276000 [5]淄博市食品药品检验研究院,淄博255035

出　　处：《药物分析杂志》2023年第10期1684-1691,共8页Chinese Journal of Pharmaceutical Analysis

基　　金：山东省重点研发计划重大科技创新工程项目(2021CXGC010511);山东省重点研发计划项目(2020RKB24001);山东省人文社会科学课题(2021-YYGL-44)。

摘　　要：目的:采用高效液相色谱建立管花肉苁蓉配方颗粒的指纹图谱及多成分含量测定方法,为管花肉苁蓉配方颗粒的鉴定及质量评价提供参考。方法:采用Agilent Eclipse Plus C_(18)(250 mm×4.6 mm,5μm)色谱柱,以乙腈-0.1%磷酸水溶液为流动相,梯度洗脱,流速1.0 mL·min^(-1),柱温30℃,检测波长238 nm,进样量10μL。结果:建立了管花肉苁蓉配方颗粒的指纹图谱,标定了12个共有峰,指认了京尼平苷酸、咖啡酸、松果菊苷、毛蕊花糖苷、管花苷A、异毛蕊花糖苷6个特征峰;并进一步建立了其含量测定方法,7批样品中上述6个成分含量分别为0.57~2.22、0.19~0.41、29.36~52.99、1.64~4.99、2.09~3.97、2.29~4.76 mg·g^(-1)。结论:本研究所建立的管花肉苁蓉配方颗粒指纹图谱和6个成分含量测定的方法可行,可为全面控制和评价管花肉苁蓉配方颗粒的质量提供科学依据。Objective:To provide reference for the identification and quality evaluation of Guanhuaroucongrong formula particles,and to establish the method of fingerprint and the multi-component content determination by HPLC.Methods:The separation was performed on an Agilent Zorbax C_(18)column(250 mm×4.6 mm,5μm)with acetonitrile-0.1% phosphoric acid aqueous solution as the mobile phase.The flow rate was 1.0 mL·min^(-1),the detection wavelength was 238 nm,the column temperature was 30℃,and the injection volume was 10μL.Results:The fingerprint was established with 12 common peaks.6 characteristic peaks including geniposidic acid,caffeic acid,echinoside,acteoside,tubuloside A and iso-acteoside were identified.The content determination method of them was further established.The contents of the above 6 components in 7 batches of samples were respectively 0.57-2.22 mg·g^(-1),0.19-0.41 mg·g^(-1),29.36-52.99 mg·g^(-1),1.64-4.99 mg·g^(-1),2.09-3.97 mg·g^(-1)and 2.29-4.76 mg·g^(-1).Conclusion:The method of fingerprint and content determination of 6 components established in this study is feasible,which can provide scientific basis for comprehensive control and evaluation of the quality of Guanhuaroucongrong formula particles.

关 键 词：高效液相色谱 管花肉苁蓉 配方颗粒 指纹图谱 含量测定 多成分分析 质量控制 

分 类 号：R917[医药卫生—药物分析学]