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刊物信息

期刊名称:药物分析杂志
主管单位:中国科学技术协会
主办单位:中国药学会
承办:中国食品药品检定研究院
主编:金少鸿
地址:北京天坛西里2号
邮政编码:100050
电话:010-67012819,67058427
电子邮箱:ywfx@nicpbp.org.cn
国际标准刊号:ISSN 0254-1793
国内统一刊号:CN 11-2224/R
邮发代号:2-237
 

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基于指纹图谱分析和多成分同时定量的护肝片质量评价研究

Quality evaluation of Hugan tablets based on HPLC fingerprint and simultaneous determination of multi-components

作者(英文):
分类号:R917
出版年·卷·期(页码):2018,38 (11):2029-2037
DOI: 10.16155/j.0254-1793.2017.01.01
-----摘要:-------------------------------------------------------------------------------------------

目的:建立护肝片的HPLC指纹图谱,并测定其主要成分的含量,为护肝片的质量控制提供可靠方法。方法:采用Agilent Zorbax SB-C18色谱柱(250 mm&#215;4.6 mm,5 μm),以乙腈(A)-0.05%磷酸水溶液(B)为流动相,梯度洗脱(0~6 min,6% A;6~9 min,6% A→40% A;9~30 min,40% A→50% A;30~45 min,50% A;45~65 min,50% A→75% A),流速1.0 mL&#183;min-1,检测波长250 nm,柱温30℃;建立护肝片HPLC指纹图谱,并对(R,S)-告依春、柴胡皂苷a、五味子醇甲、柴胡皂苷d、五味子酯甲、五味子甲素和五味子乙素的含量测定方法进行方法学考察。结果:在指纹图谱研究中,共确定护肝片HPLC指纹图谱20个共有峰,通过与混合对照品比较,指认其中7个指标成分,分别是(R,S)-告依春(1号峰)、柴胡皂苷a(3号峰)、五味子醇甲(5号峰)、柴胡皂苷d(6号峰)、五味子酯甲(8号峰)、五味子甲素(17号峰)和五味子乙素(20号峰),利用相似度软件对23批样品指纹图谱进行分析,各批样品相似度均在0.95以上。在建立的色谱条件下测定7个成分,分离度良好,方法精密度和重复性的RSD均<1.5%,供试品溶液在24 h内稳定,各成分具有良好的线性关系和较宽线性范围;6批护肝片中(R,S)-告依春、柴胡皂苷a、五味子醇甲、柴胡皂苷d、五味子酯甲、五味子甲素和五味子乙素质量分数分别为0.07~0.12、0.13~0.20、0.51~0.58、0.06~0.13、0.07~0.14、0.10~0.17和0.18~0.23 mg&#183;片-1结论:所建立的护肝片HPLC指纹图谱检测和定量测定分析方法快速、准确,可以有效地评价护肝片的质量。

-----英文摘要:---------------------------------------------------------------------------------------

Objective: To establish the HPLC fingerprint of Hugan tablets and determine the main components,so as to provide a reference for the quality control.Methods: The analysis was carried out on an Agilent Zorbax SB -C18 column(250 mm&#215;4.6 mm,5 μm) with gradient elution of acetonitrile(A)-0.05% phosphoric acid aqueous solution(B)(0-6 min,6%A;6-9 min,6%A→40%A;9-30 min,40%A→50%A;30-45 min,50%A; 45-65 min,50%A→75%A) at a flow rate of 1.0 mL&#183;min-1. The detection wavelength was 250 nm and the column temperature was 30℃. The HPLC fingerprint was established,and determination method of(R, S)-epigoitrin, saikosaponin a,schisandrin,saikosaponin d,schisantherin,deoxyschizandrin and schisandrin B was studied methodologically. Results: 20 common peaks were found in the fingerprint of Hugan tablets,7 of which were identified by comparison with the reference as(R, S)-epigoitrin(peak 1),saikosaponin a(peak 3),schisandrin(peak 5),saikosaponin d(peak 6),schisantherin(peak 8),deoxyschizandrin(peak 17) and schisandrin B(peak 20). The similarities of 23 batches of samples were above 0.95. The 7 compounds were well separated under the established chromatographic conditions. The RSD values for precision and repeatability tests were all less than 1.5% and the sample solution was stable during 24 h. All the compounds had a good linearity and wide linear range. The contents of(R, S)-epigoitrin,saikosaponin a,schisandrin,saikosaponin d,schisantherin,deoxyschizandrin and schisandrin B in 6 batches of Hugan tablets were 0.07-0.12 mg,0.13-0.20 mg,0.51-0.58 mg,0.06-0.13 mg,0.07-0.14 mg,0.10-0.17 mg tablet and 0.18-0.23 mg per tablet,respectively. Conclusion: The method is fast and accurate,and can be used for the quality control of Hugan tablets.

-----参考文献:---------------------------------------------------------------------------------------

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