杨婷,谢涛,张臻臻,魏西羽,刘厚汝,孙越,李伟,于德红
YANG Ting,XIE Tao,ZHANG Zhenzhen,WEI Xiyu,LIU Houru,SUN Yue,LI Wei,YU Dehong

• 1:华北理工大学药学院

摘要(Abstract)：

目的 建立一标多测法(quantitative analysis of multi-components with single-marker, QAMS)测定注射用丹参多酚酸中5种成分的含量。方法 采用HPLC法，Agilent C_(18)色谱柱(250 mm×4.6 mm, 5μm),以乙腈-体积分数0.05%磷酸水溶液为流动相等度洗脱，流速为1.0 mL·min~(-1),检测波长为280 nm,柱温为25℃。以丹酚酸B为参照物，建立其与丹酚酸D、迷迭香酸、紫草酸、丹酚酸Y的相对校正因子，利用一标多测法计算5种成分的含量，同时与外标法测定结果进行对比，考察一标多测法的可行性和适用性。结果 在一定的线性范围内，一标多测法的相对校正因子重复性好，两种方法计算得到的3批样品中5种成分的含量无明显差异。结论 HPLC结合一标多测的方法，可为注射用丹参多酚酸的质量控制提供参考。
Objective A quantitative analysis of multi-components with single-marker(QAMS)method was established for the determination of 5 components in salvianolic acid for injection.Methods The HPLC analysis was performed on Agilent C_(18) column(250 mm×4.6 mm, 5 μm)using acetonitrile and 0.05% phosphoric acid solution as the mobile phase at a flow rate of 1.0 mL·min~(-1),and the column temperature was 25 ℃ and the detection wavelength was 280 nm.Using salvianolic acid B as reference material, the relative correction factors of salvianolic acid B with salvianolic acid D,rosmarinic acid, lithospermic acid and salvianolic acid Y were established.The contents of five components were calculated by quantitative analysis of multi-components with single-marker method, and the results were compared with those determined by external standard method to investigate the feasibility and applicability of the QAMS method.Results Within a certain linear range, the repeatability of the relative correction factors of the method was good, and there was no significant difference in the contents of five components in three batches of samples calculated by the two methods.Conclusion HPLC combined with quantitative analysis of multi-components with single-marker is reliable, accurate and reproducible, which can provide reference for the quality control of salvianolic acid for injection.

关键词(KeyWords)： 注射用丹参多酚酸;高效液相色谱;一标多测;相对校正因子;质量控制
salvianolic acid for injection;HPLC;quantitative analysis of multi-components with single-marker;relative correction factor;quality control

Abstract:

Keywords:

基金项目(Foundation): 华北理工大学博士启动基金(28418499)

作者(Author): 杨婷,谢涛,张臻臻,魏西羽,刘厚汝,孙越,李伟,于德红
YANG Ting,XIE Tao,ZHANG Zhenzhen,WEI Xiyu,LIU Houru,SUN Yue,LI Wei,YU Dehong

DOI: 10.14066/j.cnki.cn21-1349/r.2021.0283

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