摘要
目的:建立牡丹皮中5种成分含量的一测多评方法,并验证该方法的可行性和准确性。方法:采用液相色谱法,乙腈为流动相A,0.01%的磷酸水溶液为流动相B,梯度洗脱;流速:1.0 mL·min^(-1);柱温:30℃;检测波长:250 nm。以丹皮酚为参照物,分别建立没食子酸、儿茶素、芍药苷、牡丹皮苷C的相对校准因子,利用该相对校准因子计算其他4种成分含量,同时利用外标法测定牡丹皮中4种有效成分含量,比较2种测量方法的差异,验证一测多评法的可行性和准确性。结果:12批不同产地和批号的牡丹皮中5种有效成分采用一测多评法与外标法的实测值之间无显著性差异。结论:一测多评法测定牡丹皮中5种成分可行,该方法操作简便、结果准确、重复性好,可用于牡丹皮的质量控制。
Objective:To establish aquantitative analysis of multi-components to a single-marker(QAMS)for simultaneous determination of five ingredients in Moutan Cortex and to verify the feasibility and accuracy of the method.Methods:A stable HPLC method was established under the gradient elution procedure of acetonitrile(mobile phase A)and 0.01%phosphoric acid solution(mobile phase B).The flow rate was 1.0 mL·min^(-1),the column temperature was set as 30℃,and the detection wavelength was set as 250 nm.QAMS was established and validated for Moutan Cortex.The relative correction factors(RCF)of Gallic acid,Catechin,Peoniflorin and Mudanpioside C were established with Paeonol as the reference substance,then the contents of these four ingredients were calculated with the established RCFs.The contents were also determined with external standard method.The results obtained with external standard and QAMS methods were compared to verify the feasibility and accuracy of QAMS.Results:The contents of five active ingredients in 12 batches of Moutan Cortex with the different origins determined by QAMS and external standard methods had no significant differences.Conclusion:The determination of five ingredients in Moutan Cortex by QAMS is feasible.The established method is simple to operate and has the good accuracy and repeatability.It can be used for the quality control of Moutan Cortex.
作者
王海燕
刘斌
WANG Haiyan;LIU Bin(Tai′an Testing Institute for Food and Drug Control,Tai′an 271000,China)
出处
《中国药品标准》
CAS
2021年第6期577-582,共6页
Drug Standards of China
关键词
牡丹皮
一测多评
相对校正因子
Moutan Cortex
quantitative analysis of multi-components by single marker(QAMS)
relative correction factor
