以大黄制剂为例的一测多评法应用研究  

Study on the application of QAMS with rhubarb preparation as an example

作　　者：潘海娟[1] 林玲[1] 谢学建[1] 高茗[1] PAN Hai-juan;LIN Ling;XIE Xue-jian;GAO Ming(Department of Pharmaceutical Preparation,General Hospital of Eastern Theater Command,PLA,Nanjing 210002,Jiangsu,China)

机构地区：[1]东部战区总医院(原南京军区南京总医院)药剂科,南京210002

出　　处：《东南国防医药》2021年第5期506-510,共5页Military Medical Journal of Southeast China

摘　　要：目的探讨含大黄的成方制剂新保肾片中相同待测成分的一测多评(QAMS)定量分析方法,分析其制剂质量评价的可行性。方法采用高效液相色谱法,等度洗脱,流动相为甲醇-0.1%磷酸水;Kromasil 100-5 C18色谱柱;柱温35℃;流速1.0 mL/min;检测波长254 nm。以新保肾片为例建立大黄游离蒽醌(芦荟大黄素、大黄酸、大黄素、大黄酚和大黄素甲醚)QAMS含量测定方法,建立内参物与待测成分之间的相对校正因子(f),并将结果应用于组成成分相似的其他3个大黄制剂(保肾片、炎黄保肾胶囊、新肾炎胶囊)的质量评价。结果以大黄素为内参比峰,建立的相对校正因子分别为f_(芦荟大黄素/大黄素)=0.75、f_(大黄酸/大黄素)=0.88、f_(大黄酚/大黄素)=0.89、f_(大黄素甲醚/大黄素)=3.25,建立的一测多评方法应用于保肾片、炎黄保肾胶囊、新肾炎胶囊,QAMS与外标法(ESM)数据比较相对标准偏差(RSD)均≤5%。结论以新保肾片为例建立的QAMS检测方法可以应用于其他3个大黄制剂。实验为大黄制剂质量标准的完善和提高提供数据支撑,并为拓展一测多评法在中成药质量评价和控制中的应用提供研究思路和方法参考。Objective To explore the quantitative analysis of multi-components by single-marker(QAMs)for the same components to be tested in Xinbaoshen tablets,a prescription preparation containing rhubarb,andto analyze the feasibility of preparation quality evaluation.Methods A HPLC method was used with Kromasil 100-5 C18 column and a mobile phase of Methanol-Phosphoric acid solution.Flow rate was 1.0 mL/min.The column temperature was 35℃.The detection wavelength was 254 nm and sample loop volume was 10μL.Taking Xinbaoshen tablet as an example,a QAMs method for the determination of free anthraquinone in rhubarb(aloe emodin,rhein,emodin,chrysophanol and chrysophanol methyl ether)was established.The relative correction factor(f)between the internal reference and the components to be tested was established,and the results were applied to the quality evaluation of other three rhubarb preparations with similar components(Baoshen tablet,Yanhuang Baoshen capsule and Xinshenyan capsule).Results With emodin as the nternal reference peak,the relative correction factors were as follows f aloe emodin/emodin=0.75,f rhein/emodin=0.88,f chrysophanol/emodin=0.89,f physcion/emodin=3.25.The RSD of QAMs and ES data were less than 5%.Conclusion The QAMs method established by taking Xinbaoshen tablets as an example could be applied to the other three preparations.The experiment provides data support for the improvement and improvement of rhubarb preparation quality standard,and provides research ideas and method reference for expanding the application of one test multiple evaluation method in the quality evaluation and control of Chinese patent medicine.

关 键 词：一测多评 大黄素 芦荟大黄素 大黄酸 大黄酚 大黄素甲醚 

分 类 号：R284.1[医药卫生—中药学]