DU Xin-Gang, Jiang Hui-Jie, Zhang Hui, Yan Ji-Zhong
National Resource Center of Chinese Materia Medica,China Academy of Chinese Medical Sciences Beijing 100700,China Center for Post-doctoral Research,China Academy of Chinese Medical Sciences Beijing 100700,China Anhui Jiuzhou Fangyuan Pharmaceutical Co.,Ltd. Bozhou 236800,China.
College of Pharmaceutical Sciences,Zhejiang University of Technology Hangzhou 310014,China.
Zhongguo Zhong Yao Za Zhi. 2019 May;44(10):2065-2071. doi: 10.19540/j.cnki.cjcmm.20181224.002.
A scientific and perfect quality evaluation system for Moutan Cortex Formula Granules was established,including content determination method,characteristic chromatogram method and mass spectrometry method. The content of paeoniflorin and paeonol in Moutan Cortex Formula Granules was determined by high performance liquid chromatography( HPLC),and the average content was 1. 72% and 1. 42%,respectively. The characteristic chromatogram was used to characterize Moutan Cortex Formula Granules,which contained 7 characteristic peaks,namely gallic acid,p-hydroxybenzoic acid,oxypaeoniflorin,paeoniflorin,tetragalloyl glucose,1,2,3,4,6-penta-O-galloyl-β-D-glucose and paeonol. A total of 40 compounds in Moutan Cortex Formula Granules,including gallic acids,paeoniflorins,paeonols,flavonoids and benzoic acids,were identified by mass spectrometry. In this study,a variety of analytical methods were used to evaluate the quality system of Moutan Cortex Formula Granules,which could play a positive role in improving the level of quality evaluation and process quality control.
建立了科学完善的牡丹皮配方颗粒质量评价体系，包括含量测定方法、特征图谱方法和质谱方法。采用高效液相色谱法（HPLC）测定牡丹皮配方颗粒中芍药苷和丹皮酚的含量，平均含量分别为1.72%和1.42%。采用特征图谱对牡丹皮配方颗粒进行表征，其含有7个特征峰，分别为没食子酸、对羟基苯甲酸、氧化芍药苷、芍药苷、四没食子酰葡萄糖、1,2,3,4,6-五-O-没食子酰-β-D-葡萄糖和丹皮酚。通过质谱鉴定了牡丹皮配方颗粒中包括没食子酸类、芍药苷类、丹皮酚类、黄酮类和苯甲酸类在内的共40种化合物。本研究采用多种分析方法对牡丹皮配方颗粒质量体系进行评价，对提高质量评价水平和过程质量控制具有积极作用。
