牡丹皮配方颗粒的质量评价体系研究
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摘要
建立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分析方法。利用高效液相色谱法对牡丹皮配方颗粒进行含量测定,颗粒中的芍药苷平均质量分数为1. 72%,丹皮酚平均质量分数为1. 42%。利用特征图谱对牡丹皮配方颗粒进行整体定性,包含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,1,2,3,4,6-五没食子酰葡萄糖,丹皮酚。利用质谱分析进行化学成分分析,共鉴定牡丹皮配方颗粒中40个化合物,包括没食子酸类、芍药苷类、丹皮酚类、黄酮类及苯甲酸类化合物。该研究将多种分析手段应用于牡丹皮配方颗粒的质量评价体系中,对提高质量评价和过程质量控制水平起到积极的促进作用。
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.
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.
引文
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[2] He C N,Peng Y,Feng Y X,et al. Quick comparison of Radix Paeonia Alba,Radix Paeonia Rubra,and Moutan Cortex by high performance liquid chromatography coupled with monolithic columns and their chemical pattern recognition[J]. Pharmacogn Mag,2012,8(31):237
[3]国家药典委员会.中药配方颗粒质量控制与标准制定技术要求(征求意见稿)[S]. 2016.
[4]王杰,史德胜,刘冰,等.含挥发性成分中药牡丹皮和肉桂配方颗粒不同制备工艺的比较研究[J].中草药,2015,46(24):3687.
[5]张慧,陈燕,汪佳楠,等.指纹图谱技术在中药配方颗粒质量评价及过程控制中的应用[J].中国中药杂志,2018,43(19):3822.
[6]广东省食品药品监督管理局.广东省中药配方颗粒标准[M].北京:中国医药科技出版社,2012:113.
[7]牛丽颖.中药配方颗粒质量研究[M].北京:科学出版社,2017:145.
[8] He C,Bing P,Yang D,et al. Chemical taxonomy of tree peony species from China based on root cortex metabolic fingerprinting[J]. Phytochemistry,2014,107(2014):69.
[9]胡云飞,裴月梅,吴虹,等.基于UPLC-Q-TOF-MS技术研究不同产地牡丹皮药材化学成分的差异[J].中草药,2016,47(17):2984.
[10]陈菲菲,钱大玮,郭盛,等.基于UPLC-MS的牡丹皮药材质量评价研究[J].药物分析杂志,2018,38(4):609.