中国中药杂志

2020, v.45(05) 1105-1113

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基于中药QbD理念的当归破壁粉质量评价研究
Quality evaluation of angelica broken wall powder based on QbD concept of traditional Chinese medicine

罗铮;邓雯;张前亮;方碧烟;成金乐;
LUO Zheng;DENG Wen;ZHANG Qian-liang;FANG Bi-yan;CHENG Jin-le;Research Center of Chinese Herbal Resource Science and Engineering, Guangzhou University of Chinese Medicine;Zhongshan Zhongzhi Pharmaceutical Group;Key Laboratory of Technologies and Applications of Ultrafine Granular Powder of Herbal Medicine, State Administration of Traditional Chinese Medicine;Key Laboratory of Chinese Medicinal Resource from Lingnan under Ministry of Education, Guangzhou University of Chinese Medicine;Joint Labora

摘要(Abstract):

该文以当归破壁饮片的工艺中间体当归破壁粉为研究对象,以HPLC指纹图谱结合多成分含量测定(阿魏酸、洋川芎内酯Ⅰ、阿魏酸松柏酯、藁本内酯及丁烯基苯酞)、物理指纹图谱(D_(90)、粒径分布范围、粒径分布宽度、松密度、振实密度、颗粒间孔隙率、卡尔指数、比表面积、孔体积、休止角、豪斯纳比、干燥失重及吸湿性)表征当归破壁粉的质量属性;以相似度分析、聚类分析、主成分分析及正交偏最小二乘法判别分析构建基于中药QbD"四全模式"——全息分析的质量评价方法。对不同来源的当归破壁粉进行质量评价,找出差异性指标。该质量评价方法可以科学、全面的评价当归破壁粉质量属性,可用于不同来源或不同工艺破壁粉的质量一致性评价,为中药破壁饮片的质量控制和研发提供新的思路。
In this paper, angelica broken wall powder(ABWP) was taken as the research object, HPLC fingerprint combined with multi-component determination(ferulic acid, senkyunolide I, coniferyl ferulate, ligustilide and 3-butylidenephthalide), physical fingerprint(D_(90), particle size distribution range, particle size distribution width, bulk density, tap density, inter-particle porosity, Carr index, specific surface area, pore volume, angle of repose, Hausner ratio, loss on drying and hygroscopicity)were used to characterize the quality attribute of ABWP; similarity analysis, cluster analysis, principal component analysis and orthogonal partial least squares discriminant analysis were conducted to construct the quality evaluation method of holographic analysis based on traditional Chinese medicine QbD "4 H mode", in order to evaluate the quality of ABWP from different sources and find out differentiated indicators. The quality evaluation method could be used for scientific, comprehensive evaluation of the quality attribute of ABWP, and the quality consistency evaluation of cell-wall-broken powder of different sources or different processes.It provides new ideas for quality control and research of ultrafine granular powders of traditional Chinese medicine.

关键词(KeyWords): 当归;破壁粉;质量源于设计;HPLC指纹图谱;物理指纹图谱;多元统计分析;质量评价
angelica;broken wall powder;quality by design;HPLC fingerprint;physical fingerprint;multivariate statistical analysis;quality evaluation

Abstract:

Keywords:

基金项目(Foundation): 广东省省级科技计划项目(2018B0202072008);; 广东省中药破壁饮片工程实验室项目(粤发改创新函[2018]3149号);; 中山市协同创新中心项目(2016C1014)

作者(Author): 罗铮;邓雯;张前亮;方碧烟;成金乐;
LUO Zheng;DENG Wen;ZHANG Qian-liang;FANG Bi-yan;CHENG Jin-le;Research Center of Chinese Herbal Resource Science and Engineering, Guangzhou University of Chinese Medicine;Zhongshan Zhongzhi Pharmaceutical Group;Key Laboratory of Technologies and Applications of Ultrafine Granular Powder of Herbal Medicine, State Administration of Traditional Chinese Medicine;Key Laboratory of Chinese Medicinal Resource from Lingnan under Ministry of Education, Guangzhou University of Chinese Medicine;Joint Labora

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DOI: 10.19540/j.cnki.cjcmm.20191221.310

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