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当归补血汤基准样品质量控制方法研究 被引量:3

Quality control method of substance benchmarks for Danggui Buxue Decoction
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摘要 目的 建立经典名方当归补血汤基准样品系统的质量控制方法,为其质量评价提供参考。方法 制备26批基准样品,在同一供试品溶液下,基于超高效液相色谱-二极管阵列检测器(UPLC-PDA)、UPLC-蒸发光散射检测器(ELSD)、亲水相互作用色谱-二极管阵列检测器(HILIC-PDA)法建立当归补血汤基准样品多维指纹图谱,明确其指纹图谱的峰归属和相似度范围。对毛蕊异黄酮葡萄糖苷和毛蕊异黄酮、黄芪甲苷、阿魏酸、总多糖进行定量分析,确定其含量限度范围。结果 建立当归补血汤基准样品三维指纹图谱方法,共标定了32个共有峰,通过与对照品比对,指认了其中17个共有峰,使用“中药色谱指纹图谱相似度评价系统(2012版)”计算相似度,其相似度均大于0.9。26批基准样品毛蕊异黄酮葡萄糖苷和毛蕊异黄酮、黄芪甲苷、阿魏酸、总多糖的含量均值±30%范围分别为0.075%~0.140%、0.023%~0.043%、0.103%~0.191%、4.69%~8.70%。结论 建立经典名方当归补血汤多维指纹图谱及多成分含量测定方法,适用性强,重复性、稳定性良好,可为当归补血汤基准样品及其制剂的质量控制提供依据。 Objective A comprehensive and systematical quality control method was established to provide reference for quality control and evaluation of substance benchmarks for Danggui Buxue Decoction, in order to provide reference for establishing the quality control standard. Methods Twenty-six batches of substance benchmarks were prepared. Based on a same sample solution, a multidimensional fingerprint of substance benchmarks was established by UPLC-PDA, UPLV-ELSD and HILIC-PDA to definite the common peaks and the similarity range. Five quality markers, including calycosin-7-O-β-D-glucopyranoside and calycosin,astragaloside Ⅳ, ferulic acid, and total polysaccharides, were analyzed to determine the quantitative ranges. Results According to the three-dimensional fingerprint Spectrum, thirty-two common peaks could be demarcated, while seventeen of these could be identified by reference substances. Besides, their similarities were all more than 0.9 based on the Chinese Medicine Chromatographic Fingerprint Similarity Evaluation System(2012). The ranges of mean content about calycosin-7-O-β-Dglucopyranoside plus calycosin, astragaloside Ⅳ, ferulic acid, and total polysaccharides from twenty-six batches of substance benchmarks were 0.075%—0.140%, 0.023%—0.043%, 0.103%—0.191%, and 4.69%—8.70%, respectively. Conclusion With high applicability, well repeatability and stability, the multidimensional fingerprint and multicomponent determination of DangguiBuxue Decoction can provide reference for establishing the quality control of substance benchmarks and preparations.
作者 陈锦霞 高永坚 林碧珊 陈伟钢 洪婉婷 张汝莹 陈文慧 梁浩明 CHEN Jinxia;GAO Yongjian;LIN Bishan;CHEN Weigang;HONG Wanting;ZHANG Ruying;CHENWenhui;LIANG Haoming(Sinopharm Group Guangdong Medi-Word Pharmaceutical Co.,Ltd.,Foshan 528303,China)
出处 《药物评价研究》 CAS 2022年第11期2247-2256,共10页 Drug Evaluation Research
基金 2019年容桂街道战略性新兴产业项目(RG202004001)。
关键词 经典名方 当归补血汤 基准样品 超高效液相色谱(UPLC) 指纹图谱 毛蕊异黄酮葡萄糖苷 毛蕊异黄酮 黄芪甲苷 阿魏酸 classic prescriptions Danggui Buxue Decoction substance benchmark UPLC fingerprint calycosin-7-O-β-D-glucopyranoside calycosin astragalosideⅣ ferulic acid
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