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作 者:成守玲[1] 王晓楠 信文远 陈庆 李敏 CHENG Shou-ling;WANG Xiao-nan;XIN Wen-yuan;CHEN Qing;LI Min(Anhui Jiren Pharmaceutical Co.Ltd.,Bozhou 236800,China)
出 处:《中华中医药杂志》2020年第11期5712-5715,共4页China Journal of Traditional Chinese Medicine and Pharmacy
基 金:安徽省科技重大专项项目(No.17030801009)。
摘 要:目的:建立白芍药材、饮片、提取物及配方颗粒的HPLC特征图谱,对其相关性进行评价。方法:采用HPLC法,色谱柱为Agilent HC-C18柱(250mm×4.6mm,5μm);以乙腈-0.1%磷酸溶液为流动相梯度洗脱,检测波长280nm,流速为1.0mL/min,柱温30℃。以特征图谱为对照,对药材-饮片-提取物及配方颗粒进行相关性评价。结果:9批白芍药材、饮片、提取物及配方颗粒HPLC特征图谱均有6个共有峰,经过相似度比较,白芍药材、饮片、提取物、配方颗粒特征图谱相似度均在0.91~0.97,其化学成分相关性较好。将白芍药材、饮片、提取物、配方颗粒的特征图谱进行重叠比较,白芍药材中主要色谱峰在饮片、提取物及配方颗粒的色谱图中均有体现,而饮片、提取物及配方颗粒的主要色谱峰也能在药材的图谱中找到追溯,将特征图谱用于中药配方颗粒全过程监控,可以反映生产过程各个环节的量质传递变化规律。结论:建立了白芍药材、饮片、提取物及配方颗粒的HPLC特征图谱,反映了白芍药材、饮片、提取物及配方颗粒多成分的整体面貌,为白芍配方颗粒质量控制提供借鉴。Objective:To establish the HPLC specific chromatogram of crude drug-decoction pieces-extractives-concentrated granules of Paeoniae Radix Alba and evaluate their correlation.Methods:HPLC method was used.The column was an Agilent HC-C18 column(250 mm×4.6 mm,5μm);the mobile phase was acetonitrile-0.1%phosphoric acid solution to perform gradient elution;detection wavelength was 280 nm;flow velocity was 1.0 mL/min and column temperature was 30°C.In contrast with the specific chromatogram,the correlation between crude drug-decoction pieces-extractives-concentrated granules was evaluated.Results:The HPLC specific chromatogram of 9 batches of crude drug,decoction pieces,extractives and concentrated granules of Paeoniae Radix Alba showed 6 common peaks.By the correlation comparison,the similarity of specific chromatogram of crude drug and decoction pieces,decoction pieces and extractives,extractives and concentrated granules of Paeoniae Radix Alba were 0.91 to 0.97,exhibiting the good correlation of their chemical components.Overlapping the specific chromatogram of crude drug,decoction pieces,extractives,and concentrated granules of Paeoniae Radix Alba and comparing,the main chromatographic peaks of Paeoniae Radix Alba crude drug also reflected in the chromatogram of decoction pieces,extractives,and concentrated granules.Moreover,the main chromatographic peaks of Paeoniae Radix Alba decoction pieces,extractives,and concentrated granules dated back to the chromatogram of crude drug.The rule of quantity and quality change and transfer in every step of production process could be reflected by applying the specific chromatogram to the whole process monitoring.Conclusion:The HPLC specific chromatogram of crude drug-decoction pieces-extractives-concentrated granules of Paeoniae Radix Alba is established,which reflects the overall appearance of multiple components of crude drug-decoction piecesextractives-concentrated granules of Paeoniae Radix Alba and provides a reference for the quality control of Paeoniae Radix Alba conce
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