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作 者:陈天山 夏枫耿 龚琼 CHEN Tian-shan;XIA Feng-geng;GONG Qiong(The South China Center for Innovative Pharmaceuticals,Guangzhou,Guangdong,510700)
出 处:《广西中医药大学学报》2025年第2期34-39,共6页Journal of Guangxi University Of Chinese Medicine
摘 要:[目的]建立三七丹参颗粒HPLC指纹图谱,考察生产工艺对指纹图谱的影响。[方法]采用Shim-Pack C18(4.6 mm×250 mm,5μm)色谱柱,流动相为乙腈(A)-0.05%磷酸水溶液(B),梯度洗脱,流速为1.0 ml/min,检测波长为210 nm,柱温为30℃,进样量为10μl。[结果]15批三七丹参颗粒HPLC指纹图谱共标定21个共有峰,指认出8个色谱峰成分:三七皂苷R1、人参皂苷Rg1、人参皂苷Re、丹酚酸B、人参皂苷Rb1、隐丹参酮、丹参酮Ⅰ、丹参酮ⅡA,15批三七丹参颗粒相似度>0.980。在不同生产工艺阶段,药材、提取液、浸膏、颗粒的指纹图谱相似度为0.895~0.998。[结论]该方法操作简单,精密度、重复性、稳定性好,可为三七丹参颗粒的整体质量控制提供科学依据。[Objective]To establish HPLC fingerprint chromatogram of Sanqi Danshen granules and investigate the influence of production process on the fingerprint chromatogram.[Methods]The fingerprint chromatogram was es⁃tablished through an Shim-Pack C18 column(4.6 mm×250 mm,5μm)and detection wavelength at 210 nm,using acetonitrile(A)-0.05%phosphate acid aqueous solution(B)as mobile phase at a flow rate of 1.0 ml/min.The column temperature was 30℃,and the injection volume was 10μl.[Result]A total of 21 common peaks were identified in the HPLC fingerprint chromatogram of 15 batches of Sanqi Danshen granules.The peaks of 8 compounds,which are no⁃toginsenoside R1,ginsenoside Rg1,ginsenoside Re,Salvianolic acid B,ginsenoside Rb1,cryptotanshinone,tanshi⁃noneⅠ,tanshinoneⅡA,were identified.The similarity among the 15 batches was>0.980.At different stages of the production process,the similarity of fingerprints among medicinal materials,extract,paste,and granules were in the range of 0.895~0.998.[Conclusion]This method,with simple operation,good precision,repeatability and stability,provides a scientific basis for the quality control of Sanqi Danshen granules.
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