药用辅料红糖的全波长融合指纹图谱研究
Research on Full Wavelength Fusion Fingerprint of Brown Sugar for Pharmaceutical Excipient
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摘要: 目的 研究并建立药用辅料红糖的紫外全波长融合指纹图谱。方法 采用Durashell C18-AM色谱柱(4.6 mm×250 mm,5 μm,100 A),乙腈-0.1%三氟乙酸水作流动相,流速1.0 mL/min,梯度洗脱,柱温25 ℃,采用PDA检测器进行210~400 nm全波长检测,使用Waters Empower 3色谱数据软件对210~400 nm紫外全波长数据进行融合,使用中药色谱指纹图谱相似度评价系统软件进行相似度分析。结果 35批药用辅料红糖的紫外全波长融合指纹图谱经相似度分析后共标出10个共有色谱峰,各批次的指纹图谱相似度均大于0.9,相似度良好。结论 该方法稳定准确,重复性好,可以为制定药用辅料红糖指纹图谱的质量标准提供依据。Abstract: OBJECTIVE To research and establish the full wavelength fusion fingerprint of the brown sugar for pharmaceutical excipient. METHODS With a Durashell C18-AM column(4.6 mm×250 mm,5 μm,100 A),gradient elution was performed by the mobile phase acetonitrile(A)-0.1% trifluoroacetic acid solution(B) at the flow rate of 1.0 mL/min. The column temperature was kept at 25 ℃.The detecting condition was performed with the photodiode array detector at the full wavelength from 210 nm to 400 nm. The data was fused by Waters Empower Chromatography Data Software and analysed with the similarity evaluation system for chromatographic fingerprint of chinese medicine. RESULTS There are 10 common peaks which were founded from fingerprints by similarity analysis, in the 35 batches of brown sugar for pharmaceutical excipient.The fingerprints provided credible similarities of brown sugars for pharmaceutical excipient which were greater than 0.9. CONCLUSION This method which is stable and accurate with good repeatability provides the basis for controlling the fingerprint of brown sugar for pharmaceutical excipient.
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Key words:
- pharmaceutical excipient /
- brown sugar /
- fingerprint
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