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目的:建立刺五加注射液HPLC数字化指纹图谱。方法:采用CenturysilC18BDS色谱柱(200mm×4.6mm,5μm),以1%醋酸水溶液(A)-1%醋酸乙腈溶液(B)为流动相进行梯度洗脱(0～9min,0→3%B;9～22min,3%→8%B;22～30min,8%→10%B;30～45min,10%→15%B;45～60min,15%→19%B;60～80min,19%→35%B),流速1.0mL.min-1,检测波长265nm,柱温(30.0±0.15)℃,进样量10μL。用“中药色谱指纹图谱超信息特征数字化评价系统3.0”软件计算不同批次的刺五加注射液HPLC指纹图谱的色谱指纹图谱指数F和色谱指纹图分离量指数(RF)等42个参数进行潜信息特征数字化评价。以双参照物体系结合定量结构-性质相关(QSPR)原理标定指纹峰的表观相对分子质量、峰位、洗脱动量数(δ)、折合相对积分(ф)。结果:以紫丁香苷峰为参照物峰,确定了19个共有指纹峰,建立了刺五加注射液HPLC数字化指纹图谱。获得了判别刺五加注射液质量的重要数字化信息。以双定性双定量相似度法评价刺五加注射液批间质量的稳定性。结论:所建立的HPLC数字化指纹图谱方法具有较好的稳定性和重现性,适用于刺五加注射液的质量控制。数字化指纹图谱是数字中药的核心技术,双定性双定量相似度法是宏观定性定量评价中药质量的最准确、最佳技术。
Objective: To establish HPLC digitized fingerprints of Acanthopanax senticosus injection. Methods: The gradient elution was carried out on a Centurysil C18 BDS column (200 mm × 4.6 mm, 5 μm) using a gradient of 1% acetic acid in water (A) -1% acetic acid in acetonitrile (0 to 9 min, 0 → 3% 9 to 22 min, 3% to 8% B, 22 to 30 min, 8% to 10% B, 30 to 45 min, 10% to 15% B, 45 to 60 min, 15% to 19% → 35% B), flow rate 1.0mL.min-1, detection wavelength 265nm, column temperature (30.0 ± 0.15) ℃, injection volume 10μL. 42 parameters of chromatographic fingerprinting index F and chromatographic fingerprinting index (RF) of HPLC fingerprints of different batches of Acanthopanax senticosus injection were calculated with the software “Software for Digital Characterization of Chromatographic Fingerprinting by Ultra-information Feature 3.0” Digitized evaluation of potential information features. The relative molecular mass, peak position, the number of elution momentum (δ) and the relative integral (ф) of the fingerprint peak were calibrated with the double reference system combined with quantitative structure - property correlation (QSPR) principle. Results: 19 syndromic peaks were identified with lupiride peak as the reference peak, and HPLC fingerprint of Acanthopanax senticosus injection was established. Access to determine the quality of Acanthopanax injection of important digital information. Double qualitative double quantitative similarity evaluation of Acanthopanax senticosus injection batch quality stability. Conclusion: The established HPLC digital fingerprinting method has good stability and reproducibility, and is suitable for the quality control of Acanthopanax senticosus injection. Digital fingerprint is the core technology of digital medicine. The double qualitative double quantitative similarity method is the most accurate and the best technique to qualitatively and quantitatively evaluate the quality of traditional Chinese medicine.