摘要
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 a digitized HPLC fingerprint of Ciwujia injection.Method：The chromatographic fingerprints were obtained by injecting 10 μL of the sample solution each time on a Centurysil C18 BDS column（200 mm×4.6 mm,5 μm）with the gradient elution solvent system composed of 1% acetate acid water（A）and 1% acetate acid acetonitrile（B）（0-9 min,0→3% B;9-22 min,3%→8% B;22-30 min,8%→10% B;30-45 min,10%→15% B;45-60 min,15%→19% B;60-80 min,19%→35% B）.The flow rate was 1.0 mL·min-1,the column temperature was maintained at（30.0±0.15）℃and the detection wavelength was set at 265 nm.The chromatographic fingerprints were characteristically digitized and evaluated by the software of the digitized evaluation system of Traditional Chinese Medicine（TCM）fingerprint with the super information characteristics to give 42 parameters such as chromatographic fingerprint index,chromatographic fingerprint resolution index,which can thoroughly disclose the hidden information in the fingerprints.Meanwhile,the apparent relative molecular mass,peak position,elution force index and pseudo peak area were marked in terms of the principle of quantitation system-property related（QSPR）when two peaks were selected as the referential peaks.Results：19 co-possessing peaks were selected as the fingerprint peaks of Ciwujia injection by taking syringin peak as the referential peak to establish the digitized fingerprint and obtain the important digitized information for its quality control.The stabilities among different lots of samples were evaluated by the dual qualitative and dual quantitative similarity method.Conclusions：This new digitized fingerprint method with good precision and reproducibility can be perfectly applied in the quality control of Ciwujia injection.Digitized fingerprint is certainly the core techniques of digital TCM,and the dual qualitative and dual quantitative similarity method is the accurate and best technique to assess and control the quality of modern TCM.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2009年第3期356-362,共7页
Chinese Journal of Pharmaceutical Analysis
基金
国家自然科学基金重大研究计划项目(No.90612002)
关键词
刺五加注射液
HPLC
数字化指纹图谱
色谱指纹图分离量指数
色谱指纹图相对分离量指数
双定性双定量相似度法
双参照物指纹体系
指纹峰表观相对分子质量
洗脱动量数
折合相对积分
Ciwujia injection
HPLC
digitized fingerprint
chromatographic fingerprint resolution index
chromatographic fingerprint relative resolution index
dual qualitative and dual quantitative similarity method
dual referential peaks system of fingerprint
apparent relative molecular mass of fingerprint peak
elution force index
pseudo relative peak area
