注射用苦碟子HPLC数字化指纹图谱研究  

Digitized fingerprints of Ixeris Sonchifolia Hance Injection by HPLC

作　　者：孙国祥[1] 王璐[1] 侯志飞[2] 

机构地区：[1]沈阳药科大学药学院,辽宁沈阳110016 [2]河北化工医药职业技术学院制药工程系,河北石家庄050026

出　　处：《中成药》2008年第6期784-789,共6页Chinese Traditional Patent Medicine

基　　金：国家自然科学基金重大研究计划课题(90612002)

摘　　要：目的:建立注射用苦碟子HPLC数字化指纹图谱,为注射用苦碟子质量控制提供依据。方法:采用反相HPLC法分析注射用苦碟子水溶液,以Century SIL BDS柱(250mm×4.6mm,5μm),流动相为1%醋酸水-1%醋酸乙腈低压梯度洗脱,检测波长265nm,柱温(30±0.15)℃,进样量20μL。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注射用苦碟子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分子量、峰位、洗脱动量数δ、折合相对积分φ。结果:以咖啡酸峰为参照物峰,确定21个共有峰,建立了注射用苦碟子HPLC数字化指纹图谱,获得了判别注射用苦碟子质量的重要数字化信息。以双定性双定量相似度法评价注射用苦碟子批间质量稳定。结论:所建立HPLC数字化指纹图谱具有较好的精密度和重现性,适用于注射用苦碟子的质量控制。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和最佳技术。AIM： To establish a HPLC diagitized fingerprint for Ixeris sonchifolia Hance Injection to serve as a digitized method criteria for its overall quality control. METHODS： The chromatographic fingerprints were obtained by injecting 20 txL of the sample solution each time on a Century SIL BDS column （250 mm × 4.6 mm, 5 μm） with the gradient elution solvent system composed of 1% acetic acid water and 1% acetic acid aeetonitrile. The flow rate was 1 mL/min, the column temperature was maintained at （30 ± 0.15 ）℃ and the detection wavelength was set at 265 nm. The chromatographic fingerprints were eharateristieally digitized and evaluated by the software of the digitized evaluation system of traditional Chinese medicine fingerprint with the super information characteristics to give the 42 parameters such as chromatographic fingerprint index （F） , chromatographic finger- print resolution index （RF）, which could thoroughly disclose the hidden information in the fingerprints. Meanwhile, the apparent molecular weight, the peak position, the elution fore index and the pseudo peak area were marked in terms of the principle of QSPR when the two peaks were selected as the reference peaks. RESULTS ： 21 Co-possessing peaks were selected as the fingerprint peaks of Ixeris sonehifolia Hanee Injection by taking eaffeie acid peak as the reference peak to establish the digitized fingerprint and obtain the important digital information a- bout its quanlity control. The stabilities among different batches of samples were evaluated by the dual qualitative and dual quantitative similarity method. CONCLUSION： This new digitized fingerprint method with good preci- sion and reproducibility can be perfectly applied to the quality control over Ixeris sonchifolia Hance Injection. Digitized fingerprint obtained from the dual qualitative and dual quantitative similarity method maybe extend further to assess and control the quanlity of TCM.

关 键 词：注射用苦碟子 HPLC 数字化指纹图谱 色谱指纹图分离量指数RF 色谱指纹图相对分离量指数RFr 双定性 双定量相似度法 双参照物指纹体系 指纹峰表观分子量 

分 类 号：R284.1[医药卫生—中药学]