中药色谱指纹图谱双层次控制模型理论和应用研究  

Theory of double layer model of chromatographic fingerprints and its application

作　　者：孙国祥[1] 王荧荧[1] 侯志飞[1] 陈娇[1] 刘中博[1] 

机构地区：[1]沈阳药科大学药学院,沈阳110016

出　　处：《中南药学》2015年第6期561-564,662,共5页Central South Pharmacy

基　　金：国家自然科学基金重大研究计划项目(No.90612002)

摘　　要：目的建立中药色谱指纹图谱双层次控制模型理论并应用于天王补心丸(TWBXP)HPLC定量指纹图谱评价,以丰富中药指纹图谱质控理论。方法采用特征指纹图谱作为中药指纹图谱的第一控制层次(司定性),对中药指纹图谱检测系统实行远控制;采用标准指纹图谱作为第二控制层次(司定量),对中药指纹图谱质控系统实行近控制。结果以物质三态描述第一层次特征指纹图谱属于图谱的气态,是升华得到;标准指纹图谱属于图谱的固态,具有不变性和难以应用于具体样品的检测定量;以标准制剂控制模式得到的标准指纹图谱属于图谱的液态,具有适用性强和检测引起的误差极小,其更适合我国中药质量工业化控制。以甘草酸(GHIA)为参照物峰,确定46个共有指纹峰,建立了TWBXP-HPLC定量指纹图谱,并以系统比率指纹定量法鉴别出11批样品质量均为好以上(S12除外)。结论中药色谱指纹图谱双层次控制模型理论为中药标准制剂控制模式和定量指纹图谱模式走向中药工业化应用在理论上奠定了重要基础。Objective To establish the double layer model theory for traditional Chinese medicine（TCM） chromatographic fingerprints, and apply it in the quantification of HPLC fingerprints of Tianwang Buxinpill（TWBXP） so as to broaden the profiling theory. Methods The relative characteristic profiling was served as the first layer（FL） to control the chromatographic fingerprints（CFPs） from a distance, which could qualify the system. The standard（reference） fingerprint was served as the second layer（SL） to control CFPs closely, which could also quantify the system. Results The three states were used to describe the FL designing to the gas state obtained by evaporating the original fingerprints. The standard（reference） fingerprint was the solid state that was constant and difficult to meet the practical condition in the test. The standard（reference） fingerprint obtained from detecting the standard（reference） prescription（preparation） was the liquid state with appropriate adaptability and no errors in detection. The 46 co-possessing peaks were selected as the CFP peaks when taking glycyrrhizic acid as the referential peak（PK No.32）, in which the quantified HPLC fingerprint of TWBXPs was established. The identification results were obtained by the systematically quantified ratio fingerprint method which denoted that except for S12, the 11 batches of samples were all of good or better quality. Conclusion The double layers model theory for TCM chromatographic fingerprints is the basis for the application of standard（reference） fingerprint and quantified HPLC fingerprintin in the Chinese medicine industrialization.

关 键 词：天王补心丸 定量高效液相色谱指纹图谱 中药色谱指纹图谱双层次控制模型理论 比率系统指纹定量法 中药指纹图谱的三态 保留时间定性相似度 第一层平面定性相似度 第二层平面定性相似度 立体定性相似度 四维定性相似度 

分 类 号：R286[医药卫生—中药学] O657.7[医药卫生—中医学]