系统指纹定量法评价牛黄解毒片质量  

Evaluating the quality of Niuhuangjiedu tablets by the systematic quantified fingerprint method

作　　者：孙国祥[1] 胡玥珊[1] 毕开顺[1] 

机构地区：[1]沈阳药科大学药学院,辽宁沈阳110016

出　　处：《药学学报》2009年第4期401-405,共5页Acta Pharmaceutica Sinica

基　　金：国家自然科学基金重大研究计划项目(90612002)

摘　　要：建立牛黄解毒片(Niuhuangjiedu tablets,NHJDT)HPLC指纹图谱,以系统指纹定量法评价其质量。采用RP-HPLC法,以黄芩苷为参照物峰,确定53个共有指纹峰,建立了NHJDT-HPLC指纹图谱。以宏定性相似度Sm和宏定量相似度Pm为参量对15批NHJDT进行聚类分析,确定用其中10批生成对照指纹图谱(RFP),以此RFP为标准用系统指纹定量法鉴别评价15批NHJDT质量。鉴别出9批质量合格,1批均化系数相对偏差明显偏高,5批含量明显偏低。系统指纹定量法是对系统化学指纹的整体定性分析和整体定量分析的密切整合,是评价中药质量的便捷有效方法。The HPLC fingerprints of Niuhuangjiedu tablets （NHJDT） were established and assessed by systematic quantified fingerprint method. The chromatographic fingerprints （CFPs） were determined by reversed-phase HPLC, in which the CFPs containing 53 co-possessing peaks were marked by choosing baicalin peak as the referential peak. Fifteen batches of NHJDT were identified with hierarchical clustering analysis by using macro qualitative similarities and macro quantitative similarities as variables. According to the results of classification, the referential fingerprint （RFP） was synthesized from 10 batches of NHJDTs. Taking the RFP for the qualified model, the whole 15 batches of NHJDTs were evaluated by the systematic quantified fingerprint method. Among the 15 batches of NHJDT, 9 batches were completely qualified, the relative variance of leveling coefficient of 1 batch was obviously higher while the contents of other 5 batches were lower. The systematic quantified fingerprint method closely integrates the systematic fingerprints with the macro qualitative similarities and macro quantitative similarities to perform the entire qualification and quantitation analyses, which can briefly and effectively assess the quality of Chinese traditional medicine.

关 键 词：系统指纹定量法 牛黄解毒片 HPLC指纹图谱 宏定性相似度 宏定量相似度 色谱指纹图分离量指数 

分 类 号：R917[医药卫生—药物分析学]