HPLC指纹图谱技术评价不同厂家元胡止痛片质量  

Study on Quality of Yuan-Hu Zhi-Tong Tablet from Different Manufacturers by HPLC Fingerprint

作　　者：朱海琳[1] 孟兆青[2] 丁岗[1,2] 王振中[1,2] 萧伟[1,2] 

机构地区：[1]南京中医药大学药学院,南京210046 [2]江苏康缘药业股份有限公司,连云港222001

出　　处：《世界科学技术-中医药现代化》2015年第7期1460-1466,共7页Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology

基　　金：科学技术部国家重大新药创制项目(2013ZX09402203):现代中药创新集群与数字制药技术平台;负责人:王振中

摘　　要：目的:建立元胡止痛片的HPLC指纹图谱分析方法,评价不同厂家的元胡止痛片质量。方法:构建10个厂家共12批元胡止痛片HPLC指纹图谱,对共有峰化学成分进行质谱解析,并结合相似度分析、聚类分析和主成分分析对指纹图谱进行分析。结果:对HPLC指纹图谱中的15个共有峰进行结构鉴定,其中12个成分来自延胡索,3个成分来自白芷;12批元胡止痛片指纹图谱相似度值范围在0.498-0.999之间,可以将样品分为3类;聚类分析结果将12批样品分为3大类;主成分分析采用3个主成分代表15个共有峰信息,将12批样品分为3类,分类结果主要受延胡索成分影响。3种分析方法对12批次样品分类结果基本一致,结合3种分析方法结果可以将12批样品按照质量差异分为三级。结论:不同厂家的元胡止痛片质量差异较显著,相似度分析方法结合聚类分析与主成分分析方法均可以对不同厂家的指纹图谱进行分析评价,并深入分析样品差异的影响因素,可以作为不同厂家样品质量评价的一种有效手段。This study was aimed to evaluate the quality ofYuan-Hu Zhi-Tong （YHZT） tablet from different manufacturers by high performance liquid chromatography （HPLC） fingerprint. An HPLC method was developed to establish the fingerprint of 12 batches of YHZT from 10 manufacturers. The common peaks were confirmed by mass spectrometric analysis. Similarity analysis （SA）, hierarchical cluster analysis （HCA） and principal component analysis （PCA） were applied to analyze the fingerprint chromatography. The results showed that there were 15 common peaks in which 12 components were from Corydalis Rhizoma and 3 from Radix Angelicae Dahuricae. The similar degrees of 12 batches of YHZT tablet were between 0.498 and 0.999. Based on the values, they could fall into three groups. The result of HCA showed that 12 batches of samples could be divided into 3 classes. The results of PCA indicated that the first three principal components （PCs） could represent the 15 common peaks. According to the scores of 3 PCs, 12 batches of samples could be divided into three categories. The classification result was mainly affected by the components of Corydalis Rhizoma. The classification results of three methods were basically the same. Based on the combination of three methods, 12 samples can be divided into three grades in the aspect of quality. It was concluded that the quality differences of YHZT tablet from different manufacturers were obvious. The combining application of three methods can be used in the evaluation on fingerprint of samples from different sources and influence factor analysis. It can be used as an effective method for quality evaluation.

关 键 词：元胡止痛片 指纹图谱 相似度分析 聚类分析 主成分分析 

分 类 号：R284[医药卫生—中药学]