CAJ | 학술논문

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。
목적：건립원호지통편적HPLC지문도보분석방법，평개불동엄가적원호지통편질량。방법：구건10개엄가공12비원호지통편HPLC지문도보，대공유봉화학성분진행질보해석，병결합상사도분석、취류분석화주성분분석대지문도보진행분석。결과：대HPLC지문도보중적15개공유봉진행결구감정，기중12개성분래자연호색，3개성분래자백지；12비원호지통편지문도보상사도치범위재0.498-0.999지간，가이장양품분위3류；취류분석결과장12비양품분위3대류；주성분분석채용3개주성분대표15개공유봉신식，장12비양품분위3류，분류결과주요수연호색성분영향。3충분석방법대12비차양품분류결과기본일치，결합3충분석방법결과가이장12비양품안조질량차이분위삼급。결론：불동엄가적원호지통편질량차이교현저，상사도분석방법결합취류분석여주성분분석방법균가이대불동엄가적지문도보진행분석평개，병심입분석양품차이적영향인소，가이작위불동엄가양품질량평개적일충유효수단。
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.