HPLC Fingerprint with Multi-components Analysis for Quality Consistency Evaluation of Traditional Chinese Medicine Si-Mo-Tang Oral Liquid Preparation  

作　　者：YI Yue-neng CHENG Xue-mei LIU Ling-an HU Gao-yun CAI Guang-xian DEN G Yi-de HUANG Ke-long WANG Chang-hong 

机构地区：[1]College of Chemistry ＆ Chemical Engineering, Central South University, Changsha 410083, P. R. China [2]Key Laboratory of Standardization of Chinese Medicines, Ministry of Education, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, P. R. China [3]Hunan Hansen Pharmaceutical Co., Yiyang 413000, P. R. China [4]College of Pharmacy, Central South University, Changsha 410083, R R. China [5]Laboratory of Chinese Internal Medicine, Hunan University of Chinese Medicine, Changsha 410007, R R. China

出　　处：《Chemical Research in Chinese Universities》2011年第5期756-763,共8页高等学校化学研究（英文版）

基　　金：Supported by the National Basic Research Program of China(No.2009CB523002);the National Action of Technology Personnel Servicing Enterprise Program of China(No.2009FJ5049);the Foundation of Hunan Science and Technology Committee, China(No.2009XK6032, 2009-152);the Foundation of Hunan Educational Committee, China(No.09CY001)

摘　　要：Si-Mo-Tang（SMT） oral liquid preparation, a traditional Chinese medicine, was prepared from four crude herbal drugs, Fructus Aurantii Submaturus, Radix Aucklandiae, Semen Arecae and Radix Linderae Aggregatae. A combinative method using HPLC fingerprint and quantitative analysis was developed and validated for quality consistency evaluation of SMT. Individual HPLC chromatograms were evaluated against the mean chromatogram generated via a similarity evaluation computer program. Data from chromatographic fingerprints were also processed with principal component analysis（PCA） and hierarchical cluster analysis（HCA）. Additionally, six components （naringin, isonaringin, hesperidin, neohesperidin, norisoboldine and potassium sorbate） in SMT were simultaneously determined to interpret the quality consistency. For fingerprint analysis, 20 peaks were selected as the characteristic peaks to evaluate the similarities of 26 SMT collected from different manufacturers. Among the 20 characteristic peaks, 10 peaks were assigned to be naringin, hesperidin, neohesperidin, isonaringin, neoeriocitrin, tangeretin, nobiletin, norisoboldine, 5-（ethoxymethyl）furan-2-carbaldehyde and potassium sorbate, respectively. The results of similarity analysis, PCA and HCA, indicate that the samples from different manufacturers were consistent with each other in composition. The results from the quantitative data show that the contents of six compounds were significantly different in SMT oral liquid preparations from different manufacturers. The combinative method of chromatographic fingerprint with quantitative analysis developed here offered an efficient way for the quality consistency evaluation of the traditional Chinese medicine SMT.Si-Mo-Tang（SMT） oral liquid preparation, a traditional Chinese medicine, was prepared from four crude herbal drugs, Fructus Aurantii Submaturus, Radix Aucklandiae, Semen Arecae and Radix Linderae Aggregatae. A combinative method using HPLC fingerprint and quantitative analysis was developed and validated for quality consistency evaluation of SMT. Individual HPLC chromatograms were evaluated against the mean chromatogram generated via a similarity evaluation computer program. Data from chromatographic fingerprints were also processed with principal component analysis（PCA） and hierarchical cluster analysis（HCA）. Additionally, six components （naringin, isonaringin, hesperidin, neohesperidin, norisoboldine and potassium sorbate） in SMT were simultaneously determined to interpret the quality consistency. For fingerprint analysis, 20 peaks were selected as the characteristic peaks to evaluate the similarities of 26 SMT collected from different manufacturers. Among the 20 characteristic peaks, 10 peaks were assigned to be naringin, hesperidin, neohesperidin, isonaringin, neoeriocitrin, tangeretin, nobiletin, norisoboldine, 5-（ethoxymethyl）furan-2-carbaldehyde and potassium sorbate, respectively. The results of similarity analysis, PCA and HCA, indicate that the samples from different manufacturers were consistent with each other in composition. The results from the quantitative data show that the contents of six compounds were significantly different in SMT oral liquid preparations from different manufacturers. The combinative method of chromatographic fingerprint with quantitative analysis developed here offered an efficient way for the quality consistency evaluation of the traditional Chinese medicine SMT.

关 键 词：Si-Mo-Tang oral liquid preparation Quality consistency evaluation High-performance liquid chromato-graphy（HPLC） fingerprint Quantitative determination 

分 类 号：O657.72[理学—分析化学] TS871.1[理学—化学]