CRCU

Chemical Research in Chinese Universities ›› 2011, Vol. 27 ›› Issue (5): 756-763.

• Articles • Previous Articles     Next Articles

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

YI Yue-neng1,2,3, CHENG Xue-mei2, LIU Ling-an3, HU Gao-yun4, CAI Guang-xian5, DENG Yi-de2,3, HUANG Ke-long1* and WANG Chang-hong2*   

  1. 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, P. R. China;
    5. Laboratory of Chinese Internal Medicine, Hunan University of Chinese Medicine, Changsha 410007, P. R. China
  • Received:2010-11-19 Revised:2011-03-03 Online:2011-09-25 Published:2011-09-06
  • Contact: HUANG Ke-long;WANG Chang-hong E-mail:klhuang@mail.csu.edu.cn; wchcxm@hotmail.com
  • Supported by:

    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) and the Foundation of Hunan Educational Committee, China(No.09CY001).

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Abstract: 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.

Key words: Si-Mo-Tang oral liquid preparation, Quality consistency evaluation, High-performance liquid chromatography(HPLC) fingerprint, Quantitative determination