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Yi Y.-N.,Central South University | Yi Y.-N.,Shanghai University of Traditional Chinese Medicine | Yi Y.-N.,Hunan Hansen Pharmaceutical Co. | Cheng X.-M.,Shanghai University of Traditional Chinese Medicine | And 7 more authors.
Chemical Research in Chinese Universities | Year: 2011

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, nobi-letin, 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.

Yi Y.-N.,Central South University | Yi Y.-N.,Hunan Engineering and Technology Research Center for Gastroenterological Drugs | Yi Y.-N.,Hunan Hansen Pharmaceutical Co. | Cheng X.-M.,Shanghai University of Traditional Chinese Medicine | And 8 more authors.
Pharmaceutical Biology | Year: 2012

Context: Chinese patent medicine Si-Mo-Tang oral liquid preparation (SMT) is composed of Aucklandia luppa Decne (Compositae), Citrus aurantium Linn (Rutaceae), Lindera aggregata (Sims) Kosterm (Lauraceae), and Areca catechu Linn (Arecaceae). Studies of SMT have been impeded due to the lack of quality control methods. Objective: This study aimed to simultaneously determine three alkaloids including synephrine, arecoline, and norisoboldine in SMT for the first time. Materials and methods: A strong cation exchange (SCX) high performance liquid chromatography (HPLC) method was developed to simultaneously determine synephrine, arecoline, and norisoboldine in SMT, and was compared with ion-pairing chromatography using regular reversed-phase chromatography columns. System suitability parameters of synephrine, arecoline, and norisoboldine using the SCX chromatography column were investigated. Results: Results demonstrated that good separations were achieved on an Agilent SCX (250 × 4.6 mm, 5 μm) column at 35°C. The mobile phase consisting of methanol-0.2% phosphoric acid was delivered at a constant flow of 1.0 mL min-1 and the eluent was monitored at 215 nm. The HPLC method showed good linearity for the examined concentration ranges of 2.55-255.0, 1.30-208.0, and 2.06-201.6 μg mL-1 for synephrine, arecoline, and norisoboldine, respectively. The limits of quantification (S/N = 10) were 2.55, 1.30, and 2.06 μg mL-1, the limits of detection (S/N = 3) were 1.53, 0.78, and 1.21 μg mL-1, and average recoveries were 98.99, 95.63 and 99.04%, respectively, for synephrine, arecoline, and norisoboldine. Discussion and conclusion: This method has been successfully applied to determine synephrine, arecoline, and norisoboldine in Chinese patent medicine SMT. © 2012 Informa Healthcare USA, Inc.

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