SimiaoYong'an decoction, a traditional Chinese medicine formula consisting of four herbs, has been widely used for the treatment of gangrene disease. However, its clinical application is restricted due to the lack of an effective quality control method that covers the main active compounds in the formula. In this study, a high-performance liquid chromatography with diode-array detection (HPLC–DAD) method was established for the simultaneous determination of 13 active compounds including harpagide, neochlorogenic acid, chlorogenic acid, cryptochlorogenic acid, ferulic acid, isochlorogenic acid B, isochlorogenic acid A, isochlorogenic acid C, angoroside C, harpagoside, cinnamic acid, glycyrrhizic acid, and ligustilide. Separation of these compounds was achieved using a Kromasil 100-5-C18 column with a gradient elution program consisting of acetonitrile and 0.4% phosphoric acid solution. The specificity, linearity, precision, repeatability, and accuracy tests were implemented to validate the method. The validated method was successfully applied for determination of 13 components from several finished batches of SimiaoYong'an decoction. The results demonstrated that the established method was accurate, reliable, and could be used as a suitable quality control method for the quantification of SimiaoYong'an decoction.
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Bao-Yuan Decoction (BYD), a widely used traditional Chinese medicine formula, is worth developing into modern dosage forms. To assess the quality of traditional decoction, the commonly used ultra-performance liquid chromatography coupled with diode array and evaporative light scattering detection (UPLC-DAD/ELSD) method was initially applied to develop the analytical methods for the qualitative fingerprints and simultaneous quantitation of multiple marker compounds in BYD. Based on 16 batches of BYD prepared from multiple batches of qualified crude herbs combined randomly, the characteristic fingerprints were generated, with 41 and 19 common peaks detected by DAD and ELSD, respectively. Furthermore, ginsenosides Re, Rg1 and Rb1, calycosin-7-glucoside, calycosin, liquiritin, isoliquiritin apioside, isoliquiritin, glycyrrhizic acid and cinnamic acid were qualified as marker compounds to represent the herbs composing the formula. The characteristic fingerprints and the content ranges of multiple batches of the decoction were obtained, thus providing guidance for the quality control of modern dosage forms. The combination of these qualitative and quantitative methods will be an effective operational measure by which to evaluate and control the quality of BYD from traditional decoction to modern dosage forms.
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