Study On Preparation And Quality Evaluation Of Solid Dispersion Of Ginseng Fermentation Products

Objective:A new traditional Chinese medicine raw material,n-butanol fraction of ginseng fermentation products?GMN?,has been prepared,and its pharmacodynamic material basis has been clarified.GMN solid dispersion was prepared to improve its solubility and bioavailability,and its quality was evaluated.Methods:Ginseng was biotransformed by solid fermentation,and the fermentation products of Ginseng were obtained.The main components of ginseng fermentation products were roughly separated by extraction and GMN was obtained.GMN was separated and purified by chromatographic method,and the substance basis of raw materials was analyzed by spectral analysis method.Solid dispersion technology was used to improve the water solubility and low bioavailability of GMN.The dissolution rate,differential scanning calorimetry and infrared spectroscopy were used to evaluate the quality of solid dispersion.Results:Ginseng fermentation products were obtained by biotransformation,and GMN was selected as raw material for solid dispersion preparation.Saponins in GMN were separated by chromatography column.The structures of 13 saponins were identified by physicochemical properties,thirteen compounds were identified as notoginsenoside R₂?1?,20-?S?-ginsenoside-Rf?2?,20-?S?-ginsenoside-Rg₂?3?,ginsenoside-Rc?4?,gypenoside-X??5?,ginsenoside-Rb₃?6?,20-?S?-ginsenoside-Rh₁?7?,20-?R?-ginsenoside-Rg₂?8?,20-?R?-ginsenoside-Rh₁?9?,ginsenoside III?10?,notoginsenoside E?11?,ginsenoside-Rd?12?,ginsenoside-F₂?13?.A method for the determination of ginsenoside Rd in GMN in vitro was established.This research used the dissolved method to prepare the solid dispersion and chose PVP K300 as the carrier by comparing the solubility and dissolution of different water-soluble carriers?PEG 4000,PEG6000 and PVP K30?,determining the ratio of 1:5 by comparing the solubility and dissolution of different drug-carrier ratio.The formation of solid dispersion was confirmed by the determination of dissolution rate,differential scanning calorimetry and infrared spectroscopy.The solubility of solid dispersion reached 0.098 mg/mL,nearly 13 times higher than that of raw drug,and the dissolution reached 83.21%at 45 min,which improved its solubility and bioavailability.Conclusion:The material basis,preparation method and quality evaluation of the solid dispersion of GMN,a new traditional Chinese medicine raw material,were studied in order to provide a basis for the development and innovation of ginseng medicinal materials by biotransformation.