Study On Preparation Technology And Quality Standard Of Ginseng Fermentation Dropping Pills

Objective:In order to expand the medicinal resources of ginseng and improve the utilization value of ginseng,biological transformation technology was used in this experiment to obtain ginseng fermented product from ginseng fermentation,isolate and purify the effective parts of ginseng fermented product,study its pharmacological activity,and study the formulation process and quality standard of effective parts.In order to establish a stable and reliable quality standard,the analysis of the chemical composition of effective parts is beneficial to the research and development of drop pills.Methods:In order to optimize the best factors and their range,this experiment first selects the drop distance,drug-to-matrix ratio,melting temperature,matrix ratio and condensing agent as single factor investigation content,and selects the factors and scope by using single factor method.According to the factors and ranges preferred in the single factor method,the optimal preparation process of the water-saturated n-butanol partial dropping pills of the ginseng fermented product is determined by the response surface method.Thin layer chromatography,silica gel column chromatography,ODS column chromatography and semi-prepared liquid phase were used to separate and purify water-saturated n-butanol of ginseng fermented product.The physicochemical properties and spectral data were used to identify the water-saturated n-butanol compound structure of ginseng fermented product.Results:Seven compounds were isolated and identified from the water-saturated n-butanol fraction of ginseng fermented product:ginsenoside Rh21(1),ginsenoside Rg1(2),ginsenoside Re(3),20-o-glu-ginseng Saponin Rf(4),ginsenoside Rd(5),ginsenoside Rc(6),ginsenoside Rb1(7).0.9374>0.05 indicates that the theoretical and practical fit is large of response surface,indicating that the model can reflect the true value of the experiment well.The experimental results from the response surface show that the A factor(P=0.0034<0.01)is significantly higher,the C factor(P=0.0115<0.05)and AC(P=0.0355<0.05)are significant,and A~2,B~2and C~2have significant.The optimal process was initially determined as:drug to substrate ratio=1:4.2,drop distance=5.9cm,melting temperature=81~0C.Conclusion:The preparation technology of dropping pills is reasonable and feasible.Based on the analysis of the chemical composition of water-saturated n-butanol,the quality standard with accurate content,stable quality and feasible method was established,which provided a strong support for the research and development of the dosage form.