| Objective: Department of Schisandra chinensis is the dried ripe fruit,Chinese medicine that has Sedative,astringent,Yiqi Sheng Jin,tonifying kidney effect.In recent years,domestic and foreign scholars found that Schisandra natural active ingredients(schisandrol,schisandrin A and schisandrin B)lignans in sedation hypnosis,protect nerve cells,antioxidation and liver protection,reducing serum ALT,AST and TG have a certain effect.The topic is to select the appropriate prescription made from the fruit of the chewing tablets,while the establishment of accurate and reliable quality control methods for the preparation of the relevant quality control,and related to the stability of the inspection.Methods: This experiment in selecting extraction method using orthogonal design method comparison of percolation,back-flow,decoction on content of lignans in Schisandra,optimized prescription by central composite design and response surface optimization method.The influences of some auxiliary materials in the prescription method to determine the type and amount of the single factor,combined with experimental design method,system analysis focuses on the influence factors on the prescription.By comparison of the hardness of preparation and taste,in order to optimize the central composite design response surface methodology to optimize the amount of excipients.At the same time as the Schisandra chewable tablets established quality control method is accurate and reliable.According corresponding moisture absorption test to provide relevant information for production and storage of our products.Results: The final test weight is set to 1 g,the drug content of Schisandra raw material is 430 mg,the final prescription: Schisandra extract 160 mg;sucrose 411 mg;aspartame 16 mg;calcium hydrogen phosphate 406 mg;citric acid 5 mg;menthol2 mg.To determine the chromatographic conditions of three kinds of lignans in Schisandra detection: selection of reverse column chromatography on silica gel KromasilC18 column,the detection wavelength was 250 nm.The column temperature Was 25 degrees,flow rate was 1.0 mL/min,mobile phase of methanol: acetonitrile: water =2:1:1,under this condition of Schizandrol Ashowed a good linear relationship in the 3.92~49 μg/mL range,schisandrin A in 0.99~19.8 μg/m L and schisandrin B in the range2.1~25.2 μg/mL showed a good linear relationship.Drug content determination results conform to the requirments,the method was of high specificity,high accuracy and easy to operate,this method can determine the sample content effectively.Conclusion: Schisandra lignans the optimized extraction method is simple,saving solvent;preparation of Schisandra chewable tablets in good shape,good taste,content uniformity;HPLC method with good specificity,and can be used to determine the content of three kinds of Schisandra. |
