Prepatation And Evaluation Of Xiaoshi Zhixie Granules

Subject:To preparate and evaluate the Traditional Chinese Medicine named Xiaoshi zhixie Granules used to remedy Diarrhea in children,and then,study on its preparation process, quality standard and preliminary stability.Methods:Pharmaceutical indicators was used as an indicator to screen the preparation route; Study on the extraction-. concentration、 drying and molding process by single factor experiment and orthogonal experiment, And investigate the stability of the preparation. Appropriate identification of four Herbs were made by TLC; Magnolol, Honokiol and Berberine were measured respectively by HPLC.Results:The best preparation technology was:Crushing Medicated leaven and Hordeum into powder, reserving it; take the coptis meal (cross20mesh), add eight times of0.5%sulfuric acid, warm immersion extraction stir2times under80℃,2.0hours each time, the filtrate aside, washing the filter residue with80℃above hot water, the combined filtrates from filtration and the washings are concentrated. The concentrated solution was regulated to adjust pH value to1.5～2.0with hydrochloric acid, add sodium chloride which content to10%at the same time. After12hours’ standing, drying the inclusion under reduced pressure and reserving it; take Magnolia officinalis, Atractylodes lancea, Citrus reticulata Blanco and Crataegus pinnatifida,70%ethanol heating backflow with6times quantity for2hour, extracting3times, The combined filtrates was concentrated to the relative density was1.10～1.15(60℃). Mix the above dry matter, and add Sucrose powder and Dextrin to1000g, Spray drying, blending, Packaging. Spots were obtained from the test solutions and without interference. The content of Magnolol and Honokiol was no less than1.2mg/g and the purity of Berberine was no less than5.6mg/g.Conclusion:The preparation process of the Xiaoshi zhixie Granules was steady; the quality of the Granules can be controlled and the determination methods can be reproduced.