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The Preliminary Study on Total Saponins of Astragalus Sustained-released Tablets

Author: LeiXiang
Tutor: PanXiGui
School: Wuhan University
Course: Pharmacy
Keywords: Radix D101 macroporous resin Sustained Release Tablets Quality Control Stability
CLC: TQ461
Type: Master's thesis
Year: 2005
Downloads: 212
Quote: 1
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Abstract


Purpose: the total astragalosides of preferred Astragalus of active ingredients optimum extraction and refining process to obtain higher purity the total astragalosides raw materials to prepare the total astragalosides sustained-release tablets, quality control standards establish the astragalus the total saponins sustained-release tablets at the same time, investigate its stability, and provide experimental basis for clinical application. Method: This issue through orthogonal experiments and comparative experiments, extracted three influential factors, and different purification methods, Radix indicators screening, of Astragalus alcohol extraction process and refined purification process using ultraviolet spectrophotometry spectrophotometric and HPLC quality control of Radix raw materials in order to obtain higher purity Radix raw. To changes in blood flow parameters, the thrombin time, the blood fibrin number of indicators, and the raw material is preliminary pharmacodynamic studies examine low, medium, and high dose of stasis in rats to confirm that the anticoagulant activity. Total astragalus saponins raw the main drug HPMCK ( 4 m) and the EC as a sustained release matrix material, microcrystalline cellulose for the immediate-release material, the use of uniform design method of total astragalus saponins sustained release Tablets screening, while establishing a the total astragalosides sustained-release tablets quality control standards, and high temperature (60 ° C) and high humidity (25 ° C, 92% relative humidity), the impact factor test and accelerated test (40 ° C, relative humidity of 75%), and examine its initial stability. Results: The experiment preferred the the total astragalosides best extraction process is 70% ethanol extracted twice, the first time plus 8 times the amount of extracted 1.5h the second plus 6 times the amount of extract 1h, while selecting D 101 macroporous adsorption resin resin for the separation and purification. The experiments confirmed by the D 101 macroporous the adsorption resin adsorption, elution solvent 70% ethanol for four times the amount of column volumes of elution better the total saponins purity up to 73.5%. Provisions extracted the total astragalosides raw materials, the total astragalosides purity of not less than 70%. Total astragalus saponins from raw materials to high temperature, high humidity are relatively stable, but extremely hygroscopic, it should be sealed and dry preservation; raw material pharmacodynamic study shows low, medium and high doses can significantly reduce blood viscosity, plasma viscosity, extending prothrombin time, reduce the quantity of blood fibrin. Reliable quality of raw materials can be formulated research. On uniform design the best formulation of sustained-release tablets of preliminary experiments show that the HPMC, EC, the amount of microcrystalline cellulose impact the total astragalosides sustained-release tablets dissolution main factors: the tablet in the main drug 150mg HPMC is 56mg EC 84 mg of 75mg, the MCC also provides film Astragalus saponin content of not less than 90mg, the Astragaloside the content of not less than 4.0mg; 0.5,6,12 hour release were marked The amount of 30% to 35%, 60% ~ 70% and not less than 80%. Total astragalus saponins sustained-release tablets are a more stable temperature and humidity, but it is easy to absorb moisture, it should be placed in a cool, dry place. Conclusion: the the alcohol formulation and D 101 macroporous resin adsorption method can better separation and purification of total astragalus saponins; thin layer chromatography,

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