| Summary: | 碩士 === 國立中正大學 === 化學工程所 === 96 === Abstract
The thesis used effervescent compounds (tartaric acid) treats as the control drug release factor, carries on the powder layer technology proceed drug layer and membrane coating manufacture multilayer membrane controls releases pellets; Used the differential scanning calorimeter (DSC) and the Fourier transform infrared spectrometer (FTIR) carries on the qualitative analysis, the microscope proceed to each differ layer appearance analysis, and the union yield analysis, roundness analysis, assay analysis, stability study, and carries on the dissolution test, using f1 (different factor), f2 (similarity factor) formula, and the analysis drug in pellet in controls releases the behavior performance.
Finally find between the drug layer and the start core (tartaric acid) uses the natural polymer material (acacia powder) to treat as the isolation layer is feasible, moreover the amount of 4.7% is most suitable; Controls releases layer after to demonstrate uses 4.5% (20mg/total weight (440mg)) Eudragit S100 to control drug releases is better than mixing the two polymer (Eudragit S100 and HPMCP), the dissolution profile and RLD dissolution profile is approximate; After proceed to f1 and the f2 comparison can explicitly prove two similarities; Controls releases pellet assay test talk us the coating effect have good coating yield (all formula have about 97%), moreover storage 3 months (40℃, 75% RH) proceed to test stability also very good result (initial is 101.1%, after 3 months is 101.4%).
The combined experiment result, demonstrates the use fluidized bed, moreover controlled by Eudragit S100 as control layer model to production multilayer membrane control pellet, controls the drug release to achieve the control release mechanism is feasible.
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