Measurment Of The Basal Crystallization Data And A Study On The Dilution Crystallization Technology Of Ibuprofen

Ibuprofen is widely used as antipyrotic and antirheumatic drugs. Up to now, there are somedifferences between the homemade and the overseas ibuprofen products in terms of the crystalhabits and the size distribution. In industrial manufacture of ibuprofen, crystallization is one of thekey processes that decide the product quality. Therefore, in order to improve the quality ofibuprofen, a systematic research on the crystallization process was carried out in this thesis.Producers pay more attention to the crystal habit of ibuprofen, because its shape has a majorimpact on its downstream processing (such as filting, washing and drying) and the quality of theend-product. The effects of the crystallization method and other factors such as temperature andsolvent on the crystal habit of ibuprofen were firstly investigated by SEM analysis. The diffractiondata of the ibuprofen crystal was collected by X-ray diffraction technique. Using the softwareCerius2, the ideal crystal habits of ibuprofen under vacuum condition and considering the effectsof solvent were determined, respectively.The solubilities of ibuprofen in the mixture solvents of ethanol and water were determined bythe static method and the effects of temperature, the volume ratio of the two solvents weresystematically investigated. The crystallization metastable zone and the induction period ofibuprofen in different solvent systems were determined. The interfacial tension was estimated bythe induction period data with the classical nucleation theory and then the crystal growthmechanism was discussed.The crystallization kinetics is one of the basic data for the study of the crystallizationbehavior and the scale-up and design of crystallizer. The crystallization kinetic equations of thediluent crystallization process of ibuprofen were obtained according to the population balancetheory and the mass balance equation. Then the effects of the supersaturation, the suspensiondensity and the stir speed on the crystallization process were analyzed.To improve the quality of the product and the crystal size distribution, the effects ofcrystallization conditions (such as the crystallization temperature, seeding, the addition rate of thediluent, the stir speed) on the crystallization process of ibuprofen were experimentally studiedsystematically. As a result, the relatively optimum operation schedule was found.The paper supplied a data basis for the further study and the industrial crystallizationproduction of ibuprofen. No similar research report has been published yet.