Objective:To explore the preparation technique of ketoconazole
microcapsules and the methods of quality control and to study
the pharmaceutical characteristics.Methods:The
complex coacervation,UV spectrometry,orthogonal design,accelerated and long-term tests and rotating basket method were all employed.Results:The average encapsulating rate of ketoconazole
microcapsules was about 83.42%and the mean diameter was 7.73um.The wavelength for ketoconazole content assay was 269nm.In artificial gastric juice,the linear relation was good at the concentration ranging from 0.05mg/ml to 0.15mg/ml and the intraday and interday coefficient RSD were 2.57%and 0.40%,respectively.In the condition of high temperature,high humidity,strong light or long-term room temperature,the ketoconazole in microcapsules showed stable physical and chemical property,on the other hand,ketoconazole powder had a lot of changes in both concentration and color in the same condition.The dissolution of ketoconazole microcapsules in the simulated gastric fluid obeyed the Weibull Distribution. Approximate 90% ketoconazole was released from microcapsules within 90 minutes.The parameters were:t 2/1 =25min,t d=42min,m=0.6min;howerer,the ketoconazole powder released more than 95% ketoconazole within 10 minutes in the same solvent.Conclusion:The preparation of ketoconazole microcapsules is simple and has high loading rate.The way of quantitative assay of ketoconazole microcapsules is reliable and reproducible,the microencapsulation of ketoconazole can improve the stability of ketoconazole and the releasing of ketoconazole from the microcapsules is more sustained than that of ketoconazole powder.