Study and Evaluation of Mupirocin Ointment in Vitro Release
OBJECTIVE To establish an evaluation method for the release of mupirocin ointment in vitro,according to the quali-ty research of ointment preparations at home and abroad and the technical guidelines for generic drugs.METHODS The diffusion cell method was adopted,the release membrane was polyethersulfone membrane,the receiving medium was sodium dihydrogen phos-phate buffer solution with pH 7.4,the rotation speed was 600 r·min-1,and the sample size was 300 mg.The concentration of mupirocin in the receiving solution at different time points was determined by HPLC method,and the cumulative release and release rate were calculated.The particle size morphology and particle size distribution of mupirocin ointment from different manufacturers were determined by particle size analyzer.The viscosity of preparations from different manufacturers was determined by rheometer.RESULTS The determination method for the release of mupirocin ointment in vitro was established,and the precision,durability and discrimination of this method were good,and the consistency evaluation was made for preparations from different manufacturers.There were great differences in particle size distribution and viscosity between different manufacturers.CONCLUSION The differences in particle size distribution between different manufacturers reflect the differences in preparation production process,and the differences in viscosity reflect the differences in preparation prescription,both of them can affect the release rate of mupirocin ointment in vitro.
mupirocin ointmentdiffusion cellin vitro releaseparticle size distribution