Particle Size Distribution Study of Nifedipine Prolonged-release Tablets Intermediate Products and its Effect on Dissolution
OBJECTIVE To establish a laser diffractometry for determination of the particle size and distribu-tion of nifedipine sustained-release tablet intermediates,and to explore the effect of particle size distribution on the in vitro dissolution of pharmaceutical formulations.METHODS OMEC LS-909 laser particle size analyzer with DPF-110 dry feeder was used.The determination conditions were as follows:measurement time for background of 15s,measurement time for sample of 15s;laser obscuration of 0.50%-5.00%,sample refractive index of 1.584,particle absorbance of 0.01;material density of 1.271 g/cm3,dispersion pressure of 150 kpa,feed speed of 40%,inlet width of 6 mm,and sample volume of 3.0 g.RESULTS The laser diffractometry can accurately determine the particle size distribution of nifedipine sustained-release tablet intermediates,and the precision of the method and the RSD val-ue of the sample meet the requirements;The particle size distribution values d0.5 of 4 batches of self-made samples were 321.458 μm,398.026 μm,417.958 μm and 669.346 μm,respectively.What′s more,the larger the particle size,the slower the dissolution rate of the preparation made.CONCLUSION This method is applicable to the parti-cle size and its distribution determination of nifedipine sustained-release tablet intermediates.And the particle size distribution of particles has a significant effect on dissolution.Therefore,it is essential to carry out particle size control in the production process of pharmaceutical formulations.
万方数据
维普
