Determination of Particle Size of Clostridium Butyricum Enterococcus Triple Viable Powder by Laser Light Scattering Method / 中国药师

ABSTRACT

Objective:To establish a laser light scattering method for the determination of the particle size distribution of clostridium butyricum enterococcus triple viable powder and compare the results of the sieving method.Methods:The conditions of laser scattering method were as followsthe vibration sampling rate of 80%,the dispersion pressure of 0.05 MPa,the background and sample scan time of 15 s,the shading of 0.5%-5%,the refractive index of the particles of 1.55,the particle absorption rate of 0.01,and the injection volume of 0.1-0.2 g.The eigenvalues of the particle size distribution were determined,which were the particle size cumulative distribution map of 10%,50% and 90% of the particle size value and the volume average particle diameter D.Results:The RSDs of d(0.1),d(0.5) and d(0.9) were less than 5% in the methodology study.The results of laser light scattering method showed that the particle size of 93.3% samples was below 250 μm,that of 64.2% samples was below 150 μm,that of 51.4% samples was below 125 μm,and that of 31.3% samples was below 90 μm.The results of sieving method showed that the particle size of 96.6% was below 250 μm,that of 46.4% samples was below 150 μm,that of 23.5% samples was below 125 μm,and that of 1.4% samples was below 90 μm.Conclusion:Sieving method and laser light scattering method both can characterize the particle size distribution of the sample.The laser light scattering method is simple,accurate and producible,which is suitable for the particle size control of clostridium butyricum enterococcus triple viable powder.