Nakamori Takahiko, Miyagishim Atsuo, Nozawa Yasuo, Sadzuka Yasuyuki, Sonobe Takashi
ROHTO Pharmaceutical Co., Ltd., 1-8-1 Tatsumi Nishi, Ikuno-ku, Osaka, 544-8666 Japan.
Int J Pharm. 2008 Apr 16;354(1-2):255-9. doi: 10.1016/j.ijpharm.2007.11.043. Epub 2007 Nov 29.
Effects of loads applied to a powdery layer of a mixture of lactose and crystalline cellulose (granules) on the microparticle formation were evaluated. In a 1:1 mixture, the number of particles size, 20 microm or smaller in diameter, was reduced under loading compared with the standard value. It tended to increase with increasing ratio of lactose. In samples with a particle size of 350 microm or less, the shear friction coefficient increased with increase in the load, reached a peak at a mixing ratio of 50%, and decreased with increase in the mixing ratio. These changes were similar to those of the number of particles 20 microm or smaller. These results suggest that particle formation and aggregation under loads are dependent on the mixing rate and that there is a range of mixing rates in which no changes in the particle size distribution are observed.
评估了施加于乳糖和结晶纤维素（颗粒）混合物粉末层上的负荷对微粒形成的影响。在1:1的混合物中，与标准值相比，负荷下直径20微米或更小的颗粒数量减少。其数量倾向于随着乳糖比例的增加而增加。在粒径为350微米或更小的样品中，剪切摩擦系数随负荷增加而增加，在混合比为50%时达到峰值，并随混合比增加而降低。这些变化与直径20微米或更小的颗粒数量的变化相似。这些结果表明，负荷下的颗粒形成和聚集取决于混合速率，并且存在一个混合速率范围，在该范围内未观察到粒度分布的变化。
