Chan L W, Lee C C, Heng P W S
Department of Pharmacy, National University of Singapore, 10 Kent Ridge Crescent, Singapore 119260.
Drug Dev Ind Pharm. 2002 Sep;28(8):939-47. doi: 10.1081/ddc-120006426.
Circularity, aspect ratio, modelx, and pellips were employed to study the effects of process parameters, namely varying feed loads and rotational speeds of the classifier wheel, of the fluidized bed opposed jet mill on the shape of the micronized particles produced. The Shapiro-Wilk statistical test showed that 80.0% of the shape distributions of the four descriptors were not normal. Therefore, the Kruskal-Wallis test, which is a nonparametric statistical test, was employed to analyze the data. Micronized particles were more spherical and less elongated, as indicated respectively by higher median circularity and lower median modelx values when compared to unmilled lactose. These descriptors were able to indicate that the particles had been micronized. When feed loads of 250 and 350 g were used, increasing the rotational speed of the classifier wheel was found to bring about a decrease in span values of all the shape descriptors, indicating that the micronized particles were more uniform in shape. Micronized particles produced had lower median aspect ratio values than the unmilled lactose, whereas a higher feed load of 450 g resulted in the production of micronized particles that were less uniform in shape and more elliptical in nature, as reflected by the lower median pellips values. A higher feed load of 450 g caused a high level of impingement of particles on to the rotating classifier wheel, causing decreased classifier wheel efficiency, and this resulted in a less well-controlled micronization process. Thus, aspect ratio and pellips were sensitive to the changes in performance of the classifier wheel. The four shape descriptors were proposed to be used collectively as indicators for the monitoring of the micronization process.
采用圆度、长宽比、modelx和pellips来研究流化床对喷式气流粉碎机的工艺参数(即不同的给料量和分级轮转速)对所产生的微粉化颗粒形状的影响。夏皮罗-威尔克统计检验表明,这四个描述符的形状分布中有80.0%不呈正态分布。因此,采用非参数统计检验的克鲁斯卡尔-沃利斯检验来分析数据。与未研磨的乳糖相比,微粉化颗粒更接近球形且伸长率更低,分别表现为更高的中位圆度和更低的中位modelx值。这些描述符能够表明颗粒已被微粉化。当使用250 g和350 g的给料量时,发现增加分级轮的转速会使所有形状描述符的跨度值降低,这表明微粉化颗粒的形状更均匀。所产生的微粉化颗粒的中位长宽比值低于未研磨的乳糖,而450 g的较高给料量导致所产生的微粉化颗粒形状更不均匀且更接近椭圆形,这由更低的中位pellips值反映出来。450 g的较高给料量导致颗粒大量撞击旋转的分级轮,从而降低分级轮效率,进而导致微粉化过程控制不佳。因此,长宽比和pellips对分级轮性能的变化很敏感。建议将这四个形状描述符一起用作监测微粉化过程的指标。