分析筛分法评估粒度分布.docVIP

?786? PARTICLE SIZE DISTRIBUTION ESTIMATION BY ANALYTICAL SIEVING 用分析筛分法估计粒度分布 Sieving is one of the oldest methods of classifying powders by particle size distribution. Sieving is most suitable where the majority of the particles are larger than about 75 μm, although it can be used for some powders having smaller particle sizes where the method can be validated. In pharmaceutical terms, sieving is usually the method of choice for classification of the coarser grades of single powders. It is a particularly attractive method in that powders are classified only on the basis of particle size, and in most cases the analysis can be carried out in the dry state. 筛分法是按粒子大小分布将粉末分类的最古老的方法之一。筛分法最适宜多数粒子大于75微米的粉末，尽管它也可以用于粒子更小的一些粉末，那样此方法能被验证。在制药学上，筛分法通常是作为将更粗糙的单粉分类的选择。对于仅以粒子大小为基础进行分类的粉末来说，筛分法是绝好的方法，而且在大多数情况下，分析能在干燥状态下进行。 Among the limitations of the sieving method are the need for an appreciable amount of sample (normally at least 25 g) and difficulty in sieving oily or other cohesive powders that tend to clog the sieve openings. The method is essentially a two-dimensional estimate of size because passage through the sieve aperture is frequently more dependent on maximum width and thickness than on length. 筛分法的局限性是：它需要一定重量的样粉（通常为至少25克），而且它对筛分容易堵塞滤网小孔的油性或其它粘性粉末存在困难。筛分法本质上是一种两维大小估计，因为能否通过滤网小孔更多地取决于最大宽度与厚度而非长度。 This method is intended for estimation of the total particle size distribution of a single material. It is not intended for determination of the proportion of particles passing or retained on one or two sieves. 此方法用来估计单一物料的总体粒子大小分布。它并不是用来测定粒子通过或未通过一个或两个滤网的比例。 Estimate the particle size distribution as described under Method I, unless otherwise specified in the individual monograph. Method I is the dry sieving method. Where difficulty is experienced in reaching the endpoint (i.e., material does not readily pass through the sieves) or when it is necessary to use the finer end of the sieving range (below 75 μm), Method II, which is a wet sieving technique, may be used; however