摘要
[目的]改善山梨糖醇流动性,以用作直接压片原料.[方法]对XTAB290型结晶山梨糖醇进行筛分,并对50目以下颗粒进行沸腾制粒或湿法制粒,以激光粒度仪、智能粉体测试仪分别测定不同加工处理颗粒的粒径分布和流动性.[结果]经处理后颗粒流动性均较好,可满足直接压片的要求.其中,筛分后的山梨糖醇粒径50目以上颗粒流动性指数显著提高,可满足直接压片的要求.50目以下颗粒经沸腾制粒或湿法制粒后,流动性指数明显改善,亦可满足直接压片的要求,二者粉体特征及其流动性差异较小.处理后的山梨糖醇颗粒流动性指数分别为89,83,87.[结论]山梨糖醇XTAB290经筛分后的 50目以上颗粒、50目以下经沸腾制粒或湿法制粒后,颗粒流动性均较好,可满足直接压片的要求.
Abstract
[Objective]This study aimed to improve the fluidity of sorbitol to be used as a raw material for direct tablet pressing.[Methods]XTAB290 crystalline sorbitol was sieved,and particles smaller than 50 mesh were further processed by fluidized bed granulation or wet granulation.The particle size distribution and fluidity of sorbitol were determined using a laser particle size analyzer and an intelligent micromeritics properties tester,respectively.[Results]The results showed that the flowability of the particles treated by all methods was good enough to meet the requirements for direct compression.Specifically,the sieving treatment significantly improved the flowability index of sorbitol particles with a particle size of 50 mesh or larger,which met the requirements for direct compression.Fluidized bed granulation or wet granulation further improved the flowability index of particles smaller than 50 mesh,which also met the requirements for direct compression.The differences in micromeritics and flowability between the two methods were relatively small.[Conclusion]The fluidity of sorbitol XTAB290 particles with more than 50 mesh after screening,and particles with less than 50 mesh after boiling or wet granulation is good,which can meet the requirements of direct tablet pressing.
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