药物粉体辊压成型技术的研究进展

Research Progress on Roll Compaction Technology of Pharmaceutical Powder

药物粉体的辊压成型是干法制粒技术的核心步骤。药物粉体经过一对反向旋转的轧辊压制后形成片体,片体的相对密度决定了药物颗粒的收率。出料片体的相对密度与操作参数和物料参数有关。在生产中,通过对相关参数的选择,实现对片料密度的精准控制从而达到最高的生产效率是本领域研究的重要目的。笔者首先介绍了粉体辊压成型的Johanson模型及其修正模型,指出理论模型存在假设过多的问题;其次介绍了采用数值计算方法研究药物粉体辊压成型的相关工作,对数值计算方法的优缺点进行了评述;最后介绍了试验方法研究操作参数对片体相对密度的影响。此外,笔者还展望了未来药物粉体辊压成型技术新的研究方向,指出建立三维理论模型将理论计算、数值计算和试验分析相结合是研究药物粉体辊压成型问题的发展趋势。

Roll compaction of pharmaceutical powder is an important procedure in dry granulation progress. The drug powder is pressed by a pair of backward rotating rollers to form sheet material,which the yield of drug particles are determined by the relative density of the sheet material. The relative density of the material is related to the operating parameters and material parameters. It is an important purpose of this research to achieve the highest production efficiency by precisely controlling the density of sheet materials through the selection of relevant parameters in the actual production. Firstly,Johanson model and its modified model of powder roll compaction were introduced and the problem that there were too many hypotheses in the theoretical model was pointed out. Secondly,the progress of roller compacting using the numerical calculation method was presented and both the advantages and disadvantages were reviewed. Finally,the experimental method was introduced to study the effects of operating parameters on the relative density of the sheet material. In addition,this paper also looked forward to the new research aspects of the future pharmaceutical powder roll compaction technology,and pointed out that the establishment of a three-dimensional theoretical model combining theoretical calculation,numerical calculation and experimental analysis was a new direction of theoretical research on roll compaction of pharmaceutical powders.