高剪切制粒工艺优化及质量评价

High shear granulation process optimization and quality evaluation

目的在固体制剂生产工艺转移过程中,以一个产品A为例,优化影响颗粒性质的关键工艺参数。方法通过检测产品A的颗粒粒度分布、松密度、Carr指数和片子硬度等性质,优化制剂产品工艺及控制制剂产品质量。结果采用高剪切制粒工艺,其湿混时间是影响产品性质的一个重要因素。结论控制湿混时间为2 min,150μm筛上颗粒比例在54%~59%内,松密度在640~690 g·L^(-1)内,Carr指数在14%~16%内,素片硬度为36~45 N,产品质量稳定,能够符合产业化生产要求。

Objective During the technology transfer, the quality of product A could be controlled by optimizing the critical process parameter of wet mixing time. Method Through quality test of the product A including the particle size distribution、bulk density and the tablet hardness, the production process can optimized and product quality can be controlled. Result The results show that the wet mixing time is an important factor for the high shear granulation. Conclusion The optimal wet mixing time is 2 min and the properties of product are: the percent of particle above 150 μm sieve is about 54%-59%, the bulk density is 640-690 g·L^(-1), the Carr index is 14%-16%, the tablet hardness is 36-45 N. The quality of products is stable, conforming to the production requirement.