高剪切技术工艺参数对维生素E颗粒形成的影响

目的研究高剪切制粒技术在油性药物维生素(vitam in E,VE)制粒过程中的主要影响因素。方法以颗粒粒径、分布及各粒径范围内VE含量分布的相对标准偏差(RSD/%)为指标,对高剪切制粒中黏合剂用量,搅拌桨转速及捏合时间的3因素2水平进行完全析因设计实验。结果3个因素均为影响制备VE颗粒过程和最终产品质量的关键性参数,而且搅拌桨转速和捏合时间之间对VE的含量均匀度有非常显著的交互作用。结论控制高剪切制粒过程的技术参数,可以改善油性药物(VE)颗粒的含量均匀度。

Influence of process parameters of high shear granulation on the solidification of oily drug vitamin E

Objective To investigate the influence of process parameters of high shear granulation on the solidification of oily drug with high viscosity taking vitamin E as a model drug. Methods The particle size distribution and drug content uniformity were evaluated with the RSD/% of drug content among different size fraction of granules as the unique response. Based on the results of influence factor tests, full factorial design was applied. The parameters subjected to study were amount of liquid, impeller speed and kneading time. Results The three factors were all greatly important to control the solidification process of Vitamin E. And there were extremely complicate effects between impeller speed and kneading time on drug content uniformity. Conclusions It is feasible to improve oily drug content uniformity by optimizing the process parameters of high shear granulation.