高剪切方法制备穿心莲干浸膏颗粒的影响因素考察

Influence of process parameters of high shear granulation through preparing creat extract with different flowability

目的以3批流动性不同的穿心莲干浸膏为模型药,研究高剪切方法在制粒过程中的主要影响因素。方法分别以3批穿心莲干浸膏为原料,以颗粒粒径分布及各粒径范围内脱水穿心莲内酯含量分布的相对标准偏差(RSD%)为指标,对高剪切制粒过程中黏合剂用量、搅拌桨转速及制粒时间进行三因素两水平完全析因设计实验。结果黏合剂用量及制粒时间对3批流动性不同穿心莲干浸膏制得颗粒的几何平均粒径均有显著影响;流动性较差穿心莲干浸膏进行高剪切制粒时,最终颗粒群中脱水穿心莲内酯含量均匀度受搅拌桨转速影响程度最大;浸膏流动性不同,三因素之间交互作用有所不同。结论控制高剪切制粒过程的技术参数,可以改善流动性不同的中药浸膏制得颗粒的粒径分布及含量均匀度。

Objective To investigate the influence of process parameters of high shear granulation on the granulation process for the extract of traditional Chinese medicine with different flowability, taking creat extract as a model drug. Methods The particle size distribution and drug content uniformity were evaluated. The RSD% of drug contents among different size fraction of granules was as the unique response of drug content uniformity. Full factorial design of creat extract with different flowability was applied. The parameters subjected to study included the amount of liquid,impeller speed and kneading time. Results Amount of liquid and kneading time influenced the geometric diameter significantly. For the creat extract with poor flowability, impeller speed was the most important factor to influence the dehydroanddrographolide uniformity. The three factors were all greatly important for the control of the granulation process of creat extract. Conclusions It is feasible to improve particle size distribution and drug content uniformity of particles prepared from extract with different flowability by optimizing the process parameters of high shear granulation.