基于QbD理念的油菜花粉颗粒制备工艺及物理指纹图谱研究

Study on preparation technology and physical fingerprint of rape pollen Granules based on QbD concept

目的基于质量源于设计(quality by design,QbD)理念对油菜花粉颗粒进行制备工艺研究及质量控制。方法以油菜花粉颗粒成型率(%)、休止角(°)、平衡吸湿率(%)为评价指标,通过G1-熵权法组合赋权得到综合评价指标,单因素试验结合Box-Behnken响应面法优化油菜花粉颗粒制备工艺。采用物理指纹图谱评价不同批次油菜花粉颗粒的物理质量一致性并测定临界相对湿度。结果油菜花粉颗粒最佳制备工艺为:淀粉、甘露醇作为填充剂,药辅比1∶2、乙醇浓度55%、辅料配比7∶3。10批油菜花粉颗粒物理指纹图谱相似度均大于0.99。结论基于QbD理念的油菜花粉颗粒制备工艺稳定可行,可用于油菜花粉颗粒的制备。

Objective:To study the preparation technology of rape pollen granules and control its quality based on Quality By Design(QbD).Methods:The comprehensive evaluation index was calculated by assigning weights to the forming rate,angle of repose and equilibrium moisture absorption rate with G1-entropy weight method.The preparation technology of rape pollen granules was optimized by single factor experiment combined with Box-Behnken response surface method.The physical quality consistency of different batches of rape pollen granules was evaluated by physical fingerprint,and their critical relative humidity was determined.Results:The optimal preparation technology of rape pollen granules was as follows,starch and mannitol were usedas fillers,the ratio of drug to excipients is 1∶2,the concentration of wetting agent is 55%,and the proportion of excipients is 7∶3.The similarity of the physical fingerprint of rape pollen granules in 10 batches was more than 0.99.Conclusion:Based on QbD concept,the preparation technology of rape pollen granules is stable and feasible,and it can be used for the preparation of rape pollen granules.