基于质量源于设计理念的小续命汤提取液喷雾干燥工艺及其物理指纹图谱研究

Study on spray drying process and physical fingerprint of Xiaoxuming Decoction extract based on quality by design concept

目的 基于质量源于设计(quality by design,QbD)理念,建立小续命汤提取液喷雾干燥工艺。方法 采用Plackeet-Burmann设计从药液相对密度、进料速度、进风温度、药液温度和雾化压力中筛选关键工艺参数(Critical Process Parameter,CPP),运用中心点复合设计实验对筛选得到的CPP进行优化,建立小续命汤提取液喷雾干燥工艺设计空间,同时建立物理指纹图谱并进行相似度评价。结果 药液相对密度和药液温度为关键工艺参数,CPP优化后构建的设计空间为药液相对密度1.07~1.10,药液温度30~33℃,5批验证试验的喷干粉物理指纹图谱相似度均大于0.99。结论 基于QbD理念建立的小续命汤提取液喷雾干燥工艺稳定可行,可为小续命汤颗粒中试放大研究提供参考。

Objective Based on the concept of quality by design(QbD),a spray drying process for the extract of Xiaoxuming decoction was established.Methods The Plackeet-Burmann design was used to select the Critical Process Parameter(CPP) from the relative density,feed rate,inlet air temperature,liquid temperature and atomization pressure.The selected CPPS were optimized by a center-point composite design experiment.The design space of spray drying process for the extract of Xiaoxuming Decoction was established,the physical fingerprint was established and the similarity was evaluated.Results The relative density and temperature of liquid were the key process parameters.The design space constructed after CPP optimization was the relative density of sample sofution 1.07-1.10,and the temperature of sample sofution 30-33 ℃.The similarity of physical fingerprint of dry spray powder in 5 batches of verification tests was greater than 0.99.Conclusion The spray drying process of Xiaoxuming Decoction based on QbD concept is stable and feasible,which can provide a reference for the pilot scale-up study of Xiaoxuming Decoction particles.