中药浸膏粉与辅料共混物的玻璃化转变温度对巨安神制剂干法制粒的影响

Effect of Glass Transition Temperature of Traditional Chinese Medicine Extract Powder and Excipients Blends on Dry Granulation of Ju'anshen Preparation

摘要:

目的：运用玻璃化转变理论，研究干法制粒时物料玻璃化转变温度（T_g）对制粒效果的影响。方法：以巨安神制剂浸膏粉为模型药物，测定浸膏粉与辅料混合物的T_g，比较直接混合和共溶后喷雾干燥2种物料混合方式对干法制粒效果的影响，运用物料粒径和扫描电镜图谱分析喷雾粘壁和制粒粘轮机制。结果：当喷干粉的T_g为58.8 ℃和68.5 ℃时，即高于滚轮温度（42 ℃）时，在制粒过程中不会粘轮现象；直混物的T_g均<42 ℃，会产生粘轮问题。选择麦芽糊精为巨安神颗粒的辅料，浸膏粉-麦芽糊精（1：1）。结论：T_g的高低可作为干法制粒能否顺利进行的1个评价指标，为中药颗粒剂的制备提供指导和参考。

Abstract:

Objective: To investigate effect of glass transition temperature (T_g) of material on granulating effect based on the theory of glass transition. Method: Taking Ju'anshen preparation extract powder as the model drug,T_g of the mixture of extract powder and excipients was determined,the effect of two mixing ways (direct mixing and co-solvent spray drying) on dry granulation was compared.The mechanism of sticking wall in spray drying and sticking wheel in dry granulation was analyzed by particle size and scanning electron microscopy. Result: When T_g values of spray powder was 58.8 ℃ and 68.5 ℃,which were higher than the roller temperature (42 ℃),it would not cause sticking wheel in the granulation process;while the T_g values of straight blend were less than 42 ℃,it would cause sticking wheel.Maltodextrin was chosen as the excipients of Ju'anshen granules with ratio of extract powder-maltodextrin (1:1). Conclusion: T_g values can be used as a evaluation index for dry granulation,which is a guidance for the preparation of traditional Chinese medicine granules.