高压均质技术结合喷雾干燥法制备布地奈德多孔微球

采用高压均质技术对布地奈德颗粒进行了纳米化制备，考察了均质压力和循环次数对产品粒径和粒度分布的影响。实验结果表明，粒子的大小和分布随着均质压力的增大和循环次数的增多明显下降。在100MPa和循环60次的最优条件下可制得平均粒径为0.64μm、峰宽为0.44的布地奈德颗粒。该浆料经喷雾干燥后形成了平均粒径为2.90μm的多孔微球，比表面积为8.71m²/g。与布地奈德的甲醇溶液喷干产品相比，多孔微球粒度分布更均匀、比表面积更大。经FT-IR和XRD表征，结果表明高压均质和喷雾干燥过程均没有改变布地奈德分子的化学结构，多孔微球为结晶型颗粒，而溶液喷干产品为无定型颗粒。

Preparation of porous spherical agglomerates of budesonide

High pressure homogenization (HPH) was employed to prepare submicron particles of budesonide. The main factors affecting the particle size were found to be the operating pressure and the number of cycles. The results indicated that sixty cycles and 100MPa were the optimal conditions, and budesonide was found to have a volume median particle size of 0.64μm with a peak width of 0.44 after HPH, and formed 2.90μm porous spherical agglomerates (PSA) after subsequent spray drying. Compared with conventional spray dried budesonide (SDB), the PSA had larger particle size, but narrower particle size distribution. In addition, the larger specific area (8.71m²/g) of PSA demonstrated the presence of a porous structure. As assessed by FT IR and XRD, PSA had the same chemical structure and crystal form as the crude budesonide, whereas the SDB was amorphous.