Division of Pharmaceutics, Friedrich-Alexander-University, Cauerstr 4, 91058 Erlangen, Germany.
Int J Pharm. 2010 Nov 30;401(1-2):68-71. doi: 10.1016/j.ijpharm.2010.09.023. Epub 2010 Sep 29.
The use of a small-dimensioned cyclone separator to spray-dry an aqueous solution of lysozyme on a mini spray-dryer produces consistently higher protein inactivation at all drying-air outlet temperatures examined between 50°C and 105°C. Differences in drying air flow rate through the machines will influence droplet/particle residence times within the drying chamber, but these are considered too small to explain the result. It appears more likely that a higher separation and retention of fines within the small cyclone causes higher measured protein inactivation. By virtue of their small size the fines have a greater specific surface area and suffer therefore a greater degree of protein damage when passing through the spray dryer from nozzle to collecting vessel. Although the dry powder yield is higher with the small-dimensioned cyclone than that obtained with the standard cyclone, the profile of residual moisture versus T(outlet) is irregular in shape. A possible lack of equilibrium between the attributes of the protein particles and the exhaust air needs therefore to be considered.
使用小尺寸的旋风分离器在微型喷雾干燥器上喷雾干燥溶菌酶的水溶液，在检查的 50°C 至 105°C 之间的所有干燥空气出口温度下，始终能更高程度地使蛋白质失活。机器中干燥空气流量的差异会影响到干燥室内液滴/颗粒的停留时间，但这些差异被认为太小，无法解释结果。更有可能的是，小旋风分离器中更精细的颗粒更好地分离和保留，从而导致更高的蛋白质失活测量值。由于它们的尺寸较小，因此当细粉从喷嘴通过喷雾干燥器进入收集容器时，其具有更大的比表面积，因此会受到更大程度的蛋白质损伤。尽管小尺寸旋风分离器的干粉产率高于标准旋风分离器，但残余水分与 T（出口）的关系曲线形状不规则。因此，需要考虑蛋白质颗粒和废气之间的属性是否达到平衡。
