可溶性载体对左旋硫酸沙丁胺醇胶囊型粉雾剂的体外影响

目的：通过对左旋硫酸沙丁胺醇胶囊型粉雾剂可溶性载体的考察，筛选出最佳的载体材料及制备工艺。方法：对于可溶性载体辅料，采用纳米磨与喷雾干燥仪分别制备药物、辅料的颗粒物，测定颗粒的理化性质及肺部有效沉积率。结果：喷雾干燥仪制备后，载体粒径在25.35~52.94 μm之间，其中乳糖外观圆整，粒径为25.35 μm，乳糖的休止角为33.20°，乳糖的含水量最低为0.99%，压缩度为17.68%，有效沉积率为14.21%，符合药典对粉雾剂的要求。结论：喷雾制备的乳糖，其粉体性能良好，是适合左旋沙丁胺醇粉雾剂的载体材料。

Effects of soluble carrier on levosalbutamol sulfate for dry inhalation powder

OBJECTIVE To investigate dry powder inhaler of levosalbutamol sulfate and materials for vehicle, by carefully screening the optimum carrier and preparation technology. METHODS A soluble excipient as powder carrier was prepared with levosalbutamol sulfate by nanometer grinding and spray drying apparatus. Micromeritic properties and pulmonary effective deposition rate were observed to understand dry powder inhaler. RESULTS Using the spray drying system, the particle sizes of drug mixture and excipient were in the range of 25.35-52.94 μm. Among of these additives, the characteristics of lactose particles were summarized as follows:spherical in appearance, particle size 25.35 μm, repose angle 33.20°, water content 0.99%, compression ratio 17.68%, effective deposition rate 14.21%, in accordance with the requirements of the 2015 edition China Pharmacopoeia. CONCLUSION Spray prepared lactose powder has good powder properties, is suitable as the carrier material for levosalbutamol sulfate for dry powder inhaler.