药用乳糖粉体流动性表征方法的研究

Investigation on the characterization method of the flowability for pharmaceutical lactose powder

目的对比国内外乳糖粉体性质的差异,探究流动性参数的区分性和适用性。方法利用干湿法激光粒度仪、扫描电子显微镜、PT-R粉体性质测定仪和FT4粉体流变仪,对5种国内外乳糖的粒度、形貌、静态流动性(休止角、Hausner比、压缩度、平板角、分散度等)和流变性质(动态流动性质、充气性质、透气性质和剪切性质)进行表征。结果15种乳糖的休止角均偏大,两种进口乳糖(I-1、I-2)的差角较大,国内厂家D-1和国外厂家I-2的乳糖具有较小的Hausner比和压缩度,国内厂家D-1生产的三批乳糖具有较高的基础流动能量、特性能量和空化能,国外厂家I-2乳糖的流动函数最大,其余乳糖的流动函数均小于4。结论国产乳糖与进口乳糖在流动性以及批次间一致性等方面存在差距,且与乳糖的粒度、形态特征相关。Hausner比、压缩度、流动函数和凝聚力对流动性的区分性较好,其余参数可以辅助了解药用乳糖的喷流性、分散性和微观颗粒性质。

Objective To compare the differences in the properties of domestic and imported lactose and to investigate the differentiation and applicability of different flowability parameters.Methods The particle size and size distribution,morphology,static flowability(angle of repose,Hausner ratio,compressibility,dispersion,etc.),and rheological properties(dynamic flow properties,aeration properties,permeability,etc.)of five domestic and imported lactose powders were investigated using a laser diffraction analyzer,a scanning electron microscope,a powder property tester,and an FT4 powder rheometer,respectively.Results All 15 lactoses had large angle of repose.The two imported lactoses(I-1 and I-2)had larger difference angles;domestic lactose D-1 and imported lactose I-2 had smaller Hausner ratio and compressibility;three batches of domestic lactose D-1 had higher basic flow energy,specific energy and aeration energy.The imported lactose I-2 had the largest flow factor,and the rest of lactoses had flow factor less than 4.Conclusion There are differences in terms of flowability and batch-to-batch consistency between domestic and imported lactose powders,which can be attributed to the variation in their particle sizes and morphological characteristics.Hausner ratio,compressibility,flow factor,and cohesion can better differentiate their flowability difference,while rest of the parameters can assist in understanding the airflow properties,dispersibility,and microscopic particle properties of the tested lactose powders.