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考察了d-甘露醇在连续双螺杆制粒过程中工艺参数对所得颗粒的关键质量属性(CQA)(含水量、固体状态、外观、粒度分布、比表面积、脆碎度、流动性和吸湿性)及片剂的CQA(抗张强度和脆碎度)的影响。选用外观独特、表面积大和可压性良好的d-甘露醇为模型,在Consi Gma?-25生产线(一种由粉末原料起始、经连续制造得到片剂的设备)的制粒单元
The critical mass properties (CQA), water content, solid state, appearance, particle size distribution, specific surface area, friability, fluidity and hygroscopicity of d-mannitol during the continuous twin-screw granulation process were investigated. ) And the CQA (Tensile Strength and Friability) of the tablets. The pelletizing unit was constructed using a unique appearance, large surface area and good compressibility of d-mannitol, on a Consi Gma®-25 line, a device that was continuously manufactured to obtain tablets starting from a powdered raw material