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出 处:《药学与临床研究》2013年第2期114-117,共4页Pharmaceutical and Clinical Research
摘 要:采用单因素考察法,设定流化床顶喷制粒的主要工艺参数范围,制备异麦芽酮糖醇颗粒,分别测定其堆密度、振实密度、休止角和平均粒径等,并进行直接压片,测定片剂硬度、脆碎度、片重差异和抗张强度。当实验条件为进风温度45℃,喷雾速率3 mL·min-1,喷雾压力0.5 bar时,制得颗粒流动性和压缩性能最好。该工艺通过一步法制粒,具有成本低、效率高、产品质量好等优点,颗粒应用于直接压片,在压片工艺中值得推广应用。The process parameters of fluidized bed granulation were inspected by the single Iactor analysis. The characteristic parameters of the granules such as bulk density, tapped density, angle of repose, and mean diameter were determined. The tablets were prepared by direct compression. The hardness, fragility, weight variation and tensile strength of the tablets were evaluated. The process parameters were optimized as follows: inlet air temperature (45℃), spraying rate (3 mL.min-1) and atomizing air pressure (0.5 bar). The fluid bed granulation process is reasonable and reliable. The granules can be widely used in direct compression.
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