In a production process of granules containing a biologically active substance, variation in the elution profile of the biologically active substance is reduced by heating the temperature of granules to about 50°C or higher and maintaining the temperature for about 1 minute or longer. By setting the spray speed to about 90 mg/min or more per 1 g of cores when a spray agent for a primary agent containing the biologically active substance is sprayed while spraying a binding liquid to the cores and setting the total feeding weight per unit area for a centrifugal fluidized bed coating granulation machine to about 1.5 g/cm2 or more, the variation in the elution profile of the biologically active substance from the granules is reduced.
在含有
生物活性物质的颗粒的生产过程中,通过将颗粒的温度加热至约 50°C 或更高,并保持温度约 1 分钟或更长时间,可减少
生物活性物质洗脱曲线的变化。将含有
生物活性物质的主剂的喷雾剂喷洒到芯上的同时,将喷雾速度设定为每 1 克芯约 90 毫克/分钟或更高,并将离心流化床包衣造粒机的单位面积总喂料重量设定为约 1.5 克/平方厘米或更高,可减少颗粒中
生物活性物质洗脱曲线的变化。