PROBLEM TO BE SOLVED: To provide a method for analyzing the processes of manufacturing a medicine, the method including non-destructively and rapidly conducting a qualitative analysis and a quantitative analysis on elements contained in such a solid preparation as a tablet or as a granule agent and feeding back the result of each analysis to the process of pelletization or tableting.SOLUTION: The method for analyzing processes includes a fluorescent X-ray measurement process for measuring the fluorescent X-ray of a solid preparation and an evaluation process for evaluating the content of the medicine and/or the additive in the solid preparation on the basis of the fluorescent X-ray measured in the fluorescent X-ray measurement step, one of the medicine and the additive containing an element which emits a fluorescent x-ray.SELECTED DRAWING: NoneCOPYRIGHT: (C)2019,JPO&INPIT【課題】錠剤や顆粒剤のような固形製剤に含まれる元素を、非破壊的に、短時間で定性および定量分析して、その結果を、造粒や打錠のような工程にフィードバックすることが可能な医薬品の製造工程の工程分析方法を提供する。【解決手段】 工程分析方法は、固形製剤の蛍光X線を測定する蛍光X線測定工程と、蛍光X線測定工程において測定された蛍光X線に基づいて固形製剤の薬物および/または添加物の含有量を評価する評価工程とを含み、少なくとも薬物と添加物のいずれか一方は、蛍光X線を発する元素を含有する。【選択図】なし
