液体抗がん剤調製における調製監査法の構築

概要

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Precision is important in the preparation of liquid mixtures of cancer chemotherapeutic agents because the clinically achievable dose levels of these agents are determined by the weight, body surface area and renal function of patients. We devised a checking procedure to determine if preparation was being done precisely. It involves measurement of the weights of vials and ampules before and after preparation of the drugs and then comparing the net weight difference with the theoretical weight difference. The theoretical weight difference is calculated from the preparation amount and specific gravity of the liquid cancer chemotherapeutic agent and the residual amount in the needle used for preparation.Through this checking procedure, we were able to determine that the net weight difference was outside the tolerance level when it varied by +4% or -8% from the theoretical weight difference. As the procedure requires only an electronic weighing machine and a preparation calculation sheet we created using the Microsoft Excel computer program, its use would be inexpensive. Though the increase in preparation time due to the procedure was significant, it was actually not so great. We therefore consider it to be a useful means of checking precision in the preparation of liquid cancer chemotherapeutic agents.
日本医療薬学会の論文