ガラスアンプル抗がん剤調製時のガラス粒子の混入と防止に関する研究

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The contamination of intravenous admixtures by glass particles arising from glass ampoules containing ingredients used in their preparation is now recognized as a potential health hazard. Previously studies have been done on changes with time in the size of glass particles and particle counts but there are shortcomings in the light obscuration or Coulter-based methods that were used. For instance, the necessity of having particles flowing for the counters used in these methods to count them has been controversial. In this study, therefore, we used a laser diffraction particle size analyzer (LDPSA) to determine glass particle size ranges and counts over a period of 15 minutes following the opening of ampoules. Fourteen ampoules containing 5-fluorouracil (anti-cancer drug) were studied in four experiments. At 15 minutes, the counts/1A (5mL) (mean±SD) for each of the size ranges indicated were 4,630±3,070 (0.5 to 2μm), 8,860±2,590 (2 to 3μm), 3,960±1,360 (3 to 5μm), 950±550 (5 to 7μm), 510±200 (7 to 10μm), 225±94 (10 to 15μm) and 64±55 (15 to 50μm). These results were confirmed by visual inspection and counting glass particles for the same samples using scanning electron microscopy. Further, the use of these techniques for samples after they had been passed through either a 0.45 or 0.8μm syringe filter failed to show any measureable levels of glass particles in the filtrate. Our results show that glass particles remain suspended for 15 minutes after opening glass ampoules and suggest that the use of syringe filters may reduce glass particle-associated risks in the intravenous administration of admixtures.
日本医療薬学会の論文
2009-02-10

ガラスアンプル抗がん剤調製時のガラス粒子の混入と防止に関する研究

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