国内で生産されたテガフール製剤のカプセルおよび包装外部への主薬付着についてその2

概要

論文の詳細を見る
Contamination of tegafur, an cytotoxic antimalignant agent, in packaging materials of 28 different tegafur capsules available on the Japanese market had been reproted by one of the authors. The study revealed that the tegafur contamination was not been limited to the outer shell of the capsules but extended, in some of the brands, to the exterior of the press-through package (PTP). Suggestions were made one year previously to the manufacturers of the brands to take measures to prevent the contamination from occurring. The purpose of the present study was to follow up and investigate whether any improvement was subsequently made on these brands. The existence of tegafur at the outer shell of tegafur capsules, PTP inner pockets, PTP, and aluminum pillow packs was qualitatively tested by HPLC analysis of most of the brands reported in the previous study. At the surface of most packaging materials, the existence of the active ingredient, tegafur, was demonstrated, and the contamination in some of the brands exceeded that found one year ago. In addition to the previously investigated brands, mixed granules of tegafur and uracil were studied, revealing contaimination of tegafur at the surface of stripped package films. It was suggested that some definitive means should be taken to minimize the contamination and to prevent any potential safety problem from arising by those who Continuously handle cytotoxic products.
日本医療薬学会の論文
1993-08-20