ヘマトポルフィリン・ナトリウム注射剤に対する比濁法によるエンドトキシンテストの適用

概要

論文の詳細を見る
As a preliminary study, the bacterial endotoxin test using an injection with a strong color (hematoporphyrin sodium) was examined. With the method in the 11th edition of the Japanese Pharmacopoeia, the detection sensitivity was 0.25 endotoxin unlts/ml. This method did not have sufficient detection sensitivity for endotoxin in human. Therefore, a nephelometry method using a multiplate was studied. With this method, it was possible that of 96 samples was measured in only 30 minutes. The sensitivity of this method was 0.1 endotoxin units/ml for hematoporphyrin sodium injection. When an analytical curve was prepared using standard endotoxin, high linearity was obtained. This result demonstrated that the bacterial endotoxin test by the nephelometry method will be useful as replacement for the pyrogen test in hospital pharmacy.
日本医療薬学会の論文