小児科における継続注射中のナルブフィン水塩化物の安定性および物理的適合性
Romain Paoli-Lombardo1,2, Vincent Arcani1, Delphine Dazan1
1Service Central de la Qualité et de l'Information Pharmaceutiques (SCQIP), Pharmacy Department, AP-HM, Hôpital de la Conception, Marseille, France.
PloS one
|September 4, 2025
まとめ
ナルブフィン水塩化物は,小児注入で24時間,通常の塩溶液で安定しているが,併用時にフロセミドとアンフォテリシンBのような薬剤の不適合性を確認する.
科学分野:
- 小児薬理学
- 薬剤分析
- 薬剤の安定性と適合性
背景:
- ナルブフィン水塩化物は,継続注入で小児の治療に使用されます.
- 以前より高い濃度での安定性に関するデータがあるが,小児の希釈についてはない.
- 小児の投与には24時間以上の安定性と適合性を理解する必要があります.
研究 の 目的:
- ナルブフィン塩化物の安定性を,小児用濃度で通常の塩溶液で評価する.
- ナルブフィン水塩化物と一般的に使用される小児薬の互換性を評価する.
- ナルブフィン水塩化物の定量測定のための安定性を示す染色法を検証する.
主な方法:
- 新しい高性能液体染色法 (HPLC) を検証した.
- ナルブフィン水塩化物の安定性と分解剤を24時間間,強制的な条件下 (光,熱,酸化,pH) で監視した.
- 視覚検査と粒子の計測を用いて,併用薬との物理的適合性を評価した.
主要な成果:
- HPLC方法は検証され,安定性を示すことが証明された.
- ナルブフィン水塩化物は,光から保護されていない環境温度で少なくとも24時間持続することが示された.
- フロセミドとアンフォテリシンBとの相容れない
結論:
- ナルブフィン水塩化物は24時間以上,小児用注射器ポンプで投与される通常の塩溶液で安定している.
- マルチポートマニホールドまたはYサイト接続経由で併用する場合,薬物との不適合性を慎重に検討することが重要です.
- この研究は,ナルブフィン塩化水素注入の安全な小児用薬に関する重要なデータを提供します.
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