塩酸セフォチアム製剤の品質評価 : 炭酸ガス発生による点滴筒内の液面低下

概要

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As cefotiam hydrochloride dissolves, carbon dioxide is generated due to the buffer agent used to reconstitute the powder form of the medication. The carbon dioxide causes a depression in the level of the injection liquid, which may facilitate the entry of air into the blood stream. As the safety of cefotiam hydrochloride with a decreased liquid level has not been evaluated, we compared 2 branded (A and B) and 2 generic forms (C and D) of cefotiam hydrochloride for capacity to generate carbon dioxide and lower the liquid level in the drip cylinder. In the case of Product A, we knew that a substance reducing carbon dioxide production had been added to the buffer agent but had no information in this regard for the other products tested. During the evaluation, there were no problems related to drip speed, or medication density and none arose due to differences in infusion sets. The decrease in the liquid level was greater for products B, C, and D than product A. In the case of dissolution in Pigybotol, it would be easy to eliminate the carbon dioxide but care would be needed in the case of TN. 2 port. and bag kit products, since little air has been removed.
日本医療薬学会の論文
2007-06-10