ビタミンK_2シロップの調剤後の安定性

概要

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Vitamin K_2 (K_2) syrup has begun to be administered to newborn for prophylaxis of intracranial hemorrhage due to vitamin K deficiency. The stability of K_2 syrup (2mg/ml) and its diluted solution (0.2 mg/ml) in a plastic bottle with or without an orange bag to exclude light was examined by micro high pressure liquid chromatography. When light was excluded by the orange bag, regardless of a color of bottle, the concentration of K_2 and storage temperature, the residual rate of K_2 in an ophthalmic bottle (10ml) was more than 90% after 1 month under a fluorescent light (500 lux) shed for 10-12 hours per day. But when light was not excluded by the orange bag, K_2 decomposed to less than 40% and was somewhat more stable in a brown-colored bottle than in a colorless bottle, and in syrup than in its diluted solution. K_2 in a dispensing bottle (30ml) without a light-resistant cover decomposed to 76-85% in only 9 hours under fluorescent light. Therefore, K_2 syrup and its diluted solution should be administered in light-excluding containers. Photodegradation of K_2 in the plastic bottle was inhibited when stored in an orange bag.
日本医療薬学会の論文
1986-06-20