注腸投与を目的とした抱水クロラール水溶液の安定性

概要

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The stability of chloral hydrate (CH) in aqueous solutions for rectal use was studied. The CH solution (5%) was stored in glass containers at the volume of 4 mL for 90 days at 25℃ (under 480 lux and In the dark) and 4℃ (in the dark). To observe the stability in daily use, the CH solution was also stored in glass or polypropylene bottles for dispensing at the volume of 100 mL for 90 days at 4℃ in the dark. The stability was evaluated by pH variation and the amount of CH in the solution. In both CH solutions stored in glass containers at the volume of 4 mL and glass bottles' at the volume of 100 mL for dispensing at 4℃ in the dark for 30 days, there was very little pH change in the solution. Under other conditions, a significant decrease in the pH was observed at the CH solutions stored for 30 days. However, the CH amounts In the solutions remained more than 95% at least 90 days under all tested conditions. We therefore conclude that 5% CH solution is applicable for rectal use for at least 90 days, if it is stored in glass bottles for dispensing at 4℃ in the dark.
日本医療薬学会の論文
2000-04-10