Beeman C S, Dembo J, Bogardus A
Department of Oral Health Practice, University of Kentucky College of Dentistry, Lexington 40536-0084.
J Oral Maxillofac Surg. 1994 Apr;52(4):393-6. doi: 10.1016/0278-2391(94)90445-6.
The purpose of this study was to determine the stability of reconstituted solutions of methohexital sodium over a 6-week period. Stability of methohexital was examined using reversed-phase high-performance liquid chromatography. The results indicate that reconstituted methohexital is extremely stable for up to 6 weeks when stored at 4 degrees C. When stored at room temperature, reconstituted solutions of methohexital contained increasing levels of degradation products and showed a corresponding decrease in methohexital over a 6-week period. However, the rate of degradation of the drug was slow, with less than 10% of the methohexital undergoing breakdown. In addition, tests for microbial contamination of the solutions stored at room temperature and under refrigeration were negative for up to 6 weeks. This study demonstrates that methohexital, when stored under refrigeration for up to 6 weeks, is virtually chemically identical to a freshly reconstituted solution of the drug. When stored at room temperature, there is some degradation of the drug, but it is not known whether the small amount of degradation is clinically significant. This study emphasizes the importance of obtaining scientific data to support changes in guidelines related to handling and storage of drugs.
本研究的目的是确定甲己炔巴比妥钠复溶溶液在6周内的稳定性。使用反相高效液相色谱法检测甲己炔巴比妥的稳定性。结果表明，复溶的甲己炔巴比妥在4℃储存时，长达6周都极其稳定。在室温下储存时，复溶的甲己炔巴比妥溶液在6周内降解产物水平不断增加，甲己炔巴比妥含量相应减少。然而，药物的降解速度较慢，不到10%的甲己炔巴比妥发生分解。此外，在室温及冷藏条件下储存的溶液的微生物污染检测在长达6周的时间内均为阴性。本研究表明，甲己炔巴比妥在冷藏条件下储存长达6周时，其化学性质与刚复溶的药物溶液几乎相同。在室温下储存时，药物会有一些降解，但尚不清楚少量降解是否具有临床意义。本研究强调了获取科学数据以支持药物处理和储存相关指南变更的重要性。
