Holmes S E, Aldous S
School of Pharmacy, University of Tasmania, Australia.
Am J Hosp Pharm. 1991 Feb;48(2):286-90.
The stability of miconazole when mixed with peritoneal dialysis (PD) fluid and stored in plastic bags or glass ampuls was determined. Admixtures of miconazole and PD fluid were prepared in 2-L polyvinyl chloride (PVC) bags and in 1-mL glass ampuls to give a nominal initial concentration of 20 mg/mL. Duplicate samples of each solution were assayed in duplicate by high-performance liquid chromatography immediately after preparation and at various intervals up to nine days. All admixtures were stored in ambient light at 20 +/- 2 degrees C. A substantial loss of miconazole (greater than 10% of the initial concentration) occurred within four hours for admixtures stored in PVC bags, whereas similar solutions retained more than 90% of their initial miconazole concentration for at least three days when stored in glass ampuls under the same conditions. This suggests that the observed loss of miconazole from the PVC bags was largely due to an interaction with the container, rather than to chemical degradation in solution. About 28% of the miconazole lost from the solution during storage in PVC bags was recovered from the plastic by methanolic extraction. The rapid loss of miconazole when the drug was mixed with PD fluid and stored in PVC bags indicates that such admixtures should be prepared immediately before administration.
测定了咪康唑与腹膜透析（PD）液混合并储存在塑料袋或玻璃安瓿中的稳定性。咪康唑与PD液的混合液在2升聚氯乙烯（PVC）袋和1毫升玻璃安瓿中配制，初始标称浓度为20毫克/毫升。每种溶液的重复样品在制备后立即以及在长达九天的不同时间间隔通过高效液相色谱法进行双份测定。所有混合液均在20±2℃的环境光下储存。储存在PVC袋中的混合液在四小时内出现了大量咪康唑损失（大于初始浓度的10%），而在相同条件下储存在玻璃安瓿中的类似溶液在至少三天内保留了超过90%的初始咪康唑浓度。这表明观察到的咪康唑从PVC袋中的损失主要是由于与容器的相互作用，而不是溶液中的化学降解。在PVC袋中储存期间从溶液中损失的约28%的咪康唑通过甲醇萃取从塑料中回收。当药物与PD液混合并储存在PVC袋中时咪康唑的快速损失表明这种混合液应在给药前立即配制。
