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首页> 外文期刊>American Journal of Health-System Pharmacy >Physicochemical stability of oxaliplatin in 5% dextrose injection stored in polyvinyl chloride, polyethylene, and polypropylene infusion bags
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Physicochemical stability of oxaliplatin in 5% dextrose injection stored in polyvinyl chloride, polyethylene, and polypropylene infusion bags

机译:草酸铂在5%葡萄糖注射液中的理化稳定性,储存在聚氯乙烯,聚乙烯和聚丙烯输液袋中

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Purpose. The physicochemicai stability of extemporaneous dilutions of oxaliplatin in 5% dextrose injection stored in polyvinyl chloride (PVC), polypropylene, and polyethylene infusion bags was studied. Methods. Oxalipiatin 100 mg/20 mL concentrated solution was diluted in 100 mL of 5% dextrose injection in PVC, polypropylene, and polyethylene infusion bags to produce nominal oxaliplatin concentrations of 0.2 and 1.3 mg/mL. The filled bags were stored for 14 days at 20 ℃ and protected from light, at 20 ℃ under normal fluorescent light, and at 4 ℃. A 1-mL sample was removed from each bag at time 0 and at 24, 48, 72, 120, 168, and 336 hours. The samples were visually inspected for color and clarity, and the pH values of the solutions were measured. High-performance liquid chromatography was used to assay oxaliplatin concentration. Bacterial contamination was assessed on study day 14 after incubation in trypticase soy solution for three days at 37 ℃.rnResults. Solutions of oxaliplatin 0.2 and 1.3 mg/mL in 5% dextrose injection were stable in the three container types for at least 14 days at both 4 ℃ and 20 ℃ without regard to light exposure. No color change was detected during the storage period, and pH values remained stable. No micro-bial contamination was detected in any samples over the study period. Conclusion. Oxaliplatin solutions diluted in 5% dextrose injection to 0.2 and 1.3 mg/mL were stable in PVC and PVC-free infusion bags for at least 14 days at both 4 ℃ and 20 ℃ without regard to light exposure.
机译:目的。研究了临时稀释的草酸铂在5%葡萄糖注射液中储存在聚氯乙烯(PVC),聚丙烯和聚乙烯输液袋中的理化稳定性。方法。在100 mL的5%葡萄糖注射液中,将100 mg / 20 mL的奥沙利比汀浓缩溶液在PVC,聚丙烯和聚乙烯输液袋中稀释,以产生0.2和1.3 mg / mL的奥沙利铂标称浓度。装满袋子的袋子在20℃下可存放14天,并避光,在正常荧光灯下20℃和4℃下避光。在时间0和24、48、72、120、168和336小时从每个袋子中取出1-mL样品。目视检查样品的颜色和澄清度,并测量溶液的pH值。高效液相色谱法用于测定奥沙利铂浓度。在胰蛋白酶酶解大豆溶液中于37℃温育3天后的第14天评估细菌污染。不考虑光照,在5%葡萄糖注射液中的奥沙利​​铂0.2和1.3 mg / mL溶液在3种类型的容器中在4℃和20℃至少稳定14天。在储存期间未检测到颜色变化,pH值保持稳定。在研究期间,任何样品中均未检测到微生物污染。结论。用5%葡萄糖注射液稀释的奥沙利铂溶液在0.2℃和1.3mg / mL下在PVC和无PVC输液袋中在4℃和20℃下至少可稳定放置14天,而无需考虑光照。

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