Floy B J, Royko C G, Fleitman J S
Syntex Research, Palo Alto, CA 94304.
Am J Hosp Pharm. 1990 May;47(5):1097-100.
The compatibility of ketorolac tromethamine injection with commonly used i.v. infusion solutions and administration set components was evaluated. The infusion solutions tested were 0.9% sodium chloride injection, 5% dextrose injection, 0.9% sodium chloride and 5% dextrose injection, Plasma-Lyte A pH 7.4 injection, Ringer's injection, and lactated Ringer's injection. The ketorolac tromethamine admixture concentration studied was 30 mg/50 mL for all solutions. Admixtures were stored in polyvinyl chloride bags and glass bottles at room temperature under fluorescent light and sampled at 0, 6, 24, and 48 hours. Chemical compatibility was determined by high-performance liquid chromatography, and physical compatibility was determined by visual analysis, counting of subvisible particles by HIAC, and pH measurements. Adsorption of ketorolac tromethamine to i.v. administration set components was also evaluated. Ketorolac tromethamine exhibited excellent physical and chemical stability in all six infusion solutions tested. No degradation of drug, formation of particulates, or adsorption to containers or infusion tubing was noted at any concentration for any of the solutions. After the solutions were mixed, the pH remained essentially unchanged. Ketorolac tromethamine injection was physically and chemically stable when mixed with a variety of commonly used infusion solutions and was not adsorbed to administration set components or to glass or polyvinyl chloride containers.
对酮咯酸氨丁三醇注射液与常用静脉输液溶液及输液器组件的相容性进行了评估。所测试的输液溶液有0.9%氯化钠注射液、5%葡萄糖注射液、0.9%氯化钠与5%葡萄糖注射液、pH 7.4的A液注射液、林格氏注射液和乳酸林格氏注射液。所有溶液中酮咯酸氨丁三醇的混合浓度均为30 mg/50 mL。混合物储存在聚氯乙烯袋和玻璃瓶中,室温下置于荧光灯下,并在0、6、24和48小时取样。通过高效液相色谱法测定化学相容性,通过目视分析、用HIAC计数亚可见颗粒和测量pH值来测定物理相容性。还评估了酮咯酸氨丁三醇对静脉输液器组件的吸附情况。酮咯酸氨丁三醇在所有六种测试的输液溶液中均表现出优异的物理和化学稳定性。在任何浓度下,任何溶液均未观察到药物降解、颗粒形成或对容器或输液管的吸附。溶液混合后,pH值基本保持不变。酮咯酸氨丁三醇注射液与多种常用输液溶液混合时在物理和化学上是稳定的,且不会吸附到输液器组件或玻璃或聚氯乙烯容器上。