Zhang Y, Xu Q A, Trissel L A, Williams K Y
Division of Pharmacy, University of Texas M. D. Anderson Cancer Center, Houston 77030, USA.
J Am Pharm Assoc (Wash). 2000 Jul-Aug;40(4):520-4.
To evaluate the physical compatibility and chemical stability of linezolid (Zyvox-Pharmacia) 200 mg/100 mL admixed with aztreonam (Azactam-Squibb) 2 grams and separately with piperacillin sodium (Pipracil-Lederle) 3 grams over 7 days at 4 degrees C and 23 degrees C.
Controlled experimental trial.
Laboratory.
Test samples were prepared by adding the required amount of aztreonam or piperacillin sodium to separate bags of linezolid injection 200 mg/100 mL.
Physical compatibility and chemical stability based on drug concentrations initially and after 1, 3, 5, and 7 days of storage at 4 degrees C and 23 degrees C.
All of the linezolid admixtures with aztreonam and with piperacillin sodium were clear when viewed in normal fluorescent room light and with a Tyndall beam. Measured turbidity and particulate content were low and exhibited little change throughout the study at both storage temperatures. High-performance liquid chromatography analysis found little or no loss of linezolid in any sample stored at either temperature throughout the study. Aztreonam in the linezolid admixtures was stable for 7 days, exhibiting less than 5% loss at 4 degrees C and 9% loss at 23 degrees C. Piperacillin sodium in the linezolid admixtures was stable for 7 days at 4 degrees C, exhibiting no loss, but was stable for only 3 days at 23 degrees C with losses of about 5%. Losses had increased to 9% to 12% after 5 days of storage at room temperature.
Admixtures of linezolid 200 mg/100 mL with aztreonam 2 grams or piperacillin sodium 3 grams were physically compatible and chemically stable for at least 7 days stored at 4 degrees C and for 7 days or 3 days, respectively, at 23 degrees C.
评估200毫克/100毫升的利奈唑胺(Zyvox-Pharmacia)与2克氨曲南(Azactam-Squibb)以及分别与3克哌拉西林钠(Pipracil-Lederle)混合后在4℃和23℃下7天内的物理相容性和化学稳定性。
对照实验性试验。
实验室。
通过将所需量的氨曲南或哌拉西林钠加入单独的200毫克/100毫升利奈唑胺注射液袋中来制备测试样品。
基于在4℃和23℃下储存1、3、5和7天初始及之后的药物浓度评估物理相容性和化学稳定性。
在正常荧光室内光线下和用廷德尔光束观察时,所有利奈唑胺与氨曲南以及与哌拉西林钠的混合液均澄清。在整个研究过程中,两个储存温度下测得的浊度和颗粒含量均较低且变化很小。高效液相色谱分析发现,在整个研究过程中,任何一个温度下储存的样品中利奈唑胺几乎没有损失或没有损失。利奈唑胺混合液中的氨曲南在7天内稳定,在4℃下损失小于5%,在23℃下损失9%。利奈唑胺混合液中的哌拉西林钠在4℃下7天稳定,无损失,但在23℃下仅稳定3天,损失约5%。在室温下储存5天后,损失增加到9%至12%。
200毫克/100毫升的利奈唑胺与2克氨曲南或3克哌拉西林钠的混合液在4℃下储存至少7天以及在23℃下分别储存7天或3天时物理相容且化学稳定。