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齐多夫定在5%葡萄糖注射液和0.9%氯化钠注射液中的稳定性。

Stability of zidovudine in 5% dextrose injection and 0.9% sodium chloride injection.

作者信息

Lam N P, Kennedy P E, Jarosinski P F, Gallelli J F

机构信息

University of Illinois, Chicago.

出版信息

Am J Hosp Pharm. 1991 Feb;48(2):280-2.

PMID:2003500
Abstract

The stability of zidovudine at a concentration of 4 mg/mL in 5% dextrose injection and 0.9% sodium chloride injection in polyvinyl chloride infusion bags stored at room and refrigerated temperatures for up to eight days was studied. Zidovudine was diluted in 5% dextrose injection and in 0.9% sodium chloride injection to a concentration of 4 mg/mL. Six admixtures were prepared with each diluent; three were stored at room temperature (25 +/- 1 degree C) and three were refrigerated (4 +/- 1 degree C). At 0, 3, 6, 24, 48, 72, and 192 hours, 2-mL aliquots were removed. One milliliter of each aliquot was diluted to a zidovudine concentration of approximately 40 micrograms/mL and assayed in duplicate by a stability-indicating high-performance liquid chromatographic method. Visual inspection was performed at each sampling time for precipitation, turbidity, color change, and gas formation. Sample pH was recorded at 0 and 192 hours. In all admixtures, more than 97% of the initial zidovudine concentration remained throughout the study period. No visual or pH changes were observed. Zidovudine 4 mg/mL in admixtures with 5% dextrose injection or 0.9% sodium chloride injection stored in polyvinyl chloride infusion bags was stable for up to 192 hours (eight days) at room temperature and under refrigeration.

摘要

研究了齐多夫定在室温及冷藏温度下于聚氯乙烯输液袋中浓度为4mg/mL的5%葡萄糖注射液和0.9%氯化钠注射液中的稳定性,最长达8天。将齐多夫定分别稀释于5%葡萄糖注射液和0.9%氯化钠注射液中,使其浓度达到4mg/mL。每种稀释剂制备6份混合液;3份在室温(25±1℃)下储存,3份冷藏(4±1℃)。在0、3、6、24、48、72和192小时时,取出2mL的等分试样。每份等分试样取1mL稀释至齐多夫定浓度约为40μg/mL,并通过稳定性指示高效液相色谱法进行双份测定。在每个取样时间进行目视检查,观察有无沉淀、浑浊、颜色变化和气态生成。在0和192小时记录样品pH值。在整个研究期间,所有混合液中初始齐多夫定浓度的留存率均超过97%。未观察到目视或pH值变化。在聚氯乙烯输液袋中与5%葡萄糖注射液或0.9%氯化钠注射液混合的4mg/mL齐多夫定在室温及冷藏条件下最多192小时(8天)内稳定。

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