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替考拉宁在静脉输液中的稳定性评估。

Assessment of the stability of teicoplanin in intravenous infusions.

作者信息

Galanti L M, Hecq J D, Jeuniau P, Vanbeckbergen D, Jamart J

机构信息

Medical Laboratory, Yvoir, Belgium.

出版信息

Int J Pharm Compd. 2001 Sep-Oct;5(5):397-400.

Abstract

The advance preparation of intravenous solutions of teicoplanin, which is often used in antibiotic infusions for hospitalized patients, may be advantageous. The objective of this study was to investigate the stability of teicoplanin stored at 4 deg C in polyvinyl chloride bags to determine whether such solutions could be safely stored without deterioration. Five bags containing 0.4g teicoplanin per 100 mL of 5 % dextrose injection were studied for 1 month by means of high-performance liquid chromatography, visual inspection, and pH measurement. The color of teicoplanin diluted in dextrose became slightly yellow, and the pH values of the preparations decreased significantly during the period of the study without affecting the chromatographic parameters. The teicoplanin solution was stable for 6 days at 4 deg C as a result of the shortest shelf life of 90% residual potency of the five major glycopeptide components. Despite the color and pH variations, the teicoplanin infusion remained chemically stable when stored up to 6 days at 4 deg C in polyvinyl chloride bags. Thus the infusion could be prepared in advance by a centralized intravenous admixture service for use within the limits described.

摘要

替考拉宁静脉溶液常用于住院患者的抗生素输注,提前配制可能具有优势。本研究的目的是调查替考拉宁在4℃下储存在聚氯乙烯袋中的稳定性,以确定此类溶液能否安全储存而不发生变质。通过高效液相色谱法、目视检查和pH测量,对五个装有每100 mL 5%葡萄糖注射液中含0.4g替考拉宁的袋子进行了为期1个月的研究。在研究期间,替考拉宁在葡萄糖中稀释后的颜色变为微黄色,制剂的pH值显著下降,但不影响色谱参数。由于五种主要糖肽成分90%残留效价的最短保质期,替考拉宁溶液在4℃下可稳定6天。尽管颜色和pH值有所变化,但替考拉宁输注液在4℃下于聚氯乙烯袋中储存长达6天时仍保持化学稳定。因此,可由集中静脉药物配置中心提前配制输注液,并在所描述的期限内使用。

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