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硫酸特布他林注射液用0.9%氯化钠注射液稀释后于室温下在聚氯乙烯袋中储存时的化学稳定性。

Chemical stability of terbutaline sulfate injection after diluting with 0.9% sodium chloride injection when stored at room temperature in polyvinylchloride bags.

作者信息

Gupta Vishnu D

机构信息

Pharmaceutics Division, University of Houston, Houston, Texas.

出版信息

Int J Pharm Compd. 2004 Sep-Oct;8(5):404-6.

Abstract

The stability of terbutaline sulfate (0.1 mg/mL) in 0.9% sodium chloride injection was studied at 25 deg C when stored in polyvinylchloride bags, using a stability-indicating high-performance liquid chromatographic assay method. The concentrations of the drug were directly related to peak heights, and percent relative standard deviation based on five injections was 1.0. The drug decomposed when boiled after adding sodium hydroxide, and the products of decomposition did not interfere with the assay procedure. The injection did not lose any potency after 23 days of storage at 25 deg C, and the pH value of 4.3 did not change. The physical appearance of the injection remained clear throughout the study period.

摘要

采用一种稳定性指示高效液相色谱测定法,研究了硫酸特布他林(0.1mg/mL)在25℃下于聚氯乙烯袋中储存于0.9%氯化钠注射液中的稳定性。药物浓度与峰高直接相关,基于五次进样的相对标准偏差百分比为1.0。加入氢氧化钠后煮沸时药物分解,分解产物不干扰测定过程。该注射液在25℃储存23天后未丧失任何效力,pH值4.3也未改变。在整个研究期间,注射液的外观保持澄清。

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