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氨曲南在用于家庭静脉抗生素治疗的便携式泵储液器(HIVAT)中的稳定性。

Stability of aztreonam in a portable pump reservoir used for home intravenous antibiotic treatment (HIVAT).

作者信息

Vinks A A, Touw D J, van Rossen R C, Heijerman H G, Bakker W

机构信息

Hospital Pharmacy, Academic Hospital Vrije Universiteit Amsterdam, The Netherlands.

出版信息

Pharm World Sci. 1996 Apr;18(2):74-7. doi: 10.1007/BF00579709.

Abstract

The stability of the monocyclic beta-lactam antibiotic aztreonam in portable pump reservoirs was studied during storage at temperatures of -20 degrees C and +5 degrees C and during drug delivery at 37 degrees C. Three 100-ml drug reservoirs and three glass containers containing 60 mg/ml aztreonam were stored at -20 degrees C and 2-ml samples were analysed in the freshly prepared solution and after thawing at days 7, 21, 28, 70 and after 6 months of storage. A separate triplicate batch of 100-ml prefilled drug reservoirs and glass containers containing a similar aztreonam concentration (60 mg/ml) were refrigerated and tested immediately after preparation and daily for 8 days and after 70 days. Solutions of aztreonam in duplicate freshly prepared reservoirs were tested for stability when the solution was pumped at 37 degrees C over a 24-h period. All solutions were inspected for visual changes and tested for pH. Drug concentration was analysed by high-performance liquid chromatography. No colour changes or pH differences were observed in any of the solutions in the reservoirs of containers. No statistically significant decrease in aztreonam concentration could be detected after 6 months of storage at -20 degrees C. Aztreonam was stable at 5 degrees C for at least 8 days. A 24-h pumping period at 37 degrees C showed a 3.6% decrease in aztreonam concentration. Aztreonam at a concentration of 60 mg/ml in a pump reservoir is sufficiently stable to be used in home intravenous antibiotic treatment programmes.

摘要

研究了单环β-内酰胺抗生素氨曲南在便携式输液泵储液器中于-20℃和+5℃储存期间以及在37℃给药期间的稳定性。三个100毫升的药物储液器和三个装有60毫克/毫升氨曲南的玻璃容器在-20℃下储存,在第7天、21天、28天、70天以及储存6个月后解冻,取2毫升样品在新制备的溶液中进行分析。另外一批一式三份的100毫升预填充药物储液器和装有相似氨曲南浓度(60毫克/毫升)的玻璃容器在制备后立即冷藏,并在制备后每天以及70天后进行测试。一式两份新制备的储液器中的氨曲南溶液在37℃下泵注24小时期间测试其稳定性。检查所有溶液的外观变化并测试pH值。通过高效液相色谱法分析药物浓度。在容器的储液器中的任何溶液中均未观察到颜色变化或pH差异。在-20℃下储存6个月后,未检测到氨曲南浓度有统计学意义的下降。氨曲南在5℃下至少8天稳定。在37℃下泵注24小时期间,氨曲南浓度下降了3.6%。泵储液器中浓度为60毫克/毫升的氨曲南足够稳定,可用于家庭静脉抗生素治疗方案。

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