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枸橼酸芬太尼与盐酸布比卡因在便携式泵储液器中的稳定性

Stability of fentanyl citrate and bupivacaine hydrochloride in portable pump reservoirs.

作者信息

Tu Y H, Stiles M L, Allen L V

机构信息

Pharmaceutics Section, University of Oklahoma College of Pharmacy, Oklahoma City.

出版信息

Am J Hosp Pharm. 1990 Sep;47(9):2037-40.

PMID:2220858
Abstract

The stability of fentanyl citrate and bupivacaine hydrochloride in an admixture with 0.9% sodium chloride injection in portable pump reservoirs with or without overwraps was investigated. Twelve 100-mL samples containing fentanyl 20 micrograms/mL and bupivacaine hydrochloride 1250 micrograms/mL were placed in the plastic drug reservoirs, and 1-mL quantities were withdrawn immediately after preparation and at intervals during 30 days of storage. Six reservoirs were refrigerated (3 degrees C) and six stored at room temperature (23 degrees C); three at each temperature were placed in overwraps. All samples were observed for precipitation and for change in color or pH and were analyzed for drug concentration by high-performance liquid chromatography. No precipitation or change in color or pH was observed during the 30-day storage period. No loss of fentanyl or bupivacaine was detected in either the wrapped or the unwrapped samples. Fentanyl citrate and bupivacaine hydrochloride in 0.9% sodium chloride injection appear to be compatible, and admixtures containing the two drugs at the concentrations studied can be stored without overwraps for up to 30 days at refrigerated or room temperature without any significant loss of potency.

摘要

研究了枸橼酸芬太尼和盐酸布比卡因与0.9%氯化钠注射液混合后,在有或没有外包装的便携式泵储液器中的稳定性。将十二个含有20微克/毫升芬太尼和1250微克/毫升盐酸布比卡因的100毫升样品置于塑料储药器中,制备后立即抽取1毫升样品,并在储存30天期间每隔一段时间抽取一次。六个储液器冷藏(3摄氏度),六个储液器在室温(23摄氏度)下储存;每个温度下三个置于外包装中。观察所有样品是否有沉淀、颜色或pH值变化,并通过高效液相色谱法分析药物浓度。在30天的储存期内未观察到沉淀、颜色或pH值变化。在有包装或无包装的样品中均未检测到芬太尼或布比卡因的损失。0.9%氯化钠注射液中的枸橼酸芬太尼和盐酸布比卡因似乎是相容的,含有这两种药物的混合液在研究的浓度下,可在冷藏或室温下无外包装储存长达30天,且效力无任何显著损失。

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