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盐酸昂丹司琼在便携式输液泵储液器中的稳定性。

Stability of ondansetron hydrochloride in portable infusion-pump reservoirs.

作者信息

Stiles M L, Allen L V, Fox J L

机构信息

Pharmaceutics Section, College of Pharmacy, University of Oklahoma Health Sciences Center, Oklahoma City 73190.

出版信息

Am J Hosp Pharm. 1992 Jun;49(6):1471-3.

PMID:1388331
Abstract

The stability of ondansetron hydrochloride 0.24 and 2 mg/mL when delivered by portable infusion pump at near-body temperature over various time periods was investigated. Nine 100-mL drug reservoirs were prepared, three containing ondansetron hydrochloride 2 mg/mL and six containing ondansetron hydrochloride diluted with 0.9% sodium chloride injection to 0.24 mg/mL. Three of the reservoirs containing the diluted solution were refrigerated for up to 30 days at 3 degrees C before being attached to portable infusion pumps and pumped over 24 hours at 30 degrees C. The remaining six reservoirs were attached to pumps immediately after being filled, and the solutions were delivered for up to 24 hours (the diluted solution; three reservoirs) or up to seven days (the concentrated solution; three reservoirs) at 30 degrees C. Samples were taken initially and periodically and analyzed by high-performance liquid chromatography and with a pH meter. Both the diluted and the concentrated solutions of ondansetron hydrochloride retained at least 95% of the initial drug concentration under all the conditions studied. There was no appreciable change in pH. Ondansetron hydrochloride 0.24 mg/mL was stable when stored for up to 30 days at 3 degrees C and infused over 24 hours at 30 degrees C. Ondansetron hydrochloride 2 mg/mL was stable when infused for up to one week at 30 degrees C.

摘要

研究了在接近体温的条件下,通过便携式输液泵在不同时间段输送的0.24毫克/毫升和2毫克/毫升盐酸昂丹司琼的稳定性。制备了9个100毫升的药物储存器,3个含有2毫克/毫升盐酸昂丹司琼,6个含有用0.9%氯化钠注射液稀释至0.24毫克/毫升的盐酸昂丹司琼。其中3个装有稀释溶液的储存器在3℃下冷藏长达30天,然后连接到便携式输液泵上,并在30℃下泵注24小时。其余6个储存器在装满后立即连接到泵上,溶液在30℃下输送长达24小时(稀释溶液;3个储存器)或长达7天(浓缩溶液;3个储存器)。最初和定期采集样品,通过高效液相色谱法和pH计进行分析。在所有研究条件下,盐酸昂丹司琼的稀释溶液和浓缩溶液均保留了至少95%的初始药物浓度。pH值没有明显变化。0.24毫克/毫升盐酸昂丹司琼在3℃下储存长达30天并在30℃下输注24小时时是稳定的。2毫克/毫升盐酸昂丹司琼在30℃下输注长达一周时是稳定的。

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