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盐酸昂丹司琼注射液在各种饮料中的稳定性。

Stability of ondansetron hydrochloride injection in various beverages.

作者信息

Yamreudeewong W, Danthi S N, Hill R A, Fox J L

机构信息

School of Pharmacy, University of Wyoming, Laramie, USA.

出版信息

Am J Health Syst Pharm. 1995 Sep 15;52(18):2011-4. doi: 10.1093/ajhp/52.18.2011.

DOI:10.1093/ajhp/52.18.2011
PMID:8528869
Abstract

The stability of ondansetron hydrochloride injection in beverages likely to be acceptable to patients was studied. Ondansetron hydrochloride injection (containing ondansetron 2 mg/mL) was added to apple juice, fruit punch, cherry-flavored drink, carbonated soft drinks, and hot tea to provide a nominal ondansetron concentration of 32.8, 64.5, or 95.2 micrograms/mL. Samples were stored at -3 to 28 degrees C (noncarbonated-beverage mixtures except tea), 2 to 28 degrees C (carbonated-beverage mixtures), and 25 degrees C (tea) and assayed for ondansetron concentration by high-performance liquid chromatography at 6, 24, 48, and 72 hours (noncarbonated-beverage mixtures except tea); 6, 24, and 48 hours (carbonated-beverage mixtures); and 1 hour (tea). More than 95% of the initial ondansetron concentration was retained in apple juice, fruit punch, cherry-flavored drink, Sprite, and Diet Coke throughout the periods studied. A precipitate formed immediately after ondansetron was added to hot tea, but the drug was chemically stable for at least one hour in this preparation. Ondansetron hydrochloride injection 32.7, 64.5, and 95.2 micrograms/mL (expressed as free base) was stable in various beverages when stored at -3 to 28 degrees C for up to 72 hours. Ondansetron at these same concentrations precipitated in hot tea preparations but was chemically stable for at least one hour.

摘要

研究了盐酸昂丹司琼注射液在患者可能接受的饮料中的稳定性。将盐酸昂丹司琼注射液(含昂丹司琼2mg/mL)加入苹果汁、混合果汁饮料、樱桃味饮料、碳酸软饮料和热茶中,使昂丹司琼的标称浓度达到32.8、64.5或95.2μg/mL。样品分别在-3至28℃(除茶以外的非碳酸饮料混合物)、2至28℃(碳酸饮料混合物)和25℃(茶)下储存,并在6、24、48和72小时(除茶以外的非碳酸饮料混合物);6、24和48小时(碳酸饮料混合物);以及1小时(茶)时,通过高效液相色谱法测定昂丹司琼浓度。在整个研究期间,苹果汁、混合果汁饮料、樱桃味饮料、雪碧和健怡可乐中初始昂丹司琼浓度的保留率超过95%。将昂丹司琼加入热茶后立即形成沉淀,但该药物在此制剂中化学性质稳定至少1小时。浓度为32.7、64.5和95.2μg/mL(以游离碱表示)的盐酸昂丹司琼注射液在-3至28℃下储存长达72小时时,在各种饮料中均稳定。相同浓度的昂丹司琼在热茶制剂中会沉淀,但化学性质稳定至少1小时。

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