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盐酸多巴酚丁胺与盐酸维拉帕米在0.9%氯化钠注射液和5%葡萄糖注射液中的稳定性

Stability of dobutamine hydrochloride and verapamil hydrochloride in 0.9% sodium chloride and 5% dextrose injections.

作者信息

Das Gupta V, Stewart K R

出版信息

Am J Hosp Pharm. 1984 Apr;41(4):686-9.

PMID:6720710
Abstract

The stability of dobutamine hydrochloride (250 micrograms/ml) and verapamil hydrochloride (160 micrograms/ml) alone and in combination in 0.9% sodium chloride injection or 5% dextrose injection was studied. Solutions were stored both in plastic i.v. bags and in amber-colored glass bottles at 24 degrees C and 5 degrees C for up to seven days. Before storage and at various times during storage, solutions were assayed at least in triplicate by high-performance liquid chromatography, pH was recorded, and visual appearance was noted. All solutions tested under all conditions retained at least 90% potency for seven days. In plastic i.v. bags, dobutamine either alone or in combination with verapamil in both diluents turned a light-pink color in 24 hours at 24 degrees C. The intensity of the pink color increased with time in 0.9% sodium chloride injection; in 5% dextrose injection, solutions, became clear in 48 hours. The pH of solutions prepared in plastic i.v. bags in 5% dextrose injection decreased from 4.0 to 3.1 during the seven-day period at 24 degrees C; results for solutions in amber bottles were similar. At 5 degrees C, the pH and clarity of all solutions in bags and bottles remained stable for seven days. At the concentrations tested, dobutamine hydrochloride combined with verapamil hydrochloride is stable in 0.9% sodium chloride injection and 5% dextrose injection for 48 hours at 24 degrees C and for seven days at 5 degrees C.

摘要

研究了盐酸多巴酚丁胺(250微克/毫升)和盐酸维拉帕米(160微克/毫升)单独及联合使用时在0.9%氯化钠注射液或5%葡萄糖注射液中的稳定性。溶液分别储存在塑料静脉输液袋和琥珀色玻璃瓶中,于24℃和5℃下保存长达7天。在储存前及储存期间的不同时间,至少一式三份地通过高效液相色谱法对溶液进行分析,记录pH值,并观察外观。在所有条件下测试的所有溶液在7天内至少保留90%的效价。在塑料静脉输液袋中,单独的盐酸多巴酚丁胺或与盐酸维拉帕米联合使用的两种稀释液在24℃下24小时内变为浅粉色。在0.9%氯化钠注射液中,粉色强度随时间增加;在5%葡萄糖注射液中,溶液在48小时内变清。在24℃下的7天期间,5%葡萄糖注射液中塑料静脉输液袋制备的溶液pH值从4.0降至3.1;琥珀瓶中溶液的结果相似。在5℃下,袋和瓶中所有溶液的pH值和澄清度在7天内保持稳定。在所测试的浓度下,盐酸多巴酚丁胺与盐酸维拉帕米联合使用在0.9%氯化钠注射液和5%葡萄糖注射液中于24℃下稳定48小时,在5℃下稳定7天。

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