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盐酸帕洛诺司琼与四种神经肌肉阻滞剂在模拟Y型接口给药过程中的配伍性与稳定性

Compatibility and stability of palonosetron hydrochloride with four neruomuscular blocking agents during simulated y-site administration.

作者信息

Trusley Craig, Ben Michael, Kupiec Thomas C, Trissel Lawrence A

机构信息

Enest Mario School of Pharmacy, Rutgers, The State University of New Jersey, Piscataway, New Jersey.

出版信息

Int J Pharm Compd. 2008 Mar-Apr;12(2):156-60.

Abstract

Palonosetron hydrochloride is a longer-acting selective 5-HT3 receptor antagonist that has been approved for the prevention of chemotherapy-induced nausea and vomiting and is being evaluated for the prevention of postoperative nausea and vomiting. The objective of this study was to evaluate the physical and chemical stability of palonosetron hydrochloride 50 mcg/mL when mixed with any of the neuromuscular blocking drugs cisatracurium besylate 0.5 mg/mL, rocuronium bromide 1 mg/mL, succinylcholine chloride 2 mg/mL, and vecuronium bromide 1 mg/mL during simulated Y-site administration. Triplicate samples of palonosetron hydrochloride with each of the neuromuscular blocking drugs were tested. Samples were stored and evaluated for up to 4 hours at room temperature. Physical stability was assessed by turbidimetric and particulate measurements and visual inspection. Chemical stability was assessed by high-performnace liquid chromatography. All of the admixtures were clear and colorless when viewed in normal fluorescent room light and when viewed with a Tyndall beam. Measured turbidity and particulate content were low initially and remained low throughout the study. The drug concentration was unchanged in all of the samples tested. Palonosetron hydrochloride is physically and chemically stable with cisatracurium besylate, rocuronium bromide, succinylcholine chloride, or vecuronium bromide at the concentrations tested during simulated Y-site administration over 4 hours at ambient room temperature.

摘要

盐酸帕洛诺司琼是一种长效选择性5-羟色胺3(5-HT3)受体拮抗剂,已被批准用于预防化疗引起的恶心和呕吐,目前正被评估用于预防术后恶心和呕吐。本研究的目的是评估在模拟Y型接口给药过程中,50 mcg/mL盐酸帕洛诺司琼与任何一种神经肌肉阻滞剂(0.5 mg/mL苯磺顺阿曲库铵、1 mg/mL罗库溴铵、2 mg/mL氯化琥珀胆碱和1 mg/mL维库溴铵)混合时的物理和化学稳定性。对盐酸帕洛诺司琼与每种神经肌肉阻滞剂的一式三份样品进行了测试。样品在室温下储存并评估长达4小时。通过比浊法和微粒测量以及目视检查来评估物理稳定性。通过高效液相色谱法评估化学稳定性。在正常荧光室内光线下以及用廷德尔光束观察时,所有混合物均清澈无色。最初测得的浊度和微粒含量较低,并且在整个研究过程中一直保持较低水平。所有测试样品中的药物浓度均未发生变化。在室温环境下模拟Y型接口给药4小时的测试浓度下,盐酸帕洛诺司琼与苯磺顺阿曲库铵、罗库溴铵、氯化琥珀胆碱或维库溴铵在物理和化学上是稳定的。

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