托烷司琼注射液常见临床配伍稳定性考察

In Vitro Stability of Tropisetron Hydrochloride with Representative Infusion Solutions

关键词:  盐酸托烷司琼  配伍  稳定性  液相色谱串联质谱

Key words:  tropisetron hydrochloride  compatible  stability  LC-MS/MS

摘要:

目的 考察注射用托烷司琼在注射器中与临床常见7种输液配伍的稳定性。方法 在室温下，将注射用盐酸托烷司琼加入到7种输液(果糖注射液、0.9%氯化钠注射液、乳酸钠林格注射液、5%葡萄糖注射液、复方氯化钠注射液、葡萄糖氯化钠注射液和转化糖注射液)中，模拟临床用药浓度，用液相色谱串联质谱测定配伍后不同时间配伍液的含量，同时检查配伍液的pH值、颗粒数和外观变化。结果 注射用盐酸托烷司琼与7种输液配伍后在18~25 ℃放置4 h，其外观、pH值和含量基本不变，≥10 μm和≥25 μm的颗粒数也符合规定要求。结论 注射用盐酸托烷司琼与7种输液配伍，在18~25 ℃下4 h内基本稳定。

Abstract:

OBJECTIVE To investigate the compatible stability of tropisetron hydrochloride injection with 7 different infusions. METHODS According to the clinical application of dose, tropisetron hydrochloride injection was mixed with 7 different injections included Fructose injection, 0.9% Sodium Chloride injection, sodium lactate ringer’s injection, 5% Glucose injection, Compound Sodium Chloride injection, Glucose Saline injection and Invert Sugar injection at room temperature, the compatibility content was determined by liquid chromatography tandem mass spectrometry. Color, pH, particulates contents of tropisetron was also studied. RESULTS The content, pH and color of tropisetron hydrochloride solution showed no significant change in the initial state, the number of insoluble particles(≥10 μm and ≥25 μm size) were acceptable. CONCLUSION Tropisetron hydrochloride injection was stable for up to 4 h in vitro in 7 different solutions at room temperature.