两种国产注射用伏立康唑与输液配伍稳定性研究

Study the compatibility stability of two kinds of homebred voriconazole for injection and infusion

目的考察两种国产注射用伏立康唑与输液配伍稳定性。方法测定用5%葡萄糖注射液、0.9%氯化钠注射液稀释注射用伏立康唑后的性状、p H值、不溶性微粒变化,用紫外分光光度法测定含量变化。结果以羟丙基-β-环糊精为辅料的注射用伏立康唑用这两种输液稀释后在7h内含量、不溶性微粒、p H值无改变,但用0.9%氯化钠注射液稀释时产生的不溶性微粒相对比用5%葡萄糖注射液稀释的多;以专用溶媒溶解的注射用伏立康唑在用0.9%氯化钠注射液稀释20min后,用5%葡萄糖注射液稀释3h以上产生浑浊,药物结晶析出,含量下降。结论 两种注射用伏立康唑均应用5%葡萄糖注射液稀释后静脉滴注,专用溶媒溶解的注射用伏立康唑用5%葡萄糖注射液稀释至2mg/m L后立即注射,避免长时间放置析出结晶。

Objective To investigate the compatibility stability of two kinds of homebred voriconazole for injection, which hydroxypropyl β-cyclodextrin or mixture ofpropylene glycol and ethanol as special solvent. Methods Determining the variation of compatibility voriconazole for injection dilute in 5% glucose injection or 0.9% sodium chloride injection. The characters, pH, insoluble particles, and the content were measured by UV determination. Results Voriconazole with hydroxypropyl β-cyclodextrin soluted in 5% glucose or 0.9% sodium chloride were no changes in content, insoluble particles and pH for 7 hours. But there were more insoluble particles soluted in 0.9% sodium chloride than in 5% glucose injection. They would generate crystal precipitation and the vorieonazole content decreased with special menstruum diluted with 0.9% sodium chloride after 20 minutes or with 5% glucose diluted after 3 hours. Conclusion Two kinds ofvoriconazole for injection should be diluted in 5% glucose injection. Voriconazole with special menstruum diluted in 5% glucose injection should be used immediately.