国产注射用伏立康唑与果糖注射液的配伍稳定性研究

Research on the Compatible Stability of Homebred Voriconazole Injection and Fructose Injection

目的:考察以羟丙基-β-环糊精为辅料的国产注射用伏立康唑与果糖注射液的配伍稳定性。方法:观察果糖注射液稀释的注射用伏立康唑在5 h内的溶液性状、不溶性微粒数及pH变化,建立高效液相色谱内标法测定药物的含量。结果:注射用伏立康唑与果糖注射液配伍后,5 h内溶液性状、pH及伏立康唑含量无显著变化,不溶性微粒数符合《中华人民共和国药典》规定。结论:国产注射用伏立康唑与果糖注射液在5 h内配伍稳定。

OBJECTIVE: To investigate the compatible stability of homebred voriconazole injection and fructose injection with the ingredients of hydroxypropyl-β-cyclodextrin. METHODS: To observe the changes of characters of solution,the number of insoluble particle and pH within 5 h in voriconazole injection that was diluted by fructose injection,and the internal standard method of high performance liquid chromatography was established to determine its content. RESULTS: After the compatibility of voriconazole injection and fructose injection,there were no obvious changes in the characters of solution,pH within 5 h and voriconazole content,and the number of insoluble particle had met the specification of Pharmacopoeia of the People's Republic. CONCLUSIONS: The compatibility of homebred voriconazole injection and fructose injection is stable within 5 h.