OBJECTIVE: To investigate the compatible stability of Voriconazole for injection after mixed with Fructose injection or Invert sugar injection. METHODS: Referring to package inserts, Voriconazole for injection 200 mg was dissolved with Water for injection to 20 mL, and then combined with Fructose injection 250 mL and Invert sugar injection 250 mL, respectively. At room temperature, the appearance of mixtures were observed 0, 1, 2, 3, 4, 5 h after mixing, and pH value and the number of insoluble particles were determined; the content of voriconazole was determined by HPLC. RESULTS: Under above condition, the appearance and pH value of mixtures had no significant change within 5 h; the number of particles ≥10 μm and ≥25 μm were all in line with the standard of Chinese Pharmacopoeia (2015 edition); the relative content of voriconazole was decreasing (95.28%-100%), but it changed within ±5% (RSD<2%,n=6). CONCLUSIONS: Voriconazole for injection could keep stable within 5 h after mixed with Fructose injection or Invert sugar injection.
关键词
配伍稳定性注射用伏立康唑果糖注射液转化糖注射液高效液相色谱法
Keywords
Compatibility stabilityVoriconazole for injectionFructose injectionInvert sugar injectionHPLC