【摘要】 目的:考察注射用伏立康唑与果糖注射液、转化糖注射液的配伍稳定性。方法:参考药品说明书,取注射用伏立康唑200mg经注射用水溶解并定容至20 m L后,分别与果糖注射液250 m L、转化糖注射液250 m L配伍。在室温条件下,分别于配伍后0、1、2、3、4、5 h观察各配伍液的外观,测定其p H和不溶性微粒数,并采用高效液相色谱法测定伏立康唑的含量。结果:在上述条件下,各配伍液在5 h内外观和p H均无明显变化,粒径≥10μm和≥25μm的微粒数均符合2015年版《中国药典》标准;伏立康唑的相对百分含量呈下降趋势(95.28%~100%),但其变化均在±5%范围内(RSD<2%,n=6)。结论:注射用伏立康唑与果糖注射液、转化糖注射液配伍后,在室温条件下5 h内保持稳定。更多还原

【Abstract】 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 m L,and then combined with Fructose injection 250 m L and Invert sugar injection 250 m L,respectively. At room temperature,the appearance of mixtures were observed 0,1,2,3,4,5 h after mixing,and p H value and the number of insoluble particles were determined;the content of voriconazole was determined by HPLC. RESULTS:Under above condition,the appearance and p H 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.更多还原