注射用伏立康唑与2种注射液的配伍稳定性研究
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篇名: 注射用伏立康唑与2种注射液的配伍稳定性研究
TITLE:
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200 mg经注射用水溶解并定容至20 mL后,分别与果糖注射液250 mL、转化糖注射液250 mL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pH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pH均无明显变化,粒径≥10 μm和≥25 μm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。
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 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.
期刊: 2017年第28卷第17期
作者: 崔晓红,任进民,刘萌,亢泽坤,贡莹
AUTHORS: CUI Xiaohong,REN Jinmin,LIU Meng,KANG Zekun,GONG Ying
关键字: 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 stability; Voriconazole for injection; Fructose injection; Invert sugar injection; HPLC
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