注射用伏立康唑与2种注射液的配伍稳定性研究

发布时间：2018-11-03 08:55

【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(RSD2%,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 compatibility stability of Volconazole, fructose injection and trans sugar injection for injection. Methods: with reference to the drug instruction, 200mg for injection was dissolved in water for injection to 20ml, then mixed with fructose injection 250ml and transforming sugar injection 250ml respectively. At room temperature, the appearance, pH and the number of insoluble particles of each compatibility solution were observed for 5 h after compatibility, and the content of voliconazole was determined by HPLC. Results: under the above conditions, the appearance and pH of each compatibility solution did not change significantly within 5 h, and the number of particles with particle size 鈮，

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