注射用伏立康唑与2种注射液的配伍稳定性研究  

Study on Compatible Stability of Voriconazole for Injection Combined with 2 Kinds of Injections

作　　者：崔晓红[1] 任进民[2] 刘萌[3] 亢泽坤[2] 贡莹[2] CUI Xiaohong;REN Jinmin;LIU Meng;KANG Zekun;GONG Ying(Clinical Trial Center,Beijing Hospital,Beijing 100730,China;Dept. of Pharmacy,the Second Hospital of Hebei Medical University,Shijiazhuang 050000,China;School of Pharmacy,Hebei Medical University,Shijiazhuang 050000,China)

机构地区：[1]北京医院临床试验研究中心,北京100730 [2]河北医科大学第二医院药学部,石家庄050000 [3]河北医科大学药学院,石家庄050000

出　　处：《中国药房》2017年第17期2343-2346,共4页China Pharmacy

基　　金：河北省科技计划项目(No.132777103D)

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。OBJECTIVE:To investigate the compatible stability of Voriconazole for injection after mixed with Fructose injectionor Invert sugar injection.METHODS:Referring to package inserts,Voriconazole for injection200mg was dissolved with Waterfor injection to20mL,and then combined with Fructose injection250mL and Invert sugar injection250mL,respectively.Atroom temperature,the appearance of mixtures were observed0,1,2,3,4,5h after mixing,and pH value and the number of insolubleparticles were determined;the content of voriconazole was determined by HPLC.RESULTS:Under above condition,theappearance and pH value of mixtures had no significant change within5h;the number of particles≥10μm and≥25μm were allin line with the standard of Chinese Pharmacopoeia(2015edition);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 stablewithin5h 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 

分 类 号：R978.5[医药卫生—药品]