左氧氟沙星与五种抗菌药物的配伍及稳定性研究

Study on the stability of complexes of levofloxacin and other five drugs by HPLC

  • 摘要: 目的: 研究盐酸左氧氟沙星葡萄糖注射液与五种抗菌药物的配伍及稳定性。方法: 采用高压液相色谱法(HPLC)法测定盐酸左氧氟沙星葡萄糖注射液及五种抗菌药物在25℃,24h内的含量变化、用光阻法测定不溶性微粒变化,同时观察外观并测定pH值变化。结果: 配伍溶液的外观及颜色均无明显变化。各样品溶液24h内pH值无明显改变;配伍前后不溶性微粒的测定结果均符合中国药典规定;含量测定结果表明盐酸左氧氟沙星葡萄糖注射液、甲硝唑磷酸二钠、头孢呋辛钠、头孢他啶在放置期间含量下降均少于10%;仅头孢曲松钠和头孢唑林钠2h和6h后大于10%。结论: 盐酸左氧氟沙星葡萄糖注射液与五种抗菌药物无配伍变化,配伍后的注射液应及时使用。

     

    Abstract: Objective: To study the stability of complexes of levofloxacin hydruchloride and glucose injection and other five drugs at 25℃.Metheds: The samples of the complexes were collected at the 2,4,6、8、24hafter mixing levofloxacin hydruchloride and glucose injection and other five drugs at 25℃, the contents of levofloxacin hydruchloride and glucose injection and the drugs were determined by means of HPLC. The particles and pH of the samples were also determined.Results: There were no visible sign of incompatibility in the complexes, The pH and particles of solutions, varied slightly in acceptable range. The contents of levofloxacin hydruchloride and glucose injection and three other tested drugs more than 90% of their initial levels, while the contents of of the two tested drugs lower than 90% of their initial levels.Conclusion: Levofloxacin hydruchloride and glucose injection and five other drugs were compatible,the contents of levofloxacin hydruchloride and glucose injection was stable under the experiment condition.

     

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