注射用夫西地酸钠与3种溶剂配伍稳定性研究

目的:考察注射用夫西地酸钠与果糖注射液,转化糖注射液和木糖醇注射液配伍后6 h内的稳定性。方法:采用高效液相色谱法测定夫西地酸钠与3种溶剂配伍后室温放置6 h内夫西地酸钠的含量变化,并观察其室温放置6h内外观及pH值的变化情况。色谱条件为使用NoVa-park C18柱,流动相为0.01 mol.L-1磷酸-乙腈-甲醇(16∶64∶20),检测波长为215 nm。结果:与配伍0 h比较,配伍液放置6 h内的外观、色泽均无明显变化,pH略有变化;6 h内配伍液中夫西地酸钠含量无明显变化,且均保持在97%以上,配伍液6 h内无新物质产生。夫西地酸在浓度0.484 8～3.878 4μg的范围内有良好线性关系(r=0.999 90)。结论:注射用夫西地酸钠与果糖注射液、转化糖注射液、木糖醇注射液配伍后室温放置6 h内夫西地酸性质基本稳定。

Compatible Stability of Fusidate Sodium for Injection with Fructose Injection,Calorose Injection or Xylital Injection

OBJECTIVE： To study the compatible stability of fusidate sodium for injection in fructose injection,calorose injection or xylital injection within 6 hrs.METHODS： Stored within 6 hr after mixing with fructose injection,calorose injection or xylital injection under room temperature,the content change of fusidate sodium was determined by HPLC on chromatographic column NoVa-park C18 with the mobile phase consisting of 0.1% mol·L-1 H3PO4-acetonitrile-methanol（16∶64∶20） at a detective wavelength of 215 nm.Meanwhile,the appearance and the pH value of the mixtures within 6 hrs were followed.RESULTS： As compared with 0 h,the mixtures stored within 6 hrs showed no significant change in appearance and color except a little change in its pH value;no significant differences were noted for the content of sodium fusidate in the mixtures,which maintained at above 97% and no new substances were noted within 6 hr for the mixtures.The linear range of fusidate sodium（r=0.999 90） was 0.484 8-3.878 4 μg·mL-1（r=0.999 90）.CONCLUSION： Fusidate sodium was basically stable in quality within 6 hrs after mixing with fructose injections,calorose injections or xylital injection under the room temperature.