【摘要】 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。更多还原

【Abstract】 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.更多还原