Stability of Concentrated Solution of Vancomycin Hydrochloride in Syringes for Intensive Care Units

M. Godet, J. Simar, M. Closset, J. Hecq, M. Braibant, L. Soumoy, P. Gillet, J. Jamart, B. Bihin, L. Galanti
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引用次数: 4

Abstract

Abstract Background Vancomycin is increasingly administrated by continuous infusion. But the treatment of patient in intensive care need restricted volume to prevent fluid overload. The aim of the study was to evaluate the physical and chemical stability of solutions of a high concentration of vancomycin hydrochloride in 5 % glucose or 0.9 % NaCl. Methods Eight syringes of 50 mL, containing 41.66 mg/mL of vancomycin hydrochloride four syringes in 5 % glucose and four in 0.9 % NaCl were prepared and stored at ambient temperature during 48 h. Immediately after preparation and during 48 h, vancomycin hydrochloride concentrations were measured by a high-performance liquid chromatography (HPLC). Spectrophotometric absorbance at different wavelengths, pH measurement and microscopic observations were also performed. Results All solutions were physico-chemically stable during the whole period storage at ambient temperature: no color change, turbidity, precipitation or opacity, no significant pH variations or optic densities were observed in the solutions. Any crystals were seen by microscopic analysis. Solutions are considered chemically stable as the lower limit of the 95 % unilateral confidence interval on the mean remained above 90 % of the initial concentration for at least 48 h. Conclusions Solutions of vancomycin hydrochloride 41.66 mg/mL in syringe of 5 % glucose or 0.9 % NaCl are physically and chemically stable for at least 48 h when stored in syringes at ambient temperature.
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重症监护病房注射器中盐酸万古霉素浓缩液的稳定性研究
背景万古霉素越来越多地通过持续输注给药。但在重症监护病人的治疗需要限制容量,以防止液体超载。本研究的目的是评价高浓度盐酸万古霉素溶液在5%葡萄糖或0.9% NaCl中的物理化学稳定性。方法制备8支50 mL、含41.66 mg/mL盐酸万古霉素的注射器,4支5%葡萄糖溶液,4支0.9% NaCl溶液,室温保存48 h。制备后立即和48 h内,用高效液相色谱法测定盐酸万古霉素浓度。并进行了不同波长的吸光度测定、pH测定和显微观察。结果所有溶液在常温下全贮存期物理化学性质稳定,无颜色变化、浑浊、沉淀和不透明,无明显pH变化和光密度变化。显微镜分析可以看到任何晶体。如果溶液在95%的单边置信区间内保持在初始浓度的90%以上至少48小时,则认为溶液是化学稳定的。结论盐酸万古霉素41.66 mg/mL以5%葡萄糖或0.9% NaCl为溶液,常温下在注射器中保存至少48 h,其物理化学性质稳定。
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审稿时长
12 weeks
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