【摘要】 目的 考察硫酸多黏菌素B在成品输液及高浓度储备液中的含量稳定性，为临床给药提供依据。方法 建立测定硫酸多黏菌素B含量的高效液相色谱方法，将硫酸多黏菌素B分别溶于0.9%氯化钠注射液及5%葡萄糖注射液，配成0.5、1 mg·mL^-1成品输液及5 mg·mL^-1储备液，并在4和25℃储存条件下于0、2、4、6、8、12、16、20及24 h测定多黏菌素B含量。结果 4和25℃储存条件下，0.5、1 mg·mL^-1硫酸多黏菌素B成品输液和5 mg·mL^-1硫酸多黏菌素B储备液均稳定，多黏菌素B1和多黏菌素B2含量和0 h（以100%计）比较，分别在97.23%～102.63%和97.30%～102.63%范围内。结论 硫酸多黏菌素B溶于0.9%氯化钠注射液及5%葡萄糖注射液，0.5、1和5 mg·mL^-1溶液在4和25℃储存，24 h内稳定性良好。更多还原

【Abstract】 Objective To investigate the content stability of polymyxin B sulfate in high concentration solution and its finished infusion, and to provide a scientific basis for clinical administration. Methods Polymyxin B sulfate was dissolved in 0.9% sodium chloride injection and 5% glucose solution to the concentrations of 0.5 mg·mL^-1,1 mg·mL^-1 and 5 mg·mL^-1,respectively.The content of polymyxin B was determined at 0,2,4,6,8,12,16,20 and 24 h by high-performance liquid chromatography under storage conditions of 4 ℃ and 25 ℃. Results Polymyxin B sulfate was stable in the concentrations of 0.5 mg·mL^-1,1 mg·mL^-1 and 5 mg·mL^-1,respectively, in 0.9% sodium chloride injection or 5% glucose injection.Under the storage conditions of 4 ℃ and 25 ℃,the content of polymyxin B1 and polymyxin B2 ranged from 97.23% to 101.26% and 97.30% to 102.63%,respectively. Conclusion Polymyxin B sulfate was stable within 24 h dissolved either in 0.9% sodium chloride injection or in 5% glucose injection with the concentrations of 0.5 mg·mL^-1,1 mg·mL^-1 and 5 mg·mL^-1 under the storage condition of 4 ℃ and 25 ℃.更多还原