硫酸多黏菌素B在两种溶媒中的含量稳定性  

Content Stability of Polymyxin B Sulfate in Two Solvents

作　　者：石金芳[1] 王玮[1] 姚青青 王未 高杰[1] SHI Jinfang;WANG Wei;YAO Qingqing;WANG Wei;GAO Jie(Department of Pharmacy,the First Affiliated Hospital of Soochow University,Suzhou 215000,China)

机构地区：[1]苏州大学附属第一医院药学部,苏州215000

出　　处：《医药导报》2024年第7期1135-1138,共4页Herald of Medicine

基　　金：苏州市科技发展计划指导性项目(SKYXD2022020)。

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。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℃.

关 键 词：硫酸多黏菌素B 高效液相色谱法 稳定性 

分 类 号：R978.1[医药卫生—药品] R969[医药卫生—药学]