国产和进口泮托拉唑钠在输液中的配伍稳定性考察

Compatible stability study of domestic and imported pantoprazole sodium for injection with infusion fluids

目的考察国产和进口泮托拉唑钠在输液中的配伍稳定性。方法国产和进口泮托拉唑钠按各自的药品说明书要求与相应输液配伍,在室温条件下放置6 h,用HPLC法测定配伍后不同时间点的泮托拉唑钠含量,并观察配伍溶液的外观性状和测定pH值。结果国产和进口泮托拉唑钠在0.9%氯化钠注射剂中较为稳定,而后者与5%或10%葡萄糖注射剂配伍4h后药物含量和pH值不断降低。结论临床在开具泮托拉唑钠处方或医嘱时应首选0.9%氯化钠注射剂,如有必要使用5%或10%葡萄糖注射剂仅限进口泮托拉唑钠并在4h内用完。

AIM To study the compatible stability of domestic and imported pantoprazole sodium for injection with infusion fluids. METHODS The domestic pantoprazole sodium for injection and imported pantoprazole sodium for injec- tion were added to infusion fluids respectively according to corresponding package inserts, and the mixtures were kept at room temperature for 6 h. The contents of pantoprazole sodium were determined at different time points by HPLC. The outward appearance was observed and the pH value was checked. RESULTS The domestic pantoprazole sodium for in- jection and imported pantoprazole sodium for injection were stable in 0.9% sodium chloride infusion fluids, and the latter was not stable in 5% or 10% glucose infusion fluids after 4 h with content and pH value reduced gradually. CONCLU- SION The 0.9% sodium chloride infusion fluids as solvent should be the first choice for pantoprazole sodium in pre- scription or medical advice. If necessary, 5% or 10% glucose infusion fluids are used for the imported pantoprazole sodi- um only, and must be used up within 4 h.