注射用盐酸尼莫司汀的稳定性考察

目的:考察不同温度、光照及pH值条件下注射用盐酸尼莫司汀(ACNU)与0.9%氯化钠注射液配伍的稳定性,为临床合理用药提供依据。方法:采用高效液相色谱法测定其主药含量,并观察配伍液的外观、pH值等变化。结果:ACNU检测浓度的线性范围为10～100μg.mL-1(r=0.9998);平均回收率为99.81%(RSD=0.68%);温度、光照及0.9%氯化钠注射液pH值3种因素均对ACNU稳定性有影响。结论:临床应用ACNU时应现配现用,且配伍后溶液冷藏、避光贮存不超过8h。

Stability of Nimustine Hydrochioride Injection

OBJECTIVE:To determine the stability of nimustine hydrochioride(ACNU)for injection in 0.9% NS under different temperatures,lighting conditions and pH values so as for references of clinical rational use of drugs.METHODS:The content of nimustine was determined by HPLC,and the changes of the mixed solution in appearance and pH etc were observed.RESULTS:The linear range of ACNU was 10～ 100μ g· mL-1.The average recovery of ACNU was 99.81%(RSD=0.68%).The facotors-temperature,lighting and pH of 0.9% NS did have influence on the stability of ACNU.CONCLUSION:Nimustine hydrochioride should be used immediately after it has been prepared,the mixed solution can be stored for use within 8 hours in cool and dark condition.