注射用阿魏酸钠与临床常用液体的配伍稳定性研究

目的]考察阿魏酸钠与几种临床常用液体的配伍稳定性.方法]模拟临床用药浓度和用药环境,将阿魏酸钠分别与5％、10％葡萄糖、0.9％氯化钠及葡萄糖氯化钠注射液进行配伍,定为第一组,同时配制初始浓度分别为0.2、0.4、1.2、2 mg/ml的0.9％氯化钠溶液,定为第二组,于不同时间用高效液相色谱法测定含量,观察配伍液外观变化并测定pH值.结果]在温度为25℃,照度为800 Lux条件下,配伍后8小时内,第一组配伍液外观、pH值、含量均无明显变化；第二组配伍液中,初始浓度为0.2 mg/ml和2mg/ml的样品溶液,8h测得含量分别为96.3％和99.2％.结论]阿魏酸钠在临床使用时,与四种临床常用液体配伍后,8小时内稳定,同时在临床用药允许的浓度范围内,浓度越高,稳定性也相应提高.

Study on compatible stability of sodium ferulate for injection with clincal Infusion Injection

Objective] To investigate the stability of pharmacal compatibility about sodium ferulate with commonly used Infusion Injections.. Methods] According to the clinical common proportion of dosage, sodium ferulate for injection was mixed in 5%, 10% glucose injection, 0.9% sodium chloride injection,and glucose and sodium chloride injection, and these were the first group; and the various concentrations of 0.2, 0.4, 1.2 and 2 mg/ml were confeeted in 0.9% sodium chloride injection, were the second group, the contents of sodium ferulate were detected by HPLC technology, the variation of the solution appearance and pH value were observed at different times. Results] Under the conditions of 25℃ and 800 Lux at 8 h, the first group had no significant change in the solution appea- rance, pH value and contents; in the second group, the concentration of the solution prepared 0.2mg/ml was 96.3%, the concentration of the solution prepared 2mg/ml was 99.2%. Conclusion] The compatibility of sodium ferulate with four common infusion solutions is stable, and can be used within 8 h, and in the range approved by the clincal concentration, the stability is increased according to the higher concentration of sodium ferulate.