铁离子对奥硝唑氯化钠注射液稳定性的影响

Study on effects of Fe^(3+) on the stability of ornidazole and sodium chloride injection

目的考察铁离子对奥硝唑氯化钠注射液稳定性的影响,保证制剂临床用药安全。方法分别制备不含铁离子及含微量铁离子的奥硝唑氯化钠注射液,用HPLC方法测定两种奥硝唑氯化钠注射液在不同温度不同时间的奥硝唑含量,研究奥硝唑在不同温度下的化学降解动力学,运用Arrhenius方程,预测两种奥硝唑氯化钠注射液在常温下的稳定性。结果奥硝唑氯化钠注射液中奥硝唑的降解符合一级动力学模型,25℃时,不含铁离子的奥硝唑氯化钠注射液的t0.9为1.71年,含微量铁离子的奥硝唑氯化钠注射液的t0.9为1.11年。结论微量铁离子会加速奥硝唑分解,致使奥硝唑氯化钠注射液贮存时间变短。

Objective To investigate the effects of Fe^3＋ on the stability of ornidazole and sodium chloride injection,and en- sure the safety in clinical utility. Methods Two kinds of ornidazole and sodium chloride injection which contain no Fe^3＋ and trace Fe^3＋ were prepared respectively. The content of ornidazole was determined by HPLC at different temperatures and times, which was used to study chemical dynamics of ornidazole . According to Arrhenius equation, stability of two kinds of ornidazole and sodium chloride injection at room temperature were forecasted. Results The degradation of ornidazole followed the first-order reaction kinetics model. At 25 ℃ , t0.9 of ornidazole and sodium chloride injection which not containing Fe^3＋ and containing trace Fe^3＋ were 1.71 years and 1.11 years separately. Conclusions Trace Fe^3＋ could accelerate the degradation of ornidazole, which shortened storage period of ornidazole and sodium chloride injection.