Study on the compatbility stability of amphotericin B for injection in 5％glucose injection with different pH
Objective To investigate the effect of pH change of 5％glucose injection on amphotericin B for injection through the compatibility of amphotericin B for injection with 5％glucose injection at different pH.Methods 5％glucose solution was adjusted to pH=3.2,3.4,3.6,3.8,4.0,4.2,4.4,4.6,4.8,5.0 with hydrochloric acid(HCl)and sodium hydroxide(NaOH),respectively,and then mixed with amphotericin B for injection.Amphotericin B was placed at room temperature for 0,1,2,3,4,5,6,7 h under dark conditions.The content of amphotericin B was determined by high performance liquid chromatography,and the pH changes of the test solution were investigated;the amount of amphotericin B degradation products in the infusion system was increased by accelerated experiments,finally,its chemical structure was determined by mass spectrometry.Results After the compatibility of 5％glucose injection with amphotericin B for injection at pH ≤ 3.4,there will be obvious visible turbidity precipitation;when the pH of 5％glucose injection was ≤ 4,the relative content of amphotericin B for injection decreased with the extension of storage time,and the degradation amount can reach 10％,while the degraded impurity structure was methoxy substitution impurity.Conclusion In order to ensure the safety of amphotericin B for injection,reducing the infusion time can effectively reduce the degradation of amphotericin B under the premise that the pH of the solvent meets the requirements.
amphotericin B for injection5％ glucose injectionstability
万方数据
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