三种输注方式下注射用两性霉素B配伍5%葡萄糖注射液的稳定性

Stability of amphotericin B for injection combined with 5%glucose injection under three infusion modes

目的探讨三种输注方式下注射用两性霉素B配伍5%葡萄糖注射液的稳定性。方法按照设计的三种输注方式配制供试液,在避光条件下室温放置0、1、2、3、4、5、6、7 h,高效液相色谱(HPLC)法测定两性霉素B的图谱及含量变化,同时考察供试液的外观性状、pH。结果我院目前使用的5%葡萄糖注射液pH均≥4.20,三组供试液在试验时间内外观性状均无变化,pH、主药含量变化较小,但随着放置时间的延长,杂质成分会相应增多。结论建议输液产品生产企业对其产品的具体pH予以明确,注射用两性霉素B与pH符合要求的葡萄糖配伍后可通过优化输注方式,减少降解产物。

Objective To investigate the stability of amphotericin B for injection combined with 5%glucose injection under three infusion modes.Methods The test solution was prepared according to the designed three infusion modes,and placed in room temperature for 0,1,2,3,4,5,6,and 7 h under dark conditions.The chromatogram and content changes of amphotericin B were determined by high performance liquid chromatographic(HPLC),and the appearance and pH of the test solution were also investigated.Results The p H of 5%glucose injection used in our hospital is≥4.20.There were no change in the internal and external properties of the test solutions of three groups during the test time.The changes of pH and main drug content were small,with the extension of storage time,the impurities would increase correspondingly.Conclusion It is suggested that enterprises of infusion product should define the specific p H of their products.After amphotericin B for injection is compatible with glucose with p H meet requirements,the degradation products can be reduced by optimizing the infusion mode.