Department of Pharmacy, Shanghai Public Health Clinical Center，Fudan University, No. 2901 Caolang Road, Jinshan District, Shanghai, 201508, People's Republic of China.
Department of Medicine, Shanghai Public Health Clinical Center, Fudan University, 2901 Caolang Road, Jinshan District, Shanghai, 201508, People's Republic of China.
Sci Rep. 2024 Oct 17;14(1):24397. doi: 10.1038/s41598-024-75392-3.
Fructose injection is occasionally used to dilute ademetionine 1,4-butanedisulfonate injection for patients who cannot receive glucose or sodium chloride injections in clinical settings. Since our PIVAS staff reported that discoloration occurred after ademetionine 1,4-butanedisulfonate dissolved with fructose injection, this study aims to investigate the stability of ademetionine 1,4-butanedisulfonate in fructose and glucose solutions. Ademetionine 1,4-butanedisulfonate was purchased and diluted with fructose or glucose injection for compatibility testing. The solutions were maintained under various conditions for different periods of time, after which the concentration of ademetionine 1,4-butanedisulfonate and other impurities was analyzed. The chemical structures of unknown impurities were further investigated by liquid chromatography-tandem mass spectrometry. The analytical method was validated and was deemed to be suitable for the analyses in this study. Compatibility tests indicated that ademetionine 1,4-butanedisulfonate is sensitive to temperature, illumination, and pH. When diluted with fructose or glucose, the concentration of ademetionine 1,4-butanedisulfonate decreased over time. The contents of impurities increased accordingly. Additionally, an unknown impurity was identified, speculated to be a hydroxyl oxidation product of ademetionine based on the LC-MS/MS results. Both fructose and glucose injections can be used as diluents for ademetionine 1,4-butanedisulfonate, and the resulting mixture remains stable for up to 8 h after preparation.
果糖注射液偶尔用于稀释临床中不能接受葡萄糖或氯化钠注射液的患者的腺苷蛋氨酸 1,4-丁烷二磺酸注射液。由于我院静脉用药调配中心（PIVAS）工作人员报告称，腺苷蛋氨酸 1,4-丁烷二磺酸溶解在果糖注射液后会发生变色，因此本研究旨在考察果糖和葡萄糖溶液中腺苷蛋氨酸 1,4-丁烷二磺酸的稳定性。购买了腺苷蛋氨酸 1,4-丁烷二磺酸并用果糖或葡萄糖注射液进行稀释以进行相容性测试。将溶液在不同条件下保持不同的时间段，然后分析腺苷蛋氨酸 1,4-丁烷二磺酸和其他杂质的浓度。通过液相色谱-串联质谱法进一步研究了未知杂质的化学结构。验证了分析方法，认为该方法适用于本研究中的分析。相容性测试表明，腺苷蛋氨酸 1,4-丁烷二磺酸对温度、光照和 pH 值敏感。用果糖或葡萄糖稀释时，腺苷蛋氨酸 1,4-丁烷二磺酸的浓度随时间的推移而降低。杂质的含量相应增加。此外，还鉴定出一种未知杂质，根据 LC-MS/MS 结果推测为腺苷蛋氨酸的羟基氧化产物。果糖和葡萄糖注射液均可作为腺苷蛋氨酸 1,4-丁烷二磺酸的稀释剂，配制后混合物在 8 h 内保持稳定。
