10%果糖注射液与18种药物配伍稳定性研究

Stability of 10% fructose injection mixed with 18 drugs

目的探究10%果糖注射液与18种临床常用注射药物配伍的稳定性。方法观察室温(25℃)条件下,不同时间(0、3、6 h)配伍液外观、p H、不溶性微粒、紫外吸收光谱及吸光度值变化来确定临床常用的一些药物注射液与10%果糖注射液配伍时的稳定性。结果多烯磷脂酰胆碱与10%果糖注射液配伍后配伍液外观、果糖含量、p H值较其他药物有明显变化;胰岛素注射液、丹红注射液、肾康注射液、康艾注射液、丹参酮ⅡA磺酸钠注射液配伍后微粒数目变化明显;参麦注射液等12种药物配伍后变化不明显。结论多烯磷脂酰胆碱不适宜与10%果糖注射液配伍。胰岛素注射液、丹红注射液、肾康注射液、康艾注射液、丹参酮ⅡA磺酸钠注射液与10%果糖注射液配伍时,不溶性微粒数量增加,超过中国药典规定范围,故原则上不宜与10%果糖注射液配伍。

Objective To investigate the compatibility stability of 10% fructose injection mixed with 18 commonly used injection drugs in clinical practice. Methods We observed a variety of physical and chemical properties： the appearance of the liquid at different time（0, 3 and 6 h） at room temperature, p H, insoluble particles, change of UV absorption spectrum and absorbance to determine the stability. Results Polyene phosphatidylcholine when mixed with 10% fructose injection significantly changed the appearance, p H value and UV absorption spectrum compared with other drugs. Insulin injection, Danhong injection, Shenkang injection, Kang＇ai injection and Danshinone Ⅱ A sodium injection changed the insoluble particles; While the other 12 drugs such as cefuroxime remained basically unchanged. Conclusion Polyene phosphatidylcholine is unfit for 10% fructose injection. Insulin injection, Danhong injection, Shenkang injection, Kang＇ai injection, and Danshinone Ⅱ A sodium injection when mixed with 10% fructose injection can increase the number of insoluble particles, which exceeds the scope in Chinese Pharmacopoeia and are not compatible with 10% fructose injection in principle.