注射用益气复脉(冻干)与胰岛素联合用药的稳定性考察

Study on stability of Yiqi Fumai Lyophilized Injection combined with insulin

目的考察注射用益气复脉(冻干)与胰岛素注射液联合用药的配伍稳定性,为临床合理用药提供参考。方法取同一批次注射用益气复脉(冻干)8瓶,用5%葡萄糖注射液250 mL溶解后,分别加入8 U胰岛素注射液混合均匀,考察配伍后溶液在0、4、8 h内溶液颜色及性状、pH值、不溶性微粒和紫外光谱的变化,采用HPLC法测定注射用益气复脉(冻干)中主要化学成分人参皂苷Rg1、Re、Rb1及指纹图谱变化和配伍的胰岛素含量变化情况,以评估其配伍后药液的稳定性。结果注射用益气复脉(冻干)与8 U胰岛素注射液在5%葡萄糖注射液中配伍后,8 h内外观无明显变化;pH值和紫外吸收无明显变化;配伍液中粒径≥10μm、≥25μm的微粒数均符合《中国药典》规定范围;主要化学成分人参皂苷Rg1、Re、Rb1含量情况均无显著变化,指纹图谱相似度大于0.993,配伍药液胰岛素含量无显著变化。结论注射用益气复脉(冻干)用5%葡萄糖注射液溶解后,再加入8 U胰岛素注射液混合后的药液在8 h内配伍稳定性良好。

Objective To investigate the compatibility stability of YiqiFumai Lyophilized Injection(YQFM)combined with insulin,and to provide reference for clinical medication.Methods Eight bottles of YiqiFumai Lyophilized Injection in same production batch were taken and dissolved with 250 mL 5%glucose injection,and then 8 units of insulin injection were added to mix.HPLC was used to determine ginsenosides Rg1,Re and Rb1 and the changes of fingerprint of YQFM and insulin content for evaluating the stability of the solution.Results There was no significant change in the internal and external view after the compatibility of YQFM and insulin for injection in 5%glucose injection for 8 hours,and the particle size≥10μm and≥25μm in the compatibility solution were within the range specified in the Chinese Pharmacopoeia.There was no significant change in pH value.The contents of ginsenoside Rg1,ginsenoside Re,and ginsenoside Rb1 was not significantly changed and the similarity of fingerprints was more than0.993.There was no significant change in insulin content of the compatibility liquid.Conclusion When 250 mL 5%glucose injection was used for dissolution and 8 bottles of YQFM and 8 units of insulin injection were added to mix evenly,the compatibility stability of the solution was good within 8 hours.