[关键词]
[摘要]
目的 考察不同温度及光照条件下,注射用益气复脉(冻干)(YQFM)与0.9%氯化钠注射液的配伍稳定性,为临床用药提供参考。方法 模拟临床应用,以0.9%氯化钠注射液为溶媒,按说明书要求与YQFM进行混合,考察配伍溶液在室温、高温、光照、暗处条件下,6 h内溶液颜色及性状、pH、不溶性微粒及人参皂苷Rg1、Re、Rb1和五味子醇甲含量以及指纹图谱的变化。结果 YQFM与0.9%氯化钠注射液配伍后6 h内,室温、高温、光照、暗处条件下,配伍液颜色及外观、pH变化不明显,溶液中粒径≥ 10 μm、≥ 25 μm的微粒数均符合《中国药典》规定范围;人参皂苷Rg1、Re、Rb1和五味子醇甲含量变化RSD<2.50%;且各时间点指纹图谱与0 h相比,相似度均大于0.997。结论 YQFM与0.9%氯化钠注射液配伍后6 h内,在室温、高温、光照、暗处条件下,溶液均较稳定。
[Key word]
[Abstract]
Objective To investigate the compatibility stability of Yiqi Fumai Lyophilized Injection (YQFM) combined with 0.9% sodium chloride injection under different temperature and light conditions to provide reference for clinical medication. Methods We mixed YQFM with 0.9% sodium chloride injection according to the requirements of the instructions. The color, pH, and insoluble particles were observed and determined. The content changes of main compounds including ginsenosides Rg1, Re, Rb1, and schisandrin in YQFM were determined by HPLC at 0, 2, 4, 6 h after mixing. Results Within 6 hours after YQFM and 0.9% sodium chloride injection were mixed, there is no obvious change in color and pH value. The number of particles (≥ 10 and ≥ 25 μm) met the requirements of Chinese Pharmacopoeia. There is no change was found in ginsenosides Rg1, Re, Rb1, and schisandrin values (RSD< 2.50%). The similarity of fingerprint was larger than 0.997. Conclusion Within 6 hours after YQFM and 0.9% sodium chloride injection were mixed, the solution was stable under room temperature, high temperature, light, and dark conditions.
[中图分类号]
R965.3
[基金项目]
天津市科技计划项目(18YFCZZC00430)