艾迪注射液与5%葡萄糖注射液或0.9%氯化钠注射液的配伍稳定性  

Investigation on the compatibility stability of Aidi injection with 5%glucose injection or 0.9%sodium chloride injection

作　　者：张生潭[1] 武红娜 段利瑶 宝志 李彦儒 姚超然 姚晨 ZHANG Shengtan;WU Hongna;DUAN Liyao;BAO Zhi;LI Yanru;YAO Chaoran;YAO Chen(Department of Pharmacy,Integrated Traditional and Western Medicine Hospital of Cangzhou of Hebei Province,Cangzhou 061001,China;Department of General Affairs,Cangzhou Center for Food and Drug Control,Cangzhou 061000,China)

机构地区：[1]河北省沧州中西医结合医院药学部,沧州061001 [2]沧州市食品药品检验所综合科,沧州061000

出　　处：《中国临床药学杂志》2024年第12期929-934,共6页Chinese Journal of Clinical Pharmacy

基　　金：河北省中医药管理局指令性科研课题(编号2023245);河北省卫生健康委员会医学科研课题(编号20220688)。

摘　　要：目的考察在不同放置时间与温度条件下,艾迪注射液与5%葡萄糖注射液(5%GS)或0.9%氯化钠注射液(0.9%NS)的配伍稳定性,以促进临床安全与合理用药。方法按照艾迪注射液的药品说明书要求,在模拟临床实际应用情况下分别配制艾迪注射液与0.9%NS或5%GS的配伍溶液,即NS配伍溶液和GS配伍溶液。考察2种配伍溶液在不同放置时间(0、1、2、4、8、12、24 h)及温度(25、35、45℃)下的外观性状、pH值、不溶性微粒以及样品溶液中人参皂苷Rg1、人参皂苷Rb1、紫丁香苷的含量变化。结果24 h内NS配伍溶液和GS配伍溶液的外观形状均未发生明显变化,pH值波动在人体可耐受的范围(4~9)内;放置时间对于粒径≥10μm的不溶性微粒数量影响无统计学意义,而放置温度对不同粒径的不溶性微粒数量均有一定影响;3种成分含量在0.9%NS中的降解速度要低于在5%GS中。结论艾迪注射液优先选择与0.9%NS的配伍,配伍好的溶液建议在温度≤25℃,并在1~2 h内输注完成。AIM To investigate the compatible stability of Aidi injection with 5%glucose injection(5%GS)or 0.9%sodium chloride injection(0.9%NS)at different storage times and temperatures,to provide reference for clinical safety and rational use of the Aidi injection.METHODS According to the instructions,compatibility solutions of Aidi injection with 0.9%NS or 5%GS were to be prepared to simulate the clinical application,named the NS compatibility solution and the GS compatibility solution,respectively.Changes in appearance,pH value,insoluble particles,and the content of ginsenoside Rg1,ginsenoside Rb1,and syringin in 2 compatibility solutions were investigated under different storage times(0,1,2,4,8,12,24 h)and temperatures(25,35,45°C).RESULTS No significant changes in appearance were observed for either the NS compatibility solution or the GS compatibility solution within 24 hours,and the pH value fluctuated within the range tolerable by the human body(4-9).There was no significant difference in the number of insoluble particles with a particle size of≥10μm by the placement time,while the temperature exhibited a certain effect on the number of insoluble particles.The degradation rate of 3 components in 0.9%NS was lower than that in 5%GS.CONCLUSION In preparing Aidi injection,it is recommended to mix with 0.9%NS preferentially,the mixed medicine should be infused within 1-2 hours at a temperature below 25℃.

关 键 词：艾迪注射液 配伍稳定性 含量测定 成品输液 

分 类 号：R28[医药卫生—中药学]