布托啡诺、尼卡地平、乌拉地尔和替罗非班经微量注射泵配伍给药的稳定性与相容性研究OA

OBJECTIVE To investigate the stability and compatibility of butorphanol,nicardipine,urapidil,and tirofiban.METHODS A micro-infusion pump was used to simulate the infusion process.Samples were collected in real time from the needle tip at 0,2,4,6,and 8 h after mixing of the four drugs.The appearance,pH,and number of insoluble particles were examined.The contents of butorphanol,nicardipine,urapidil,and tirofiban were determined using the ultra-high-performance liquid chromatography method.RESULTS Within 8 hours,all mixed solutions remained clear and transparent,with no visible turbidity,precipitation,color change,or gas generation.The pH fluctuation ranged from 0.02 to 0.09,both within 0.1 pH units.The number of insoluble particles≥10 μm in size in each compatibility solution was≤9,and the number of insoluble particles≥25 μm was≤2,meeting the requirements of the 2025 edition of the Chinese Pharmacopoeia(Volume Ⅳ).The relative percentage contents of butorphanol,nicardipine,urapidil,and tirofiban at 8 hours after compatibility mixing ranged from 92.38%to 113.40%.CONCLUSIONS Within 8 hours under simulated clinical micro-infusion pump infusion conditions,the stability and compatibility of the mixed solution containing butorphanol,nicardipine,urapidil,and tirofiban were satisfactory.