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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
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| 篇名： | 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 |
| TITLE： | Study on the stability and compatibility of butorphanol，nicardipine，urapidil and tirofiban administered via micro-infusion pump |
| 摘要： | 目的 考察布托啡诺、尼卡地平、乌拉地尔及替罗非班的配伍稳定性与相容性。方法采用微量注射泵模拟输注，分别于4种药物配伍后0、2、4、6、8h时在针头处实时采样，考察其外观、pH、不溶性微粒数；采用超高效液相色谱法测定布托啡诺、尼卡地平、乌拉地尔、替罗非班含量。结果8h内，各配伍溶液的外观均保持澄清透明状态，无肉眼可见的浑浊、沉淀、颜色变化及气体产生；pH波动幅度为0.02～0.09，均小于0.1个pH单位；各配伍溶液中粒径≥10μm的不溶性微粒数均未超过9粒，粒径≥25μm的不溶性微粒数均未超过2粒，均符合2025年版《中国药典》（四部）的相关规定。布托啡诺、尼卡地平、乌拉地尔、替罗非班在配伍后8h时的相对百分含量为92.38%～113.40%。结论在模拟临床微量注射泵输注条件下的8h内，布托啡诺、尼卡地平、乌拉地尔、替罗非班配伍溶液的稳定性、相容性均较好。 |
| ABSTRACT： | 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. |
| 期刊： | 2026年第37卷第12期 |
| 作者： | 赵晓玉；段舒怡；安旭娜；张俐婷；范理菊；安静；董占军 |
| AUTHORS： | ZHAO Xiaoyu，DUAN Shuyi，AN Xuna，ZHANG Liting，FAN Liju，AN Jing，DONG Zhanjun |
| 关键字： | 布托啡诺; 尼卡地平; 乌拉地尔; 替罗非班; 微量注射泵; 联合输注; 稳定性; 相容性 |
| KEYWORDS： | butorphanol; nicardipine; urapidil; tirofiban; micro-infusion pump; combined infusion; stability; compatibility |
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