Zhang Linzhong, Kong Lingchun, Deng Qi, Chao Yukai, Fu Chibing, Meng Yutong
Second hospital of Shanxi Medical University CN, Taiyuan, Shanxi, China.
Sichuan Haisco Pharmaceutical Co., Ltd., Chengdu, China.
Curr Ther Res Clin Exp. 2025 Jul 28;103:100810. doi: 10.1016/j.curtheres.2025.100810. eCollection 2025.
To evaluate the physical and chemical compatibility and stability of a cipepofol (ciprofol) and etomidate (EC) mixture for intravenous anesthesia and assess the physiochemical stability of the drugs during co-administration through the same intravenous line.
High-performance liquid chromatography and other analytical techniques were employed to investigate the stability of the EC mixture. The mixture was prepared and stored at 4°C, 25°C, or 37°C for 24 h, and its appearance, pH, osmotic pressure, particle size, zeta potential, drug content, and related substances were evaluated at 0, 1, 3, 6, 12, and 24 h.
The EC mixture maintained physical stability, with no significant changes in appearance, pH (fluctuation, ≤0.07 units), osmotic pressure (relative standard deviation [RSD] < 2.0%), or particle size observed over 24 h. Zeta potential remained within acceptable limits (ranging from -40 to -30 mV), indicating good colloidal stability. Chemically, drug content remained at ≥99.9% of the initial level (RSD < 1.2%), and impurity levels stayed within the specified limits (maximum single impurity ≤ 0.13%, total impurities ≤ 0.37%).
The findings suggest that the EC mixture was physically and chemically compatible and stable for up to 24 h at various temperatures, making this regimen a potentially safe and effective option for intravenous anesthesia. This finding is significant for improving patient comfort and reducing adverse drug reactions during anesthesia induction and maintenance.
评估西泊酚（环泊酚）与依托咪酯（EC）混合用于静脉麻醉时的物理化学相容性及稳定性，并通过同一静脉通路给药期间评估药物的物理化学稳定性。
采用高效液相色谱法及其他分析技术研究EC混合物的稳定性。制备混合物并分别在4℃、25℃或37℃下储存24小时，在0、1、3、6、12和24小时时评估其外观、pH值、渗透压、粒径、ζ电位、药物含量及有关物质。
EC混合物保持物理稳定性，24小时内外观、pH值（波动≤0.07单位）、渗透压（相对标准偏差[RSD]<2.0%）或粒径均无显著变化。ζ电位保持在可接受范围内（-40至-30mV），表明具有良好的胶体稳定性。化学方面，药物含量保持在初始水平的≥99.9%（RSD<1.2%），杂质水平保持在规定限度内（最大单个杂质≤0.13%，总杂质≤0.37%）。
研究结果表明，EC混合物在不同温度下24小时内物理化学性质相容且稳定，使该方案成为静脉麻醉潜在安全有效的选择。这一发现对于提高患者舒适度及减少麻醉诱导和维持期间的药物不良反应具有重要意义。
