Compatibility and Stability of Cipepofol (Ciprofol) and Etomidate Mixture for Intravenous Anesthesia

IF 1.5 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Current Therapeutic Research-clinical and Experimental Pub Date : 2025-01-01 DOI:10.1016/j.curtheres.2025.100810

Linzhong Zhang MD , Lingchun Kong MA , Qi Deng MS , Yukai Chao MA , Chibing Fu MA , Yutong Meng MA

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引用次数: 0

Abstract

Objective

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.

Methods

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.

Results

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%).

Conclusions

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.

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西泊酚（环丙酚）与依托咪酯复合静脉麻醉的相容性及稳定性

目的评价西泊酚（环丙酚）与依托咪酯（EC）复合静脉麻醉的理化相容性和稳定性，评价两种药物在同一静脉给药过程中的理化稳定性。方法采用高效液相色谱法等分析技术对复方乙醛的稳定性进行考察。分别于4°C、25°C、37°C条件下保存24 h，分别于0、1、3、6、12、24 h评价其外观、pH、渗透压、粒径、zeta电位、药物含量及相关物质。结果EC混合物保持物理稳定性，外观、pH（波动≤0.07单位）、渗透压（相对标准偏差[RSD] = 2.0%）、pH值（波动≤0.07单位）、渗透压（相对标准偏差[RSD] = 2.0%）、Zeta电位保持在可接受的范围内（范围从- 40到- 30 mV），表明良好的胶体稳定性。化学上，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的限度内（最大单一杂质≤0.13%，总杂质≤0.37%）。研究结果表明，EC混合物在不同温度下具有物理和化学相容性和长达24小时的稳定性，使该方案成为静脉麻醉的潜在安全有效的选择。这一发现对于改善麻醉诱导和维持过程中患者的舒适度和减少药物不良反应具有重要意义。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Current Therapeutic Research-clinical and Experimental 医学-药学

CiteScore

3.50

自引率

0.00%

发文量

审稿时长

3 months

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