鸦胆子油乳注射液及配置后静脉输液的室温稳定性研究

Stability Studies of Brucea Javanica Oil Emulsion Injection and Diluted Infusion in Non-PVC Infusion Bag at Room Temperature

目的考察说明书中贮存条件要求冷藏,且须临用前即配即用的鸦胆子油乳注射液的原液和稀释后的静脉输液在室温(25℃)下的稳定性,为该药品的临床管理与使用提供依据。方法模拟临床给药剂量和给药时间,考察性状、p H、渗透压、颗粒细度和油酸含量在室温下放置不同时间点的变化。结果在室温下,鸦胆子油乳注射液原液放置72 h质量稳定,配置后静脉输液(30 m L∶250 m L 0.9%生理盐水)在24 h内各项理化指标均无明显变化。结论鸦胆子油乳注射液在医院内部的短时间药物配送无需严格实施冷链管理;配置后静脉输液室温放置24 h稳定,无需"即配即用"。

OBJECTIVE To investigate the stability of Brucea javanica oil emulsion injection and diluted infusion in non-PVC infusion bags at room temperature（25 ℃）, because the package insert of this product notifies that it should be stored at a refrigerator and should be extemporaneously prepared prior to medication administration. METHODS Pharmaceutical analysis was performed on Brucea javanica oil emulsion injection and its diluted infusion prepared with 30 m L undiluted injection and 250 m L 0.9% sodium chloride injection in non-PVC infusion bags in a simulated clinical situation. The character, p H, osmotic pressure, particle fineness and content of oleic acid in the admixture were determined at different time at room temperature. RESULTS Undiluted Brucea javanica oil emulsion injection could keep stable for at least 72 h under 25 ℃, and its diluted infusion remained stable 24 h in non-PVC infusion bag under 25 ℃. CONCLUSION In clinical practice, it is appropriate to escape the strict cold chain requirements on Brucea javanica oil emulsion injection during drug dispensing and logistics distribution. And it is unnecessary to extemporaneously prepare the infusion of Brucea javanica oil emulsion just before intravenous administration.