Abstract:
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 mL undiluted injection and 250 mL 0.9% sodium chloride injection in non-PVC infusion bags in a simulated clinical situation. The character, pH, 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 ℃. CONCLUSIONS 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.