Washington C, Koosha F, Davis S S
Department of Pharmaceutical Sciences, University of Nottingham, University Park, U.K.
J Clin Pharm Ther. 1993 Apr;18(2):123-31. doi: 10.1111/j.1365-2710.1993.tb00578.x.
The paper describes an in-depth study of the parenteral fat emulsions, Intralipid 20% and Ivelip 20%. A large number of emulsion samples from separate containers and batches was sampled. The parameters measured were droplet size (both by photon correlation and laser diffraction), pH and zeta potential. These parameters were re-measured after the emulsions were subjected to a number of accelerated stability tests (freeze-thaw cycling, autoclaving and shaking). The results demonstrate that although the Intralipid is stable, it can show some variability between separate batches. The stability of Ivelip is high, and the variability between separate batches is extremely low.
该论文描述了对肠外脂肪乳剂英脱利匹特20%和艾伟利普20%的深入研究。从不同容器和批次中抽取了大量乳剂样本。所测量的参数包括液滴大小(通过光子相关法和激光衍射法)、pH值和zeta电位。在对乳剂进行了多项加速稳定性试验(冻融循环、高压灭菌和振荡)后,重新测量了这些参数。结果表明,尽管英脱利匹特是稳定的,但不同批次之间仍可能存在一些差异。艾伟利普的稳定性很高,不同批次之间的差异极低。