Résumé
Objective To investigate the intravenous lipid emulsion of vinorelbine, stability of the emulsion and factors influencing the stability. Methods The vinorelbine intravenous lipid emulsion injection was prepared by the processing process including the colostrum preparation, high pressure homogenization, filling and sealing, and rotary hot pressing sterilization. The effect of different temperatures on the stability of the emulsion was investigated by the orthogonal design using the emulsion particle size, pH and drug content as indicators. Results The three batches of pilot products were characterized by the emulsion particles with the average particle size ＜300 nm, uniform particle size distribution and no more than 1μm particles, as detected by the dynamic light scattering method. The emulsion showed an excellent stability at 5℃ within 6 months, but a gradual increase of the temperature significantly affected the stability of the emulsion, which caused the increase of particle size and decrease of pH. Conclusion The key parameters, processing conditions and engineering supports from the present study might be helpful for the industrial production of the drug-containing lipid nanoemulsion of vinorelbine for intravenous injection.