摘要
目的制备稳定的氟比洛芬酯脂微球注射液。方法通过单因素考察及正交实验优化筛选得到氟比洛芬酯脂微球的最佳处方和工艺,并研究所得制剂的离心稳定常数K e、粒径、ζ电位、pH值等性质。结果确定氟比洛芬酯脂微球注射液的处方组成及工艺为:10%的注射用大豆油、1.2%的蛋黄卵磷脂、0.6%的F68、0.4%的油酸、2.0%的甘油和90%的注射用水。均质前调节pH为8.0,80 MPa均质6次,于121℃灭菌15 min,灭菌后仍能保持良好的稳定性,制得脂微球注射液氟比洛芬酯的含量为95.59%。结论该处方工艺可行,制得的脂微球稳定性良好。
OBJECTIVE To prepare stable flurbiprofen axetil lipid microsphere for intravenous injection. METHODS The optional formulation and prepared procedure were obtained through the single factor and crosscut design of experiment, and the stability constant of centrifugation Ke, particle size, Zeta potential, the pH of the product were studied. RESULTS The optional formulation and procedure were 10% soybean oil for intravenous injection, 1.2% soybean lecithin, 0. 6% F68,0. 4% oleic acid,2.0% glycerol and 90% water for injection, pH was adjusted to 8.0 before homogenization and the sample was homogenized at a pressure of 80 MPa for 6 times. Finally, the lipid microspheres were sterilized for 15 rain by sterilizing at 121℃ and exhibited good stability after steriliza- tion. The content of Flurbiprofen Axetil lipid microspheres was 95.59%. CONCLUSION The preparation process is feasible to pre- pare lipid microsphere with good physical stability.
出处
《中国药学杂志》
CAS
CSCD
北大核心
2013年第21期1847-1851,共5页
Chinese Pharmaceutical Journal
关键词
氟比洛芬酯
脂微球
处方筛选
工艺优化
稳定性
flurbiprofen axetil
lipid microsphere
formulation optimization
process optimization
stability
