ABSTRACT
Objective:To study the formula of triptolide (TRI) self-microemulsifying drug delivery system (SMEDDS) and evaluate the pharmaceutical properties.Methods:The formula and preparation process of triptolide self-microemulsion were screened by the solubility test and pseudo-ternary phase diagram.With the average particle size and self-microemulsifying time as the indices,the further formula optimization of triptolide self-microemulsion was carried out.The pharmaceutical properties of triptolide self-microemulsion were evaluated.Results:The optimal formula of TRI SMEDDS was as follows:the amount of medium chain triglycerides (MCT) was 20%,that of polyoxyethylene castor oil (EL-35) was 40%,and that of polyethylene glycol 400 (PEG-400) was 40% in the oil phase.The average particle size was 43.48 nm,and the time of self-microemulsification was less than 30 s.Conclusion:The average particle size and the appearance of triptolide self-microemulsion are accordance with the requirements of pharmaceutics.Triptolide self-microemulsion has good sustained-release effect,which lays foundation for the further study on pharmacodynamics.
ABSTRACT
Objective:To investigate the stability of flurbiprofen axetil lipid microspheres injection combined with 0. 9% sodium chloride injection or 5% dextrose injection, and provide theoretical basis for the clinical application. Methods:The content changes of flurbiprofen axetil in the mixture of flurbiprofen axetil lipid microspheres injection and 0. 9% sodium chloride injection or 5% dextrose injection were determined in 5 h at 25℃ away from light, and the changes in the appearance and particle size of flurbiprofen axetil lip-id microspheres were investigated. The changes in the appearance and particle size of flurbiprofen axetil lipid microspheres in the mix-ture of flurbiprofen axetil lipid microspheres injection and 0. 9% sodium chloride injection before and after freezing and thawing were also investigated. Results:The appearance, particle size and content had no significant changes in all mixtures in 5 h at 25 ℃ away from light. The appearance and particle size of flurbiprofen axetil lipid microspheres in the mixture before and after freezing and thawing had no significant changes as well. Conclusion:The mixture of flurbiprofen axetil lipid microspheres injection and 0. 9% sodium chlo-ride injection or 5% dextrose injection is stable in 5 h away from light.