Preparation and evaluation of pirfenidone submicroemulsion
Objective To prepare pirfenidone submicroemulsion(PFD-SE),optimize the prescription of PFD-SE,and determine the mechanism of drug release in vitro.Methods PFD-SE was prepared by high pressure homogenization method,and the centrifugal stability constant Ke was used as the evaluation index.The formulation of PFD-SE was optimized by Box-Behnken effect surface method,and the in vitro drug release behavior of PFD-SE was determined by dialysis.Results The optimal prescription of PFD-SE was as follows:PFD 0.250%,medium chain triglyceride 2.500%,soybean lecithin S100 0.237%,polyoxyethylene 40 hydrogenated castor oil 0.311%,and ultrasound for 8.9 min.In vitro release of PFD-SE followed the First order kinetic equation,and PFD-SE prolonged the retention time of the drug in vivo compared with pirfenidone solution.The stability test showed that PFD-SE had good stability at room temperature and 4℃.Conclusion PFD-SE prepared in this study has good stability and sustained release,which provides a new idea for the development of new dosage forms of PFD.
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