论文部分内容阅读
目的:以S-SEDDS替代液态自乳化制剂中的表面活性剂制备非诺贝特固体自乳化制剂。方法:比较了固体自乳化制剂与市售产品、液体自乳化制剂的体外溶出情况及体内生物利用度。结果:表明本研究的固体自乳化制剂用水分散后平均粒径为820.2±26.5(nm);溶出度试验结果显示,30min累积溶出度达到80%以上,本研究制备的非诺贝特固体自乳化制剂AUC(0-24)为22.7±8.2 mgoL-1oh与SEDDS的AUC(0-24)(24.9±7.6mgoL-1oh)没有显著性差异(P>0.05),与市售微粉化胶囊(13.8±10.5mgoL-1oh)相比能够显著提高药物的生物利用度(P<0.05)。结论:S-SEDDS有液体自乳化给药系统的效果。
OBJECTIVE: To prepare fenofibrate solid self-emulsifying formulations by using S-SEDDS instead of surfactants in liquid self-emulsifying formulations. Methods: The self-emulsifying formulations of solid and commercial products, liquid self-emulsifying formulations in vitro dissolution and in vivo bioavailability. The results showed that the average particle size of the self-emulsifying solid was 820.2 ± 26.5 (nm) after water dispersion. The dissolution test showed that the cumulative dissolution reached 30% after 30 min. The self-emulsification of fenofibrate solid The formulation AUC (0-24) was 22.7 ± 8.2 mgoL-1 oh did not differ significantly from the AUC (0-24) of SEDDS (24.9 ± 7.6 mgoL-1 oh) (P> 0.05) 10.5mgoL-1oh) significantly improved the bioavailability of the drug (P <0.05). Conclusion: S-SEDDS has the effect of liquid self-emulsifying drug delivery system.