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目的 :探讨以聚乳酸为载体材料的氟尿嘧啶微球体外释药的规律与机理。方法 :考察了 6种因素对氟尿嘧啶微球体外释药的影响及微球释药前后的形态变化 ;以P <0 .0 5、相关系数R愈大愈好、残差平方和 (SUM )愈小愈好为判断标准 ,对累积释药曲线进行零级、一级、Higuchi、Ritger Peppas、扩散 松弛、Hixson Crowell和扩散 溶蚀 7种释药模型的拟合。 结果 :投药量、PVA浓度、相体积比及粒径对氟尿嘧啶微球体外释药影响显著 ,而振荡速率、60 Co灭菌及 4℃ ,2 5℃放置 3个月均对体外释药几乎无影响。释药后微球粒径增大 ,大多呈网状结构 ,并有少量聚乳酸碎片。经处方优化的微球 ,扩散 溶蚀模型拟合效果最好。结论 :氟尿嘧啶微球体外释药以药物扩散和材料降解为主。
Objective: To investigate the rules and mechanism of in vitro drug release of fluorouracil microspheres with polylactic acid as carrier. Methods: The effects of six factors on the in vitro release of fluorouracil microspheres and morphological changes of microspheres before and after drug release were investigated. With P <0.05, the greater the correlation coefficient R, the better the residual sum of squares (SUM) The results showed that the smaller the better the better, the cumulative release curve for zero-order, a, Higuchi, Ritger Peppas, diffusion relaxation, Hixson Crowell and diffusion dissolution of seven kinds of release model fitting. RESULTS: The drug release rate, PVA concentration, phase volume ratio and particle size had a significant effect on the in vitro drug release of fluorouracil microspheres. However, the osmotic rate, 60Co sterilization and 3 months at 4 ℃ and 25 ℃ influences. After release of drug-loaded microspheres increased in size, mostly mesh structure, and a small amount of polylactic acid fragments. The microspheres optimized by diffusion have the best fitting effect. Conclusion: In vitro drug release of fluorouracil microspheres is mainly based on drug diffusion and material degradation.