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采用乳化溶剂挥发法制备W/O/W型5-FU-PLGA复乳微球,采用单因素设计考察了第一相体积比(内水相与油相)、第二相体积比(初乳与外水相)对复乳稳定性的影响,采用正交设计考察了搅拌温度、搅拌时间、辅料浓度和有机相中载体材料浓度对微球质量的影响,并对制备条件进行优化。最适宜制备条件为:第一相体积比为1∶2,第二相体积比为1∶1,搅拌温度为10℃、搅拌时间为6 h、辅料浓度为0.5%、有机相中载体材料浓度为15%。依据最适宜条件制备的微球圆整度良好、粒径范围窄,平均粒径5.20μm,载药量为5.34%,包封率为77.22%。体外释放试验表明微球具有明显的缓释效果,释放行为符合Higuchi模型。
The W / O / W 5-FU-PLGA multi-emulsion microspheres were prepared by emulsion solvent evaporation method. The volume ratio of the first phase (internal water phase and oil phase), the volume fraction of the second phase And external water) on the stability of the multiple emulsion. The effects of stirring temperature, stirring time, concentration of auxiliary materials and carrier material concentration in the organic phase on the microsphere quality were investigated by orthogonal design. The preparation conditions were optimized. The optimum preparation conditions are as follows: the volume ratio of the first phase is 1: 2, the volume ratio of the second phase is 1: 1, the stirring temperature is 10 ℃, the stirring time is 6 h, the concentration of the auxiliary material is 0.5% 15%. The microspheres prepared according to the most suitable conditions have a good roundness, a narrow particle size range, an average particle size of 5.20 μm, a drug loading of 5.34% and an encapsulation efficiency of 77.22%. In vitro release test showed that the microspheres have a sustained release effect, release behavior in line with Higuchi model.