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目的优化单凝聚法制备氟苯尼考缓释微球工艺。方法以单凝聚法制备微球,以粒径、包封率的总评“归一值”为评价指标,采用星点设计考察芯材比、成囊pH、搅拌速度3因素对微球制备的影响,对结果进行二项式拟合,效应面法选取最佳工艺条件,优化工艺后制得的微球在人工体液中进行体外释放。结果最佳工艺条件为药/囊材0.375、成囊pH 4.8、搅拌速度615 r·min-1;制得的微球圆整均一,粒径40~50μm,包封率57.45%,载药量17.52%,制得的微球在Hank’s人工模拟体液中有良好的缓释特征。结论优化制备工艺条件下制得的微球外形良好,载药量较大,缓释效果好。
Objective To optimize preparation of florfenicol sustained-release microspheres by single-coacervation. Methods The microspheres were prepared by single-coacervation. The particle size and entrapment efficiency were evaluated by using the “normalized value” as the evaluation index. The star-point design was used to investigate the effect of core-material ratio, The results were binomial fit, effect surface method to select the best processing conditions, microspheres obtained after optimization of the process of artificial body fluids for in vitro release. Results The optimum conditions were as follows: drug / capsule material 0.375, capsule pH 4.8 and stirring speed 615 r · min-1. The prepared microspheres were evenly and uniformly distributed with particle size 40-50 μm and entrapment efficiency 57.45% 17.52%. The prepared microspheres have good sustained release characteristics in Hank’s artificial simulated body fluid. Conclusion The microspheres prepared under optimal preparation conditions have good shape, larger drug loading capacity and good sustained-release effect.