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目的:制备卡托普利蜡质骨架缓释微丸,并考察其体外释放性能。方法:以石蜡为骨架材料,淀粉为填充辅料熔融搅拌制备含药微丸,以释放度为指标,考察处方工艺因素对微丸体外释放度的影响,通过释放度曲线药动学拟合确定骨架微丸缓释机理。结果:微丸体外释药行为符合Higuchi方程Q=5.2861+0.5024t1/2(r=0.9967),在2,6,12h的体外释放度分别为44.94%,75.12%,93.12%。结论:该制备技术操作灵活,成型快,收率高,制得微丸性能较好。
OBJECTIVE: To prepare captopril wax skeleton sustained-release pellets and study its in vitro release performance. Methods: The drug-containing pellets were prepared by melt mixing with paraffin wax and starch as filling materials. The influence of prescription factors on the in vitro release of pellets was investigated by taking the release rate as an index. The skeletal structure Pellets slow release mechanism. RESULTS: The in vitro release behavior of the pellets was in accordance with the Higuchi equation Q = 5.2861 + 0.5024t1 / 2 (r = 0.9967). The release rates in vitro were 44.94%, 75.12% and 93.12% at 2,6,12 h, respectively. Conclusion: The preparation technique has the advantages of flexible operation, rapid prototyping, high yield and good pellet preparation performance.