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目的制备以氧氟沙星为主药的胃漂浮缓释微丸。方法以微晶纤维素为骨架材料,采用挤出滚圆法制备氧氟沙星微丸。以Kollicoat SR30D为内层包衣材料(缓释层),碳酸氢钠为中间层(产气层),Eudragit RL30D为外层包衣材料(阻滞层)进行包衣,制成氧氟沙星胃漂浮微丸。通过星点设计-效应面优化法考察了胃漂浮微丸的处方,分别考察各处方微丸的漂浮性和体外释放性质。结果试验制得的胃漂浮微丸既能快速起漂、持续漂浮达8 h以上,又能达到2、4、8和24 h累计释放率分别为(32.37±0.88)%、(50.18±0.37)%、(69.36±0.89)%和(97.64±0.87)%的缓释效果。结论所制得的包衣微丸在人工胃液(p H=1.2)中具有良好的漂浮性能和缓释性能。
Objective To prepare sustained-release gastric-release pellets with ofloxacin as main drug. Methods of microcrystalline cellulose as the skeleton material, the preparation of ofloxacin pellets by extrusion spheronization. Kollicoat SR30D as the inner coating material (sustained release layer), sodium bicarbonate as the middle layer (gas generation layer), Eudragit RL30D as the outer coating material (retardation layer) were coated to form ofloxacin Stomach floating pellets. The prescription of gastric floating pellets was investigated by the method of star spot design-response surface optimization and the floating and the release properties of each pellet were investigated. Results The gastric floating pellets prepared in this study could both quickly float and persist for more than 8 h, and reached the cumulative release rates of (32.37 ± 0.88)% and (50.18 ± 0.37) at 2,4,8 and 24 h, respectively %, (69.36 ± 0.89)% and (97.64 ± 0.87)%, respectively. Conclusion The prepared coated pellets have good floating performance and sustained release performance in artificial gastric juice (p H = 1.2).