吲哚布芬缓释微丸的制备及其体外释放

发布时间：2018-07-25 07:00

【摘要】：目的制备一种工艺简便、易于放大生产的吲哚布芬缓释微丸。方法结合流化床的底喷技术与液相层积法进行空白丸芯上药制备载药微丸,以新型水分散体Kollicoat~汶SR30D为包衣材料制备缓释微丸,考察包衣处方因素、热处理条件和释放介质等因素对释放度的影响。采用BET比表面积分析仪测定衣膜孔隙度和比表面积,探讨致孔剂对衣膜孔隙度的影响机制。初步考察微丸在不同条件下的稳定性并推测其体外的释放机制。结果吲哚布芬缓释微丸圆整度良好,包衣膜光滑完整,载药质量分数约为50%,在加速试验和长期试验中均能保持稳定的释药特性。致孔剂的添加能够增加衣膜内部的孔容及孔隙数量,从而显著增加膜层的比表面积。微丸体外释药机制符合一级动力学。结论所制得的吲哚布芬缓释微丸释药平稳、性质稳定、制备工艺简便、易于操作。
[Abstract]:Objective to prepare an indole-ibufen sustained-release pellet which is simple and easy to be amplified. Methods combined with the bottom spray technique of fluidized bed and the liquid phase stratification method, the drug loaded pellets were prepared by using the blank pellet core and the new water dispersion Kollicoatine SR30D as the coating material. The factors of coating prescription were investigated. The effect of heat treatment conditions and release medium on the release degree. The porosity and specific surface area of the coating film were measured by BET surface area analyzer, and the mechanism of the effect of pore-forming agent on the porosity of the coating film was discussed. The stability of pellets under different conditions was investigated and the release mechanism of pellets in vitro was inferred. Results the indole ibufen sustained release pellets had a good roundness, a smooth coating film, a drug loading mass fraction of about 50%, and stable release characteristics in both accelerated and long-term tests. The addition of pore-forming agent can increase the pore volume and the number of pores in the film, thus increasing the specific surface area of the film. The drug release mechanism of pellets in vitro accords with the first order kinetics. Conclusion the indole ibufen sustained-release pellets are stable, simple and easy to operate.
【作者单位】：沈阳药科大学药学院;
【分类号】：R943

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