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目的考察硫酸特布他林脉冲控释微丸释放度的影响因素。方法采用滚制法制备载药丸芯,使用水溶胀性材料为内包衣溶胀层,乙基纤维素水分散体为外包衣控释层制备脉冲控释微丸,并考察十二烷基硫酸钠(SDS)含量、溶胀层和控释层包衣增重量对药物释放的影响。结果药物通过控释层衣膜破裂而释放,内包衣层中SDS的加入与否、溶胀层和控释层厚度对脉冲控释微丸的释药时滞和释药速率均具有显著性影响。结论制备的脉冲控释微丸,在模拟人体内胃肠道pH值变化条件下达到了时滞为4.5h,时滞后1.5h累积释药80%以上的脉冲释药效果。
Objective To investigate the influencing factors of the release of terbutaline sulfate controlled release pellets. Methods The drug-loaded pellets were prepared by the rolling method. The water-swellable material was used as the inner coating swelling layer and the ethyl cellulose aqueous dispersion as the outer coating controlled-release layer to prepare the pulse controlled release pellets. The effects of sodium dodecyl sulfate SDS) content, swelling layer and controlled release coating weight gain on drug release. Results The release of the drug through the release of the film of the controlled release coating and the addition of SDS in the inner coating, the swelling layer and the controlled release layer thickness had a significant effect on the release delay and drug release rate of the controlled release pellets. Conclusion The controlled release pellets prepared in this study achieved a pulse release of more than 80% with a cumulative time of 4.5 h and 1.5 h after lag time in the simulated human gastrointestinal pH.