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目的研究制备盐酸拉贝洛尔时控缓释微丸。方法采用挤出滚圆法制备载药丸芯,通过流化床包衣法分别覆上交联羧甲基纤维素钠作为溶胀层、乙基纤维素和羟丙甲纤维素作为控释层制备时控缓释微丸,通过单因素考察筛选溶胀层、控释层的处方组成对体外释药性能的影响。结果以微晶纤维素、羧甲基淀粉钠和乳糖为添加剂可制得性能良好的高载药微丸。随着溶胀层厚度的增加,药物释放时滞变短,速率显著增加;随着控释层包衣厚度的增加,时滞延长,释药减慢;控释层中羟丙甲纤维素用量增加,时滞缩短;控释层中增塑剂用量增加,时滞延长。结论所得包衣微丸具有良好的释药性能,有广阔的应用前景。
Objective To study the preparation of labetalol hydrochloride controlled release sustained-release pellets. Methods The pellets were prepared by extrusion-spheronization method. The fluidized bed coating method was coated with sodium croscarmellose as swelling layer and ethylcellulose and hypromellose as controlled release layer to prepare time-controlled The sustained-release pellets were selected to investigate the influence of the formulation composition of the controlled-release layer on the release properties in vitro by single-factor investigation. Results Microcapsules, sodium carboxymethyl starch and lactose were used as additives to prepare highly loaded drug-loaded pellets. With the increase of the thickness of the swelling layer, the drug release delay became shorter and the rate increased significantly. With the increase of the thickness of the controlled release coating, the time delay extended and the drug release slowed down. The dosage of hypromellose in the controlled release layer increased , The time lag shortened; controlled release layer plasticizer dosage increased delay prolongation. Conclusion The obtained coated pellets have good release properties and broad application prospects.