摘要
目的研究TRH-03肠溶微丸的处方优化及制备工艺。方法采用流化床包衣法,以载药量及释放量为考察指标,对TRH-03肠溶微丸的处方、上药和包衣工艺进行了优化。结果制得的3批肠溶微丸圆整度好,其载药率分别为35.63%、35.04%、35.64%;在人工胃液中保持不释药,人工肠液中45min内释放率分别为89.58%、88.96%、88.36%,载药量稳定且重现性好,体外释放度符合中国药典2010年版二部的要求。结论本方法制备工艺简单易行,重复性好,适合进一步的工业化生产。
Objective To study the preparation and formulation optimization of the enteric coated TRH-03 pellets.Methods The enteric-coated TRH-03 pellets were prepared with fluid bed coating technology.The drug loading rate and dissolution of the pellets were used as indexes to optimize the coating formulation.Results The prepared TRH-03 pellets had excellent geometric roundness and a drug loading rate of 35.63%,35.04%,and 35.64%.The TRH-03 pellets were stable in artificial gastric juice while in artificial intestinal juice the dissolution rate at 45 min was 89.58%,88.96%,and 88.36%.The drug-loading was reproducible and the TRH-03 release from the coated pellets conformed to relevant pharmacopoeia requirements.Conclusion The method is simple,feasible and repeatable.It is worth further application in mass production.
出处
《中南药学》
CAS
2011年第10期736-739,共4页
Central South Pharmacy
关键词
TRH-03
肠溶微丸
流化包衣
TRH-03
enteric coated pellet
airflow coating method
