泮托拉唑钠肠溶微丸胶囊的处方工艺研究

Study on formulation and preparation of Pantoprazole Enteric-coated Pellet Capsules

目的研制泮托拉唑钠肠溶微丸胶囊。方法采用流化床包衣法制备泮托拉唑钠肠溶微丸,将制备好的微丸装入胶囊即得泮托拉唑钠肠溶微丸胶囊。结果胶囊在人工胃液中耐酸良好,在人工肠液中能够迅速溶出。结论该工艺简单易行、重现性良好、生产周期短、成本低、适合工业化生产。

Objective To develop the prescription processing of Pantoprazole Enteric - coated Pellet Capsules （PECPC）. Methods The pantoprazole enteric - coated pellets were prepared by fluid - bed coating method. Pantoprazole enteric - coated pellets were encapsulated into hard capsules to obtain PECPC. Results The prepared PECPC were well re-sistant to acid in the artificial gastric juice and dissolved quickly and completely in the artificial intestinal liq-uid. Conclusion The prepared Pantoprazole Enteric - coated Pellet Capsules was feasible in technology,reproducible in quality,short cycle and low cost in production. It was worth further development and application in industry.