复方萘普生钠肠溶-埃索美拉唑镁速释微丸型胶囊剂的研制

Study on the compound capsule of enteric-coated naproxen sodium and immediate-release esomeprazole magnesium pellets

目的制备复方萘普生钠肠溶-埃索美拉唑镁速释微丸。方法通过粉末层积法制备萘普生钠载药微丸,依次包肠溶层(ACRYL-EZE 93F)、埃索美拉唑镁层、隔离层(Opadry YS-1-7027),制备多层微丸。考察了萘普生钠载药微丸的制备工艺、肠溶层耐酸力及埃索美拉唑镁的稳定性。结果粉末层积法制备的目标(700~830μm)萘普生钠微丸具有较高载药量,肠溶层的耐酸力符合要求,埃索美拉唑镁的稳定性较好。结论用多层包衣微丸的形式可以实现萘普生钠肠溶-埃索美拉唑镁速释的释药模式,并且制剂的稳定性较好。

Objective To prepare the compound capsule containing enteric-coated naproxen sodium and immediate-release esomeprazole magnesium pellets. Method naproxen sodium pellets were developed in coating pan by powder layering technich which were coated with enteric layer(ACRYL-EZE 93F), esomeprazole magnesium, protection layer(Opadry YS-1-7027), sequentially. The preparation procedure of naproxen sodium pellets, the acid resistance of enteric layer and the stability of esomeprazole magnesium were evaluated. Results Naproxen sodium pellets had a relatively high drug loading. The acid resistance of enteric layer meet the requirement. Esomeprazole magnesium had a good stability. Conclusion Compound preparation of enteric-coated naproxen sodium and immediate-release esomeprazole magnesium can be realized in the dosage form of multiple-layer pellets.