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采用流化床包衣技术对微晶纤维素丸芯分别进行上药层、隔离层和肠溶层包衣,制备了两种在肠内释放速率不同的微丸(微丸A和微丸B),再按照一定比例装入胶囊,制成右旋兰索拉唑脉冲肠溶胶囊。以主药释放度为考察指标,采用单因素法优化隔离层增重,微丸A的肠溶层增重以及微丸B的肠溶层包衣液组成、增塑剂种类和包衣增重。结果表明,在隔离层增重15%,微丸A的肠溶材料采用Eudragit L30D-55、增重为40%,微丸B的肠溶材料采用Eudragit S100、加入10%枸橼酸三乙酯做增塑剂、增重为50%的条件下,能制得在酸中2 h基本不释药、在p H 7.0磷酸盐缓冲液中1 h和4 h分别基本释放完全的微丸A和微丸B。将微丸A和微丸B按照主药含量25%∶75%的比例混合,装入2号胶囊壳,所得胶囊与市售胶囊体外释药行为基本一致。
The microcrystalline cellulose cores were respectively coated with drug layer, isolation layer and enteric layer by using fluidized bed coating technology. Two kinds of pellets with different release rates in the intestine (pellets A and pellets B ), Then according to a certain percentage of loaded capsules, made of dexlansoprazole pulse enteric-coated capsules. Taking the release rate of the main drug as index, the single factor method was used to optimize the weight gain of the isolation layer, the enteric layer weight gain of pellet A, the enteric coating liquid composition of pellet B, the type of plasticizer and the weight gain of coating . The results showed that the weight gain of the pellet A was 15%, the enteric material of pellet A was Eudragit L30D-55, the weight gain was 40%, the enteric material of pellet B was Eudragit S100, 10% triethyl citrate A plasticizer was added at a weight gain of 50% to produce substantially no release for 2 h in acid and complete release of complete pellets A and B respectively in pH 7.0 phosphate buffer for 1 h and 4 h, respectively Pellets B. The pellets A and pellets B were mixed according to the ratio of 25%: 75% of the main drug content, and filled into the No. 2 capsule shell. The obtained capsules and the commercially available capsules showed the same release behavior in vitro.