兰索拉唑肠溶微丸片的制备

Preparation of lansoprazole enteric-coated pellets-type tablets

目的研究兰索拉唑肠溶微丸片的制备方法。方法利用流化床底喷包衣的方式制备兰索拉唑肠溶微丸,采用直接压片法,将肠溶微丸与一定的辅料混合后压制成片,并进行体外释放度的评价。结果当Eudragit L30D-55与-Eudragit NE30D的质量比为9:1,衣膜增重的质量分数为60%,增塑剂的用量为聚合物质量的30%,肠溶微丸-混合辅料(MCC-KG802-PVPP-XL-硬质富马酸钠的质量比为190:9:1)的质量比为5:5时,肠溶片在pH1.0的盐酸中1h累积释放度<10%,pH6.8磷酸盐缓冲液中1h累积释放度>80%。结论制备的兰索拉唑肠溶微丸片的体外释放度实验符合要求,该技术有望在将来应用于工业化生产。

Objective To study the preparation of lansoprazole enteric-coated tablet compacted by pellets. Method The enteric-coated lansoprazole pellets were prepared by fluid bed coating technology. The lansoprazole enteric-coated tablets were prepared by direct compression of the enteric-coated pellets and suitable excipients. In vitro drug release behaviors were evaluated before and after compression of the pellets. Result For final formulation, the ratio of Eudragit L30D-55/NE30 D was 9∶1, the coating level was 60%(w), the plasticizer content was 30%, and enteric-coated pellets / excipients( MCC-KG802/PPVP-XL / sodium stearyl fumarate = 190∶9∶1) was 5∶5. The release of enteric-coated tablets in artificial gastric fluid within 1 h was less than 10%, while in artificial intestinal fluid within 1 h was more than 80%. Conclusion Quite well release behavior of lansoprazole enteric-coated pellets tablet was achieved. And this method and formulation may be used in industrial production.