泮托拉唑钠肠溶微丸型片剂的制备

Preparation of pantoprazole sodium enteric-coated pellets-type tablets

研究泮托拉唑钠肠溶微丸型片剂制备方法。采用流化床包衣法制备泮托拉唑钠肠溶微丸,将肠溶微丸与适合的辅料混合采用直接压片法制备泮托拉唑钠微丸型片剂。用体外释放度法及扫描电镜法观察压片前后药物的体外累计释放量及微丸形态。结果表明,优化处方:衣膜增重55%,增塑剂含量20%,Eudragit L30D-55/NE30D为8∶2,肠溶微丸/辅料(MCC/PPVP/PEG 6000,2∶1∶1)为5∶5时,肠溶片在0.1 mol.L-1盐酸中2 h累积释放百分数<10%,pH 6.8磷酸盐缓冲液中1 h累积释放百分数>85%。制备的泮托拉唑钠肠溶微丸片的释药行为较好,有望应用于工业生产。

This study is to prepare the pantoprazole sodium enteric-coated tablet which is compacted by pellets.The enteric-coated pantoprazole sodium pellets were prepared by fluid bed coating technology.The pantoprazole sodium enteric-coated tablets were prepared by direct compression of the enteric-coated pellets and suitable excipients.In vitro dissolution method and scanning electron microscope method were used for the observation of the drug release behavior before and after compression of the pellets.The optimized formulation is： the coating level is 55%,the plasticizer content is 20%,the ratio of Eudragit L30D-55/NE30D is 8∶2,enteric-coated pellets / excipients（MCC/PPVP/PEG 6000 = 2∶1∶1） is 5∶5,the enteric-coated tablets release in artificial gastric fluid in 2 h is less than 10%,while in artificial intestinal fluid in 1 h is more than 85%.The release behavior of pantoprazole sodium enteric-coated pellets-type tablet is quite well.And it may be used in industrial production.