泮托拉唑钠肠溶片薄膜包衣工艺研究

Pantoprazole sodium enteric-coated tablets film coating technology research

目的研究泮托拉唑钠肠溶片的包衣工艺。方法对该肠溶片的肠溶衣组成和包衣工艺参数进行摸索筛选。结果聚合物6.5%、三醋酸甘油酯1.6%、滑石粉8.0%、二氧化钛2.0%、红氧化铁5.0%，用80%乙醇溶液配成固含量为7%的包衣液，进风温度70～80℃，片床温度35～45℃，包衣增重10%时，可生产出质量合格稳定的肠溶片。结论按该工艺生产的泮托拉唑钠肠溶片符合质量标准要求，工艺稳定可靠，可用于大生产。

dioxide, iron oxide red 8%2%5%, with 80%ethanol solution with a solid content of coating liquid 7%, air inlet temperature 70~80 ℃, piece of bed temperature 35~45 ℃, coating weight of 10%, can produce quality stable intestinal dissolving tablets. Conclusions By pantoprazole sodium enteric-coated tablets produced by this technology to meet the quality requirements, the technology is stable and reliable, and can be used for mass production.