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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。
Objective To study the coating process of pantoprazole sodium enteric-coated tablets. Methods Enteric-coated enteric coating composition and coating process parameters were screened and screened. Results Polymer 6.5%, triacetin 1.6%, talc 8.0%, titanium dioxide 2.0%, red iron oxide 5.0%, with 80% ethanol solution dubbed the solid content of 7% of the coating solution, air temperature 70 ~ 80 ℃, the bed temperature 35 ~ 45 ℃, coating weight gain of 10%, can produce stable quality qualified enteric-coated tablets. Conclusion According to the quality standards, the pantoprazole sodium enteric-coated tablets produced by the process are stable and reliable and can be used for large-scale production.