雷贝拉唑钠肠溶片的工艺优化及体外评估  

Process Optimization and in vitro Evaluation of Rabeprazole Sodium Enteric-Coated Tablets

作　　者：张帅 柏翔 范哲 周耀 刘青锋 贺敦伟 施斌 ZHANG Shuai;BAI Xiang;FAN Zhe;ZHOU Yao;LIU Qingfeng;HE Dunwei;SHI Bin(School of Medicine and Pharmacy,Ocean University of China,Qingdao 266003,China;HQ Pharma(Shanghai)Co.,Ltd.,Shanghai 201807,China)

机构地区：[1]中国海洋大学医药学院,山东青岛266003 [2]上海则正医药科技股份有限公司,上海201807

出　　处：《生物化工》2025年第1期80-84,共5页Biological Chemical Engineering

摘　　要：目的:以溶出度和溶出曲线相似因子(f_(2))为评价指标,对雷贝拉唑钠肠溶片的制剂处方和工艺进行优化。方法:采用单因素控制变量法对崩解剂用量及肠溶层包衣增重进行考察,并采用Box-Behnken响应面法优化包衣工艺,从而确定自研产品的最优处方工艺。对优化的处方工艺进行初步放大,考察其体外溶出曲线。结果:经过处方工艺优化,明确了雷贝拉唑钠肠溶片处方的最佳工艺为崩解剂用量17.0%,肠溶层包衣增重13.0%,包衣工艺过程中喷液量4 g/min、进风量80 m^(3)/h、片床温度45℃。结论:本研究确定的雷贝拉唑钠肠溶片处方工艺在中试生产可行,可以为后续工业化生产提供参考。Objective:The formulation and process of rabeprazole sodium enteric-coated tablets are optimized with dissolution and dissolution curve similarity factor(f_(2))as evaluation indexes.Methods:The amount of disintegrant and weight gain of enteric-coated layer coating are investigated by single factor optimization,and the coating process is optimized by Box-Behnken response surface design to determine the optimal formulation process of rabeprazole sodium enteric-coated tablets.The optimized formulation are preliminarily scaled up to confirm its in vitro dissolution curves.Results:After optimization of the formulation process,the optimum formulation process of rabeprazole sodium entericcoated tablets is determined as follows:disintegrant dosage 17.0%,enteric coating coating weight gain 13.0%,spray volume 4 g/min,air inlet volume 80 m^(3)/h,bed temperature 45℃.Conclusion:The formulation process of rabeprazole sodium enteric-coated tablets obtained in this study is feasible in pilot production,which could lay a foundation for subsequent industrial production.

关 键 词：雷贝拉唑钠肠溶片 处方开发 Box-Behnken响应面法 

分 类 号：R943[医药卫生—药剂学]