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目的:制备右旋雷贝拉唑钠肠溶微丸,并考察其体外释放度。方法:采用流化床底喷包衣技术制备右旋雷贝拉唑钠上药微丸,再用HPMC E5包隔离衣,最后使用丙烯酸树脂L30D-55包肠溶衣,制成右旋雷贝拉唑钠肠溶微丸。并比较自研制剂与参比制剂体外释放度的相似性。结果:右旋雷贝拉唑钠肠溶微丸包衣处方为:HPMC E5隔离衣层增重为12.0%,丙烯酸树脂L30D-55肠溶衣层增重为45.0%,增塑剂用量为聚合物重量的8.0%。体外释放度结果显示,自研制剂和参比制剂f_2相似因子大于50,说明两种制剂体外释放行为相似。结论:制备的右旋雷贝拉唑钠肠溶微丸的释药行为较好,有望应用于工业生产。
Objective: To prepare dexrazole sodium enteric-coated pellets and investigate its in vitro release. METHODS: The dexrazole sodium drug-loaded pellets were prepared by fluidized bed bottom spray coating technique, and then separated by HPMC E5 bag. Finally, the L30D-55 enteric coated with acrylic resin was used to make dexrazole Lazachocine enteric-coated pellets. The similarities between in vitro release of self-made and reference preparations were compared. Results: The prescription of dexrazole sodium enteric coated pellets was: the weight gain of HPMC E5 isolation coating was 12.0%, the weight gain of the enteric coating of acrylic resin L30D-55 was 45.0%, the amount of plasticizer was polymerization The weight of the material 8.0%. The results of in vitro release showed that the f_2 similarity factor of self-made and reference preparations was more than 50, indicating that the in vitro release behaviors of the two preparations were similar. Conclusion: The prepared dexrazole sodium enteric-coated pellets have good release behavior and are expected to be used in industrial production.