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目的制备雷贝拉唑钠肠溶胶囊并考察其质量。方法以微丸载药量、收率为指标,采用L9(34)正交试验设计优选微丸制备工艺条件;以有关物质为指标,采用单因素试验对隔离液处方进行筛选优化;以累积溶出度为指标,采用单因素试验对肠溶衣液处方进行筛选优化。结果微丸制备工艺条件为蔗糖与主药比例6∶1、包衣造粒机转速100 r·min-1、微晶纤维素与主药比例3∶1;选用12%HPMC作为隔离层成膜材料;15%Eudragit L30D-55作为肠溶层材料;制备的3批雷贝拉唑钠肠溶胶囊稳定性好,耐酸力均在95%以上,30 min溶出度均在98%以上,含量、有关物质均符合规定;进行加速试验,耐酸力、溶出度、含量、有关物质均符合规定。结论经3批中试产品验证,结合加速试验结果,表明优选的工艺条件所得的产品具有较好的肠溶效果和释药性能,并具有较好的稳定性。
Objective To prepare rabeprazole sodium enteric-coated capsules and investigate its quality. Methods The pellets were prepared by orthogonal design of L9 (34) orthogonal design with the drug loading and yield of pellets as the index. The relevant substances were used as indexes to optimize the preparation of the pellet by single factor test. Degree as an indicator, using single factor test for the optimization of the enteric coating solution prescription. Results The preparation conditions of pellets were as follows: the ratio of sucrose to main drug was 6:1, the speed of coating granulator was 100 r · min-1, the ratio of microcrystalline cellulose to main drug was 3:1; 12% HPMC was used as the separator Materials; 15% Eudragit L30D-55 was used as enteric layer material. The three batches of rabeprazole sodium enteric-coated capsules were prepared with good stability and acid resistance of more than 95% Related substances are in line with the provisions; to accelerate the test, acid resistance, dissolution, content, the relevant substances are in line with the provisions. Conclusion The results of three batches of pilot products, combined with accelerated test results, show that the products obtained under the optimized process conditions have good enteric effect and drug release performance, and have good stability.