基于释放曲线及虚拟生物等效模拟评价奥美拉唑肠溶胶囊包材保护性

目的 通过分析加速实验前后奥美拉唑肠溶胶囊释放曲线的变化,以考察药品包装材料的保护性。方法 对市售6家生产企业的奥美拉唑肠溶胶囊进行高温高湿条件下的加速试验,分别通过桨法和流通池法测定其释放曲线并进行相似因子评价和虚拟生物等效模拟分析。结果 加速试验对个别生产企业的奥美拉唑肠溶胶囊的释放存在影响。相比常规桨法溶出方法,流通池溶出方法更具区分力。释放曲线的评价分析结果表明,F企业的奥美拉唑肠溶胶囊试验后存在生物不等效风险。结论 市售奥美拉唑肠溶胶囊的包材保护性总体良好,但应用长时间后存在风险,提示药品包装材料有待改进。

Evaluation of the Protective Function of Packaging Materials for Omeprazole Enteric-coated Capsules Based on Release Profiles and Virtual Bioequivalence Simulations

OBJECTIVE To analyze the changes in the release profiles of omeprazoleenteric coated capsules before and after the ccelerated testing and examine theprotective function of pharmaceutical packaging materials. METHODS Omeprazole enteric-coated capsules of six manufacturers were subjected to accelerated testing at high temperature and humidity. The release profiles were respectively determined by paddle and flow-through cell method, and similarity factor evaluation and virtual bioequivalence simulation were performed. RESULTS The accelerated testing had effects on the release of omeprazole enteric-coated capsules from partial manufacturers. Compared with conventional paddle apparatus, the flow-through cell dissolution method was more discriminating.The evaluation of the release profiles indicated a risk of bioequivalence of omeprazole enteric-coated capsules from manufacturer F after the influencing factor testing. CONCLUSION Although the protective function of pharmaceutical packaging materials are generally well, there were risks in the long-term situation, suggesting that pharmaceutical packaging materials need to be improved.