奥美拉唑肠溶胶囊处方工艺验证及稳定性考察

The study of prescription process certification and stability of Omeprazole Enteric Capsules

目的验证奥美拉唑肠溶胶囊处方及稳定性考察。方法将优选处方工艺制备的奥美拉唑肠溶胶囊按照《中国药典》2015年版方法进行有关物质、含量、耐酸力、溶出度等进行测定,并进行稳定性考察。结果奥美拉唑肠溶胶囊中含量、有关物质、耐酸力、溶出度及稳定性试验均符合《中国药典》2015年版质量标准的要求,所制得的胶囊剂在人工胃液中保持良好的耐酸力,并且在人工肠液中可以迅速完全的溶出。结论此工艺有效地解决了奥美拉唑的稳定性问题,而且制备工艺合理,重现性好,准确度高,适合大规模生产。

Objective To screen the optimal prescription of Omeprazole Enteric Capsules and observe its stability. Methods Omeprazole Enteric Capsules synthesised with optimizing prescription were determined according to methods of China Pharmacopoeia（2015 edition）for related substances,assay,acid - resistance,dissolution and the stability was inves-tigated. Results Assay,related substance,acid - resistance,dissolution and stability test of Omeprazole Enteric Capsules all met with the quality standard in China Pharmacopoeia（2015 edition）. The capsules had good acid - resistance and dis-solved fast and completely in artificial intestinal juice. Conclusion This process had solved the stability of omeprazole ef-fectively. The preparation process with good reproducibility and high accuracy was suitable for mass production.