目的：分析与评价不同厂家奥美拉唑肠溶胶囊（omeprazole enteric-coated capsules,OEC）的药品质量,为药品的质量管控提供参考。方法：抽取 13 批次不同厂家的 OEC 作为研究对象,采用《中国药典（2020 年版）》中所载的对 OEC 的检查方法,检查和分析 OEC 的溶出度、杂质含量、药物含量等质量指标。结果：13 批次 OEC 的溶出量均高于 90.00%,均符合《中国药典》的相关要求,且达到无需检测耐酸力的标准;13 批次 OEC 的最大单个杂质和总杂质的含量均远小于规定的限度,其中通过一致性评价的 4 批次 OEC 的结果好于其他批次的 OEC;13 批次 OEC 的含量均匀度均符合要求,但有 1 批次的 OEC 的结果为 14.24%,接近 15.00% 的规定限度,存在较大的风险;13 批次 OEC 的含量均符合标准要求,但有 3 批次的 OEC 的结果分别为 91.14%、92.70% 和 93.30%,接近 90.00%的下限要求,存在较大的风险。结论：所有不同厂家和批次的 OEC 均符合标准要求,但个别批次 OEC 的结果仅稍好于标准限度,存在一定的产品质量风险,故部分厂家仍应继续完善药品生产质量保障体系,确保用药的安全性。

Objective: To analyze and evaluate the drug quality of omeprazole enteric-coated capsules (OEC) from different manufacturers, so as to provide reference for the quality control of drugs. Methods: 13 batches of OECs from different manufacturers were selected as the research objects, and the quality indexes of OECs such as dissolution, impurity content and drug content were inspected and analyzed with the methods contained in Chinese Pharmacopoeia (2020). Results: The dissolution quantity of 13 batches of OECs was higher than 90.00%, which met the relevant requirements of Chinese Pharmacopoeia and reached the standard without testing acid resistance; the content of the largest single impurity and total impurities of 13 batches of OECs was far less than the specified limit. The results of 4 batches of OECs that passed the consistency evaluation were better than those of other batches; the content uniformity of 13 batches of OECs met the requirements, but the results of 1 batch of OECs was 14.24%, which was close to the specified limit of 15.00%, with a great risk; the content of 13 batches of OECs met the standards, but the results of 3 batches of OECs were 91.14%, 92.70% and 93.30%, respectively, which were close to the lower limit of 90.00%, with a great risk. Conclusion: All OECs in different batches from different manufacturers meet the standards, but the results of few batches of OECs are slightly better than the standard limit with a certain product quality risk. Therefore, some manufacturers should continue to improve the drug production quality assurance system to ensure the medication safety.