目的:建立考察氢氯噻嗪片溶出过程的方法,初步评价制剂质量。方法:用光纤溶出度测定仪实时监测氢氯噻嗪片的溶出过程。考察同一厂家10批产品的溶出曲线。结果:显示样品批间差异和批内差异均很大,说明该厂家生产工艺不稳定。结论:光纤溶出度实时测定仪能够有效监测固体药物的体外溶出过程,为改进制剂工艺、监控制剂工艺稳定性,提高药品分析能力提供有益的参考。 OBJECTIVE: To establish a method to investigate the dissolution process of hydrochlorothiazide tablets and to evaluate the quality of preparation. Methods: The dissolution of hydrochlorothiazide tablets was monitored in real time by using optical fiber dissolution tester. Investigate the same manufacturer 10 batches of product dissolution curve. Results: Differences between samples and between batches showed significant differences, indicating that the manufacturer’s production process is not stable. Conclusion: The real-time optical fiber dissolution tester can effectively monitor the dissolution process of solid drugs in vitro and provide a useful reference for improving the preparation process, monitoring the stability of the preparation process and improving the analysis ability of the drug.