光纤药物溶出度实时测定仪监测氢氯噻嗪片的溶出度

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 an analytical method for the whole process of dissolution of hydrochlorothiazide tablets. Methods: The release process of Hydrochlorothiazide tablets was determined simultaneously with FODT-601 Fiber.Optic Medicine Dissolution Process Real Time Test System. Results: A comparision of the dissolution curve of hydrochlorothiazide tablets of different batches from the same manufacturer indicates that the variance inter.batch and the variance in-tra-batch was comparatively large,it suggesting instable techrological processes. Conclusions: The process analysis can reflect the real disslution and obtain total information.It can provide useful information on how to improve the preparation technology and to monitor the stability of the preparation technology.