光纤药物溶出度实时测定仪监测甲氨蝶呤片的溶出度

The Process Monitoring of the Dissolution of Methopterin Tablets with Fiber-optic Medicine Dissolution Process Real Time Test System

目的建立考察甲氨蝶呤片溶出过程的方法,初步评价制剂质量。方法用光纤溶出度实时测定仪实时监测甲氨蝶呤片的溶出过程。结果考察1个厂家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测定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供有益的参考。

Aim To establish an analytical method for the whole process of dissolution of Methopterin Tablets.Methods The release process of Methopterin Tablets was determined simultaneously with FODT-601 Fiber-optic Medicine Dissolution Process Real Time Test System.Results A comparision of the dissolution curve of Methopterin Tablets of different batches from the same manufacturer indicates that the variance inter-batch and the variance intra-batch was comparatively large,It suggesting instable techrological processes.Conclusions This 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.