光纤药物溶出仪实时监测苯妥英钠片的溶出度

目的对某厂家9个批次的苯妥英钠片溶出度进行测定,评价其制剂质量。方法运用FODT-601光纤药物溶出仪,选择258nm/550nm双波长法,消除赋形剂干扰,测定溶出曲线,实时监测苯妥英钠片的溶出过程,并与药典方法测定结果进行比较。结果该厂家每个批次间样品的溶出曲线差异较大,说明该厂生产工艺不稳定。结论本法测定结果与药典方法基本一致,能够有效测定苯妥英钠片的体外溶出过程,为厂家改进制剂工艺、监控制剂工艺稳定性提供有益的参考。

The Process Monitoring of the Dissolution of Phenytoin Sodium Tablets from the Same Manufacturer with Fiber-optic Medicine Dissolution/Release Rate Process Test System

Objective To exmine the feasibility of a real-time and process monitoring of the dissolution of phenytoin sodium tablets of different batches from the same manufacturer,and compare with standard test methods.Methods The release process of phenytoin sodium tablets was determined simultaneously with FODT-601 Fiber-optic medicine dissolution process real time test system.The interference of adjutants was cancelled by two wavelengths（258 nm/550 nm）.Results A comparison of the dissolution curve of phenytoin sodium tablets of different batches from the same manufacturer indicates that the stripping curves were comparatively large,suggesting instable technological processes.Conclusion This process analysis can reflect the real disslution and obtain reliable information.It can provide useful information on how to improve the preparation technology and monitor its stability.