光纤药物溶出度原位过程监测仪实时测定10厂家苯妥英钠片溶出度

目的:建立以光纤药物溶出度原位过程监测仪考察苯妥英钠片溶出过程的方法,初步评价制剂质量。方法:用光纤药物溶出度原位过程监测仪实时监测10个厂家苯妥英钠片的溶出过程,绘制实时溶出曲线,测定时间为45min,测定波长为258nm,参比波长为550nm,探头为5.0mm,测定光程为1cm,取样间隔为30s;与《中国药典》2005年版方法比较溶出度。结果:各厂家之间样品的溶出曲线差异较大;2种方法溶出度测定结果基本一致,相对平均偏差均小于3%。结论:该监测仪能够有效监测苯妥英钠片的体外溶出过程,可为改进制剂工艺、监控制剂工艺稳定性提供有益的参考。

Process Monitoring of the Dissolution Rate of Phenytoin Sodium Tablets from 10 Manufacturers with Fiber-optic Medicine Dissolution Process Real Time Test System

OBJECTIVE： To establish the method for the dissolution determination of Phenytoin sodium tablets by Fiber-optic medicine dissolution process real time test system. METHODS： The release process of Phenytoin sodium tablets from 10 manufacturers was determined simultaneously with test system. The dissolution curves of Phenytoin sodium tablets were recorded. The determination condition was as follows： determination time of 45 min, determination wavelength of 258 nm, reference wavelength of 550 nm, probe of 5.0 mm, optical distance of 1 cm and sampling interval of 30 s. The results of study were compared with the dissolution rate stated in Chinese Pharmacopeia （2005 edition）. RESULTS： The dissolution curves of Phenytoin sodium tablets were different significantly among the manufacturers. The dissolution rates determined by 2 kinds of methods were in substantial agreement. The RSD were all less than 3%. CONCLUSIONS： This test system can reflect the real dissolution process. It can provide useful information on how to improve the preparation technology and to monitor the stability of the preparation technology.